2025年落下帷幕，医药行业这一年可谓波澜壮阔。仿制药领域更是风起云涌。既有集采价格战的激烈厮杀，又有监管"风暴"的强力洗礼，而首仿药的争夺 战，更是成为这场行业大戏中的核心看点。 这足以证明，即便在严苛环境下，首仿药市场依然释放着强大吸引力。 这不仅仅是数量的竞争，更是研发速度、立项眼光和注册策略的综合比拼。首仿药，已成为衡量药企仿制药研发实力的核心指标之一。 二、科伦再首仿王座，齐鲁制药紧随其后 2025年的首仿排行榜，呈现"一超多强，新老交替"的格局。 在国内首仿药领域，齐鲁、科伦、恒瑞医药、石药集团为头部企业。科伦药业展现出持续的领跑优势。2022年与恒瑞均以7款首仿并列榜首，2023年以6款首 仿位居榜首。尽管2024年首仿获批数量有所回调，但仍成功斩获4款首仿药。2025年，科伦再度以6款首仿强势回归榜首，进一步巩固其龙头地位。 一、集采深水区，首仿药成"避风港" 第十一批国家药品集采围绕"稳临床、保质量、反内卷、防围标"系统优化规则，堪称行业分水岭。此次集采品种多，且首次纳入胰岛素专项、生物类似药及 中成药大品种，降价压力从化学药延伸至更多治疗领域。 在常规仿制药进入"微利时代"的背景下，首仿药 ...

Core Viewpoint - Heng Rui Medicine has received acceptance for its drug application for Haiqubopai Ethanolamine Tablets from the National Medical Products Administration, aimed at treating chemotherapy-induced thrombocytopenia in adult patients [1][2] Group 1: Drug Approval and Clinical Trials - The National Medical Products Administration has issued an acceptance notice for the drug application of Haiqubopai Ethanolamine Tablets, which is indicated for adult patients with chemotherapy-induced thrombocytopenia [1] - The Phase III clinical trial (SHR8735-301) for Haiqubopai Ethanolamine Tablets achieved its primary endpoint in May 2025, demonstrating significant efficacy compared to the control group with good safety and tolerability [1] Group 2: Existing Approvals and Market Context - Haiqubopai Ethanolamine Tablets have previously been approved for two indications: chronic primary immune thrombocytopenia in adults with poor response to corticosteroids and immunoglobulins, and severe aplastic anemia in adults with poor response to immunosuppressive therapy [2] - The drug is an oral non-peptide thrombopoietin receptor (TPO-R) agonist that promotes platelet production through the activation of TPO-R mediated STAT and MAPK signaling pathways [2] - Similar products available in the international market include Eltrombopag, Avatrombopag, and Lusutrombopag, with a combined global sales forecast of approximately $2.59 billion for 2024 [2] - The cumulative R&D investment for Haiqubopai Ethanolamine Tablets has reached approximately 445.87 million yuan [2]

Core Viewpoint - Heng Rui Medicine has received the acceptance notice from the National Medical Products Administration for its drug application of Haequbopag Ethanolamine Tablets, aimed at treating adults and children aged 6 and above with persistent and chronic primary immune thrombocytopenia (ITP) who have had inadequate responses to previous treatments [1][2] Company Summary - Haequbopag Ethanolamine Tablets are an oral non-peptide thrombopoietin receptor (TPO-R) agonist that promotes platelet production by activating the TPO-R mediated STAT and MAPK signaling pathways [2] - The company has invested approximately 44.587 million yuan in the research and development of Haequbopag Ethanolamine Tablets to date [2] Industry Summary - Similar products already available in the international market include Eltrombopag (GlaxoSmithKline/Novo Nordisk, brand name Promacta), Avatrombopag (Dova Pharmaceuticals, brand name Doptelet), and Lusutrombopag (Shionogi, brand name Mulpleta) [2] - The total global sales of these similar products are projected to be approximately 2.59 billion USD in 2024 [2] - In China, Eltrombopag was approved in 2017 under the name Aequbopag Ethanolamine Tablets, Avatrombopag was approved in 2020 as Maleic Acid Avatrombopag Tablets, and Lusutrombopag was approved in 2023 as Lusutrombopag Tablets [2]