截至2025年3月31日 09:40，恒生医疗保健指数(HSHCI)上涨0.02%，成分股乐普生物-B(02157)上涨4.72%，翰森制药(03692)上涨4.66%，晶泰控股-P(02228)上 涨4.13%，锦欣生殖(01951)上涨3.04%，百济神州(06160)上涨2.66%。恒生医疗ETF(513060)上涨0.84%，最新价报0.48元，盘中成交额已达2.30亿元，暂居可 比ETF1/3。 规模方面，恒生医疗ETF近半年规模增长2.70亿元，实现显著增长，新增规模位居可比基金1/3。 数据显示，杠杆资金持续布局中。恒生医疗ETF最新融资买入额达4.20亿元，最新融资余额达5.76亿元。 绝对收益方面，截至2025年3月28日，恒生医疗ETF自成立以来，最高单月回报为28.34%，最长连涨月数为4个月，最长连涨涨幅为38.75%，上涨月份平均收 益率为7.00%。 超额收益方面，截至2025年3月28日，恒生医疗ETF近1年超越基准年化收益为2.04%。 消息面上，3月26日国家医保局召开优化医药集采工作研发会，会后相关优化细则《进一步优化药品集采政策的方案（征求意见稿）》流出，主要内容包 括： ...

Group 1 - The Hang Seng Healthcare Index (HSHCI) has seen a strong increase of 1.80%, with notable gains from companies such as Lepu Biopharma-B (up 16.56%) and Zai Lab (up 10.27%) [1] - The Hang Seng Medical ETF (513060) has risen by 2.11%, marking its third consecutive increase, with a trading volume of 4.69 billion yuan [1][2] - The second Boao Lecheng Stem Cell Conference has opened, marking a new phase of standardized and high-quality development in China's stem cell industry [2] Group 2 - Financial analysts predict that the approval and implementation of more projects in the stem cell sector will lead to advanced treatment methods benefiting the public [2] - The domestic medical innovation industry is expected to experience multiple growth opportunities, particularly for companies with true innovation capabilities in new drug development [2] - The Hang Seng Medical ETF has seen a significant growth in scale, increasing by 34.09 billion yuan over the past year, ranking in the top third among comparable funds [2] Group 3 - Since its inception, the Hang Seng Medical ETF has achieved a maximum monthly return of 28.34% and an average monthly return of 7.00% [3] - The ETF has outperformed its benchmark with an annualized excess return of 2.02% over the past year [3] - The ETF's management fee is 0.50%, and the custody fee is 0.15% [3] Group 4 - The tracking error of the Hang Seng Medical ETF is 0.033%, the highest tracking precision among comparable funds [4] - The latest price-to-earnings ratio (PE-TTM) of the Hang Seng Medical Healthcare Index is 24.97, indicating it is at a historical low compared to the past year [4] - The top ten weighted stocks in the Hang Seng Medical Healthcare Index account for 55.64% of the index, with companies like WuXi Biologics and BeiGene among the leaders [4][6]

Core Viewpoint - Lepu Biopharma-B (02157.HK) reported a total revenue of approximately RMB 367.8 million for the year ending December 31, 2024, representing a year-on-year growth of 63.2% [1] Group 1: Revenue Breakdown - The revenue from the sales of Puyouheng® (Pralsetinib injection) reached approximately RMB 300.3 million in 2024, which is three times the revenue of approximately RMB 101.4 million recorded in 2023 [1] - The company recorded approximately RMB 22 million in revenue from licensing business, derived from milestone payments and technology transfer services under the CMG901 licensing agreement [2] - Revenue from CDMO services amounted to approximately RMB 45.5 million [3] Group 2: Sales and Marketing Strategy - The company has established an efficient sales and marketing team for the commercialization of Puyouheng®, focusing on product promotion, positioning, and brand management strategies [1] - The team aims to enhance brand recognition among leading doctors and patient groups through academic promotion activities and product education [1] - As of December 31, 2024, the company has completed the bidding process on procurement platforms across 27 provinces in China and has covered approximately 81 cities through various sales channels [2] Group 3: Strategic Partnerships and Future Outlook - The company is committed to advancing global cooperation strategies and actively pursuing external licensing collaborations [2] - In January 2025, the company entered into an exclusive licensing agreement with ArriVent, granting them global exclusive rights to develop, manufacture, and commercialize MRG007 outside Greater China, with potential total payments of up to USD 1.2 billion [2] - The company strategically utilizes its remaining production capacity to provide CDMO services to Lepu Medical and/or its subsidiaries, generating approximately RMB 45.5 million in related revenue for 2024 [3]

Financial Performance - Total revenue for the year ended December 31, 2024, reached RMB 367.8 million, representing a year-over-year increase of 63.2%[12] - The company reported a net loss attributable to owners of approximately RMB 411.4 million for the year ended December 31, 2024, up from a loss of approximately RMB 22.1 million in 2023[12] - The company recorded a net loss of RMB 424.19 million for the year ended December 31, 2024, compared to a net loss of RMB 30.30 million in 2023[82] - The gross profit for the year ended December 31, 2024, is RMB 292.97 million, compared to RMB 197.08 million in 2023, indicating a gross margin improvement[82] - The company reported a significant increase in revenue, reaching RMB 1.5 billion for the fiscal year ending December 31, 2024, representing a 25% year-over-year growth[127] Revenue Sources - Revenue from the commercialization of Puyuheng® (Putilizumab Injection) amounted to RMB 300.3 million, approximately three times the revenue of RMB 101.4 million recorded in 2023[4] - The group recorded approximately RMB 22.0 million in revenue from licensing business, derived from milestone payments and technology transfer services under the CMG901 licensing agreement[20] - CDMO services generated approximately RMB 45.5 million in revenue for the group[20] - Revenue from pharmaceutical product sales reached RMB 300.3 million, up from RMB 101.4 million in the previous year, representing a growth of 196%[96] - Revenue from CDMO services amounted to approximately RMB 45,497,000 in 2024, compared to zero in 2023, accounting for 12.37% of total revenue[97] Research and Development - R&D expenses decreased from approximately RMB 458.1 million for the year ended December 31, 2023, to approximately RMB 437.7 million for the year ended December 31, 2024, a reduction of about 4.4%[12] - The total R&D expenses for the year ended December 31, 2024, amount to RMB 437.70 million, slightly decreased from RMB 458.07 million in 2023[82] - Research and development costs (excluding depreciation, amortization, and employee benefits) increased to RMB 274,524,000 in 2024 from RMB 249,019,000 in 2023[106] - The company plans to strengthen its ADC platform and develop innovative technologies to support the next generation of drug development[45] - The company is focused on developing innovative biotherapies for autoimmune and oncology treatments, with ongoing clinical trials expected to yield results in the next 12 months[125] Clinical Trials and Product Development - The company is conducting I/II phase trials for MRG003 in combination with Puyuheng® for solid tumors, with positive data presented at major conferences[5] - MRG007 has shown strong anti-tumor activity in preclinical models and an exclusive licensing agreement was signed with ArriVent, potentially yielding up to $1.2 billion in milestone payments and royalties[9][11] - CG0070 received Breakthrough Therapy Designation (BTD) from the CDE for the treatment of BCG-unresponsive bladder cancer, highlighting its innovative and effective profile[13] - MRG003 received acceptance for its new NDA for R/M NPC from the National Medical Products Administration, currently undergoing priority review[21] - The company plans to launch two new products in the oncology space by the end of 2025, targeting a combined market potential of RMB 500 million[131] Financial Position - As of December 31, 2024, cash and cash equivalents stood at RMB 401.3 million, compared to RMB 426.0 million in 2023, remaining relatively stable year-over-year[12] - The company's bank borrowings increased to RMB 794.4 million in 2024 from RMB 694.3 million in 2023, with unsecured loans accounting for RMB 534.1 million[64] - The company's equity attributable to owners decreased to RMB 702.8 million in 2024 from RMB 896.9 million in 2023, a decline of 21.6%[84] - The group's debt-to-asset ratio as of December 31, 2024, is 70.1%, an increase from 62.7% as of December 31, 2023[68] - Current liabilities increased to RMB 1,043.5 million in 2024 from RMB 899.6 million in 2023, reflecting a rise of 16%[85] Strategic Initiatives - The company has established a highly efficient sales and marketing team for the commercialization of Putili monoclonal antibody, covering approximately 81 cities in China[20] - The company is strategically leveraging remaining capacity to provide CDMO services, expecting to generate up to RMB 36.0 million in related revenue in 2025[20] - The company plans to expand its market presence through new product launches and strategic partnerships in the oncology sector[123] - The company is expanding its market presence in Southeast Asia, targeting a 15% market share by 2026[129] - The company has initiated a new marketing strategy focusing on digital channels, aiming to increase customer engagement by 40%[128]

Investment Rating - The report maintains a "Buy" rating for the company [1]. Core Insights - The report highlights that the commercialization of the company is beginning to show results, with the ADC pipeline entering a harvest phase [5][16]. - The company is focusing on precision oncology, with a diverse pipeline that includes antibodies, ADCs, bispecific antibodies, and oncolytic viruses [8][41]. - The ADC drugs are being developed with innovative technologies and are targeting new indications to avoid market saturation [8][41]. Summary by Sections Company Overview - The company is described as a fully integrated biotech firm that is expanding through continuous development and innovation [6]. - The report emphasizes the comprehensive patent layout and deep investment in IO+ADC, indicating a promising future [6]. ADC Pipeline - Multiple ADCs are highlighted as having first-in-class potential, with MRG003 expected to be the first approved EGFR ADC in China [6][8]. - MRG004 is anticipated to be the first domestic TF-ADC, while CMG901 is on track to be the first Claudin18.2 ADC to market [6][8]. - The oncolytic virus CG0070 is expected to be a preferred treatment option for NMIBC [6]. Financial Projections and Valuation - The report forecasts revenues of 306 million, 504 million, and 870 million CNY for 2024, 2025, and 2026 respectively, with growth rates of 36%, 65%, and 73% [11]. - The net profit is projected to be -405 million, -278 million, and -207 million CNY for the same years, indicating significant losses initially but improving over time [11]. - The valuation is based on discounted cash flow and pipeline sales peak multiples, estimating a market value of 100.8 billion and 114.1 billion HKD [8][11]. Clinical Data and Efficacy - MRG003 has shown promising efficacy in clinical trials for NPC and HNSCC, with an overall objective response rate (ORR) of 47.4% and a disease control rate (DCR) of 79.0% [28][49]. - The safety profile of MRG003 is favorable, with most adverse events being mild to moderate and no treatment-related deaths reported [28][42]. - The report suggests that MRG003 combined with PD-1 therapy could become the new standard treatment for NPC, potentially replacing existing regimens [42][39].

（於中華人民共和國註冊成立的股份有限公司） 股份代號 : 2157 2024 中期報告 目錄 | --- | --- | |-------|--------------------------| | | | | 2 | 公司資料 | | 4 | 財務概要 | | 5 | 管理層討論及分析 | | 23 | 其他資料 | | 28 | 中期財務資料的審閱報告 | | 29 | 中期簡明綜合全面虧損表 | | 30 | 中期簡明綜合資產負債表 | | 32 | 中期簡明綜合權益變動表 | | 33 | 中期簡明綜合現金流量表 | | 34 | 中期簡明綜合財務資料附註 | | 59 | 釋義及技術詞彙 | 樂普生物科技股份有限公司 二零二四年中報 2 非執行董事 楊紅冰先生 核數師 蒲珏女士 公司資料 執行董事 蒲忠傑博士（董事長） 隋滋野博士（總經理） 胡朝紅博士（聯席總經理） （自2024年1月31日起退休） 聯席公司秘書 李昀軼女士 黎少娟女士(FCG, HKFCG) 授權代表 蒲忠傑博士 黎少娟女士(FCG, HKFCG) | --- | --- | |-------------------------- ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不會就因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 Lepu Biopharma Co., Ltd. 樂普生物科技股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2157） 截至2024年6月30日止六個月的 中期業績公告 董事會欣然宣佈本集團截至2024年6月30日止六個月的未經審核綜合中期業績， 連同2023年同期之比較數字。 業務摘要 於報告期內及直至本公告日期，我們在推進產品管線及業務營運方面均取得重 大進展： 普佑恆®（普特利單抗注射液）的銷售收入合共人民幣94.8百萬元，較2023年同期 增加一倍。 於報告期內，本集團錄得總收入人民幣133.3百萬元，主要來自銷售普佑恆®（普 特利單抗注射液）。於2024年上半年，本集團錄得銷售普佑恆®（普特利單抗注射 液）的收入為人民幣94.8百萬元，較2023年同期錄得約人民幣44.0百萬元增加一 倍。 ADC管線及其與癌症免疫的聯合療法的重大進展 － MRG003：我們已完成NPC ...

Financial Performance - Total revenue for 2023 reached RMB 225 million, with a significant reduction in losses[6] - Net loss for 2023 was approximately RMB 30 million, a reduction of about 96% compared to the previous year[7] - Adjusted net loss, excluding the impact of other gains, was around RMB 250 million[7] - Total revenue for the year ended December 31, 2023, was RMB 225.4 million, primarily from licensing business and commercialization of the product Puyuheng® (Putilizumab Injection) which generated sales revenue of RMB 101.4 million[16] - The company reported a significant reduction in losses by approximately 95.7% compared to the year ended December 31, 2022[16] - The net loss for the company decreased significantly from RMB 699.4 million in 2022 to RMB 30.3 million in 2023[44] - The adjusted net loss (non-IFRS measure) for the year was RMB 250.6 million, compared to RMB 699.4 million in the previous year, indicating a reduction in losses[47] - Cash used in operating activities for the year was RMB 250.8 million, a decrease of RMB 230.1 million from RMB 480.9 million in the previous year, attributed to increased commercialization revenue from products[48] - As of December 31, 2023, cash and cash equivalents were RMB 426.0 million, down from RMB 669.4 million as of December 31, 2022, primarily due to ongoing R&D activities[48] Revenue Sources - Revenue from CMG901 BD amounted to RMB 124 million, following a licensing agreement with AstraZeneca[6] - Sales revenue from Puyuheng® (Putilizumab injection) was RMB 101 million, marking the first full accounting year of sales[6] - Licensing income from the agreement with AstraZeneca regarding CMG901 amounted to approximately RMB 109.5 million, contributing to a total of RMB 124.0 million in licensing business revenue[16] - Other gains from investment activities totaled approximately RMB 220 million, including RMB 104 million from the partial sale of investment in Haoyang Bio[7] Research and Development - The company is focused on developing innovative antibody-drug conjugates (ADCs) to address unmet clinical needs in cancer treatment[5] - The ADC technology platform is being advanced to develop superior and innovative drugs[5] - MRG003 is currently undergoing a pivotal Phase IIb clinical study for NPC, with promising data showing an overall response rate (ORR) of 47.4% and disease control rate (DCR) of 79.0% in previous studies[18] - MRG002 is in a pivotal Phase II clinical trial for HER2-positive breast cancer liver metastasis, with patient enrollment completed and data indicating good results[19] - The company has initiated multiple clinical trials, with five in the registration phase in China and one ongoing in the US[13] - The company continues to focus on the development of its candidate drugs while assessing market demand and competitive landscape in oncology[17] Product Development and Clinical Trials - The ADC product MRG003 is expected to be commercially available in 2024, with promising clinical data for NPC and HNSCC, and has received FDA's IND and Fast Track Designation[8] - MRG002 has achieved primary endpoints in its Phase II clinical trial for HER2-positive advanced breast cancer, and is currently preparing for NDA submission[8] - MRG004A has shown positive efficacy signals in pancreatic cancer and has received FDA orphan drug designation, with ongoing I/II clinical trials in the US and China[8] - The combination therapy of MRG003 and PDR001 has completed Phase I trials, showing good preliminary data, with further results expected at the 2024 ASCO meeting[10] - The Hi-TOPi ADC platform has developed candidate drug MRG006A, which is entering the IND application stage, expected in Q2 2024[11] - The company aims to accelerate the development of MRG003 and MRG002, with NDA submissions anticipated in 2024[12] Market Expansion and Commercialization - The company aims to strengthen its production capacity and expand its market presence both domestically and internationally[5] - The company is expanding its commercialization efforts in the Chinese market, enhancing brand image and product market influence[12] - The company has completed bidding procedures on procurement platforms in 21 provinces and has expanded its sales network to cover approximately 76 cities[30] - The company is actively seeking global business development opportunities for its ADC technology platform[12] Corporate Governance and Management - The company has adopted a corporate governance code since its H-share listing on February 23, 2022, and has complied with all applicable governance code provisions during the reporting period[123] - The board consists of six male members and three female members, achieving a one-third representation of women[131] - The company has set measurable goals for board diversity, aiming for at least one-third female representation[131] - The company has implemented mechanisms to ensure independent viewpoints are available to the board, including regular meetings with independent non-executive directors[129] - The company has established an Audit Committee, Remuneration and Assessment Committee, Nomination Committee, and Strategic Committee to enhance corporate governance[146][148][150][151] Environmental, Social, and Governance (ESG) Initiatives - The company emphasizes the importance of ESG management and continuously optimizes its ESG strategies to enhance governance and operational quality[182] - The company is committed to reducing the negative environmental impact of its operations and addressing potential risks related to climate change[183] - The company has established an environmental management system to minimize its operational environmental footprint and fulfill its ecological responsibilities[192] - The company has implemented various energy-saving measures, including variable frequency control for production equipment, multi-effect distillation machines, and active power filters to reduce energy consumption[197] Risks and Challenges - The company faces significant risks related to the development, production, and commercialization of its candidate drugs, including potential delays and cost overruns[74] - Regulatory approval processes for drugs are lengthy and unpredictable, which could adversely affect the company's business and financial performance[76] - The company may rely on third-party manufacturers for clinical development and commercialization, posing risks if these parties fail to deliver adequate quality or quantity[75] Shareholder Information - The total number of shares issued as of December 31, 2023, was 1,659,444,838, including 1,605,176,474 H shares and 54,268,364 domestic shares[90] - The company has a diverse shareholder base, including various investment partnerships and funds[96] - The percentage of shares held by major shareholders is significant, with some holding over 5% of the total shares[93] Charitable Contributions - The company made charitable donations of approximately RMB 3,405,906 during the reporting period, compared to RMB 1,392,540 in 2022, representing a significant increase of 144%[111]

Investment Rating - The report assigns a "Strong Buy" rating to the company with a target price of HKD 6.6 [2][3]. Core Insights - The company focuses on innovative biopharmaceuticals for cancer treatment, particularly in targeted therapy and immunotherapy, with a rich pipeline of Antibody-Drug Conjugates (ADCs) [2][15]. - The lead product, MRG003, is the fastest progressing EGFR ADC in China, showing promising efficacy in nasopharyngeal carcinoma and head and neck squamous cell carcinoma [2][20]. - The company has a strategic advantage in combining its PD-1 monoclonal antibody, Prutilizumab, with ADCs, which is expected to enhance pipeline value in the emerging IO+ADC treatment landscape [2][11]. Financial Projections - Expected revenues for 2024, 2025, and 2026 are HKD 339 million, HKD 589 million, and HKD 1.106 billion, representing year-on-year growth rates of 45.8%, 73.5%, and 87.9% respectively [3][12]. - The company is projected to achieve a net profit of HKD 1.77 billion by 2026, following losses in the earlier years [3][12]. Pipeline Overview - MRG003 has completed patient enrollment for its pivotal IIb clinical trial for nasopharyngeal carcinoma and is expected to apply for market approval in 2024 [20][27]. - MRG004A, the first TF ADC in China, is in early clinical trials for pancreatic cancer and has shown initial positive efficacy signals [32][34]. - The company is also developing CMG901, which has been licensed to AstraZeneca and is currently in global Phase III trials [2][18]. Clinical Development - The report highlights the potential of combining ADCs with immunotherapy, noting that nearly half of existing immunotherapy treatments could transition to IO+ADC combinations, potentially expanding the market by 100-200% [2][11]. - Initial clinical data for MRG003 in head and neck squamous cell carcinoma shows an overall response rate (ORR) of 43% in patients who have progressed after standard treatments [29][30]. Market Position - The company is positioned as a leading biotech in the IO+ADC space, with a diverse and differentiated pipeline that includes multiple ADC candidates and a PD-1 monoclonal antibody already on the market [2][15].

Revenue and Financial Performance - Revenue increased by approximately 1,347.2% from RMB 15.6 million in 2022 to RMB 225.4 million in 2023[2] - Total revenue of RMB 225.4 million was achieved, with significant progress in product pipeline and business operations[3] - Total revenue for 2023 reached RMB 225.4 million, primarily from licensing business and commercialization of Puheng® (Puliximab Injection)[9] - Revenue for the year ended December 31, 2023, reached RMB 225.4 million, a 1,347.2% increase compared to RMB 15.6 million in 2022[29] - Revenue for 2023 increased significantly to RMB 225.352 million from RMB 15.572 million in 2022, with gross profit rising to RMB 197.075 million from RMB 13.567 million[50] - Revenue from pharmaceutical product sales and licensing income for the year ended December 31, 2023, was RMB 225.352 million, compared to RMB 15.572 million in 2022[60] - Licensing income from KYM Biosciences Inc. accounted for RMB 109.52 million, representing 48.60% of the company's total revenue in 2023[61] - The company's revenue from licensing agreements with AstraZeneca for CMG901 was approximately RMB 123.967 million in 2023[63] R&D Expenses and Clinical Trials - R&D expenses decreased by 12.6% from RMB 524.3 million in 2022 to RMB 458.1 million in 2023[2] - R&D expenses decreased to RMB 458.1 million in 2023 from RMB 524.3 million in 2022, with clinical research-related expenses decreasing by RMB 31.6 million[32][33][34] - R&D expenses for 2023 decreased to RMB 458.073 million from RMB 524.285 million in 2022[50] - Clinical research expenses decreased to RMB 173,425 thousand in 2023 from RMB 204,991 thousand in 2022, a decline of 15.4%[66] - Preclinical research costs decreased significantly to RMB 34,463 thousand in 2023 from RMB 71,211 thousand in 2022, a drop of 51.6%[66] - MRG003 completed patient enrollment for NPC IIb phase registration clinical study, with NDA expected to be filed in 2024[3] - MRG002 completed patient enrollment for HER2 high-expression BC liver metastasis II phase key clinical trial in China, with good data observed[3] - CG0070 completed patient enrollment for phase III clinical trial in the US and received FDA FTD and BTD in December 2023[4] - MRG004A received FDA ODD for the treatment of PC in December 2023[4] - MRG004A received FDA FTD for the treatment of relapsed or refractory pancreatic cancer in March 2024[4] - MRG003, an EGFR-targeted ADC, has shown high affinity and tumor cell-killing efficacy in clinical trials[10] - MRG002, a HER2-targeted ADC, is in clinical development for multiple indications, including NPC and HNSCC[7] - MRG004A, a TF-targeted ADC, has received FDA ODD and FTD for treating PC and is in clinical trials in the US[6] - MRG003 achieved an ORR of 47.4% and DCR of 79.0% in NPC patients previously treated with PD-1 (L1) and platinum-based chemotherapy as of March 15, 2023[11] - MRG003 received FDA IND approval and FTD for R/M NPC treatment in October and November 2023, respectively[11] - MRG003's 2.0mg/kg dose group showed an ORR of 39.3% and DCR of 71.4%, with mPFS of 7.3 months in NPC patients[11] - MRG003's 2.3mg/kg dose group demonstrated an ORR of 55.2% and DCR of 86.2% in NPC patients, with mPFS not yet mature[11] - MRG002 showed promising data in HER2-high BC liver metastasis, with patient enrollment completed for the Phase II trial in China[12] - MRG001 achieved a CR rate of 17.6% and ORR of 38.2% in CD20-positive DLBCL patients who failed second-line or above treatment as of July 28, 2023[15] - CMG901 demonstrated a confirmed ORR of 33% and DCR of 70% in CLDN18.2-positive GC/GEJ patients across three dose groups as of July 24, 2023[16] - CMG901's 2.2mg/kg dose group showed a confirmed ORR of 42% and mPFS of 4.8 months in CLDN18.2-positive GC/GEJ patients[16] - MRG004A received FDA ODD for PC treatment in December 2023, with Phase I data to be presented at the 2024 ASCO annual meeting[14] - CG0070 demonstrated a 75.7% overall CR rate in NMIBC patients who failed BCG treatment, with 68.2% and 63.6% CR rates at 3 and 6 months, respectively[19] - MRG003 combined with Puyouheng® showed promising preliminary data in solid tumors, with Phase II trials ongoing and data expected to be presented at ASCO 2024[21] - MRG002 combined with Puyouheng® demonstrated positive preliminary data in HER2-expressing solid tumors, with Phase II trials ongoing and data expected at ESMO 2024[21] - CG0070 combined with Puyouheng® received IND approval for Phase I/II trials in BCG-unresponsive NMIBC patients[21] - The company's Hi-TOPi platform for ADCs has advanced MRG006A to IND-enabling studies, with IND submission expected in Q2 2024[22] - The TOPAbody T-cell engager platform has progressed CTM012 to IND-enabling studies, with IND submission planned for 2024[23] - The company's clinical trials include Phase I, Phase II, and Phase III studies to evaluate safety, efficacy, and dosage[88] - The company's clinical trials aim to provide evidence for drug approval through registration trials[88] Net Loss and Financial Metrics - Net loss attributable to the company's owners decreased significantly by 96.8% from RMB 689.1 million in 2022 to RMB 22.1 million in 2023[2] - Adjusted net loss (non-IFRS) decreased from RMB 699.4 million in 2022 to RMB 250.6 million in 2023[2] - Net loss decreased significantly by approximately 95.7% compared to 2022[9] - The company's loss decreased from RMB 699.4 million in 2022 to RMB 30.3 million in 2023[37] - Adjusted net loss (non-IFRS measure) was approximately RMB 250.6 million for the year ended December 31, 2023, compared to RMB 699.4 million in 2022[37] - Net loss for 2023 was RMB 30.301 million, a substantial reduction from the net loss of RMB 699.441 million in 2022[50] - Net loss for the year ended December 31, 2023, was approximately RMB 30.3 million, with net cash used in operating activities of approximately RMB 250.8 million[56] - Fair value gains on financial liabilities measured at fair value through profit or loss were RMB 174,976 thousand in 2023, compared to a loss of RMB 62,816 thousand in 2022[67] - Dilution gain from an associate company amounted to RMB 116,388 thousand in 2023, with no comparable figure in 2022[68] - Gain from the sale of an investment in an associate company was RMB 103,874 thousand in 2023, with no comparable figure in 2022[68] Product Sales and Licensing - Sales revenue from Puheng® (Puliximab Injection) reached RMB 101.4 million in 2023[9] - Licensing revenue from KYM's agreement with AstraZeneca for CMG901 development and commercialization amounted to RMB 109.5 million[9] - Sales revenue from pharmaceutical products in 2023 was RMB 101.4 million, a 551.1% increase from 2022[29] - Puyouheng® (Pudilizumab Injection) achieved sales revenue exceeding RMB 100 million in 2023[25] - The company's licensing business generated total revenue of approximately RMB 124.0 million in 2023, including RMB 109.5 million received from KYM[25] - KYM Biosciences Inc. received a $63.0 million upfront payment and is eligible for up to $1,125.0 million in additional payments upon achieving development, regulatory, and commercial milestones[63] - KYM Biosciences Inc. entered into a global exclusive licensing agreement with AstraZeneca on February 23, 2023[86] Operational and Administrative Expenses - The company's sales and marketing expenses for 2023 were RMB 43.3 million, up significantly from RMB 1.7 million in 2022[30] - Administrative expenses decreased to RMB 86.7 million in 2023 from RMB 138.8 million in 2022, primarily due to reduced listing expenses[31] - Employee benefit expenses increased to RMB 198,906 thousand in 2023 from RMB 188,344 thousand in 2022, a rise of 5.6%[66] - Depreciation and amortization expenses rose to RMB 102,572 thousand in 2023 from RMB 95,446 thousand in 2022, an increase of 7.5%[66] - Total number of employees as of December 31, 2023, is 429, with total salary costs increasing to RMB 198.9 million from RMB 188.3 million in 2022 due to the expansion of the sales team following product commercialization[45] Financial Position and Liabilities - Cash and cash equivalents decreased from RMB 669.4 million in 2022 to RMB 426.0 million in 2023, mainly due to ongoing R&D activities[40] - Bank borrowings increased to RMB 694.3 million in 2023 from RMB 650.0 million in 2022, with unsecured loans totaling RMB 394.0 million[40] - The company's asset-liability ratio decreased to 62.73% in 2023 from 64.39% in 2022[41] - Capital commitments for property, plant, and equipment were RMB 456.6 million as of December 31, 2023, compared to RMB 482.0 million in 2022[42] - The company sold a 15% stake in Haoyang Biotech for RMB 125 million, reducing its ownership to 5.68%[41] - Total assets as of December 31, 2023, were RMB 2.384 billion, a slight decrease from RMB 2.529 billion in 2022[52] - Total liabilities as of December 31, 2023, were RMB 1.496 billion, down from RMB 1.628 billion in 2022[53] - Cash and cash equivalents as of December 31, 2023, were approximately RMB 426.0 million, with net current liabilities of approximately RMB 222.4 million[56] - Trade receivables stood at RMB 38,014 thousand as of December 31, 2023, with a provision for impairment of RMB 212 thousand[74] - Trade payables as of December 31, 2023, amounted to RMB 207,611 thousand, with RMB 196,909 thousand due within one year and RMB 10,702 thousand due within one to two years[81] - The fair value of the variable consideration payable as of December 31, 2023, includes 4.375% of the actual net sales of the PD-1 product in 2023 (approximately RMB 4,436,000) and 4.375% of the estimated net sales of the PD-1 product in 2024 (approximately RMB 6,015,000)[79] - The fair value of financial liabilities measured at fair value through profit or loss as of December 31, 2023, was RMB 272,625 thousand, compared to RMB 448,282 thousand as of December 31, 2022[80] Corporate Governance and Share Structure - The company has adopted and complied with the Corporate Governance Code and the Standard Code for Securities Transactions[45][46] - The company did not recommend the payment of a final dividend for the year ended December 31, 2023[47] - The company did not purchase, sell, or redeem any of its listed securities during the year ended December 31, 2023[47] - The company's shares include domestic shares, unlisted foreign shares, and H shares, each with a par value of RMB 1.00[89] - The company's board includes executive directors Dr. Zhongjie Pu (Chairman) and Dr. Ziye Sui (General Manager), non-executive directors Ms. Jue Pu and Mr. Hongbing Yang, and independent non-executive directors Mr. Demin Zhou, Mr. Haifeng Yang, and Mr. Fengmao Hua[90] - The company's H-shares were listed on the Main Board of the Hong Kong Stock Exchange on February 23, 2022[86] - The company issued 126,876,000 H shares at a price of HKD 7.13 per share during the global offering in 2022[76] - The company issued an additional 899,000 H shares at HKD 7.13 per share as part of the over-allotment option exercise in 2022[77] Product Approvals and Market Penetration - Puheng® (Puliximab Injection) received conditional approval in China for MSI-H/dMMR and unresectable or metastatic melanoma[8] - The company's product Putrelimab (Puyouheng®) was included in the 2023 CSCO and CSGO guidelines for treating melanoma and MSI-H/dMMR solid tumors[26] - The company has completed bidding procedures on procurement platforms in 21 provinces and covers approximately 76 cities as of December 31, 2023[26] - The company plans to accelerate the NDA application for MRG003 and expects to submit the NDA in 2024[28] - The company aims to expand its commercialization team and deepen market penetration for Puyouheng® in 2024[29] Research and Development Platforms - The company is involved in the development of ADC (Antibody-Drug Conjugate) technology, specifically using valine-citrulline linkers that are stable in blood circulation and effectively cleaved by lysosomal cathepsins after ADC internalization[90] - The company's research includes the development of monoclonal antibodies and PD-1/PD-L1 inhibitors[87] - The company's products target diseases such as HNSCC, NHL, NMIBC, and NPC[87] - The company focuses on the discovery and development of innovative biologics in the fields of autoimmune and oncology therapies[86] - KYM Biosciences Inc. is a joint venture established in the United States by the company and AstraZeneca[86] Financial Income and Costs - Financial income decreased from RMB 45.9 million in 2022 to RMB 8.3 million in 2023, primarily due to reduced exchange gains[36] - Financial costs increased from RMB 8.6 million in 2022 to RMB 16.0 million in 2023, mainly due to higher interest on borrowings[36]