Core Viewpoint - The pharmaceutical sector is experiencing a rebound, with significant stock price increases for several companies following regulatory support for innovative drug clinical trial approvals [1] Group 1: Stock Performance - Several pharmaceutical stocks have seen notable gains, including: - Hutchison China MediTech (00013) up 11.04% to HKD 27.96 - Innovent Biologics (09969) up 10.76% to HKD 18.63 - Zai Lab (09688) up 7.84% to HKD 26.14 - Lepu Biopharma-B (02157) up 7.3% to HKD 8.53 - CanSino Biologics (09926) up 6.5% to HKD 136 [1] Group 2: Regulatory Developments - The National Medical Products Administration (NMPA) has proposed to optimize the review and approval process for innovative drug clinical trials, aiming to complete reviews within 30 working days for eligible applications [1] - This initiative supports key national R&D projects and encourages global early-stage synchronized development and international multi-center clinical trials [1] Group 3: Market Sentiment and Challenges - There are concerns regarding potential restrictions on Chinese innovative drugs in the U.S. market, but many pharmaceutical companies believe these rumors will not significantly impact the prospects for Chinese drugs abroad [1] - HSBC notes that the short-term emotional impact of these rumors may be greater than the actual damage, as prohibiting patent transactions is technically challenging [1] - Global pharmaceutical companies are facing a "patent cliff" risk and are in need of high-quality Chinese assets to strengthen their product pipelines, leading to lobbying against such administrative orders [1]

Core Viewpoint - Pharmaceutical stocks experienced a rebound today, with significant gains observed in several companies following regulatory news from the National Medical Products Administration (NMPA) regarding the optimization of clinical trial review and approval processes for innovative drugs [1] Group 1: Stock Performance - Hutchison China MediTech (00013) rose by 11.04%, trading at HKD 27.96 [1] - Innovent Biologics (09969) increased by 10.76%, trading at HKD 18.63 [1] - Zai Lab (09688) saw a rise of 7.84%, trading at HKD 26.14 [1] - Lepu Biopharma-B (02157) gained 7.3%, trading at HKD 8.53 [1] - CanSino Biologics (09926) increased by 6.5%, trading at HKD 136 [1] Group 2: Regulatory Developments - The NMPA announced a plan to further optimize the review and approval process for clinical trials of innovative drugs, aiming to complete reviews within 30 working days for eligible applications [1] - This initiative supports key national R&D projects and encourages global early-stage synchronized development and international multi-center clinical trials [1] Group 3: Market Sentiment and Risks - Recent negative rumors regarding potential restrictions on Chinese innovative drugs entering the U.S. market have been noted, but several pharmaceutical companies believe these rumors do not currently impact the expectations for Chinese innovative drugs abroad [1] - HSBC indicated that the short-term emotional impact of these rumors may be greater than the actual damage, as prohibiting patent transactions is technically challenging [1] - Global pharmaceutical companies are facing a "patent cliff" risk and are in need of high-quality Chinese assets to strengthen their product pipelines, leading to lobbying against such administrative orders [1]

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]

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》（以下简称"《上市规则》"）和《上海证券交易所上市公司自律监管指引第 11 号 ——持续督导》等相关规定，中国国际金融股份有限公司（以下简称"中金公司" 或"保荐机构"）作为诺诚健华医药有限公司（以下简称"诺诚健华"、"公司"）首 次公开发行股票并在科创板上市以及持续督导工作的保荐机构，负责诺诚健华上市 后的持续督导工作，并出具 2025 年半年度持续督导跟踪报告，本持续督导期间为 2025 年 1 月 1 日至 2025 年 6 月 30 日。 | 一、持续督导工作情况 | | --- | | 序号 | 工作内容 | 持续督导情况 | | --- | --- | --- | | 1 | 建立健全并有效执行持续督导工作制度，并针对具体 的持续督导工作制定相应的工作计划 | 保荐机构已建立健全并有效执 | | | | 行了持续督导制度，并制定了 | | | | 相应的工作计划 | | 2 | 根据中国证监会相关规定，在持续督导工作开始前， 与上市公司或 ...

Core Viewpoint - Nocera Health experienced a stock price decline of 2.02% on September 5, 2023, with a current price of 27.15 CNY per share, despite a year-to-date increase of 121.09% [1] Company Overview - Nocera Health, established on November 3, 2015, and listed on September 21, 2022, is based in Beijing and focuses on the research, production, and commercialization of biopharmaceuticals, particularly in oncology and autoimmune diseases [1] - The company's revenue composition includes 87.67% from drug sales, 12.04% from technology licensing, and 0.15% each from testing and R&D services [1] Financial Performance - For the first half of 2025, Nocera Health reported a revenue of 731 million CNY, reflecting a year-on-year growth of 74.26%, while the net profit attributable to shareholders was -30.09 million CNY, an increase of 88.51% year-on-year [2] Shareholder Information - As of June 30, 2025, the number of shareholders increased by 13.80% to 15,200, with an average of 0 circulating shares per shareholder [2] - The top ten circulating shareholders include notable funds such as China Europe Medical Health Mixed A and E Fund Precision Medical Flexible Allocation Mixed A, with changes in their holdings noted [3]