Core Insights - The trend of license-out transactions involving Chinese pharmaceutical companies continues into 2025, with over 20 deals reported in Q1 alone, including significant agreements worth over $1 billion [2] - However, there is a concerning "return rate" of 40% for completed license-out transactions from 2020, indicating a growing trend of terminated collaborations [5] - The industry is experiencing a "clearing" phase after a surge in business development (BD) activities, with many companies facing challenges in maintaining partnerships [5][6] Group 1: Business Development Trends - In Q1 2025, notable transactions included Roche's $1 billion deal with Innovent Biologics and Lepu Biopharma's $1.2 billion collaboration with ArriVent [2] - Companies like InnoCare and Baillie Gifford have successfully capitalized on BD opportunities, with InnoCare's license-out deals exceeding $6 billion, contributing to its successful IPO [2] - The overall BD transaction volume is expected to reach new highs in 2025, driven by increased interest from global pharmaceutical companies in Chinese innovative drugs [2] Group 2: Challenges and Terminations - As of April 2025, 25 out of 62 completed license-out transactions from 2020 have been terminated, reflecting a 40% return rate [5] - Recent high-profile disputes include Novo Nordisk's $800 million claim against Henlius for alleged fraud and GAVI's termination of a pre-purchase agreement with Clover Biopharmaceuticals [6] - The primary reasons for these terminations include disappointing clinical data and strategic shifts by the buying companies, leading to increased competition and pressure on Chinese biotech firms [6][8] Group 3: Financial Implications - The milestone achievement rate for Chinese innovative drugs is only 22%, indicating that most companies only receive the initial payment, which typically constitutes 2%-5% of the total deal value [9][11] - The financial impact of terminated collaborations is significant, as companies lose potential milestone payments and face challenges in maintaining market confidence [9][12] - The NewCo model is emerging as a more favorable alternative, allowing for shared risk and deeper collaboration between Chinese firms and multinational corporations [13][14] Group 4: Future Outlook - The BD landscape is expected to see an increase in "return" events, as the market matures and companies face heightened scrutiny [15] - Successful future collaborations will require Chinese companies to demonstrate superior clinical data and competitive advantages in the global market [18][19] - The industry must balance the urgency of BD with long-term strategic planning to avoid reliance on potentially volatile partnerships [17][18]

目录 | 关于本报告 | 01 | | --- | --- | | 报告简介 | 01 | | 报告范围 | 01 | | 本报告出现的附属公司名称及简称对照表 | 01 | | 编制依据 | 01 | | 信息来源 | 01 | | 报告原则 | 02 | | 报告批准与获取 | 02 | | 免责声明 | 02 | | 董事长致辞 | 03 | | 关于诺诚健华 | 05 | | 公司概况 | 05 | | 企业使命、愿景与价值观 | 05 | | 诺诚健华 2024 年大事件 | 07 | | 数说 2024 | 08 | | 2024 年度荣誉奖项 | 09 | | ESG 管理 | 11 | | 附录 | 86 | | 意见反馈 | 100 | 1 2 诚信经营，行稳致远 绿色发展，守护未来 | 公司治理 | 17 | | --- | --- | | 风险管控 | 21 | | 廉洁守规 | 25 | | 气候变化 | 29 | | --- | --- | | 环境管理 | 32 | | 节约资源 | 34 | | 绿色运营 | 36 | 3 品质争先，进而有为 4 关爱员工，以人为本 | 人才吸引 ...

此乃要件 請即處理 閣下如對本通函任何方面或應採取的行動有任何疑問，應諮詢股票經紀或其他註冊證券交易商、銀行經理、 律師、專業會計師或其他專業顧問。 閣下如已將名下所有諾誠健華醫藥有限公司的股份出售或轉讓，應立即將本通函交予買主或承讓人或經手 買賣的銀行、股票經紀或其他代理商，以便轉交買主或承讓人。 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通函的內容概不負責，對其準確性或完整性亦 不發表任何聲明，並明確表示，概不就本通函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。 InnoCare Pharma Limited 諾誠健華醫藥有限公司 （ 於 開 曼 群 島 註 冊 成 立 的 有 限 公 司 ） （股份代號：9969） (1) 2024年年度報告； (2) 董事會2024年度工作報告； (3) 2024年度公司利潤分配計劃； (4) 建議發行及購回股份的一般授權； (5) 重選退任董事； (6) 重新委任核數師； (7) 建議為董事及高級管理層購買責任保險； (8) 建議更新人民幣股份發行募集資金用途； 及 (9) 股東週年大會通告 諾誠健華醫藥有限公司謹訂於2025年 ...

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之內容概不負責，對其準確 性或完整性亦不發表任何聲明，並明確表示，概不對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。 InnoCare Pharma Limited 諾誠健華醫藥有限公司 （ 於 開 曼 群 島 註 冊 成 立 的 有 限 公 司 ） （股份代號：9969） 董事會召開日期 諾誠健華醫藥有限公司 主席兼執行董事 崔霽松博士 香港，2025年4月28日 於本公告日期，董事會包括主席兼執行董事崔霽松博士；執行董事趙仁濱博士；非執行董事 施一公博士及謝榕剛先生；以及獨立非執行董事胡蘭女士、董丹丹博士及管坤良教授。 諾誠健華醫藥有限公司（「本公司」）董事會（「董事會」）謹此宣佈，本公司將於 2025年5月13日（星期二）舉行董事會會議，藉以（其中包括）考慮及批准本公司 及其附屬公司截至2025年3月31日止三個月之未經審核第一季度業績及其發佈。 承董事會命 ...

Financial Performance - InnoCare Pharma reported a revenue of $150 million for the fiscal year 2024, representing a 25% increase compared to the previous year[1]. - InnoCare Pharma anticipates a revenue guidance of $200 million for the next fiscal year, reflecting a projected growth rate of 33%[1]. - The company reported a net loss of $10 million for the fiscal year, which is an improvement from a net loss of $15 million in the previous year[1]. - InnoCare Pharma's gross margin improved to 60%, up from 55% in the prior year, indicating better cost management and pricing strategies[1]. - Total revenue increased by 36.7% from RMB 738.5 million in 2023 to RMB 1,009.4 million in 2024, driven by strong sales growth of the drug Oubatinib[46]. - Gross profit rose by 42.8% from RMB 610.1 million in 2023 to RMB 871.0 million in 2024, with a gross margin of 86.3%, up 3.7 percentage points from 82.6% in 2023[46]. - The net loss for the year decreased by 29.9% from RMB 645.6 million in 2023 to RMB 452.9 million in 2024[48]. - Adjusted net loss for the year was RMB 430.8 million in 2024, compared to RMB 490.7 million in 2023, after excluding certain non-cash items[49]. Research and Development - The company is actively developing three new drug candidates, with clinical trials expected to commence in Q2 2024[1]. - InnoCare Pharma has invested $20 million in R&D for innovative therapies, focusing on unmet medical needs in oncology and autoimmune diseases[1]. - The company is conducting over 30 ongoing global trials across various clinical stages, indicating a strong commitment to research and development[17]. - The company is committed to developing high-quality innovative drugs and expanding its pipeline to meet the growing global demand for innovative therapies[57]. - The company is actively developing a range of innovative oral therapies for autoimmune diseases, including small molecules and oral cyclic peptides[36]. - The company is exploring potential mergers and acquisitions to enhance its product portfolio and market reach, with a budget of $50 million allocated for this purpose[1]. - The company aims to enhance value through excellence in clinical trials, accelerated product development, and improved operational efficiency despite global market volatility[51]. Product Development and Pipeline - The company has established strategic partnerships with two leading biotech firms to accelerate the development of its pipeline products[1]. - The monoclonal antibody, Tisagenlecleucel, is expected to receive Biologics License Application (BLA) approval in the first half of 2025[18]. - The company aims to establish itself as a leader in the hematology field, focusing on significant diseases such as Non-Hodgkin Lymphoma (NHL) and leukemia[18]. - The company has a robust pipeline of innovative high-value assets, including two commercialized products[17]. - The company is committed to leveraging both monotherapy and combination therapy to address major diseases effectively[18]. - The company plans to submit an IND application for ICP-B794 in the first half of 2025, further advancing its pipeline in solid tumor therapies[42]. - The company is expanding its pipeline through internal R&D and strategic collaborations, focusing on complementary assets that enhance clinical development and commercialization capabilities[67]. Clinical Trials and Approvals - The NDA for first-line CLL/SLL treatment with ibrutinib has been accepted by the CDE, with approval expected within the year[23]. - The combination therapy of tazemetostat and lenalidomide has received priority review from the NMPA, with BLA approval expected in the first half of 2025[23]. - The company is conducting a study for ICP-490 in NHL, with the first patient expected to be enrolled by March 2025[25]. - The company is conducting a Phase IIb trial for Socitinib (ICP-332) in ITP patients, with a registration trial initiated in China in H1 2023[65]. - The company plans to submit an NDA for Orelabrutinib in SLE by H1 2026, following positive results from a Phase IIa trial[64]. - The company plans to submit an NDA application for ITP treatment in the first half of 2026[129]. Market Expansion and Strategy - InnoCare Pharma plans to expand its market presence in Europe and North America, targeting a 15% market share in these regions by 2025[1]. - The company is exploring strategic partnerships to accelerate global reach and enhance regulatory and clinical capabilities in key markets[55]. - The strategic partnership with Prolium for the development and commercialization of ICP-B02 marks a key step in expanding international influence[62]. - The company has established a large molecule CMC pilot facility in Beijing for early clinical supplies and is constructing a new R&D center and large molecule production facility[182]. Financial Stability and Investments - Cash and cash equivalents as of December 31, 2024, were approximately RMB 7.8 billion, providing flexibility for clinical development and investment in competitive product lines[48]. - The company has a cash balance of RMB 7.8 billion at year-end, providing financial stability and flexibility to navigate macroeconomic challenges[56]. - The company plans to issue up to 12,337,750 shares under the 2024 RMB share incentive plan to attract and retain talent[184]. Clinical Efficacy and Safety - ICP-248 has shown promising results in early-stage trials for CLL/SLL patients, with an overall response rate (ORR) of 100%, complete response rate (CRR) of 53.4%, and undetectable minimal residual disease (uMRD) rate of 46.2% after 12 weeks of treatment[22]. - The ORR for relapsed/refractory CLL/SLL patients treated with 125mg ICP-248 is 87.5%, with a CRR of 6.3%[26]. - The ORR for relapsed/refractory MCL patients treated with 125mg ICP-248 is 79.2%, with a CRR of 37.5%[26]. - The company is exploring the efficacy of ICP-488 in psoriasis patients and other autoimmune diseases, with patient recruitment for a Phase III trial initiated in March 2025[38]. - The company has successfully completed patient recruitment for a Phase II pivotal trial evaluating Tazemetostat combined with Lenalidomide, with results expected to be presented at the EHA 2024 conference[96].

Investment Rating - The report maintains an "Accumulate" rating for the pharmaceutical and biotechnology sector [4]. Core Viewpoints - The domestic weight loss drug market is entering commercialization, emphasizing the importance of sales capabilities for companies [1][19]. - The competition in the global weight loss drug market is intensifying, particularly between Novo Nordisk and Eli Lilly, where marketing strategies play a crucial role in sales performance [19][23]. - Companies with advanced R&D progress and strong sales execution will hold competitive advantages in the commercialization phase of weight loss drugs [1][19]. Summary by Sections Market Review - The pharmaceutical and biotechnology index rose by 1.16%, outperforming the CSI 300 index by 0.77 percentage points but underperforming the ChiNext index by 1.08 percentage points, ranking 15th among 31 sub-industries [1][15]. - The Hong Kong Hang Seng Healthcare Index increased by 8.44%, outperforming the Hang Seng Index by 6.12 percentage points [1][15]. Company Updates - Recent clinical application updates include Baiyi Shenzhou's injection BGB-B2033 and Nuo Cheng Jian Hua's injection ICP-B794, both newly undertaken [27]. - Ongoing clinical trials include Bo Rui Pharmaceutical's BGM0504 and Hua Dong Pharmaceutical's HDM1002, currently in Phase III [27]. Investment Strategy - The report suggests a structural selection of investment opportunities based on payment willingness and ability, focusing on three payment channels: in-hospital payments, out-of-pocket payments, and overseas payments [2]. - Key recommended companies include Heng Rui Pharmaceutical, Mai Rui Medical, and United Imaging Healthcare [2]. Company Profit Forecasts and Valuation - Heng Rui Pharmaceutical is rated "Accumulate" with a projected EPS of 0.99 yuan for 2024 and a PE ratio of 51 [3]. - Mai Rui Medical is rated "Buy" with a projected EPS of 11.47 yuan for 2024 and a PE ratio of 19 [3]. - United Imaging Healthcare is also rated "Buy" with a projected EPS of 2.88 yuan for 2024 and a PE ratio of 44 [3].

Investment Rating - The report does not explicitly state an investment rating for the industry, but it suggests a long-term focus on domestic innovative drugs in the oncology field and AI medical investment opportunities [3][4]. Core Insights - The pharmaceutical and biotechnology sector saw a weekly increase of 1.16%, outperforming the Wind All A index (1.15%) and the CSI 300 index (0.38%) [3][8]. - The upcoming ASCO conference is highlighted as a significant event for domestic innovative drug companies, with over 70 oral presentations and more than 10 major studies expected [3][4]. - The Ministry of Industry and Information Technology and six other departments issued a plan for the digital transformation of the pharmaceutical industry, aiming for significant advancements by 2027 and full coverage by 2030 [3][4]. Market Weekly Review - The pharmaceutical and biotechnology sector increased by 1.16% from April 21 to April 25, outperforming the Wind All A index and the CSI 300 index [3][8]. - Notable performers included medical research outsourcing (6.34%) and raw materials (4.72%), while blood products (-3.26%) and vaccines (-6.38%) continued to decline [3][9]. - Individual stock performances showed significant gains for Yong'an Pharmaceutical (31.4%), Shuyou Shen (28.4%), and Erkang Pharmaceutical (27.7%), while *ST Jiyuan (-43.2%), Nanhua Biological (-35.3%), and Shuangcheng Pharmaceutical (-27.7%) faced substantial losses [3][11]. Industry News and Key Company Announcements - On April 25, Kangfang Bio announced FDA approval for its drug Anike for the treatment of recurrent or metastatic nasopharyngeal carcinoma [12]. - The same day, Kangfang Bio also reported the approval of its PD-1/VEGF bispecific antibody for first-line treatment of specific lung cancer types [13]. - The digital transformation plan for the pharmaceutical industry aims to enhance competitiveness and quality management through AI and data integration by 2030 [3][4].

Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical and biotechnology industry [1]. Core Insights - The approval of 康方生物's依沃西单抗 for first-line treatment of PD-L1 positive non-small cell lung cancer (NSCLC) has significantly increased global interest in PD-1/VEGF dual antibodies, indicating a promising investment opportunity in this sector [21][23]. - The report highlights the strong performance of the A-share pharmaceutical index, which has increased by 1.2% this week and decreased by 0.3% year-to-date, outperforming the CSI 300 index by 0.8% and 3.5% respectively [4][9]. - The report suggests a ranking of favored sub-industries as follows: innovative drugs > CXO > traditional Chinese medicine > medical devices > pharmacies > pharmaceutical commerce [10][11]. Summary by Sections Industry Trends - The A-share pharmaceutical index has shown a weekly increase of 1.2% and a year-to-date decrease of 0.3%, while the H-share biotechnology index has increased by 9% this week and 30% year-to-date, outperforming the Hang Seng Technology Index by 7% and 18.5% respectively [4][9]. - Specific sectors such as raw materials (+4.7%), medical services (+3.4%), and chemical drugs (+2.7%) have seen significant price increases, while pharmaceutical commerce (-0.3%), traditional Chinese medicine (-0.5%), and biological products (-0.9%) have experienced declines [4][9]. Research and Development Progress - 康方生物's依沃西单抗 has been approved for use in treating PD-L1 positive NSCLC, marking a significant milestone in the development of PD-1/VEGF dual antibodies [21]. - The report notes that several companies, including 三生制药 and 宜明昂科, are advancing their PD(L)1/VEGF dual antibodies through various clinical stages, indicating a competitive landscape in this therapeutic area [23]. Investment Strategy - The report recommends focusing on growth-oriented stocks primarily in the innovative drug sector, with specific mentions of companies such as 信达生物, 康方生物, and 恒瑞医药 [11]. - For undervalued stocks, the report suggests looking into traditional Chinese medicine companies like 佐力药业 and 东阿阿胶, while high-dividend stocks are recommended from the same sector, including 江中药业 and 云南白药 [11].

Core Viewpoint - The approval of the new BTK inhibitor, Oubatinib (brand name: Yinuokai), by the National Medical Products Administration (NMPA) in China for first-line treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) represents a significant advancement in the treatment options available for lymphoma patients [1] Group 1: Company Overview - Nocare Biopharma (stock codes: 688428 on SSE; 09969 on HKEX) is a biopharmaceutical high-tech company focused on the development of innovative drugs for malignant tumors and autoimmune diseases [3] - The company has multiple new drug products at various stages of commercialization, clinical trials, and preclinical research, with branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States [3] Group 2: Product Approval and Impact - Oubatinib has previously been approved in China for treating relapsed/refractory CLL/SLL, mantle cell lymphoma (R/R MCL), and marginal zone lymphoma (R/R MZL), all of which are included in the national medical insurance [1] - The first-line approval for CLL/SLL is expected to benefit a larger number of lymphoma patients, with clinical trials showing a complete remission rate of 12.1% [1] - Experts have highlighted Oubatinib's high selectivity and low off-target effects, which enhance its efficacy and safety in treating blood cancers [1] Group 3: Clinical Research and Expert Opinions - Clinical researchers noted that Oubatinib demonstrated significant efficacy and safety even during the challenges posed by the COVID-19 pandemic, confirming its innovative nature [1] - The drug has been included as a Class I recommendation in the CSCO lymphoma treatment guidelines for first-line therapy of CLL/SLL, indicating its recognized importance in clinical practice [1] - Experts anticipate that the accumulation of real-world data will further guide clinical practices and improve treatment options for more lymphoma patients [1]