Group 1 - The A-share market experienced fluctuations on September 12, with a rebound in the innovative drug concept in the afternoon [1] - The Tianhong Innovative Drug ETF (517380) showed a "W" shaped reversal in the morning and continued to strengthen in the afternoon, rising by 1.50% with a trading volume exceeding 58 million yuan [1] - Notable stocks within the Tianhong Innovative Drug ETF included Nocare Pharma-U, which rose over 14%, and Zhaoyan New Drug, which hit the daily limit [1] Group 2 - The Biopharmaceutical ETF (159859) increased by 0.88%, with a trading volume exceeding 90 million yuan, featuring stocks like Junshi Biosciences-U and WuXi AppTec among the top gainers [1] - As of September 11, the Tianhong Innovative Drug ETF had seen a net inflow of over 79 million yuan over four consecutive days, while the Biopharmaceutical ETF had a net inflow of over 220 million yuan over three days [1] Group 3 - The Tianhong Innovative Drug ETF is the largest in the market, covering both A-shares and Hong Kong stocks, and is the only ETF tracking the Hang Seng-Hushen-Hong Kong Innovative Drug Select 50 Index [1] - The Biopharmaceutical ETF closely tracks the Guozheng Biopharmaceutical Index, which covers various sectors including innovative drugs, CXO, vaccines, and blood products [1] Group 4 - The National Medical Products Administration announced measures to optimize the review and approval of clinical trials for innovative drugs, aiming to complete reviews within 30 working days for eligible applications [1] - This initiative supports key national research and encourages global early-stage synchronized research and international multi-center clinical trials [1] Group 5 - Short-term outlook suggests that many innovative drug stocks have seen significant gains since the beginning of the year, which may lead to profit-taking in response to negative news [2] - The biotech sector in China is expected to maintain high investment value due to continuous innovation breakthroughs and improved profitability [2] Group 6 - The Hong Kong innovative drug sector reported a net profit of 1.8 billion yuan in the first half of the year, marking its first profit since turning around [2] - The industry is entering a new cycle driven by profitability, with leading companies achieving profits through the commercialization of products and accelerating the conversion of research value [2]

Core Points - The Shanghai Composite Index is at 3881.52 points, above the five-day moving average, with a slight increase of 0.16% [1] - The total trading volume of A-shares today is 20,744.93 billion yuan, with 378 A-shares breaking through the five-day moving average [1] Summary by Category Stock Performance - The top three stocks with the highest deviation rates from the five-day moving average are: - Mengguli (盟固利) with a deviation rate of 10.01% and a price increase of 14.25% [2] - Nuocheng Jianhua (诺诚健华) with a deviation rate of 9.72% and a price increase of 12.72% [2] - Zhaoxin Co. (兆新股份) with a deviation rate of 8.44% and a price increase of 10.10% [2] Trading Activity - The trading turnover rates for the top three stocks with the highest deviation rates are: - Mengguli (盟固利) at 24.56% [2] - Nuocheng Jianhua (诺诚健华) at 6.63% [2] - Zhaoxin Co. (兆新股份) at 10.18% [2] Additional Stocks - Other notable stocks with significant price increases and deviation rates include: - Anglikang (昂利康) with a 10.00% increase and an 8.04% deviation rate [2] - Toukeng Life (透景生命) with a 10.43% increase and an 8.01% deviation rate [2] - Huafu Fashion (华孚时尚) with a 10.06% increase and a 7.89% deviation rate [2]

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） ...

Core Viewpoint - Nuo Cheng Jian Hua (09969) experienced a significant stock price increase of 12.96%, reaching HKD 19, with a trading volume of HKD 406 million following the approval of its drug Ibrutinib (Yinokai) for treating relapsed/refractory marginal zone lymphoma (R/R MZL) in Singapore [1] Company Developments - On September 8, Nuo Cheng Jian Hua announced that Ibrutinib received approval from the Health Sciences Authority (HSA) of Singapore for treating adult patients with R/R MZL, marking the second indication approved in Singapore [1] - Ibrutinib has already been approved in China for treating patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), relapsed/refractory mantle cell lymphoma (R/R MCL), and R/R MZL, all of which are included in the national medical insurance [1] Financial Performance - According to Western Securities (002673), Nuo Cheng Jian Hua achieved revenue of CNY 731 million in the first half of 2025, representing a year-on-year growth of 74.3% [1] - Sales of the core product Ibrutinib reached CNY 637 million, reflecting a year-on-year increase of 52.8% [1] - The approval of Ibrutinib for the new indication of first-line CLL/SLL has been recommended as a level 1 treatment in the 2025 CSCO lymphoma guidelines, enhancing its market potential in hematological malignancies [1] Product Pipeline - In May 2025, the company’s second innovative drug, Tanxizhuo Monoclonal Antibody, was approved for use in combination with Lenalidomide for treating relapsed/refractory DLBCL, further enriching the company's commercial product portfolio [1]

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]