每经AI快讯，9月12日，诺诚健华(09969.HK)午后放量走高，截至发稿，涨12.96%，报19港元，成交额 4.06亿港元。 （文章来源：每日经济新闻） ...

消息面上，9月8日，诺诚健华宣布，宜诺凯(奥布替尼)已获得新加坡卫生科学局(HSA)的批准，用于治 疗复发/难治性边缘区淋巴瘤(R/R MZL)成人患者。这是宜诺凯在新加坡获批的第二项适应症。据悉，宜 诺凯已在中国获批用于治疗既往至少接受过一次治疗的CLL/SLL、套细胞淋巴瘤(R/R MCL)和边缘区淋 巴瘤(R/R MZL)，三项适应症均已纳入中国国家医保。 西部证券（002673）指出，2025上半年诺诚健华实现收入7.31亿元，同比增长74.3%，其中核心产品奥 布替尼销售6.37亿元，同比增长52.8%。奥布替尼销售持续高增长，期内，奥布替尼治疗1L CLL/SLL新 适应症获批上市，并获2025版CSCO淋巴瘤指南1级推荐，进一步拓展奥布替尼在血液瘤领域市场潜 力，市场渗透率显著提升。此外，2025年5月公司第二款创新药坦昔妥单抗获批上市，用于联合来那度 胺治疗复发难治性DLBCL，商业化产品矩阵持续丰富。 诺诚健华(09969)午后放量走高，截至发稿，涨12.96%，报19港元，成交额4.06亿港元。 ...

Core Viewpoint - Nocera Health (09969) experienced a significant stock increase of 12.96%, reaching HKD 19, with a trading volume of HKD 406 million following the approval of its drug Ibrutinib for a new indication in Singapore [1] Group 1: Company Developments - Nocera Health announced on September 8 that Ibrutinib has received approval from the Health Sciences Authority (HSA) of Singapore for the treatment of relapsed/refractory marginal zone lymphoma (R/R MZL) in adult patients, marking the second indication approved in Singapore [1] - The company reported a revenue of CNY 731 million for the first half of 2025, representing a year-on-year growth of 74.3%, with sales of its core product Ibrutinib reaching CNY 637 million, a 52.8% increase year-on-year [1] - The approval of Ibrutinib for the new indication of first-line CLL/SLL has been included in the 2025 CSCO lymphoma guidelines with a level 1 recommendation, enhancing its market potential in hematological malignancies [1] Group 2: Market and Product Insights - Ibrutinib has already been approved in China for the treatment of patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), relapsed/refractory mantle cell lymphoma (R/R MCL), and relapsed/refractory marginal zone lymphoma (R/R MZL), all of which are covered by the national medical insurance [1] - The company is expanding its product portfolio with the approval of its second innovative drug, Tansimab, in May 2025 for use in combination with Lenalidomide for the treatment of relapsed/refractory DLBCL, further enriching its commercial product matrix [1]

Investment Rating - The report maintains an "Overweight" rating for the innovative drug sector, indicating that the industry is expected to outperform the overall market [5][11]. Core Insights - The report emphasizes the long-term investment value of Chinese innovative drugs, highlighting three main supporting logics: innovation upgrades, profitability inflection points, and normalization of outbound business development (BD) [5]. - Chinese biotech companies are demonstrating significant capabilities in global innovation, with notable products emerging in the PD-1/VEGF dual antibody and EGFR/c-MET dual antibody ADC categories [5]. - Leading biotech firms like BeiGene and Innovent Biologics are projected to reach profitability in 2025, suggesting a sustained high growth trajectory for the sector [5]. - The total value of license-out agreements from mainland China to Europe and the US has reached $94.3 billion as of September 2025, significantly surpassing the $51.9 billion recorded for the entirety of 2024 [5]. Summary by Sections Industry Overview - The report discusses the potential impact of a proposed US government draft that aims to limit American pharmaceutical companies from acquiring experimental drugs from China, although the likelihood of this draft being implemented is considered low [5]. - The report argues that even if the US tightens regulations, Chinese biotech can still pursue collaborations with European firms and establish overseas companies to navigate these restrictions [5]. Company Valuations - The report includes a valuation table for key companies in the pharmaceutical and biotech sector, detailing market capitalization, earnings per share (EPS) projections, and price-to-earnings (PE) ratios for 2024 to 2027 [6]. - Notable companies mentioned include: - Hengrui Medicine with a market cap of 453.3 billion yuan and a projected PE ratio of 68.3 for 2024 [6]. - BeiGene with a market cap of 436.5 billion yuan, expected to turn profitable by 2026 [6]. - Innovent Biologics and other firms are also highlighted for their growth potential and market performance [6].

Core Viewpoint - The approval of Ibrutinib (Yinokai) for the treatment of relapsed/refractory marginal zone lymphoma (R/R MZL) in Singapore marks a significant step in the international expansion of the company [1] Group 1: Product Approval and Development - Ibrutinib has received approval from the Health Sciences Authority (HSA) in Singapore for treating adult patients with R/R MZL, representing the second indication approved for the drug in Singapore [1] - The company is advancing Ibrutinib's global development in the field of autoimmune diseases, in addition to its application in lymphoma treatment [1] Group 2: Market Context and Patient Needs - Marginal zone lymphoma (MZL) is a type of indolent B-cell non-Hodgkin lymphoma (NHL) primarily affecting the elderly, with an increasing incidence rate globally [1] - There is a lack of effective treatment options for MZL patients who experience disease progression or relapse after first-line therapy [1] Group 3: Previous Approvals - Earlier in April, Ibrutinib was approved in China for first-line treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) [2] - The drug has also been approved in China for treating R/R CLL/SLL, R/R mantle cell lymphoma (MCL), and R/R MZL, with all three indications included in the national medical insurance [2]

Group 1 - The core point of the article is that Innovent Biologics has received approval from the Health Sciences Authority of Singapore for its drug Ibrutinib (宜诺凯®) to treat relapsed/refractory marginal zone lymphoma (R/R MZL) in adult patients, marking a significant step in the company's international expansion [2] - Ibrutinib is a highly selective BTK inhibitor developed by Innovent, which aims to improve safety and efficacy by avoiding off-target adverse events, and is being advanced for the treatment of hematological malignancies and autoimmune diseases [2] - The approval in Singapore is the second indication for Ibrutinib, following its earlier approval for first-line treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) in China [3] Group 2 - Marginal zone lymphoma (MZL) is a type of indolent B-cell non-Hodgkin lymphoma (NHL) primarily affecting the elderly, with a rising incidence globally, and patients with disease progression/relapse after first-line treatment currently lack effective treatment options [2]

Core Insights - The company Innovent Biologics has received approval from the Health Sciences Authority of Singapore for its drug Ibrutinib (Yinokai) to treat relapsed/refractory marginal zone lymphoma (R/R MZL) in adult patients, marking a significant step in its international expansion [1] - Ibrutinib is a highly selective BTK inhibitor that has demonstrated good efficacy and safety in treating R/R MZL, providing new treatment options for lymphoma patients in Singapore [1] - The company is also advancing the global development of Ibrutinib for autoimmune diseases, in addition to its applications in hematologic malignancies [1] Company Developments - In April of this year, Ibrutinib was approved in China for first-line treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) [2] - Prior approvals in China include treatments for previously treated CLL/SLL, relapsed/refractory mantle cell lymphoma (R/R MCL), and R/R MZL, all of which are covered by the national health insurance [2] Industry Context - Marginal zone lymphoma (MZL) is a type of indolent B-cell non-Hodgkin lymphoma (NHL) primarily affecting the elderly, with a rising incidence rate globally [1] - Patients with MZL who progress or relapse after first-line treatment currently lack effective therapeutic options [1]

Company Overview - InnoCare Pharma is a leading biopharmaceutical company focused on developing treatments for cancer and autoimmune diseases, with a commitment to addressing unmet medical needs globally [5] Product Approval - HIBRUKA (orelabrutinib) has received approval from the Health Sciences Authority (HSA) of Singapore for treating adult patients with relapsed or refractory marginal zone lymphoma (R/R MZL) [1][2] - This marks the second indication approval for orelabrutinib in Singapore, following its previous approval for other indications [2] Product Efficacy and Safety - Orelabrutinib is a highly selective BTK inhibitor that has shown good efficacy and safety in treating R/R MZL, providing a new treatment option for local lymphoma patients [2] - The drug's high target selectivity minimizes off-target effects, enhancing both safety and efficacy [2] Market Context - Marginal zone lymphoma (MZL) is an indolent B-cell non-Hodgkin's lymphoma primarily affecting middle-aged and elderly patients, with an increasing annual incidence globally [3] - Patients with R/R MZL often lack effective treatment options after first-line therapy [3] Previous Approvals - In April 2025, orelabrutinib was approved in China for the first-line treatment of chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL) and has received approvals for three other indications, including R/R CLL/SLL, R/R mantle cell lymphoma (MCL), and R/R MZL, all included in China's National Reimbursement Drug List [4]

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） 海外監管公告 本公告乃諾誠健華醫藥有限公司（「本公司」）根據香港聯合交易所有限公司證 券上市規則第13.10B條作出。 茲載列本公司於上海證券交易所網站刊登之《中國國際金融股份有限公司關於 諾誠健華醫藥有限公司2025年半年度持續督導跟蹤報告》。 承董事會命 諾誠健華醫藥有限公司 主席兼執行董事 崔霽松博士 香港，二零二五年九月五日 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。 中国国际金融股份有限公司 关于诺诚健华医药有限公司 2025 年半年度持续督导跟踪报告 根据《证券发行上市保荐业务管理办法》《上海证券交易所科创板股票上市规 则 ...

Group 1 - The company is engaged in the research, development, production, and commercialization of innovative biopharmaceuticals, with a focus on oncology and autoimmune diseases [5][6][12] - The company has received conditional approval for its main product, Acalabrutinib (Ibrutinib), which is used for treating various types of blood cancers [5][9] - The company has not yet achieved profitability and is facing cumulative losses, with significant ongoing research and development expenses [5][23] Group 2 - In the first half of 2025, the company reported revenue of 731 million yuan, a year-on-year increase of 74.26%, but still incurred a net loss of 30 million yuan [5][6] - The company is required to complete confirmatory clinical trials for Acalabrutinib to obtain full approval, which introduces uncertainty regarding its market potential [9][10] - The company faces intense competition in the market, with existing products and ongoing clinical trials from other companies [12][22] Group 3 - The company has established a production facility in Guangzhou that meets GMP standards, but faces risks related to supply chain disruptions and regulatory compliance [17][18] - The company is subject to strict regulatory oversight, which may impact its ability to market and sell its products effectively [16][28] - The company is actively seeking strategic partnerships to enhance its research and commercialization efforts, but faces challenges in establishing these relationships [19][24]