Core Viewpoint - China National Pharmaceutical Group (China Biologic) has entered into an exclusive licensing agreement with Sanofi for the global development, production, and commercialization of the JAK/ROCK inhibitor, Ruxolitinib, which is expected to generate significant upfront and milestone payments for the company [1][2]. Group 1: Licensing Agreement Details - The agreement grants Sanofi exclusive rights to develop, produce, and commercialize Ruxolitinib globally [1]. - China Biologic will receive an upfront payment of $135 million and potential milestone payments up to $1.395 billion based on development, regulatory, and sales achievements [1]. - The agreement includes tiered royalties based on annual net sales of Ruxolitinib, with the royalties being in the double digits [1]. Group 2: Product Information - Ruxolitinib is a first-in-class oral small molecule JAK/ROCK inhibitor that targets both the JAK/STAT pathway and the ROCK pathway to reduce inflammation and fibrosis [1]. - The drug has been approved by the National Medical Products Administration (NMPA) in China for first-line treatment of intermediate-2 or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), and post-essential thrombocythemia myelofibrosis (PET-MF) in adult patients [2]. - Ruxolitinib is also showing potential in treating chronic graft-versus-host disease (cGVHD), having entered Phase III clinical trials in China and being included in the breakthrough therapy program by the CDE [2]. - Clinical data published in the journal "Blood" indicates that Ruxolitinib has superior 12-month failure-free survival rates compared to other approved therapies and shows strong treatment responses in fibrotic-dominant organs, with potential to overcome resistance to other treatments [2].

2026年2月，罗伐昔替尼(商品名：安煦® )已获得中国国家药品监督管理局(NMPA)批准上市，用于中 危-2或高危的塬发性⻣髓纤维化 (PMF)、真性红细胞增多症后⻣髓纤维化(PPV-MF) 或塬发性血小板增 多症后⻣髓纤维化 (PET-MF) 成年患者的一线治疗。 此外，罗伐昔替尼在慢性移植物抗宿主病 (cGVHD) 治疗领域亦展现出突破性潜力：在中国已进入 III期 临床试验阶段，并于2025年8月被CDE纳入突破性治疗药物程序;在美国已获准开展II期临床研究。其治 疗cGVHD的Ib/IIa期临床数据已发表于《Blood》期刊，研究显示，与其他已获批疗法相比，罗伐昔替尼 的12个月无失败生存率(FFS)表现更优，且在纤维化主导的器官中展现出更强的治疗应答，并具有克服 芦可替尼耐药的潜力。 据悉，罗伐昔替尼是一款全球首创(First-in-Class)的新型、强效口服小分子JAK/ROCK抑制剂，通过双通 路协同实现抗炎与抗纤维化。一方面，它靶向JAK/STAT通路，直接阻断炎症信号传导，从源头减少髓 系细胞产生的炎症因子;另一方面，它靶向ROCK通路，通过调节STAT3/STAT5磷酸化来下调过度活化 ...

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份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。 （於開曼群島註冊成立之有限公司） 網站：www.sinobiopharm.com （股份編號：1177） 自願公告 與SANOFI就羅伐昔替尼訂立獨家授權協議 中國生物製藥有限公司（「本公司」，連同其附屬公司統稱「本集團」）董事會（「董事會」）欣然宣佈， 本集團附屬公司正大天晴藥業集團股份有限公司（「正大天晴」）已與Sanofi S.A.的一間全資附屬公司 （「Sanofi」）就本集團的JAK/ROCK抑制劑羅伐昔替尼在全球的開發、生產及商業化訂立獨家授權協議 （「協議」）。 根據協議條款，本集團將授予Sanofi在全球範圍內開發、生產及商業化羅伐昔替尼的獨家許可。本集 團有權獲得1.35億美元的首付款、以及最高13.95億美元的潛在開發、監管及銷售里程碑付款，同時 還將獲得基於羅伐昔替尼年度淨銷售額的最高雙位數的階梯式特許權使用費。協議的生效以慣常的 交割條件為前提，包括取得相關監管部門的批准。 關於 ...

Core Viewpoint - China National Pharmaceutical Group's self-developed drug TQ05105 (Ruxolitinib) has been included in the Breakthrough Therapy Designation (BTD) program by the CDE for the treatment of chronic graft-versus-host disease (cGVHD) [1][2] Group 1: Drug Development and Approval - Ruxolitinib is the fastest progressing JAK/ROCK dual small molecule inhibitor globally [1] - The company submitted a marketing application for Ruxolitinib to the CDE in July 2024, which has been accepted for the treatment of intermediate to high-risk myelofibrosis (MF) [1] - Currently, Ruxolitinib is undergoing a Phase III clinical trial for cGVHD in China and has been approved for a Phase II clinical trial in the United States [1] Group 2: Clinical Trial Results - The Phase Ib/IIa clinical results for Ruxolitinib were published in the top journal "Blood," involving 44 patients with moderate to severe steroid-refractory or dependent cGVHD [2] - No dose-limiting toxicities were observed, and there were no adverse events leading to discontinuation related to Ruxolitinib [2] - The best overall response rate (BOR) was 86.4%, with a 12-month failure-free survival rate (FFS) of 85.2% [2] - 88.6% of participants reduced their steroid dosage requirements, and 59.1% experienced improvement in cGVHD-related symptoms [2] - The company is accelerating the global clinical development of Ruxolitinib to provide better treatment options for patients worldwide [2]

Core Viewpoint - China Biologic Products (01177.HK) announced that its self-developed drug TQ05105 (a JAK/ROCK inhibitor) has been included in the Breakthrough Therapy Designation (BTD) program by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China for the treatment of chronic graft-versus-host disease (cGVHD) [1] Group 1 - TQ05105 is the fastest developing dual small molecule inhibitor of JAK/ROCK globally [1] - The company submitted a marketing application for TQ05105 to the CDE in July 2024, which has been accepted for the treatment of intermediate to high-risk myelofibrosis (MF) [1] - Currently, TQ05105 is undergoing a Phase III clinical trial for cGVHD in China, and has been approved to conduct a Phase II clinical trial in the United States [1] Group 2 - The Phase III clinical trial for TQ05105 in treating moderate to severe cGVHD is currently in the subject recruitment phase [1] - The company aims to accelerate the global clinical development of TQ05105 to provide better treatment options for patients worldwide as soon as possible [1]