Core Viewpoint - The article highlights the rapid development of the Chinese innovative pharmaceutical company, Nuo Cheng Jian Hua, since its establishment in 2015, showcasing its competitive advantages through continuous innovation and the successful commercialization of its core product, Obinutuzumab [4][5]. Group 1: Company Development - Nuo Cheng Jian Hua has established a rich product pipeline in hematological malignancies, autoimmune diseases, and solid tumors, with its core product, Obinutuzumab, achieving commercialization [4][5]. - The company has successfully listed on both the Hong Kong Stock Exchange and the Sci-Tech Innovation Board, benefiting from supportive policies for innovative drug companies [8][10]. - As of December 31, 2024, Nuo Cheng Jian Hua reported a cash balance of 7.76 billion yuan, indicating strong financial health [12]. Group 2: Product Innovation - Obinutuzumab, a novel BTK inhibitor developed by the company, has received approval for a new indication in first-line treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) [5][7]. - The drug has shown potential effects in treating demyelinating diseases due to its high target selectivity and ability to penetrate the blood-brain barrier [5]. - The company anticipates the approval of five to six innovative drugs in the next three to five years, with three to four products entering international markets [7]. Group 3: Industry Context - The Chinese biopharmaceutical industry has experienced robust growth, supported by favorable policies and a vibrant innovation ecosystem [13]. - Recent measures from the Beijing Municipal Medical Security Bureau aim to enhance the quality of innovative drug development and streamline clinical trial approvals [13][14]. - The industry is expected to see accelerated innovation and commercialization of domestic drugs, driven by policy support and company initiatives [15].

创新药概念持续活跃 百济神州等多股创历史新高 智通财经4月30日电，百济神州、诺诚健华、锦波生物均创出历史新高，科伦药业、益方生物、泽璟制 药、华东医药、恒瑞医药等涨幅靠前。消息面上，2025年一季度，已经出现了超20笔涉及中国药企全球 授权的交易，BD交易有望在今年再创新高。 ...

此外，诺诚健华还履行社会责任，在乡村振兴、教育支持、患者关爱等方面开展公益活动，向内蒙古太 卜寺旗和阿鲁科尔沁旗捐赠图书，向青海省玉树州曲麻莱县捐赠爱心洗漱包等。其还与患者组织合作， 传递淋巴瘤患者的坚韧与力量，从而激发社会各界对患者的关注与支持。 对此，诺诚健华联合创始人、董事长兼首席执行官崔霁松博士说："2025年是我们发展进程中的第十 年，站在新的起点，我们将继续秉承'科学驱动创新，患者所需为本'的理念，以更开放的姿态拥抱行业 变革，加速推进研发、商业化和全球化，持续完善质量管理体系，深入践行绿色低碳发展战略，积极履 行企业社会责任。" 4月30日，北京生物医药高科技公司诺诚健华正式发布2024年环境、社会和公司治理（ESG）报告，这 也是公司连续第六年发布ESG报告。2024年，公司将ESG理念融入企业发展战略，在创新研发中突破边 界，在质量管控中精益求精，在绿色转型中勇担使命，在公益活动中传递温度，努力实现公司经济效益 与社会效益的双赢，持续为利益相关方创造长期价值。 今年其ESG报告包括"诚信经营 行稳致远""绿色发展 守护未来""品质争先 进而有为""关爱员工 以人为 本""社会互助 和谐前行" ...

此 乃 要 件 请 即 处 理 阁下如对本通函任何方面或应采取的行动有任何疑问，应咨询股票经纪或其他注册证券交易商、银行经理、 律师、专业会计师或其他专业顾问。 阁下如已将名下所有诺诚健华医药有限公司的股份出售或转让，应立即将本通函交予买主或承让人或经手 买卖的银行、股票经纪或其他代理商，以便转交买主或承让人。 香港交易及结算所有限公司及香港联合交易所有限公司对本通函的内容概不负责，对其准确性或完整性亦 不发表任何声明，并明确表示，概不就本通函全部或任何部分内容而产生或因倚赖该等内容而引致的任何损 失承担任何责任。 InnoCare Pharma Limited 诺诚健华医药有限公司 （于开曼群岛注册成立的有限公司） （股份代号：9969） (1) 2024年年度报告； (2) 董事会2024年度工作报告； (3) 2024年度公司利润分配计划； (4) 建议发行及购回股份的一般授权； (5) 重选退任董事； (6) 重新委任核数师； (7) 建议为董事及高级管理层购买责任保险； (8) 建议更新人民币股份发行募集资金用途； 及 (9) 股东周年大会通告 诺诚健华医药有限公司谨订于2025年6月20日（星期五 ...

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].