每经AI快讯，信达生物(01801.HK)跌逾5%，截至发稿跌5.43%，报87港元，成交额18.6亿港元。 ...

Core Viewpoint - The stock of Innovent Biologics (01801) has experienced a significant decline of over 6%, currently trading at 87 HKD with a transaction volume of 1.86 billion HKD, despite the inclusion of seven innovative products in the new medical insurance directory [1] Group 1: Product Developments - Innovent Biologics has successfully included seven innovative products, including the PD-1 inhibitor Tyvyt (sintilimab injection), in the new medical insurance directory, expanding the indications for mature products [1] - With the recent addition of indications, Tyvyt now has all eight approved indications covered by medical insurance [1] - The new drugs included in the directory target areas such as oncology and chronic diseases [1] Group 2: Financial Transactions - Innovent Biologics has completed a share issuance to Takeda Pharmaceutical, issuing 6.9138 million shares, which accounts for approximately 0.4% of the total issued share capital, raising nearly 780 million HKD in net proceeds [1] - There have been significant large transactions in the market, involving approximately 13.0734 million shares at an average price of 92 HKD per share, totaling over 1.2 billion HKD [1]

Core Viewpoint - The stock of Innovent Biologics (01801) has experienced a significant decline of over 6%, currently trading at 87 HKD with a transaction volume of 1.86 billion HKD, despite the inclusion of seven innovative products in the new medical insurance directory [1] Group 1: Product Developments - Innovent Biologics has successfully included seven innovative products, including the PD-1 inhibitor Tyvyt (sintilimab injection), in the new medical insurance directory, expanding the indications for mature products [1] - With the recent additions, all eight approved indications for Tyvyt are now covered by medical insurance, which may enhance market access and patient affordability [1] Group 2: Financial Transactions - The company has completed a share issuance to Takeda Pharmaceutical, issuing 6.9138 million shares, which represents approximately 0.4% of the total issued share capital, raising nearly 780 million HKD in net proceeds [1] - There have been significant large transactions in the market, involving approximately 13.0734 million shares at an average price of 92 HKD per share, totaling over 1.2 billion HKD [1]

Core Insights - Innovent Biologics announced initial data from the first-in-human trial of IBI3003, a novel trispecific antibody targeting GPRC5D, BCMA, and CD3 for relapsed or refractory multiple myeloma, showing favorable tolerability and encouraging efficacy signals, especially in high-risk patients [1][10][11] Group 1: Study Design and Patient Demographics - IBI3003 is designed to target both GPRC5D and BCMA to overcome single antigen escape in multiple myeloma [2] - The Phase 1 study enrolled 39 patients with a median age of 62 years, where 64.1% were classified as high-risk and 46.2% had extramedullary disease [5] - Patients had a median of 4 prior lines of therapy, with 76.9% being refractory to their last treatment [5] Group 2: Treatment Administration and Safety Profile - IBI3003 was administered subcutaneously once weekly, with a switch to every two weeks for patients achieving a partial response after 6 months [4] - The safety profile was manageable, with 97.4% of patients experiencing treatment-emergent adverse events, primarily hematological disorders [8][10] - The incidence of cytokine release syndrome (CRS) was 64.1%, with all cases being Grade 1-2 and resolved with treatment [8] Group 3: Efficacy Results - Among patients treated with 120 g/kg, the overall response rate (ORR) was 83.3%, including stringent complete response in 4 cases and very good partial response in 7 cases [7][9] - The minimal residual disease negativity rate was 100% among patients achieving complete response or better [14] - Encouraging efficacy was particularly noted in high-risk patients, including those with extramedullary disease or prior anti-BCMA and/or anti-GPRC5D therapies [10][11] Group 4: Future Outlook - The company is conducting ongoing dose optimization for IBI3003 in the Phase 1 study, with expectations for deeper anti-tumor responses with continued treatment [10][12] - There is an urgent clinical need for effective treatments in patients with relapsed or refractory multiple myeloma, particularly those with high-risk features [11]

Group 1 - The top three stocks with the highest short-selling ratios are New World Development Co. Ltd. (100.00%), China Resources Beer (100.00%), and AIA Group Ltd. (100.00%) [1][2] - The stocks with the highest short-selling amounts are Xiaomi Corporation (2.196 billion), Ping An Insurance (1.956 billion), and Alibaba Group (1.160 billion) [1][3] - The stocks with the highest deviation values are Bank of China (52.21%), China Mobile (41.86%), and Café de Coral Holdings (40.03%) [1][2] Group 2 - The top ten short-selling ratio rankings include New World Development Co. Ltd. (100.00%), China Resources Beer (100.00%), and AIA Group Ltd. (100.00%) [2] - The top ten short-selling amounts include Xiaomi Corporation (2.196 billion), Ping An Insurance (1.956 billion), and Alibaba Group (1.160 billion) [3] - The top ten deviation values include Bank of China (52.21%), China Mobile (41.86%), and Café de Coral Holdings (40.03%) [3]

Core Insights - The National Healthcare Security Administration (NHSA) has officially announced the latest version of the National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Catalog, which includes 114 new drugs and 19 drugs in the first version of the Commercial Health Insurance Innovative Drug Catalog, effective from January 1, 2026 [1][2][3] Industry Summary - The NHSA has adjusted the drug catalog for the eighth time since its establishment, with a total of 949 new drugs added over the years, and the medical insurance fund has spent over 4.6 trillion RMB on negotiated drugs, driving sales exceeding 6 trillion RMB [1][2] - The new catalog includes 50 first-class innovative drugs, with an overall success rate of 88%, significantly higher than the 76% in 2024 [3] - The inclusion of drugs for major diseases such as triple-negative breast cancer, pancreatic cancer, and lung cancer, as well as rare diseases and chronic conditions, addresses gaps in basic medical insurance coverage [2][3] Company-Specific Updates - Green Leaf Pharmaceutical has successfully included five new products in the NHSA's drug catalog, including MiMeiXin® and ZhanBiJia® [4] - Fuhong Hanlin announced that its product Fuzhuoning® has been included in the NHSA's drug catalog for specific indications [5] - Junshi Biosciences reported that its products Tuoyi® and Junshida® have been successfully included in the NHSA's drug catalog [6] - Innovent Biologics has successfully added seven innovative products to the new NHSA drug catalog, including Daboru® and Xindimian® [6]

Major Events - Chuangsheng Group-B (06628) announced updated efficacy data for osemitamab triple therapy as a first-line treatment for gastric or gastroesophageal junction adenocarcinoma at ESMO Asia [1] - Strength Development (01277) plans to acquire 100% equity of Taiyuan Shidi for approximately 384 million yuan and acquire Dongzhimen property for a total of 86.33 million yuan [1] - Innovent Biologics (01801) completed a global strategic collaboration with Takeda Pharmaceutical and issued 6.9138 million shares under general authorization [1] - Ascentage Pharma-B (06855) received FDA and EMA approval for global registration of a Phase III clinical trial for Nilotinib as a first-line treatment for Ph+ ALL [1] - Baiao Saitou-B (02315) announced that its business partner IDEAYA received IND approval from the FDA for IDE034 [1] - Jinfang Pharmaceutical-B (02595) initiated a registration clinical trial for GFH375, the world's first oral KRAS G12D inhibitor in a controlled chemotherapy Phase III study [1] - Xixiangfeng Group (02473) signed a business cooperation agreement with Hello Car Rental to develop car rental services in designated cities under a "co-branded store" model [1] - International Commercial Settlement (00147) signed a computer chip sales agreement with Hong Kong Antarctic Light to seize growth opportunities in the IC chip market [1] - CSPC Pharmaceutical Group (01093) received clinical trial approval in the U.S. for a GLP-1/GIP receptor dual agonist injection [1] - MIRXES-B (02629) plans to collaborate with Crystal Technology to build an AI-enabled integrated "diagnosis and treatment" research and industrialization platform [1] - Zhengtong Automobile (01728) intends to invest approximately 816 million yuan to acquire Xiamen Xinda 4S dealership and automotive sales and export business [1] - Guorui Life (00108) plans to acquire 78.3% of Beijing Chunyu Tianxia Software for 269 million yuan [1] - Innovent Biologics (01801) successfully included seven innovative products (including new indications) in the 2025 National Medical Insurance Drug List [1] - Peijia Medical-B (09996) had its registration application for the TaurusNXT® "non-aldehyde cross-linked" transcatheter aortic valve replacement system accepted by the National Medical Products Administration [1] - Fosun Pharma (02196) had new drugs included in the National Medical Insurance Directory and commercial insurance innovative drug directory [1] - Junshi Biosciences (01877) had Tuoyi® new indications and Junshida® included in the National Medical Insurance Directory [1] - Valiant Biotech-B (09887) presented clinical data for LBL-034 at the 67th ASH Annual Meeting [1] - Canfite BioPharma (09926) had all approved indications for five marketed drugs successfully included in the latest National Medical Insurance Drug List [1] - Fuhong Hanlin (02696) had Fuzhuoning® (Citrus Acid Vovizili Capsules) included in the National Medical Insurance Drug List [1] - Green Leaf Pharmaceutical (02186) successfully included five new products in the 2025 National Medical Insurance Drug List or commercial insurance innovative drug directory [1] - Yinnuo Pharmaceutical-B (02591) had its core products included in the National Medical Insurance Drug List [1] Operating Performance - Poly Real Estate Group (00119) reported a contract sales amount of approximately 47.7 billion yuan for the first 11 months, a year-on-year decrease of 8.45% [2] - GAC Group (02238) reported November automobile sales of approximately 179,700 units, a year-on-year decline of 9.72% [2] - Xiehe New Energy (00182) reported an equity power generation of 697.23 GWh in November, a year-on-year increase of 7.77% [2]

Core Viewpoint - The recent adjustments to the national basic medical insurance directory and the introduction of the commercial insurance innovative drug directory mark significant steps towards enhancing access to innovative treatments in China, particularly for high-cost therapies like CAR-T drugs [2][6]. Summary by Sections National Basic Medical Insurance Directory Adjustments - A total of 114 new drugs were added to the basic medical insurance directory, including 50 first-class innovative drugs [2]. - The total number of drugs in the basic medical insurance directory has increased to 3,253, comprising 1,857 Western medicines and 1,396 traditional Chinese medicines [3]. - New inclusions cover various fields such as oncology, chronic diseases, mental health, and pediatric medications, with several rare disease treatments also added [3]. Commercial Insurance Innovative Drug Directory - The commercial insurance innovative drug directory aims to include high-innovation drugs that exceed the basic insurance scope but offer significant clinical value and patient benefits [6]. - A total of 121 drugs underwent formal review for the commercial insurance directory, with 24 entering price negotiation, ultimately resulting in 19 drugs from 18 companies being included [6]. - Notable inclusions are five CAR-T therapies, which previously cost over one million yuan per injection, making them unaffordable for many patients [6]. Performance of Pharmaceutical Companies - Several leading pharmaceutical companies have reported their successes in the 2025 national medical insurance negotiations, with Heng Rui Pharmaceutical having 20 drugs included, contributing 7.554 billion yuan to their total revenue [5]. - Innovent Biologics announced that 7 of its new drugs were included in the updated national medical insurance directory, with 12 of its 17 innovative drugs now covered [5]. Specific Drug Inclusions - The directory includes drugs for Alzheimer's disease, such as the monoclonal antibodies from Eisai and Eli Lilly, and several rare disease treatments [7]. - Some high-profile drugs, like Novo Nordisk's semaglutide and Bristol-Myers Squibb's nivolumab, were not included despite passing the formal review [8]. Implementation Timeline - The new directory is set to be officially implemented nationwide on January 1, 2026 [9].

Core Insights - The Chinese medical insurance directory will undergo its largest expansion of innovative drugs in history starting January 1, 2026, adding 114 new drugs, including 50 class 1 innovative drugs, while removing 29 drugs that are either unavailable or can be replaced by better alternatives [1][2] - The total number of drugs in the directory will increase to 3,253, significantly enhancing coverage for key areas such as oncology, chronic diseases, mental health, rare diseases, and pediatric medications [1][2] - The inclusion of innovative drugs in the medical insurance directory reflects a strong commitment to support genuine innovation and differentiated innovation in the healthcare sector [1][2] Medical Insurance Directory Expansion - The new directory will include 114 drugs, with nearly 44% being class 1 innovative drugs, indicating a growing emphasis on innovative treatments [1][2] - The directory will enhance the insurance coverage for critical areas, improving access to necessary medications for patients [1][2] Innovative Drug Market Dynamics - The entry of innovative drugs into the medical insurance directory is a key driver for market growth, with those included typically experiencing rapid sales growth within a year [4] - Companies like Heng Rui Medicine and Innovent Biologics have successfully included multiple innovative products in the new directory, indicating a trend towards increased market access for innovative therapies [4][5] Clinical Needs and Treatment Options - The new directory addresses significant clinical needs, particularly in oncology, with new drugs targeting various types of cancers, thereby expanding treatment options for patients [9][10] - The inclusion of targeted therapies for conditions like severe asthma and breast cancer provides patients with more accessible and effective treatment options [6][10] Commercial Insurance Directory - The introduction of a commercial insurance directory for innovative drugs aims to balance clinical value, corporate profits, and the sustainability of insurance funds [2][12] - The commercial insurance directory includes 19 innovative drugs, highlighting a focus on high-value treatments that exceed basic insurance coverage [12][15] Policy and Regulatory Environment - Recent reforms in drug approval and medical insurance payment systems have created a conducive environment for the development of innovative drugs in China [17][18] - The acceleration of drug approvals and the establishment of a more rigorous evaluation system for innovative drugs are reshaping the landscape for pharmaceutical companies [17][18] Future Outlook - The ongoing expansion of the medical insurance directory signifies a shift towards making innovative drugs more accessible and affordable for the general population, enhancing overall healthcare outcomes [20][21] - The collaboration between policy, industry, and capital markets is essential for fostering high-quality development in the innovative drug sector [19][20]

Core Viewpoint - The company, Innovent Biologics (01801), has successfully included seven innovative products in the new National Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug List (2025), enhancing patient accessibility and affordability for critical diseases in China [1] Group 1: Product Inclusion - Seven innovative drugs have been added to the updated National Medical Insurance Drug List, effective January 1, 2026 [1] - The included products are: - Daboshu (Sintilimab injection, anti-PD-1 monoclonal antibody) with new indications - Xinbimin (Tremelimumab N01 injection, anti-IGF-1R monoclonal antibody) - Aoyixin (Leratinib tablets, EGFR TKI) - Dabotai (Fuzuloparib tablets, KRAS G12C inhibitor) - Dabolet (Entrectinib capsules, ROS1 TKI) - Ruituo (Sepantronium capsules, RET inhibitor) - Jiepalin (Pirtobrutinib tablets, BTK inhibitor) [1] Group 2: Impact on Patients - The inclusion of these drugs covers significant diseases such as lung cancer, liver cancer, gastric cancer, esophageal cancer, gynecological tumors, hematological tumors, as well as cardiovascular and metabolic diseases [1] - The company aims to enhance the accessibility and affordability of medications for patients, aligning with its mission to develop high-quality biologics that are affordable for the public [1] Group 3: Commitment to Patients - The company is committed to a patient-centered approach and will actively cooperate with medical insurance policies to ensure the effective implementation of these drugs across various regions [1] - The goal is to expedite the availability of high-quality medications to more patients and families [1]