Product Launch and Market Expansion - Henlius successfully launched China's first biosimilar drug, Hanlikang®, and the first domestically produced trastuzumab, Hanquyou®, in Europe, marking a significant milestone in international market entry[8] - The company launched two major products in 2020, Hanquyou® and Handayuan®, further solidifying its leadership position in the Chinese biosimilar market[10] - Hanquyou® was successfully launched in nearly 20 EU countries, marking a significant step in the company's international expansion efforts[10] - Hanquyou® (Zercepac®) was successfully launched in August 2020, with marketing authorization granted by the EU in July 2020, marking it as the first Chinese biosimilar monoclonal antibody approved in the EU[21] - The company entered into a binding agreement with Accord Healthcare Inc. in September 2020 to develop and commercialize Hanquyou® in the US and Canada[25] - The company has successfully launched 3 products in China and 1 product in the EU during the reporting period[36] - The company has established commercial rights in China and several Southeast Asian countries for its products[35] - The company has a diverse product pipeline addressing various cancers and autoimmune diseases, enhancing its market position[35] Financial Performance - Total revenue for the year ended December 31, 2020, was approximately RMB 587.6 million, a significant increase from RMB 90.9 million in 2019[14] - Total revenue for 2020 reached RMB 587,586 thousand, a significant increase from RMB 90,929 thousand in 2019, representing a growth of 546%[16] - The total loss for the year was approximately RMB 993.5 million, an increase of about RMB 118.0 million compared to a loss of RMB 875.5 million in 2019[15] - The net loss attributable to shareholders for 2020 was RMB 993,541 thousand, compared to RMB 875,465 thousand in 2019, reflecting a 13.5% increase in losses[16] - The total assets as of 2020 amounted to RMB 6,439,176 thousand, up from RMB 5,899,817 thousand in 2019, indicating an increase of 9.1%[17] - The total liabilities for 2020 were RMB 3,240,404 thousand, an increase from RMB 1,899,402 thousand in 2019, representing a growth of 70.8%[17] - The gross profit recorded was RMB 405.5 million, reflecting a significant increase of 2,022% compared to the previous year, driven by the contribution from key commercialized products[80] Research and Development - Research and development expenses for the year ended December 31, 2020, were approximately RMB 894.1 million, up from RMB 607.8 million in 2019, reflecting the expansion of clinical activities[15] - The company is advancing seven preclinical research projects targeting various therapeutic areas, including CTLA-4 and SARS-CoV-2[32] - Clinical trials for HLX10 (PD-1) in various cancer treatments progressed, with significant milestones achieved in 2020 and early 2021[28][30] - The company has received IND approvals for multiple products, indicating progress in clinical development[35] - HLX10 (anti-PD-1 monoclonal antibody) has received clinical trial approvals in China, the US, and several EU countries, with ongoing studies for various cancers[47] - The company has received IND approval for HLX26 (recombinant anti-LAG-3 humanized monoclonal antibody) in January 2021, with further approvals in April 2021[62] Production Capacity and Infrastructure - The commercial production capacity was increased to 20,000 liters following the addition of four 2,000-liter bioreactors and the certification of the Xuhui base by EU GMP[12] - The Xu Hui base has achieved a commercial production capacity of 20,000 liters, with GMP certification from both China and the EU[52] - The Songjiang Base (I) has completed the construction of a 24,000-liter production capacity and has begun GMP production of clinical samples since May 2020[53] - The company is investing up to RMB 1.72 billion in the construction of the "Songjiang Base (II)" to enhance overall production capacity[100] Corporate Governance and Management - The board of directors has established a profit distribution policy prioritizing cash dividends while considering the company's growth and capital structure[111] - The board consists of at least three independent non-executive directors, with one possessing appropriate professional qualifications or accounting knowledge, ensuring compliance with listing rules[167] - The company emphasizes the importance of human resources, providing a fair work environment and competitive compensation, along with regular training for employees[155] - The board has established five committees, including the audit committee, to oversee various aspects of the company's affairs, with clear written terms of reference[174] - The company has established a robust internal control system that effectively mitigates risks in daily operations[161] Social Responsibility and Community Engagement - The company actively engaged in social responsibility initiatives, including donations of medical supplies to combat COVID-19 and health awareness campaigns in rural areas[12] - The company has established a public welfare fund in collaboration with the Shanghai Fosun Public Welfare Foundation, focusing on health education and patient care during the COVID-19 pandemic[64] - The group donated RMB 7.6 million during the reporting period[135] Market Risks and Challenges - The company faces potential market risks due to intense competition in the biopharmaceutical market, which may impact its ability to innovate and maintain market share[105] - The company has significant ongoing R&D efforts, with several candidate drugs in clinical development, which involves high costs and uncertainties[106] - The company anticipates an increase in sales revenue denominated in foreign currencies as it expands into overseas markets, which may expose it to exchange rate risks[104]

Financial Performance - For the six months ended June 30, 2020, the total revenue of the group was RMB 110.4 million, an increase of approximately RMB 93.4 million compared to RMB 17.0 million for the same period in 2019[14]. - The total loss for the group was RMB 448.0 million, an increase of RMB 131.1 million compared to RMB 316.9 million for the same period in 2019, primarily due to the expansion of R&D activities[14]. - The gross profit for the six months ended June 30, 2020, was RMB 52.0 million, representing an increase of approximately RMB 46.3 million, with a growth rate of 812.3% compared to the same period in 2019[80]. - The company reported a net loss of RMB 447,982,000 for the six months ended June 30, 2020, compared to a net loss of RMB 316,930,000 for the same period in 2019, representing a year-over-year increase in loss of approximately 41.3%[121]. - Revenue from external customers for the six months ended June 30, 2020, was RMB 110,392 thousand, with RMB 101,144 thousand from mainland China and RMB 9,248 thousand from overseas[141]. Research and Development - Research and development expenses for the same period were approximately RMB 756.9 million, an increase of about RMB 228.4 million from RMB 528.5 million in the prior year[14]. - The group has expanded its R&D efforts, leading to a significant increase in expenses and ongoing clinical trials for multiple innovative products[14][20]. - The company is actively pursuing new indications and expanding its product pipeline through various clinical studies and regulatory approvals[16][18]. - The IND for HLX11, targeting metastatic breast cancer, was approved in January 2020, with the first patient dosed in a phase I clinical trial in September 2020[22]. - The company aims to accelerate the clinical research plans for multiple products, including HLX26, HLX23, and HLX15, on a global scale[72]. Clinical Trials and Approvals - The marketing authorization application for HLX02 was approved by the European Commission in July 2020, and the NDA was approved by the National Medical Products Administration in August 2020[17]. - The phase III clinical trial for HLX04, targeting metastatic colorectal cancer, achieved its primary endpoint in August 2020[18]. - The first patient was dosed in a phase II clinical study of HLX10 combined with chemotherapy for advanced cervical cancer during the reporting period[20]. - Approximately 20 clinical trials are being conducted simultaneously in multiple countries including China, Taiwan, Australia, Poland, Ukraine, the Philippines, and Turkey for 10 products and 8 combination therapy regimens[32]. - The company has over 30 clinical trial approvals globally for 18 products and 2 monoclonal combination therapy regimens[32]. Commercialization and Market Strategy - The company has launched its first domestic monoclonal antibody biosimilar, HLX01, and the first monoclonal antibody biosimilar approved in both China and Europe, HLX02 (trastuzumab)[32]. - The company is actively pursuing the commercialization of its products across multiple jurisdictions, supported by a robust quality management system[55]. - The company aims to enhance the accessibility and affordability of biopharmaceuticals through efficient commercial operations and strategic planning[58]. - The company has established strategic commercial partnerships with leading pharmaceutical companies, covering over 90 countries and regions globally[64]. - HLX02 (injection trastuzumab) received approval for commercialization in China in August 2020, with plans to cover approximately 1,500 hospitals nationwide by the end of 2020[68]. Financial Position and Investments - Cash and cash equivalents as of June 30, 2020, were RMB 1,146.4 million, a decrease attributed to various expenditures related to R&D and clinical activities[91]. - The company is constructing a new production base in Songjiang, with an expected investment of no more than RMB 1.72 billion for the first phase of the project[101]. - The company has contracted but unrecognized capital commitments for property, plant, and equipment totaling RMB 485.1 million, primarily related to machinery purchases and renovations[103]. - The company reported a significant increase in salaries and wages, amounting to RMB 7,982 thousand for the six months ended June 30, 2020, compared to RMB 5,799 thousand for the same period in 2019[168]. - The company has received GMP compliance certificates for HLX02 and HLX03 from both the Polish health authority and the Shanghai Drug Administration, confirming compliance with EU and local regulations[56]. Risks and Challenges - The company is facing market risks due to intense competition in the biopharmaceutical sector, which may impact its ability to innovate and capture market share[108]. - The ongoing COVID-19 pandemic poses potential risks to the company's operations, including clinical trial progress and supply chain disruptions[110]. - The company has not engaged in any significant acquisitions or disposals as of June 30, 2020[105]. - The company’s operations are not affected by seasonality[142]. - The company has not disclosed any new product developments or market expansions in the recent reporting period[186]. Corporate Governance and Shareholder Information - The audit committee reviewed the unaudited interim results for the six months ending June 30, 2020[187]. - The company has adhered to high standards of corporate governance and transparency throughout the reporting period[186]. - The company’s major shareholder, Scott Shi-Kau Liu, holds approximately 36.09% of the H shares through a controlled entity[175]. - Fosun Pharma's major shareholder, Fosun New Drug, holds approximately 73.03% of the domestic shares and 48.94% of the total shares[181]. - The total issued and fully paid shares remained at 543,494,853 as of both December 31, 2019, and June 30, 2020, with a par value of RMB 1.00 per share[159].

Company Overview - Henlius successfully listed on the Hong Kong Stock Exchange in September 2019, marking a significant milestone in its growth journey[14]. - The company aims to provide affordable high-quality biopharmaceuticals, aligning with EU, China, and US standards for research and production[14]. - Henlius expresses gratitude to shareholders and stakeholders for their ongoing support and trust[14]. Product Development and Pipeline - HLX02, a biosimilar drug, became the first domestically produced biosimilar to be accepted for marketing in the EU, highlighting Henlius's commitment to internationalization[14]. - The company aims to further develop its product pipeline to create more value for patients and deliver excellent results for investors[14]. - The company launched its first biosimilar drug, Hanlikang, which improved drug accessibility for non-Hodgkin lymphoma patients[16]. - The company has commercialized several products, including HLX01 and HLX12, with HLX01 receiving its first prescription in May 2019[27]. - The company is advancing multiple new drug applications (NDA), including HLX03 and HLX04, which are currently under priority review by the National Medical Products Administration[27]. - The company has established a comprehensive pipeline that integrates innovative monoclonal antibodies and tumor immunotherapy combination therapies, focusing on a "biosimilar and innovative combination" product development strategy[33]. - The company has a total of 10 products and 8 combination therapy schemes undergoing clinical trials across various regions[33]. Financial Performance - Total revenue for the year ended December 31, 2019, was RMB 909.29 million, compared to RMB 74.21 million for the year ended December 31, 2018, representing a significant increase[21]. - The total loss for the year ended December 31, 2019, was RMB 875.5 million, an increase of RMB 370.7 million from RMB 504.8 million for the year ended December 31, 2018, mainly due to the expansion of research and development activities[22]. - The gross profit for the year ended December 31, 2019, was RMB 191 million, representing an increase of approximately RMB 171 million, with a growth rate of 855% due to the approval and commercialization of HLX01[62]. - The sales cost for the year ended December 31, 2019, was RMB 718 million, an increase of approximately RMB 664 million, attributed to the production costs of HLX01[61]. Research and Development - Research and development expenses for the year ended December 31, 2019, were RMB 607.8 million, an increase of RMB 242.4 million from RMB 365.4 million for the year ended December 31, 2018, primarily due to additional clinical trials for candidate drugs[22]. - The company is focused on transforming from a biotech to a biopharma entity, emphasizing innovation in product development and operational strategies[19]. - The company has received approvals for 35 clinical trials globally for 15 products and 2 monoclonal antibody combination therapy schemes, with over 20 clinical trials ongoing in multiple countries including China, Taiwan, Australia, Poland, Ukraine, and the Philippines[33]. Manufacturing and Production - The company established a new base in Songjiang to meet the growing global production capacity needs, adhering to international GMP standards[16]. - The company is expanding its manufacturing capabilities with the construction of a new base in Songjiang, covering an area of 200 acres[27]. - The company has established a biopharmaceutical production base in Shanghai with a capacity of 14,000 liters, meeting short-term production needs, and is expanding with a new facility planned for 24,000 liters[43]. Strategic Partnerships and Collaborations - Collaborations with international biotech and pharmaceutical companies were established to enhance global commercialization efforts, particularly in emerging markets[18]. - A strategic partnership was established with KG Bio for exclusive development and commercialization rights in 10 Southeast Asian countries, with an upfront payment of USD 10 million[27]. - The company is collaborating with Jiangsu Wanbang to leverage their successful commercialization experience in the rheumatology field for HLX03[53]. Corporate Governance and Compliance - The board of directors is committed to high corporate governance standards to protect shareholder interests and enhance corporate value[154]. - The company has established a risk management and internal control system to maintain high standards of corporate governance and identify potential risks[182]. - The audit committee assists the board in overseeing the implementation and monitoring of the risk management and internal control systems[182]. Social Responsibility - The company has committed to social responsibility initiatives, including establishing a dedicated public welfare fund and participating in health poverty alleviation efforts[18]. - The company is committed to social responsibility and sustainable development, focusing on health education and patient care initiatives[51]. - The company donated RMB 4.3 million during the reporting period[126]. Market Challenges - The company faces market risks due to intense competition in the biopharmaceutical market, which may impact its ability to innovate and capture market share[89]. - The COVID-19 pandemic may pose potential risks to the company's operations, including clinical trial progress and production base construction[91].

Company Overview - Shanghai Henlius Biotech, Inc. is the first biopharmaceutical company in China to commercialize biosimilar products, specifically monoclonal antibody biosimilars[6]. - The company has developed over 20 candidate biologics and multiple tumor immunotherapy combination therapies, with two monoclonal candidates accepted for new drug application by the National Medical Products Administration[6]. - The company’s H-shares have been listed on the Hong Kong Stock Exchange since September 25, 2019[6]. - The company aims to provide high-quality and cost-effective innovative drugs to global patients[6]. - The management team has over 25 years of experience in drug development from leading international biopharmaceutical companies[6]. Product Pipeline and Development - The product pipeline includes HLX01 (Hanlikang®), which is already commercialized, and several candidates in various stages of clinical trials[6]. - The company has made significant progress in the development of its core biosimilar products, with HLX02 and HLX03's new drug applications accepted for priority review by the National Medical Products Administration[16]. - The Phase III clinical trial for HLX01 focused on treating CD20 positive diffuse large B-cell lymphoma, with approvals for all three indications previously treated by the reference drug, MabThera[16]. - HLX02's Phase III clinical trial targets HER2 positive metastatic breast cancer, with applications submitted for all three indications, including gastric cancer[16]. - The company is preparing to submit a new drug application for HLX04, a biosimilar to Avastin, for metastatic colorectal cancer and non-squamous non-small cell lung cancer[16]. - The company has expanded its pipeline of innovative biologics, with HLX01 completing Phase I/II trials for rheumatoid arthritis and entering Phase III trials[17]. - HLX22, a novel therapeutic monoclonal antibody, has received clinical trial approval for gastric and breast cancer treatments, with global development rights secured[17]. - The company is actively pursuing a "Global+Combo" strategy, with ongoing clinical trials for HLX10 in combination with other candidates for head and neck squamous cell carcinoma[19]. Financial Performance - As of June 30, 2019, the company's revenue was approximately RMB 17.0 million, a significant increase attributed to the sales growth of core products, including the delivery of 20,638 vials of HLX01 to Fosun Pharma[31]. - The sales revenue from HLX01 (Hanlikang®) amounted to RMB 13.3 million, with marketing and sales expenses borne by Fosun Pharma under a profit-sharing arrangement[31]. - The company confirmed other income of approximately RMB 11.3 million, primarily from bank interest and government subsidies related to capital expenditures and R&D activities[32]. - For the six months ended June 30, 2019, the group reported revenue of RMB 17,039,000, with a gross profit of RMB 5,743,000[62]. - The group incurred a loss before tax of RMB 316,930,000, compared to a loss of RMB 199,444,000 in the prior year[62]. - The basic and diluted loss per share for the period was RMB 0.70, up from RMB 0.46 in the previous year[62]. Research and Development - Research and development expenses for the six months ended June 30, 2019, amounted to approximately RMB 528.6 million, an increase of about RMB 133.7 million or 33.9% compared to RMB 394.9 million for the same period in 2018[35]. - The R&D centers in Shanghai, Taipei, and California will enhance innovation capabilities, focusing on developing various tumor immunotherapy combinations[26]. - The company plans to increase its R&D budget by 15% in 2020 to accelerate the development of innovative therapies[149]. Market Expansion and Strategy - The company is focused on expanding its market presence and enhancing its product offerings through ongoing research and development[6]. - The company is pursuing internationalization of its products, including marketing authorization applications for HLX02 in the EU and exclusive development rights for HLX10 in Southeast Asia[27]. - The company aims to expand its product pipeline in oncology and autoimmune diseases, focusing on high-quality, cost-effective biopharmaceuticals[22]. - The company has expanded its market presence in Southeast Asia, securing distribution agreements in three new countries[149]. Corporate Governance and Shareholder Information - The company is committed to high standards of corporate governance and has complied with all applicable codes since its listing[139]. - The company aims to enhance shareholder value through transparency and accountability[139]. - Fosun Pharma holds approximately 73.03% of the shares in Henlius, translating to 49.33% of the total equity[134]. - The company has adopted several share incentive plans, which are not subject to the restrictions of the listing rules[141]. Future Outlook - Future strategies include advancing clinical trials for existing candidates and exploring new therapeutic areas[6]. - The company has provided a revenue guidance of RMB 2.5 billion for the full year 2019, indicating a growth target of 20%[149]. - The company is currently developing three new biosimilar drugs, with expected market launch in 2020[149]. - The company is in discussions for a potential acquisition of a local biotech firm to enhance its R&D capabilities[149].