M N 2 May 2024 CMB International Global Markets | Equity Research | Company Update Henlius Biotech (2696 HK) Strong product sales in 1Q  Strong sales maintained in 1Q24. Henlius Biotech (Henlius) recorded total Target Price HK$20.33 revenue of RMB1.349bn in 1Q24, up 35% YoY. Of this, HANQUYOU’s sales in (Previous TP HK$18.67) China was RMB671mn (+25% YoY, -4% QoQ), which accounted for 23% of our Up/Downside 21.2% previous FY24 estimate. In 1Q24, serplulimab (PD-1) experienced robust Current Price HK$16.78 ...

Financial Performance - Henlius achieved its first full-year profit in 2023, marking a significant milestone in its journey to become a global innovative biopharmaceutical company[7] - Revenue in 2023 reached RMB 5,394.9 million, a 67.8% increase compared to RMB 3,214.7 million in 2022[11] - Net profit for 2023 was RMB 546.0 million, a significant turnaround from a loss of RMB 695.3 million in 2022[12] - R&D expenses in 2023 decreased to RMB 1,118.7 million from RMB 1,394.5 million in 2022, reflecting optimized resource allocation[12] - Total assets increased to RMB 9,903.6 million in 2023, up from RMB 8,924.3 million in 2022[14] - The company achieved operating revenue of approximately RMB 5,394.9 million, a year-on-year increase of 67.8%[55] - The company recorded gross profit of approximately RMB 3,918.8 million, an increase of RMB 1,548.7 million year-on-year, driven by the strong sales growth of Hanquyou® and Hansizhuang®[61] - The company recorded other income and gains of approximately RMB 68.9 million, including government subsidies and bank interest income[62] - Total revenue for the year ended December 31, 2023, was RMB 68,914 thousand, a decrease from RMB 105,552 thousand in 2022[63] - R&D expenses for 2023 were RMB 1,433.6 million, a decrease of RMB 749.6 million compared to RMB 2,183.2 million in 2022, due to project licensing and optimized resource allocation[65] - Administrative expenses increased to RMB 383.8 million in 2023 from RMB 354.0 million in 2022, driven by higher staff costs and operational expenses[66] - Sales and distribution expenses for 2023 were RMB 1,754.2 million, primarily due to increased sales of Han Qu You®, Han Si Zhuang®, and the launch of Han Bei Tai®[67] - The company reported a profit of RMB 546.0 million for 2023, a significant improvement from a loss of RMB 695.3 million in 2022[69] - Cash and bank balances increased to RMB 987.7 million in 2023 from RMB 680.5 million in 2022, reflecting a growth of RMB 307.2 million[70] - Trade receivables increased to RMB 647.8 million in 2023 from RMB 455.5 million in 2022, with no significant changes in accounting estimates or assumptions[72] - Total interest-bearing bank and other borrowings stood at RMB 3,819.6 million as of December 31, 2023, primarily for clinical trials, commercialization, and operational expenses[74] - The current ratio improved to 52.8% in 2023 from 43.8% in 2022, indicating better liquidity management[78] - The capital-to-debt ratio decreased to 59.5% in 2023 from 64.7% in 2022, reflecting a reduction in net debt relative to equity[78] Product Sales and Market Performance - Core product Han Qu You® generated sales of RMB 2,644 million in the Chinese market, benefiting over 180,000 patients[9] - H drug Han Si Zhuang® achieved sales of RMB 1,120 million in its first full year of sales, with 4 approved indications and a 5th under review[9] - The company has 5 products approved in China and 2 internationally, with over 560,000 patients benefiting globally[9] - Han Qu You® received approvals in multiple countries including Cambodia, Singapore, Thailand, Philippines, and Brazil in 2023[15] - Hanquyou® (Trastuzumab for Injection) achieved sales revenue of approximately RMB 2,644.4 million, a year-on-year increase of RMB 950.0 million, representing a growth rate of 56.1%[56] - Hansizhuang® (Serplulimab) achieved sales revenue of approximately RMB 1,119.8 million, a year-on-year increase of RMB 780.7 million, representing a growth rate of 230.2%[56] - Hanbeitai® (Bevacizumab) achieved sales revenue of approximately RMB 119.4 million since its commercialization in January 2023[56] - Hanlikang® (Rituximab) generated sales revenue of approximately RMB 518.6 million and licensing income of RMB 21.9 million under profit-sharing arrangements[56] - Handayuan® (Adalimumab) generated sales revenue of approximately RMB 58.6 million under profit-sharing arrangements[56] - The company recorded licensing income of RMB 6.0 million for Zercepac® in the European market[57] - The company confirmed R&D service income of RMB 311.8 million for HLX11 and HLX14 under the agreement with Organon LLC[57] - The company confirmed licensing income of RMB 111.1 million for Hansizhuang® under the agreement with Intas[58] Global Expansion and Commercialization - The company emphasized the importance of globalization, stating that going global is not an option but a necessity for biopharmaceutical companies[8] - Henlius is focusing on building a "globalizable" product portfolio, organizational capabilities, and localized commercial strategies to expand its global presence[8] - The company is strategically planning its production capacity with a forward-looking approach, incorporating advanced technologies and stringent quality management to support global product distribution[8] - The company has 5 products approved in China and 2 internationally, with over 560,000 patients benefiting globally[9] - Han Qu You® received approvals in multiple countries including Cambodia, Singapore, Thailand, Philippines, and Brazil in 2023[15] - The company signed agreements with Boston Oncology, LLC and PT Kalbe Genexine Biologics for commercialization of Hanlikang® and Hansizhuang® in the Middle East and North Africa regions in 2023[18] - The company signed an agreement with Intas for commercialization of Hansizhuang® in Europe and India in October 2023[18] - Hansizhuang® (PD-1) is approved for MSI-H solid tumors, squamous non-small cell lung cancer, extensive-stage small cell lung cancer, and esophageal squamous cell carcinoma in China[24] - Hanquyou® (trastuzumab) is approved for HER2-positive breast cancer and metastatic gastric cancer in over 40 countries, including China, the UK, Germany, France, and Australia[24] - Hanlikang® (rituximab) is approved for CD20-positive non-Hodgkin's lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis in China[24] - Handayuan® (adalimumab) is approved for TNF-α-related conditions such as rheumatoid arthritis, ankylosing spondylitis, psoriasis, and uveitis in China[24] - HANSIZHUANG® (serplulimab injection) has been approved for four indications in China, covering MSI-H solid tumors, sqNSCLC, ES-SCLC, and ESCC, and has initiated overseas sales[29][31] - HANSIZHUANG® has been approved in Indonesia for the treatment of ES-SCLC under the brand name Zerpidio®, marking its first overseas market approval[32] - HANSIZHUANG®'s production lines have received EU GMP certification, facilitating further expansion in overseas markets[32] - HANSIZHUANG® has been recommended in 9 clinical guidelines in China, including the CSCO guidelines for lung cancer, esophageal cancer, and colorectal cancer[30] - HANSIZHUANG®'s NDA for the treatment of non-squamous NSCLC in China has been accepted by the NMPA, marking its fifth indication in the country[31] - HANQUYOU® (trastuzumab for injection) has been approved in multiple countries, including Cambodia, Singapore, Thailand, the Philippines, and Brazil, with its BLA accepted by the FDA and NDS by Health Canada[28] - HANQUYOU® has been commercialized in China with a professional sales team covering approximately 1,800 hospitals and 36,000 doctors[27] - HANQUYOU® has established partnerships with international pharmaceutical companies, covering approximately 100 countries and regions globally[28] - HANSIZHUANG®'s MAA for ES-SCLC treatment has been accepted by the EMA, and it has received the Innovation Passport designation in the UK[32] - HANSIZHUANG® has submitted MAAs in Thailand, Singapore, and Malaysia, advancing its commercialization in Southeast Asia[32] - The company has signed licensing agreements with Boston Oncology, LLC, FBD Biologics Limited, PT Kalbe Genexine Biologics, and Intas for the commercialization of Hanlikang® and Hansizhuang® in the Middle East, North Africa, Europe, and India[35] R&D and Clinical Trials - The company is committed to innovation, continuously improving its internal R&D capabilities while leveraging partnerships to amplify its innovation value[8] - The company's product pipeline includes 59 molecules, with over 30 clinical trials ongoing globally[9] - HLX14 (denosumab biosimilar) met the primary endpoint in its international multicenter Phase 3 clinical study for postmenopausal osteoporosis in April 2024[19] - Hansizhuang® combined with chemotherapy achieved the primary endpoint in a Phase 3 clinical study for advanced non-squamous non-small cell lung cancer (nsNSCLC) in October 2023, demonstrating good efficacy and safety[20] - HLX15 (recombinant anti-CD38 fully human monoclonal antibody injection) completed the first subject dosing in a Phase 1 clinical study in healthy male subjects in China in February 2023[20] - HLX07 (recombinant anti-EGFR humanized monoclonal antibody injection) combined with chemotherapy completed a Phase 1b/2 clinical study in China, showing good safety and tolerability in advanced solid tumor patients in February 2023[20] - HLX208 (BRAF V600E inhibitor) was included in the Breakthrough Therapy Designation program by the CDE for treating BRAF V600E-mutated adult Langerhans cell histiocytosis (LCH) and Erdheim-Chester disease (ECD) in April 2023[20] - HLX13 (recombinant anti-CTLA-4 fully human monoclonal antibody injection) completed the first subject dosing in a Phase 1 clinical study in healthy male subjects in China in December 2023[20] - HLX04-O (recombinant anti-VEGF humanized monoclonal antibody injection) showed good safety, tolerability, and preliminary efficacy in a Phase 1/2 clinical study for wet age-related macular degeneration (wAMD) in July 2023[20] - HLX42 (targeting EGFR antibody-novel DNA topoisomerase I inhibitor conjugate) received Fast Track Designation from the FDA for treating EGFR-mutated advanced or metastatic NSCLC in December 2023[20] - HLX14 (recombinant anti-RANKL fully human monoclonal antibody injection) completed a Phase 1 clinical study in healthy male subjects in China in January 2024, showing high similarity in pharmacokinetics and pharmacodynamics to marketed denosumab[20] - The company's pipeline includes 59 molecules (48 innovative drugs and 11 biosimilars) and 18 R&D platforms, covering monoclonal antibodies, bispecific antibodies, antibody-drug conjugates, recombinant proteins, and small molecule conjugates[22] - The company is advancing multiple Phase III trials, including HLX10 (PD-1) for ES-SCLC and HLX11 (pertuzumab) for HER2-positive breast cancer[24] - HLX14 (RANKL) achieved the primary endpoint in an international multicenter Phase 3 clinical study for osteoporosis (OP) in April 2024[42] - HLX208 (BRAF V600E) was officially included in the breakthrough therapy drug program by the CDE in April 2023 for the treatment of adult Langerhans cell histiocytosis (LCH) and Erdheim-Chester disease (ECD)[43] - HLX42 (EGFR ADC) completed the first patient dosing in its Phase 1 clinical study for solid tumors in March 2024[43] - The company's pipeline includes 59 molecules (48 innovative drugs and 11 biosimilars) and 18 R&D platforms, covering monoclonal antibodies, bispecific antibodies, ADCs, recombinant proteins, and small molecule conjugates[46] - HLX42 (EGFR ADC) received Fast Track Designation from the FDA for treating advanced or metastatic NSCLC patients with EGFR mutations[44] - HLX43 (PD-L1 ADC) has entered clinical trials in China after receiving approvals from both the NMPA and FDA[45] - HLX13 (CTLA-4) has entered clinical trials for liver cancer treatment after receiving NMPA approvals[44] - The company is advancing its Hanjugator platform for developing high-safety, high-selectivity, and high-efficacy ADC products[46] - The company is focusing on oncology and autoimmune diseases, aiming to deepen product innovation and international collaboration in 2024[50] Production and Capacity - The company's production capacity reached 48,000 liters across two GMP-certified facilities, supporting global supply[10] - The company has a total commercial production capacity of 48,000 liters, including 24,000 liters at the Xuhui base and 24,000 liters at the Songjiang base (Phase 1)[23] - The company is constructing a new production base, Songjiang Base (II), in Shanghai with an investment of up to RMB 2.54 billion to meet the anticipated market demand for its drug pipeline, enhancing its monoclonal antibody R&D and production capabilities[79] - As of December 31, 2023, the company had capital commitments of approximately RMB 209.3 million for machinery and equipment, primarily related to the purchase of machinery, laboratory renovations, and capitalized R&D expenses[81] - The company reported total construction-in-progress assets of RMB 572.055 million as of December 31, 2023, compared to RMB 712.240 million in the previous year[80] - The Songjiang Base (Phase II) is under construction, with a planned capacity of 36,000 liters for its first two phases, and the third phase has commenced above-ground construction[48] - The Xuhui Base has obtained GMP certifications from China and the EU, enabling dual-market supply and supporting overseas market expansion[48] Corporate Governance and Leadership - Wenjie Zhang resigned as CEO on July 17, 2023, and Zhu Jun was appointed as the new CEO on the same date[157] - The company deviated from the Corporate Governance Code by having Wenjie Zhang serve as both Chairman and CEO until July 17, 2023[158] - The Board of Directors consists of a balanced mix of executive, non-executive, and independent non-executive directors to ensure strong independent judgment[156] - The company has established mechanisms to ensure the Board receives independent views and opinions, including access to all company data and professional advice[160] - All directors, including non-executive and independent non-executive directors, have extensive and valuable business experience and expertise[161] - The company has adopted a standard code for securities transactions, and no violations were reported during the reporting period[155] - The Board is responsible for leading and monitoring the company, overseeing strategy implementation, and ensuring robust internal controls and risk management[161] - Independent non-executive directors provide balanced and independent judgment on corporate actions and operations[161] - The company has a corporate governance framework and policies in place to strengthen the Board's ability to govern and oversee the company's business conduct[154] - The company complies with the requirement to have at least three independent non-executive directors, with at least one possessing appropriate professional qualifications[159] - The company provided training courses for directors, covering topics such as director responsibilities and corporate governance, with all training costs borne by the company[163] - The Audit Committee held 4 meetings during the reporting period to review financial performance, risk management, and internal control systems[166] - The Remuneration Committee held 5 meetings to review and approve compensation policies and equity incentive plans for directors and senior management[167] - The Nomination Committee held 4 meetings to review the structure, size, and composition of the Board, as well as the independence of independent non-executive directors[169] - The company established five Board committees, including Audit, Remuneration, Nomination, Strategy, and ESG Committees, each with clearly defined terms of reference[165] - Newly appointed directors received comprehensive induction materials to ensure a proper understanding of the company's operations and legal responsibilities[162] - The Audit Committee met with external auditors 3 times during the reporting period to discuss audit-related matters[166] - The Nomination Committee considers various factors when evaluating director candidates, including character, qualifications, diversity, and independence[169] - The company encourages all directors to participate in relevant training courses and provides internal briefings and reading materials for continuous professional development[163] - The Remuneration Committee ensures transparency in setting compensation policies and prevents directors from participating in decisions regarding their own remuneration[167] - The Strategic Committee held a total of 2 meetings during the reporting period[170] - The Environmental, Social, and Governance (ESG) Committee held a total of 2 meetings during the reporting period[171] - The Board achieved a female director ratio of 9.1% (1 out of 11 members)[172] - The company's senior management has a female ratio of 57.1% (4 out of 7 members)[173] - The overall employee gender ratio is 51.2% female (1,861 out of 3,637 employees)[173] - The Board held a total of 22 meetings, with all directors maintaining a 100% attendance rate except for newly appointed members[176] - The company held 4 shareholder meetings during the reporting period, including 1 annual general meeting and 1 extraordinary general meeting[177] - The company's Board diversity policy aims to consider factors such as gender, age, cultural background, and professional experience when appointing directors[172] - The ESG Committee is responsible for setting the company's ESG vision, goals, strategies, and framework[171] - The Strategic Committee focuses on long-term development strategies, major investment decisions, and significant capital operations[170] - The company has established an internal audit department to oversee and manage business operations, ensuring compliance with internal and external regulatory requirements[178] - The company's risk management and internal control systems are designed to maintain the highest standards of corporate governance and identify and mitigate potential risks[178] - The board of directors has reviewed and confirmed the effectiveness of the risk management and internal control systems for the year ending December 31, 2023[179] - The company has implemented control procedures to strictly prohibit unauthorized access and use of insider information[179] - The company revised its "Fund Business Management System" in September 2023

港股公司报告 | 公司点评 复宏汉霖（02696） 证券研究报告 2024年03月 24日 投资评级 产品持续放量，加速海外市场开拓 行业 医疗保健业/药品及生 物科技 事件 6个月评级 买入（维持评级） 当前价格 14.16港元 2024 年 3 月 21 日复宏汉霖公布2023 年年度报告：2023 全年实现营业收 目标价格 港元 入53.95亿元（yoy+67.82%）；归母净利润5.46亿元（2022年为-6.95 亿元）； 依靠核心品种（曲妥珠单抗及斯鲁利单抗）高速放量，公司在 2023H1 首 基本数据 次实现盈利后全年业绩维持高增长。 港股总股本(百万股) 543.49 核心品种销售高速增长，商业化能力得到认证 港股总市值(百万港元) 7,695.89 2023全年曲妥珠单抗国内实现收入26.4亿元（yoy+56.1%），海外收入0.93 每股净资产(港元) 4.45 亿元（yoy+162.3%），保持高速增长；斯鲁利单抗实现收入 11.20 亿元 资产负债率(%) 77.86 （yoy+230.2%）增长态势迅猛；贝伐珠单抗实现收入1.19亿元、利妥昔单 一 年内最高/最低(港元) 17.40 ...

M N 25 Mar 2024 CMB International Global Markets | Equity Research | Company Update Henlius Biotech (2696 HK) Anticipating sustained profitability  Profit turnaround driven by core business operations. Henliu’s FY23 revenue Target Price HK$18.67 increased 67.8% YoY to RMB5.40bn, driven by strong sales of HANQUYOU (Previous TP HK$18.67) (trastuzumab biosimilar) and serplulimab (PD-1). HANQUYOU recorded Up/Downside 31.8% RMB2.74bn revenue in FY23, +58% YoY. We think HANQUYOU may be free from Current Price HK ...

Financial Performance - Total revenue for 2023 reached RMB 5,394.9 million, a 67.8% increase compared to RMB 3,214.7 million in 2022, driven by drug sales, R&D services, and licensing income[2] - The company achieved a net profit of RMB 546.0 million in 2023, a significant turnaround from a loss of RMB 695.3 million in 2022, primarily due to expanded commercialization of core products[2] - Revenue for 2023 increased to RMB 5,394,909 thousand, up 67.8% from RMB 3,214,730 thousand in 2022[88] - Gross profit for 2023 was RMB 3,918,797 thousand, a 65.3% increase from RMB 2,370,109 thousand in 2022[88] - Net profit for 2023 was RMB 546,019 thousand, compared to a net loss of RMB 695,259 thousand in 2022[88] - The company recorded gross profit of RMB 3,918.8 million, an increase of RMB 1,548.7 million year-on-year, driven by strong sales growth of Hanquyou® and Hansizhuang®[52] - The company reported a net profit of RMB 546.0 million, a significant improvement from a loss of RMB 695.3 million in the previous year[60] - The company reported a profit attributable to ordinary equity holders of RMB 546,019 thousand in 2023, compared to a loss of RMB 695,259 thousand in 2022[115] R&D Expenses and Investments - R&D expenses for 2023 decreased to RMB 1,118.7 million, down by RMB 275.8 million from RMB 1,394.5 million in 2022, reflecting optimized resource allocation and focus on unmet clinical needs[2] - Total R&D expenses for the period were approximately RMB 1,433.6 million, a decrease of RMB 749.6 million compared to the previous year, primarily due to optimized resource allocation and external licensing of certain projects[56] - R&D expenses for 2023 decreased to RMB 1,118,732 thousand from RMB 1,394,514 thousand in 2022[110] - The company's pipeline includes 59 molecules (48 innovative drugs and 11 biosimilars) and 18 R&D platforms, covering various drug forms such as monoclonal antibodies, bispecific antibodies, antibody-drug conjugates, and recombinant proteins[8] - The company's pipeline includes 59 molecules (48 innovative drugs and 11 biosimilars) and 18 R&D platforms as of the latest practicable date[34] Product Approvals and Market Expansion - HANQUYOU® (trastuzumab) received regulatory approvals in Cambodia, Singapore, Thailand, the Philippines, and Brazil in 2023, with BLA and NDS applications submitted to the FDA and Health Canada respectively[3] - HANSIZHUANG® (serplulimab) gained approvals for new indications in China, including ES-SCLC and ESCC, and received EMA and BPOM approvals for ES-SCLC in Europe and Indonesia[3] - HANQUYOU® expanded its overseas commercialization to Thailand, the Philippines, and Brazil, with its marketing applications in the US and Canada also accepted[10] - HANSIZHUANG® (serplulimab) received approval for its third and fourth indications in mainland China: extensive-stage small cell lung cancer (ES-SCLC) and esophageal squamous cell carcinoma (ESCC)[10] - HANSIZHUANG®'s ES-SCLC indication received acceptance from the European Medicines Agency (EMA) and approval from the Indonesian Food and Drug Administration (BPOM)[10] - Hanquyou® (Trastuzumab for Injection) has been approved in over 40 countries and regions, including the UK, Germany, Spain, France, Italy, Sweden, Australia, Singapore, Argentina, and Brazil[13] - Hanquyou® has received approval for marketing applications in Cambodia, Singapore, Thailand, the Philippines, and Brazil in 2023, with the FDA accepting its Biologics License Application (BLA) in February 2023 and Health Canada accepting its New Drug Submission (NDS) in July 2023[15] - Hansizhuang® (Serplulimab Injection) has been approved for four indications, including MSI-H solid tumors, sqNSCLC, ES-SCLC, and ESCC, and has initiated overseas sales[15] - Hansizhuang® has been approved for the treatment of ES-SCLC in Indonesia under the brand name Zerpidio®, marking its first overseas market approval and making it the first Chinese anti-PD-1 monoclonal antibody approved in Southeast Asia[18] - Hansizhuang®'s Marketing Authorization Application (MAA) for ES-SCLC treatment was accepted by the European Medicines Agency (EMA) in March 2023, and its production lines received EU GMP certification in December 2023[18] - Hansizhuang® received the Innovation Passport designation from the UK's MHRA in January 2024, facilitating its market access in the UK[18] - Hansizhuang®'s fifth indication for NSCLC treatment in China was accepted by the National Medical Products Administration (NMPA) in December 2023[17] Clinical Trials and Drug Development - HANSIZHUANG®'s international Phase 3 clinical trials for LS-SCLC and ES-SCLC progressed, with first patient dosing completed in the US, Australia, and the EU, and 81 trial centers opened in the US[4] - HLX04-O (recombinant anti-VEGF humanized monoclonal antibody injection) completed the first patient dosing in the US for its international multicenter Phase 3 clinical study for wet age-related macular degeneration (wAMD) treatment in February 2023, with additional first patient dosing completed in China, the EU, and Australia[5] - HLX208 (BRAF V600E inhibitor) combined with Hansizhuang® (serplulimab injection) completed the first patient dosing in China for its Phase 1b/2 clinical study for non-small cell lung cancer (NSCLC) treatment in February 2023[5] - HLX26 (recombinant anti-LAG-3 humanized monoclonal antibody injection) combined with Hansizhuang® and chemotherapy completed the first patient dosing in China for its Phase 2 clinical study for advanced NSCLC treatment in August 2023[5] - HLX26 combined with Hansizhuang® completed the first patient dosing in China for its Phase 2 clinical study for metastatic colorectal cancer (mCRC) treatment in June 2023[5] - Hansizhuang® combined with chemotherapy achieved the primary endpoint in its Phase 3 clinical study for advanced non-squamous NSCLC treatment in October 2023, demonstrating good efficacy and safety[5] - HLX13 (recombinant anti-CTLA-4 fully human monoclonal antibody injection) completed the first patient dosing in China for its Phase 1 clinical study in healthy male subjects in December 2023[6] - HLX42 (targeting EGFR antibody-novel DNA topoisomerase I inhibitor conjugate) received Fast Track Designation from the FDA for the treatment of EGFR-mutated advanced or metastatic NSCLC in December 2023[6] - HLX14 (recombinant anti-RANKL fully human monoclonal antibody injection) successfully completed its Phase 1 clinical study in healthy male subjects in China in January 2024, showing high similarity in pharmacokinetics and pharmacodynamics to marketed denosumab[6] - HLX51 (recombinant anti-OX40 humanized monoclonal antibody) received IND approval from the National Medical Products Administration (NMPA) for treating advanced/metastatic solid tumors and lymphoma in March 2023[27] - HLX6018 (recombinant anti-GARP/TGF-β1 humanized monoclonal antibody injection) received IND approval from the NMPA for treating idiopathic pulmonary fibrosis in March 2024[28] - HLX99 (small molecule innovative drug) had its IND application for treating amyotrophic lateral sclerosis (ALS) accepted by the NMPA in March 2024[28] - HLX26 (LAG-3+PD-1) completed the first patient dosing in a Phase 2 clinical study for metastatic colorectal cancer (mCRC) in June 2023[30] - HLX208 (BRAF V600E) was officially included in the Breakthrough Therapy Designation program by the NMPA in April 2023 for treating Langerhans cell histiocytosis (LCH) and Erdheim-Chester disease (ECD)[30] - HLX42 (EGFR ADC) and HLX43 (PD-L1 ADC) received FDA Fast Track Designation for treating advanced or metastatic non-small cell lung cancer with EGFR mutations in December 2023[32] - HLX6018 (GARP/TGF-β1) clinical trial application was approved by the National Medical Products Administration (NMPA) in March 2024[33] Commercialization and Licensing Agreements - The company signed licensing agreements with Boston Oncology, FBD Biologics, PT Kalbe Genexine Biologics, and Intas Pharmaceuticals for commercialization of HANLIKANG® and HANSIZHUANG® in MENA, Europe, and India[4] - The company signed agreements with Boston Oncology, LLC and FBD Biologics Limited in 2023 for the commercialization of Hanlikon® in the Middle East, North Africa, and globally for HCB301[20] - The company signed agreements with PT Kalbe Genexine Biologics and Intas Pharmaceuticals Ltd. in 2023 for the commercialization of Hansizhuang® in the Middle East, North Africa, Europe, and India[21] - The company terminated the collaboration with Chiome Bioscience, Inc. on the TROP2-targeted antibody due to market conditions and commercial feasibility[21] - The company recorded licensing income of RMB 6.0 million from the Zercepac® agreement with Accord[48] - The company recorded R&D service income of RMB 311.8 million from the agreement with Organon LLC for HLX11 and HLX14[48] - The company recorded R&D service income of RMB 171.6 million from the agreement with Fosun Pharma Industrial for Hansizhuang® in the US[49] Production Capacity and Infrastructure - The company has a total commercial production capacity of 48,000 liters, with the Xuhui and Songjiang (Phase 1) bases each contributing 24,000 liters[8] - The company has a total commercial production capacity of 48,000 liters across its Xuhui and Songjiang (I) bases[35] - The Xuhui base achieved dual-market supply normalization for China and the EU, with Hanlikang®, Hansizhuang®, and Hanquyou® production lines passing GMP inspections in Indonesia, Brazil, and the Netherlands[36] - The Songjiang (II) base Phase I project is under construction, with a planned capacity of 36,000 liters, and underground structure construction for Phase III was completed during the reporting period[36] - The company is investing up to RMB 2.54 billion in the construction of the Songjiang Base (II) to enhance monoclonal antibody drug R&D and production capabilities[72] - Capital expenditures for construction in progress decreased to RMB 472.8 million in 2023 from RMB 624.2 million in 2022[73] - The company has committed but not yet incurred capital expenditures of approximately RMB 209.3 million for plant and machinery[73] Sales and Distribution - The company has a commercialization team of nearly 1,500 people, promoting 5 products in mainland China, including HANQUYOU® and HANSIZHUANG®[11] - Hanquyou®'s sales team in China has effectively penetrated the market, covering approximately 1,800 hospitals and 36,000 specialized doctors[16] - The company plans to expand the sales team for Hansizhuang® and establish a dedicated sales team for the newly approved esophageal squamous cell carcinoma (ESCC) indication in 2024[39] - Sales and distribution expenses amounted to RMB 1,754.2 million, primarily due to increased marketing expenses for products like Hanquyou®, Hansizhuang®, and Hanbeita®[58] Product Sales Performance - Hanquyou® (Trastuzumab for Injection) achieved sales revenue of approximately RMB 2,644.4 million, a year-on-year increase of RMB 950.0 million, representing a growth rate of 56.1%[47] - Hansizhuang® (Serplulimab) achieved sales revenue of approximately RMB 1,119.8 million, a year-on-year increase of RMB 780.7 million, representing a growth rate of 230.2%[47] - Hanbeitai® (Bevacizumab) achieved sales revenue of approximately RMB 119.4 million since its commercialization in January 2023[47] - Hanlikang® (Rituximab) generated sales revenue of approximately RMB 518.6 million and licensing income of RMB 21.9 million under profit-sharing arrangements[47] - Handayuan® (Adalimumab) generated sales revenue of approximately RMB 58.6 million under profit-sharing arrangements[47] - Zercepac® (Trastuzumab, European trade name) achieved revenue of approximately RMB 69.5 million, with additional revenue of RMB 23.1 million from Trastuzumab API sales outside China[48] Financial Position and Liabilities - Cash and bank balances increased by RMB 307.2 million to RMB 987.7 million, with significant holdings in RMB, USD, and other currencies[61] - Inventory remained stable at approximately RMB 757.4 million, consistent with the previous year[65] - Trade receivables increased to RMB 647.8 million from RMB 455.5 million, with no significant changes in accounting estimates or assumptions[65] - Total interest-bearing bank and other borrowings stood at RMB 3,819.6 million, primarily used for clinical trials, commercialization, and operational expenses[67] - The company's total outstanding debt as of December 31, 2023, was RMB 4,093.1 million, with the majority due within one year[69] - Total assets pledged as collateral for loans amounted to RMB 907.5 million for property, plant, and equipment, and RMB 192.6 million for land use rights[70] - The current ratio improved to 52.8% in 2023 from 43.8% in 2022, while the quick ratio increased to 37.9% from 28.7% over the same period[71] - The capital debt ratio decreased to 59.5% in 2023 from 64.7% in 2022[71] - Total assets increased to RMB 7,227,539 thousand in 2023, up 7.3% from RMB 6,732,766 thousand in 2022[91] - Net current liabilities decreased to RMB 2,391,401 thousand in 2023, down 14.9% from RMB 2,810,036 thousand in 2022[91] - Equity attributable to owners of the parent company increased to RMB 2,192,301 thousand in 2023, up 34.0% from RMB 1,636,332 thousand in 2022[91] Risks and Challenges - The company faces market risks due to intense competition in the biopharmaceutical market and potential impacts from centralized drug procurement policies[77] - Operational risks include uncertainties in clinical development and regulatory approval processes for candidate drugs[78] - The company is exposed to force majeure risks such as natural disasters, which could significantly impact operations and financial performance[79] ESG and Corporate Governance - The company focuses on ESG management, emphasizing corporate governance, product quality, talent development, environmental sustainability, and social responsibility[37] - In 2024, the company will deepen innovation in oncology and autoimmune diseases, expand markets, and strengthen international collaboration to enhance its global R&D, production, and sales capabilities[38] Future Plans and Expectations - The company expects the Marketing Authorization Application (MAA) for Hansizhuang® combined with chemotherapy for extensive-stage small cell lung cancer (ES-SCLC) to be approved in the EU in 2024[41] - The company plans to submit a Biologics License Application (BLA) for Hansizhuang® combined with chemotherapy for ES-SCLC in the US in 2024[41] - The company anticipates the BLA for Hanquyou® for HER2-overexpressing breast cancer and gastric cancer to be approved in the US in 2024[41] - The company expects the New Drug Submission (NDS) for Hanquyou® for HER2-positive early breast cancer to be approved in Canada in 2024[41] - The company plans to complete the GMP compliance inspection for HLX14 in the EU and the drug production license inspection for HLX04-O and HLX11 in China in 2024[44] - The company aims to complete the Process Performance Qualification (PPQ) batch production for the second-generation process of Hansizhuang® at the Songjiang Base (II) in 2024[44] - The company signed a framework agreement to acquire 100% equity of a licensed subsidiary of Shanghai Baodao Pharmaceutical Co., Ltd., aiming to enhance commercialization capabilities in China[40] Accounting and Financial Reporting - The company did not recommend the payment of a final dividend for the reporting period[83] - The company did not purchase, sell, or redeem any of its listed securities during the reporting period[84] - The company's net current liabilities as of December 31, 2023, were RMB 2,391,401 thousand, with the board considering it appropriate to prepare the financial statements on a going concern basis[93] - The company adopted new and revised International Financial Reporting Standards (IFRS) for the first time in the current year's financial statements, including IFRS 17, IAS 1 (Amendment), and IAS 12 (Amendment)[95] - IAS 1 (Amendment) requires entities to disclose significant accounting policy information, but it did not impact the measurement, recognition, or presentation of any items in the company's financial statements[95] - IAS 8 (Amendment) clarified the distinction between changes in accounting estimates and changes in accounting policies, but it had no impact on the company's financial statements as its methods and policies were already consistent with the amendments[96] - IAS 12 (Amendment) narrowed the scope of the initial recognition exception for deferred taxes related to assets and liabilities arising from a single transaction, requiring entities to recognize deferred tax assets and liabilities for temporary differences from leases and decommissioning obligations[96] - The company determined temporary differences arising from right-of-use assets and lease liabilities under IAS 12 (Amendment), but the overall deferred tax balances in the consolidated financial position statement were not materially affected due to offsetting conditions[96] - IAS 12 (Amendment) introduced mandatory temporary exceptions for deferred tax recognition and disclosure related to Pillar Two legislation under the OECD's tax reform, but it had no

Financial Performance - For the nine months ended September 30, 2023, the total revenue of the company was approximately RMB 3,927.8 million, an increase of approximately RMB 1,793.6 million or 84.0% compared to RMB 2,134.2 million for the same period in 2022[3]. - The company reported a net profit of approximately RMB 407.8 million for the nine months ended September 30, 2023, an increase of approximately RMB 750.3 million compared to a loss of RMB 342.5 million for the same period in 2022, primarily due to the commercialization and sales growth of core products[3]. - The company achieved operating revenue of approximately RMB 3,927.8 million, representing an increase of about 84.0% compared to the same period last year[9]. - Total comprehensive income for the period reached RMB 407,820,000, compared to a loss of RMB 345,065,000 in the previous period[23]. - The company reported a pre-tax profit of RMB 411,751,000, a significant recovery from a loss of RMB 341,546,000 in the prior period[29]. Revenue Breakdown - Sales revenue of Hanquyou® in China reached approximately RMB 1,942.2 million, representing an increase of approximately RMB 664.7 million or 52.0% year-on-year; sales revenue of Hanshuang® in China was approximately RMB 865.4 million, an increase of approximately RMB 660.1 million or 321.4% year-on-year[3]. - Revenue from biopharmaceutical product sales was RMB 3,378,405,000, significantly up from RMB 1,967,789,000 year-over-year, indicating a growth of about 71.7%[39]. - The company’s revenue from external customers in mainland China was RMB 3,569,568,000, while overseas revenue was RMB 358,242,000, reflecting a significant increase in domestic sales[38]. Research and Development - The company recognized R&D clinical expenses of approximately RMB 974.8 million, a decrease of approximately RMB 397.5 million compared to RMB 1,372.3 million for the same period in 2022, mainly due to increased investment in collaborative development projects[3]. - The R&D budget has been increased by 20% to support innovation in new technologies and product lines[4]. - Research and development expenses for the period were RMB 817,601,000, a decrease from RMB 903,284,000 in the previous year, reflecting a reduction of approximately 9.5%[42]. Market Expansion and Product Development - New product development includes HLX10, which is expected to launch in Q3 2024, targeting a market size of $A billion[4]. - The company is expanding its market presence in Asia, aiming for a 10% market share by the end of 2025[4]. - The company plans to enter the European market with a new product line, projected to generate $C million in revenue within the first year[4]. - Hanquyou®'s New Drug Submission was accepted by Health Canada in July 2023, and Hanshuang® received approval for a new indication in September 2023 from the National Medical Products Administration in China[5]. Financial Health and Assets - Non-current assets increased to RMB 7,087,094,000 from RMB 6,732,766,000 year-over-year, reflecting growth in property, plant, and equipment[24]. - The net asset value increased to RMB 2,054,085,000 from RMB 1,636,332,000, reflecting improved financial health[24]. - As of September 30, 2023, the unaudited total assets amounted to RMB 4,398,241,000, an increase of 8.8% from RMB 4,044,705,000 as of December 31, 2022[51]. Cash Flow and Liabilities - Net cash flow from operating activities was RMB 572,079,000, slightly down from RMB 608,834,000 in the previous year[29]. - The company reported a net decrease in cash and cash equivalents of RMB (98,596) thousand for the nine months ended September 30, 2023, compared to an increase of RMB 513,930 thousand in the same period of 2022[30]. - Total liabilities remained stable at RMB 5,001,117,000, compared to RMB 5,001,578,000, indicating effective management of current liabilities[24]. Strategic Initiatives - A strategic acquisition of Company B was announced, expected to enhance product offerings and increase market penetration by 15%[4]. - The company is focused on maximizing the commercial value of biosimilars and exploring innovative drugs through clinical-oriented research and external collaborations[7]. - The company continues to enhance its "research-production-sales integration" capabilities to support international expansion in oncology and autoimmune diseases[7]. Management and Governance - The independent auditor issued an unqualified review opinion on the company's financial statements as of September 30, 2023, resolving previous audit concerns[8]. - The company’s ultimate parent is Shanghai Fosun Pharmaceutical (Group) Co., Ltd., and the ultimate controlling shareholder is Mr. Guo Guangchang[31]. - The board approved the issuance of the interim consolidated financial information on November 15, 2023[79]. Related Party Transactions - The group reported related party revenue of RMB 1,886,523 thousand for the nine months ended September 30, 2023, compared to RMB 1,234,113 thousand for the same period in 2022, representing a growth of approximately 52.9%[63]. - Trade receivables from related parties totaled RMB 368,741 thousand as of September 30, 2023, significantly increasing from RMB 179,728 thousand as of December 31, 2022, indicating a growth of approximately 104.5%[68].

Financial Performance - Revenue for the first half of 2023 reached RMB 2,500.47 million, a significant increase from RMB 1,289.39 million in the same period of 2022[75] - Gross profit for the first half of 2023 was RMB 1,778.83 million, compared to RMB 983.79 million in the first half of 2022[75] - Net profit for the first half of 2023 was RMB 239.98 million, a turnaround from a net loss of RMB 252.10 million in the same period of 2022[75] - Net profit for the six months ended June 30, 2023, was RMB 239.98 million, compared to a net loss of RMB 252.095 million in the same period last year[79][81] - Total comprehensive income for the six months ended June 30, 2023, was RMB 243.268 million, compared to a total comprehensive loss of RMB 253.607 million in the same period last year[79][81] - The company reported a profit attributable to ordinary equity holders of RMB 239,980 thousand in H1 2023, compared to a loss of RMB 252,095 thousand in H1 2022[102] Assets and Liabilities - Total assets as of June 30, 2023, amounted to RMB 6,975.37 million, up from RMB 6,732.77 million at the end of 2022[78] - Total liabilities as of June 30, 2023, were RMB 4,954.45 million, slightly down from RMB 5,001.58 million at the end of 2022[78] - The company's equity attributable to owners of the parent company as of June 30, 2023, was RMB 1,889.53 million, up from RMB 1,636.33 million at the end of 2022[78] - Total equity as of June 30, 2023, was RMB 1.889 billion, compared to RMB 2.078 billion as of June 30, 2022[79][81] - The company's net current liabilities as of June 30, 2023, amounted to RMB 2,337,538,000[87] Cash Flow - Cash flow from operating activities for the six months ended June 30, 2023, was RMB 332.46 million, compared to a negative cash flow of RMB 103.113 million in the same period last year[83] - Cash flow from financing activities for the six months ended June 30, 2023, was RMB 156.497 million, compared to RMB 845.54 million in the same period last year[85] - Cash and cash equivalents at the end of June 30, 2023, were RMB 632.156 million, compared to RMB 215.084 million at the end of June 30, 2022[85] Revenue Breakdown - Revenue from external customers in Mainland China for the six months ended June 30, 2023, was RMB 2,221,702,000, a significant increase from RMB 1,239,689,000 in the same period in 2022[93] - Total revenue from customer contracts for the six months ended June 30, 2023, was RMB 2,499,136,000, compared to RMB 1,288,739,000 in the same period in 2022[94] - Revenue from the sale of biopharmaceutical products for the six months ended June 30, 2023, was RMB 2,152,901,000, up from RMB 1,181,622,000 in the same period in 2022[94] - Licensing revenue for the six months ended June 30, 2023, was RMB 14,037,000, compared to RMB 31,606,000 in the same period in 2022[94] - Revenue from R&D services for the six months ended June 30, 2023, was RMB 331,452,000, a significant increase from RMB 74,964,000 in the same period in 2022[94] - Revenue recognized at a point in time for the six months ended June 30, 2023, was RMB 2,160,904,000, compared to RMB 1,201,164,000 in the same period in 2022[94] - Revenue recognized over time for the six months ended June 30, 2023, was RMB 338,232,000, up from RMB 87,575,000 in the same period in 2022[94] R&D and Expenses - R&D expenses for the first half of 2023 were RMB 547.83 million, slightly up from RMB 534.50 million in the same period of 2022[75] - Sales and distribution costs for the first half of 2023 increased to RMB 782.95 million from RMB 378.64 million in the first half of 2022[75] - R&D expenses remained stable at RMB 547,828 thousand in H1 2023 compared to RMB 534,497 thousand in H1 2022, a slight increase of 2.5%[96] - The company recognized expenses of RMB 2.285 million, cost of sales of RMB 302,000, deferred development costs of RMB 38,000, and inventory of RMB 2,000 in other reserves for the six months ended June 30, 2023[80] Related Party Transactions - Revenue from licensing to related parties increased to RMB 10.851 million in 2023, up from RMB 9.283 million in 2022[116] - Sales of goods to related parties surged to RMB 1.204518 billion in 2023, compared to RMB 742.868 million in 2022[116] - Services provided to related parties amounted to RMB 22.411 million in 2023, down from RMB 30.093 million in 2022[116] - Purchases of services from related parties rose to RMB 17.629 million in 2023, up from RMB 8.855 million in 2022[116] - Trade receivables from related parties increased to RMB 391.812 million in 2023, compared to RMB 179.728 million in 2022[118] - Deposits with related parties stood at RMB 193 million in 2023, with no comparable figure in 2022[116] - Trade payables to related parties decreased to RMB 302,000 in 2023, down from RMB 429,000 in 2022[119] - Other payables and accrued expenses to related parties totaled RMB 22.707 million in 2023, down from RMB 26.164 million in 2022[119] - Long-term payables to related parties increased significantly to RMB 754.717 million in 2023, up from RMB 235.849 million in 2022[119] - Contract liabilities with related parties rose to RMB 516.55 million in 2023, compared to RMB 501.187 million in 2022[119] Financial Assets and Liabilities - The fair value of financial assets at fair value through profit or loss as of June 30, 2023, was RMB 25.20 million[72] - The fair value of financial assets at fair value through profit or loss decreased significantly to RMB 25.202 million as of June 30, 2023, from RMB 160.186 million at the end of 2022[122][124] - Non-current portion of interest-bearing bank and other borrowings had a fair value of RMB 1.003927 billion as of June 30, 2023, up from RMB 965.952 million at the end of 2022[126][127] - The company's financial assets at fair value through profit or loss are classified as Level 3 in the fair value hierarchy, indicating significant unobservable inputs[124] Government Subsidies and Exchange Rates - Government subsidies decreased to RMB 14,505 thousand in H1 2023 from RMB 22,110 thousand in H1 2022, a decline of 34.4%[95] - Foreign exchange gains dropped significantly to RMB 7,820 thousand in H1 2023 from RMB 28,388 thousand in H1 2022, a decrease of 72.4%[95] - Exchange rate fluctuations resulted in a gain of RMB 3.288 million for the six months ended June 30, 2023, compared to a loss of RMB 1.512 million in the same period last year[79][81] Interest and Tax Expenses - Interest income increased to RMB 2,712 thousand in H1 2023 from RMB 704 thousand in H1 2022, a growth of 285.2%[95] - Bank and other borrowing interest expenses rose to RMB 64,237 thousand in H1 2023 from RMB 55,652 thousand in H1 2022, an increase of 15.4%[97] - Current tax expense in Mainland China increased to RMB 3,956 thousand in H1 2023 from RMB 953 thousand in H1 2022, a significant rise of 315.1%[99] Shareholder and Equity Information - FHL holds a 53.61% stake in the company's domestic shares and a 6.32% stake in H-shares[136] - HenLink owns 100% of the non-listed foreign shares, representing 2.92% of the total shares[137] - Cayman Henlius holds a 26.77% stake in H-shares, equivalent to 8.05% of the total shares[136] - Qatar Investment Authority holds a 6.96% stake in H-shares through Qatar Holding LLC[136] - Wenjie Zhang holds a 6.30% stake in HenLink, Inc. through ordinary shares[133] - 復星新藥 holds a 73.03% stake in domestic shares, representing 48.94% of the total shares[136] - 復星醫藥產業發展 holds a 6.97% stake in domestic shares, representing 4.67% of the total shares[136] - 復星國際 holds an 80.00% stake in domestic shares and a 21.03% stake in H-shares[136] - 復星實業 holds a 19.78% stake in H-shares, representing 5.95% of the total shares[136] - Al Rayyan Holding LLC holds a 6.96% stake in H-shares, representing 2.09% of the total shares[136] - FHL directly holds approximately 73.67% of Fosun International's shares as of June 30, 2023[138] - Fosun High-Tech holds approximately 35.82% of Fosun Pharma's shares as of June 30, 2023[138] - Scott Shi-Kau Liu holds approximately 64.20% of Cayman Henlius' shares, while Wei-Dong Jiang holds approximately 35.80% as of June 30, 2023[139][140] Share Incentive Plans - The 2018 Share Incentive Plan involved a total of 22,750,000 shares, representing approximately 4.19% of the company's total issued shares as of the report date[152] - The 2018 Share Incentive Plan was revised in December 2020, introducing new restrictions on the transfer of incentive shares and a special adjustment mechanism[153] - The 2020 Share Incentive Plan involved the purchase of restricted interests from resigned 2018 participants, totaling 360,700 domestic shares and 2,420,000 non-listed foreign shares, representing approximately 0.51% of the company's total issued shares[155] - The 2020 Share Incentive Plan's first batch of restrictions for the first category of participants was lifted on April 30, 2021, with 60% of the shares being unrestricted[156] - The 2020 Share Incentive Plan's second batch of restrictions for the second category of participants was lifted on April 30, 2022, with 25% of the shares being unrestricted[156] - The 2020 Share Incentive Plan's third batch of restrictions for the third category of participants will be lifted on April 30, 2023, with 55% of the shares being unrestricted[156] - As of June 30, 2023, 283,400 shares for Executive Director WENJIE ZHANG were vested on April 30, 2023, with a weighted average market price of HKD 14.14[157] - As of June 30, 2023, 599,502 shares for the five highest-paid individuals were vested on April 30, 2023, with a weighted average market price of HKD 14.14[157] - As of June 30, 2023, 149,790 shares for other grant recipients by category were vested on April 30, 2023, with a weighted average market price of HKD 14.14[157] - As of June 30, 2023, 44,000 shares for other grant recipients were vested on May 16, 2023, with a weighted average market price of HKD 14.14[157] - 79,800 unvested shares under the 2018 Share Incentive Plan were vested on May 16, 2023, for a resigned employee, with a weighted average closing price of HKD 14.14 per share[158][159] - 44,000 unvested shares under the 2020 Share Incentive Plan were vested on May 16, 2023, for a resigned employee[159] - WENJIE ZHANG, the former CEO, had 275,000 shares vested under the 2020 Share Incentive Plan, with a weighted average closing price of HKD 19.42 per share[161] - The top five highest-paid individuals, including WENJIE ZHANG, had 481,738 shares vested under the 2020 Share Incentive Plan, with a weighted average closing price of HKD 19.42 per share[161] - 42,000 unrestricted shares were transferred to WENJIE ZHANG under the 2020 Share Incentive Plan, with a total fair value of approximately RMB 396,000 (HKD 22.5 per share)[162] - The 2018 Share Incentive Plan was fully granted on April 14, 2018, with no cancellations or forfeitures during the reporting period[159] - The 2020 Share Incentive Plan was fully granted on December 10, 2020, with no cancellations or forfeitures during the reporting period[162] - The company corrected an unintentional error in the 2022 Annual Report regarding the 2020 Share Incentive Plan's share movement[160] Global Offering and Proceeds - The global offering of H shares raised a net amount of approximately HKD 3,147.1 million (RMB 2,800.9 million) after deducting listing expenses[146] - Approximately 24.8% (RMB 693.7 million) of the net proceeds from the global offering were allocated to ongoing clinical trials, regulatory filings, and registrations for core products[147] - The company allocated approximately 16.8% (RMB 470.8 million) of the net proceeds for clinical trials, regulatory filings, and registrations of other biosimilar candidates (including HLX12, HLX11, and HLX14), with RMB 470.8 million used as of December 31, 2022[148] - Approximately 48.4% (RMB 1,356.3 million) of the net proceeds were allocated for clinical trials, regulatory filings, and registrations of innovative biologics and tumor immunotherapy combinations, with RMB 1,345.4 million used as of December 31, 2022[148] - RMB 226.7 million of the company's own liquidity funds were used for clinical trials, regulatory filings, and registrations of other biosimilar candidates (including HLX12, HLX11, and HLX14)[149] - RMB 243.3 million of the company's own liquidity funds were used for clinical trials, regulatory filings, and registrations of HLX10 and tumor immunotherapy combinations (including HLX10+HLX07)[149] - As of June 30, 2023, all funds raised for R&D projects were fully utilized, including RMB 2,320.0 million from global offering proceeds and RMB 480.9 million from the company's own liquidity funds[150] - The company decided not to proceed with the proposed A-share issuance and listing on the Shanghai Stock Exchange's STAR Market as of July 3, 2023[151] Company Operations and Facilities - Songjiang Base (II) is under construction with a total planned area of 200 mu for the Henlius Biopharmaceutical Industrialization Base (II)[166] - The company has a production base in Xuhui District, Shanghai[166] - The company's Songjiang Base (I) is located in Songjiang District, Shanghai[166] - The company's HenLink, Inc. was incorporated in the Cayman Islands on August 15, 2014[164] - The company's Shanghai Guoyun Biotechnology Partnership was established on August 9, 2017[166] - The company's Jiangsu Fosun Pharmaceutical Sales Co., Ltd. is a wholly-owned subsidiary[165] Other Financial Information - The company adopted new and revised International Financial Reporting Standards (IFRS) effective January 1, 2023, with no material impact on the interim condensed consolidated financial statements[90] - The company is currently assessing the impact of Pillar Two income taxes, with no disclosure required for interim periods ending on or before December 31, 2023[91] - No significant events have occurred since the end of the reporting period[129] - The board of directors did not recommend any interim dividend for the reporting period[131] - The report period refers to the six months ended June 30, 2023[165] - The last practicable date for determining the contents of this report is September 21, 2023[165] - The company's H shares were listed on the Hong Kong Stock Exchange on September 25, 2019[165] - Global offering includes 6,469,600 H shares for Hong Kong public offering and 58,225,800 H shares initially available for subscription, with an additional 4,366,400 H shares under the over-allotment option[164]

Financial Performance - For the six months ended June 30, 2023, the total revenue of Shanghai Henlius Biotech, Inc. was approximately RMB 2,500.5 million, an increase of approximately RMB 1,211.1 million or 93.9% compared to RMB 1,289.4 million for the same period in 2022, primarily driven by drug sales and R&D services [3]. - The net profit for the six months ended June 30, 2023, was approximately RMB 240.0 million, a significant increase of approximately RMB 492.1 million compared to a loss of RMB 252.1 million for the same period in 2022, mainly due to the commercialization and expanding sales of core products [3]. - The group recorded a gross profit of approximately RMB 1,778.8 million, an increase of about RMB 795.0 million compared to the same period last year [42]. - Revenue for the six months ended June 30, 2023, was RMB 2,500,470,000, a 94.3% increase from RMB 1,289,394,000 in the same period of 2022 [76]. - The company reported a profit before tax of RMB 339,021 thousand for the six months ended June 30, 2023, compared to a profit of RMB 75,165 thousand for the same period in 2022 [92]. Product Development and Approvals - The company’s product Hanquyou® (trastuzumab injection) received FDA acceptance for a biologics license application (BLA) for multiple indications in February 2023 [4]. - In July 2023, Health Canada accepted the new drug submission (NDS) for Hanquyou® for the treatment of HER2-positive early breast cancer [4]. - The product Hanshuang® (sulruvimab injection) received approval for a new indication for extensive-stage small cell lung cancer (ES-SCLC) in January 2023 [4]. - The NDA for the fourth indication of Hanshuang® for esophageal squamous cell carcinoma has been accepted in China, and the MAA for extensive-stage small cell lung cancer has been accepted in the EU [9]. - The company has established collaborations for licensing Hanlikang® (rituximab injection) and other products with Boston Oncology, LLC, FBD Biologics Limited, and PT Kalbe Genexine Biologics [4]. Clinical Trials and Research - The international multi-center Phase 3 clinical trial for Hanshuang® in combination with chemotherapy for limited-stage small cell lung cancer (LS-SCLC) completed the first patient dosing in the U.S. in January 2023 [5]. - The company’s clinical research projects are progressing efficiently, with multiple trials ongoing in various regions including the U.S., China, and Australia [5]. - In February 2023, the Phase 1 clinical trial of HLX15 (recombinant anti-CD38 fully human monoclonal antibody injection) was completed with the first subject dosed in male health participants in China [6]. - The company is advancing clinical trials for over 30 projects globally, with significant progress in multiple international studies [21]. - The company has received approval for three clinical trials during the reporting period, including HLX26 for advanced non-small cell lung cancer [22]. Sales and Market Expansion - The company achieved its first half-year profitability during the reporting period, driven by effective commercialization of products like Hanquyou® and Hanshuang® [9]. - As of August 24, 2023, five products with 18 indications have been successfully launched in mainland China, and one product has been launched in Europe and Australia [9]. - The sales team for Hanquyou® has effectively penetrated the Chinese market, supported by flexible dosage forms for personalized treatment [11]. - The company is actively expanding its product portfolio and market reach through strategic collaborations and new product registrations [12]. - The core product, Hanquyou®, has been successfully marketed in approximately 40 countries and regions, including the UK, Germany, and Australia [12]. Financial Position and Liquidity - As of June 30, 2023, the group's cash and bank balances were approximately RMB 759.2 million, with current assets totaling RMB 2,616.9 million [51]. - The group has outstanding bank and other borrowings of approximately RMB 3,688.5 million as of June 30, 2023, primarily for clinical research and operational expenses [56]. - The current ratio was 52.8%, and the quick ratio was 36.6%, indicating improved liquidity compared to 43.8% and 28.7% respectively as of December 31, 2022 [59]. - The group confirmed other income and gains of approximately RMB 26.8 million during the reporting period [44]. - The company has not reported any significant events occurring after the reporting period [102]. Corporate Governance and Management - The independent auditor issued a qualified opinion regarding the group's financial performance for the year ended December 31, 2022, due to insufficient evidence supporting the existence and valuation of certain financial instruments [69]. - The group has established an independent board committee to investigate issues related to the investment management agreement and will provide updates on significant developments [69]. - The company has adhered to corporate governance codes, with a notable exception regarding the separation of the roles of Chairman and CEO, which are held by the same individual [71]. - As of July 17, 2023, the CEO position was transitioned to a new appointee while the previous CEO remains as Chairman of the Board [71]. - The group had no significant acquisitions or disposals as of June 30, 2023 [62].

Financial Performance - The company achieved a historical revenue high of over 3.2 billion CNY for the fiscal year ending December 31, 2022[8]. - Total revenue for the year ended December 31, 2022, was approximately RMB 3,214.7 million, a significant increase from RMB 1,682.5 million in 2021, representing an increase of 91.2%[11]. - The total loss for the year was approximately RMB 695.3 million, a decrease of RMB 288.8 million compared to a loss of RMB 984.1 million in 2021, primarily due to increased gross profit from the commercialization of core products[12]. - Gross profit amounted to approximately RMB 2,370.1 million, an increase of RMB 1,210.4 million year-on-year, driven by the sales growth of Hanquyou® and Hanshuang®[77]. - The group reported a loss of approximately RMB 695.3 million for the year, a reduction of about RMB 288.8 million from a loss of RMB 984.1 million in the previous year[85]. Product Sales and Market Expansion - Sales revenue from core product Hanquyou® reached nearly 1.7 billion CNY, benefiting over 110,000 patients in China[8]. - The first innovative product, H drug Hanshuang®, generated over 300 million CNY in sales within 9 months of launch, serving over 20,000 patients[8]. - Hanquyou® achieved sales revenue of approximately RMB 1,694.4 million, representing a year-on-year increase of RMB 826.4 million, or 95.2%[72]. - Hanshuang® generated sales revenue of approximately RMB 339.1 million during the reporting period[72]. - The company has successfully registered its product Hanquyou® in over 30 global markets, including Australia and Argentina, enhancing its international presence[16]. Research and Development - Research and development expenses for the year were approximately RMB 1,394.5 million, an increase of RMB 370.6 million from RMB 1,023.9 million in 2021, reflecting the company's commitment to innovative drug development[12]. - The company has a total of 57 molecules in its pipeline, including 10 biosimilars and 47 innovative drugs, covering various drug forms such as monoclonal antibodies and small molecule conjugates[30]. - The company is actively pursuing clinical trials for innovative targets such as BRAF and LAG-3, with over 30 clinical trials ongoing across multiple countries[10]. - The company has received orphan drug designation for Hanshuang® from the FDA and the European Commission for small cell lung cancer treatments[49]. - The company has successfully advanced 7 domestic and international clinical research projects, including the approval of multiple IND applications for various drug combinations and treatments[25]. Production Capacity and Facilities - The company achieved a commercial production capacity of 48,000 liters following the certification of its second commercial production base, which is expected to enhance production capabilities significantly[12]. - The group has a total commercial production capacity of 48,000 liters, with 24,000 liters from the Xuhui base and 24,000 liters from the Songjiang base (Phase I)[32]. - The Songjiang base (Phase II) completed the construction and installation of major production buildings in the second half of 2022, and the quality control laboratory has been activated[32]. - The company plans to invest up to RMB 2.54 billion in the construction of the new production base in Songjiang, which will enhance its R&D and production capabilities for monoclonal antibody biopharmaceuticals[97]. - The company’s first commercial production base in Xu Hui has received GMP certification from both China and the EU, enabling regular supply to both markets[62]. Strategic Partnerships and Collaborations - The partnership with Organon set a record for the highest single transaction in global biosimilar licensing in nearly 5 years, with potential revenue reaching significant levels[8]. - In February 2022, the company signed an agreement with Getz Pharma to commercialize Han Da Yuan® in Pakistan, the Philippines, and Vietnam[23]. - The company has signed agreements with Abbott and Eurofarma in May 2022 to commercialize Han Li Kang® and Han Qu You® in Brazil and surrounding regions[23]. - The company entered into a collaboration and licensing agreement with Palleon for the global co-development and commercialization of a dual-function HER2-sialidase fusion protein[23]. - The company is actively pursuing international collaborations and partnerships for its products, enhancing its market presence[33]. Corporate Governance and Compliance - The company is committed to high standards of corporate governance, ensuring sustainable returns for shareholders and managing overall business risks effectively[174]. - The board of directors includes a balanced mix of executive and non-executive directors, ensuring strong independent judgment[177]. - The company has established an internal control system that complies with relevant laws and regulations, ensuring the protection of shareholders' rights[170]. - The company emphasizes compliance with regulatory requirements and has maintained a close working relationship with regulatory bodies[164]. - The company has implemented control procedures to prevent unauthorized access to and use of insider information[200]. Employee and Community Engagement - The company is committed to corporate social responsibility, actively engaging in public health initiatives and community support during the pandemic[65]. - The company has a total of 3,406 employees as of December 31, 2022, with 1,130 in R&D and technology[106]. - The company has achieved a target of 40% female representation in senior management, with 4 out of 10 senior managers being female[195]. - The company encourages all directors to participate in relevant training courses, with costs covered by the company[184]. - The company made donations totaling RMB 27.5 million during the reporting period[140].

Financial Performance - For the year ended December 31, 2022, the total revenue of the company was approximately RMB 3,214.7 million, an increase of approximately RMB 1,532.2 million or 91.1% compared to RMB 1,682.5 million for the year ended December 31, 2021[2]. - The total loss for the company was approximately RMB 695.3 million for the year ended December 31, 2022, a decrease of approximately RMB 288.8 million compared to RMB 984.1 million for the year ended December 31, 2021[2]. - The group achieved revenue of approximately RMB 3,214.7 million, representing a year-on-year growth of 91.1%[52]. - Sales revenue from Hanquyou® reached approximately RMB 1,694.4 million, an increase of RMB 826.4 million or 95.2% compared to the same period last year[52]. - Sales revenue from Hanshuang® amounted to approximately RMB 339.1 million during the reporting period[52]. - The group recorded sales revenue of approximately RMB 553.9 million from Hanlikang® and RMB 20.9 million from licensing income[52]. - The group reported a net loss of RMB 695,259,000 for the year, compared to a net loss of RMB 984,052,000 in 2021, indicating an improvement in financial performance[97]. - The basic and diluted loss per share for the year was RMB 1.28, compared to RMB 1.83 in the previous year[97]. Research and Development - The company recognized R&D clinical expenses of approximately RMB 2,183.2 million for the year ended December 31, 2022, an increase of approximately RMB 419.5 million compared to RMB 1,763.7 million for the year ended December 31, 2021[2]. - The company's R&D expenses for the year ended December 31, 2022, were approximately RMB 2,183.2 million, an increase of about RMB 419.5 million compared to RMB 1,763.7 million in 2021, driven by increased investment in innovative R&D projects[62]. - The company is focusing on the clinical development of multiple innovative therapies, with significant progress in clinical trial applications and patient recruitment[31]. - The company has successfully advanced 9 products and 5 combination therapies to obtain multiple clinical trial approvals globally, including IND approvals for targets such as EGFR×4-1BB and PDL1×TIGIT[8]. - The pipeline currently consists of a total of 57 molecules, including 10 biosimilars and 47 innovative drugs, covering various drug forms such as monoclonal antibodies and small molecule conjugates[9]. Product Development and Approvals - The company received conditional approval from the National Medical Products Administration for Hanshuang® in March 2022 for the treatment of adult patients with advanced solid tumors[3]. - Hanshuang® received orphan drug designation from the FDA and EC for the treatment of small cell lung cancer (SCLC) in April and December 2022[5]. - HLX60, a recombinant anti-GARP humanized monoclonal antibody, commenced a Phase 1 clinical trial in Australia for advanced or metastatic solid tumors in August 2022, with the first patient dosed in December 2022[5]. - HLX301, a recombinant anti-PD-L1 and anti-TIGIT bispecific antibody, completed the first patient dosing in a Phase 1 clinical study for locally advanced or metastatic solid tumors in Australia in February 2022[5]. - The company has received clinical approval for its PD-1 product, HLX10, in multiple countries including China, the US, and Australia, with commercial partners such as KGBio and Fosun Pharma[10]. Market Expansion and Partnerships - The company signed an agreement with Getz Pharma in February 2022 to grant a license for the commercialization of Handayuan® in Pakistan, the Philippines, and Vietnam[4]. - The company is focusing on expanding its market presence with partnerships in over 30 countries, including the UK, Germany, and France[10]. - The company has established global partnerships with renowned firms, enhancing its international commercialization efforts for products like Hanquyou® and Hanlikang®[12]. - The company is actively expanding its international market presence and aims to accelerate its global operational strategy while generating substantial licensing and R&D service revenue[51]. Sales and Commercialization - The company has successfully commercialized five products with 18 indications in China and one product in Europe and Australia as of March 24, 2023[11]. - Hanquyou® has been commercialized in all provinces in China, with a professional sales team of over 550 people driving market penetration[13]. - The company achieved significant sales growth for its core product, Hanquyou®, during the reporting period, driven by a strong commercialization strategy[51]. - The company is focused on building a strong market presence through collaborations in areas such as physician education and patient management, particularly for HER2-positive cancer treatments[13]. Financial Position and Liabilities - The company had interest-bearing bank and other borrowings of approximately RMB 3,416.0 million as of December 31, 2022, incurred for ongoing clinical research, commercialization expenses, and normal operational costs[73]. - The debt-to-equity ratio increased to 64.7% in 2022 from 51.8% in 2021, indicating a higher reliance on debt financing[77]. - The company’s total assets less current liabilities stood at RMB 3,922,730,000 in 2022, down from RMB 4,213,119,000 in 2021[100]. - The company maintained its commitment to continuous operation, supported by unused bank financing and expected cash flows from operating, financing, and investing activities[101]. Compliance and Governance - The independent auditor's report expressed a qualified opinion due to limitations in obtaining sufficient evidence regarding certain financial assets[94]. - The company expresses regret for non-compliance with specific regulations and emphasizes no intention to conceal information related to the investment management agreement[139]. - The company plans to enhance training for directors, senior management, and financial personnel regarding compliance with listing rules[139]. - A comprehensive internal control assessment will be conducted to improve internal control processes and coordination among departments[139].