Core Insights - Innovent Biologics announced that PECONDLE® (picankibart injection) achieved both primary and key secondary efficacy endpoints in the Phase 3 CLEAR-2 study for moderate-to-severe plaque psoriasis, marking it as the first China-developed IL-23p19 monoclonal antibody to receive market approval from the NMPA in November 2025 [1][11]. Study Design and Results - The CLEAR-2 study was a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial involving 566 participants, focusing on the efficacy of picankibart during maintenance treatment and after withdrawal [2]. - At Week 56, 89.3% of participants in the 100 mg group and 90.1% in the 200 mg group maintained a PASI 90 response, significantly higher than the withdrawal groups [3]. - All key secondary endpoints were met, showing significant improvements in skin clearance and quality of life for participants receiving picankibart compared to those in withdrawal [4]. Efficacy and Safety - Picankibart demonstrated durable efficacy post-withdrawal, with maintenance treatment significantly reducing the risk of losing PASI 90 response compared to withdrawal groups [5]. - The safety profile of picankibart remained favorable throughout the study, with no new safety signals identified [6]. Clinical Implications - The results of the CLEAR-2 study provide critical insights into the necessity of maintenance therapy and the durability of post-withdrawal responses, offering assurance for chronic psoriasis patients [7]. - The successful Phase 3 results validate picankibart's advantages as a next-generation IL-23p19 inhibitor, emphasizing its potential for deep, durable remission and improved quality of life for patients [8]. Background on Psoriasis and Treatment - Psoriasis is a chronic inflammatory disease affecting a significant portion of the population, with moderate-to-severe cases representing nearly 30% of patients [9]. - Current systemic treatments in China include various agents, with biologics, particularly IL-23 inhibitors, gaining prominence due to their efficacy and safety [9]. About PECONDLE® - PECONDLE® is a monoclonal antibody developed by Innovent that targets the IL-23p19 subunit, offering a potential treatment option for psoriasis and other autoimmune diseases [10]. - The product has received approval for treating moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy, with ongoing studies exploring additional indications [11]. Company Overview - Innovent Biologics, founded in 2011, focuses on developing high-quality biopharmaceuticals for various diseases, including cancer and autoimmune disorders, and has launched 17 products to date [12][13].

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 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]

Core Viewpoint - The company, Innovent Biologics (01801.HK), has successfully included seven innovative products in the new National Medical Insurance Drug List (2025), enhancing patient accessibility and affordability for critical diseases [1] Group 1: Product Inclusion - Seven innovative drugs have been added to the National Medical Insurance Drug List, including: - Daberhu (Sintilimab injection, anti-PD-1 monoclonal antibody) with new indications - Xinbimin (Tislelizumab injection, anti-IGF-1R monoclonal antibody) - Aoyixin (Leratinib tablets, EGFR TKI) - Dabet (Fuzuloparib tablets, KRASG12C inhibitor) - Dabele (Dabrafenib capsules, ROS1 TKI) - Ruituo (Sepantronium capsules, RET inhibitor) - Jiepal (Pirtobrutinib tablets, BTK inhibitor) [1] Group 2: Disease Coverage - The newly included drugs address significant social burdens in oncology (lung cancer, liver cancer, gastric cancer, esophageal cancer, gynecological tumors, and hematological malignancies) as well as cardiovascular and metabolic diseases [1] Group 3: Company Mission and Commitment - The company is committed to developing high-quality biopharmaceuticals that are affordable for the public, emphasizing continuous innovation and patient-centered approaches [1] - The company aims to cooperate with medical insurance policies to ensure that high-quality drugs reach more patients and families promptly [1]

Core Viewpoint - The company has successfully included seven innovative products in the 2025 version of the National Medical Insurance Drug List, enhancing patient accessibility and affordability for critical diseases [1][2]. Group 1: Product Inclusion - Seven innovative products from the company have been added to the new National Medical Insurance Drug List, including: - Dabrus (Sintilimab injection, anti-PD-1 monoclonal antibody) with new indications - Xinbimin (Tislelizumab injection, anti-IGF-1R monoclonal antibody) - Aoyixin (Leratinib tablets, EGFR TKI) - Dabrut (Fuzuloparib tablets, KRAS G12C inhibitor) - Dabele (Entrectinib capsules, ROS1 TKI) - Ruituo (Sepantronium capsules, RET inhibitor) - Jiepal (Pirtobrutinib tablets, BTK inhibitor) [1] Group 2: Impact on Patients - The inclusion of these products covers significant diseases such as lung cancer, liver cancer, gastric cancer, esophageal cancer, gynecological tumors, and hematological tumors, which are major social burdens [2] - The company aims to enhance the accessibility and affordability of medications for patients, aligning with its mission to develop high-quality biopharmaceuticals that are affordable for the public [2] - The company is committed to patient-centered approaches and will actively cooperate with medical insurance policies to ensure that high-quality drugs reach more patients and families promptly [2]

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。 信達生物製藥 INNOVENT BIOLOGICS, INC. （於開曼群島註冊成立的有限公司） （股份代號：1801） 自願公告 達伯舒®、信必敏®等七款創新產品（含新適應症） 成功納入2025年版國家醫保藥品目錄 本公告由信達生物製藥（「本公司」，連同其附屬公司統稱「本集團」）自願作出，以 告知本公司股東及潛在投資者本集團最新業務更新。 本公司董事會（「董事會」）欣然宣佈，本公司七款創新產品成功納入新版《國家基 本醫療保險、生育保險和工傷保險藥品目錄（2025年）》（「國家醫保藥品目錄」）， 包括：達伯舒® （信迪利單抗注射液，抗PD-1單克隆抗體）新增適應症、信必敏® （替妥尤單抗N01注射液，抗IGF-1R單克隆抗體）、奧壹新® （利厄替尼片，EGFR TKI）、達伯特® （氟澤雷塞片，KRAS G12C抑制劑）、達伯樂® （己二酸他雷替尼膠 囊，ROS1TKI）、睿妥® （塞普替尼膠囊，RET ...

Group 1 - The National Healthcare Security Administration released the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Catalog, along with the Commercial Health Insurance Innovative Drug Catalog [1] - Innovent Biologics has seven innovative products successfully included in the new medical insurance catalog, including the PD-1 inhibitor, Tyvyt (sintilimab injection), which has a new indication for advanced endometrial cancer [1][2] - Tyvyt is the only PD-1 inhibitor in its treatment area to be included in the medical insurance catalog, and it has been approved for eight indications since its launch in 2018, covering various cancers [1] Group 2 - Another innovative drug included in the new medical insurance catalog is IBI302 (teprotumumab), which is the first IGF-1R antibody drug approved in China and the second globally, marking a significant advancement in the treatment of thyroid eye disease [2] - Other innovative drugs added to the catalog target prevalent diseases such as lung cancer and hematological malignancies, including drugs like IBI308 (lazertinib), IBI310 (entrectinib), and IBI311 (ibrutinib) [2] - The inclusion of innovative drugs in the medical insurance catalog is a crucial step towards making these treatments accessible and affordable for more patients in China [2]

Core Viewpoint - Innovent Biologics has successfully included seven innovative products in the new National Medical Insurance Drug List (2025), which will be implemented on January 1, 2026 [1] Group 1: Product Inclusion - The seven innovative products included 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) - Dabote® (furazolidone tablets, KRAS G12C inhibitor) - Dabolet® (dihydroartemisinin capsules, ROS1 TKI) - Ruituo® (sepafitinib capsules, RET inhibitor) - Jiepalin® (pembrolizumab tablets, BTK inhibitor) [1] Group 2: Implementation Timeline - The new National Medical Insurance Drug List will officially take effect on January 1, 2026 [1]