Core Viewpoint - The Hong Kong pharmaceutical sector is experiencing a rebound, particularly in innovative drug companies, with the Hong Kong Stock Connect Innovative Drug ETF (520880) rising over 3% after a five-day decline, indicating increased investor interest despite recent lows [1][8]. Group 1: Market Performance - The Hong Kong Stock Connect Innovative Drug ETF (520880) opened high and is currently up over 3%, recovering from a historical low reached after five consecutive days of decline [1][8]. - The ETF has seen a net inflow of over 135 million yuan in the past five days, suggesting a strategic accumulation by investors [1][8]. - The Hong Kong medical sector ETF (159137) also opened higher, with significant contributions from major stocks like WuXi Biologics and BeiGene, indicating a broader market recovery [3][10]. Group 2: Company Developments - China National Pharmaceutical Group's stock surged over 5% following the announcement of an exclusive licensing agreement with Sanofi for a drug, which includes an upfront payment of $135 million and potential milestone payments totaling up to $1.395 billion [1][10]. - The innovative drug business development (BD) in China surpassed $50 billion in the first two months of 2026, with upfront payments nearing $3 billion, highlighting a significant growth trend in the sector [3][10]. - Companies like Rongchang Biologics and Junshi Biosciences are transitioning to profitability, with Rongchang expected to report a net profit of 709 million yuan in 2025 [3][10]. Group 3: Investment Opportunities - The Hong Kong Stock Connect Innovative Drug ETF (520880) and its associated funds are positioned as efficient investment vehicles for those looking to capitalize on the innovative drug sector, with over 70% of the top ten holdings being leading companies [5][12]. - The Hong Kong medical ETF (159137) encompasses a wide range of innovative medical concepts, including brain-computer interfaces and AI healthcare, providing diverse investment opportunities [6][12].

中国生物制药(01177)涨超5%，暂领升蓝筹。截至发稿，涨5.25%，报6.01港元，成交额1.46亿港元。 消息面上，中国生物制药日前宣布，与赛诺菲就罗伐昔替尼，一款全球首创(First-in-Class)的新型、强 效口服小分子JAK/ROCK抑制剂达成独家授权协议。根据协议，中国生物制药子公司正大天晴授予赛诺 菲在全球范围内开发、生产及商业化罗伐昔替尼的独家许可。中国生物制药有权获得最高15.3亿美元的 付款，其中包括1.35亿美元的首付款以及潜在开发、监管及销售里程碑付款，另外还将获得基于罗伐昔 替尼年度净销售额的最高双位数的阶梯式特许权使用费。协议的生效以惯常的交割条件为前提，包括取 得相关监管部门的批准。 ...

Policy Developments - The State Administration for Market Regulation has revised the "Special Medical Purpose Formula Food Production License Review Guidelines (2026 Edition)," which includes 7 chapters and 43 articles, imposing strict requirements on production sites, equipment, processes, personnel management, and system management [1] - The guidelines adjust the production license variety details according to the 2025 version of special medical food standards and clarify environmental hygiene control and key equipment monitoring requirements based on the 2023 version of good manufacturing practices [1] Regulatory Changes - Starting March 1, the "Special Regulations on the Supervision of Traditional Chinese Medicine Production" will be implemented, prohibiting the external purchase of packaged traditional Chinese medicine pieces and mandating standardized labeling [2] - This regulation aims to address issues of quality in traditional Chinese medicine pieces, which have frequently been highlighted in inspections by various drug regulatory agencies [2] Drug and Device Approvals - Tuoxin Pharmaceutical's subsidiary has obtained NSF 173 GMP DI certification, indicating compliance with stringent quality and safety audits [3] - Newnow's subsidiary has received approval for clinical trials of SYS6053, a drug for patients with Type A hemophilia [4] - Anke Biological's investee company has been granted approval for clinical trials of PA3-17 injection for treating pediatric and adolescent relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma [5] - Sunshine Nuohuo has received approval for clinical trials of BTP4327, aimed at patients with uncontrolled hypertension [6] Capital Market Activities - Aidi Pharmaceutical plans to raise up to 1.277 billion yuan through a private placement, with over 60% of the funds allocated to HIV innovative drug projects [8] Major Industry Events - China National Pharmaceutical Group has signed an exclusive licensing agreement with Sanofi for the development, production, and commercialization of the JAK/ROCK inhibitor rovalpitinib, receiving an upfront payment of $135 million and potential milestone payments of up to $1.395 billion [9] - Gilead Sciences presented new data on the BIC/LEN single-tablet regimen for HIV treatment, showing effective maintenance of viral suppression in patients switching from other regimens [10][11] Licensing Agreements - Deciphera Pharmaceuticals has entered into a global exclusive licensing agreement with UCB for ATG-201, a CD19/CD3 bispecific T-cell engager, with an upfront payment of $60 million and potential milestone payments exceeding $1.1 billion [12] - Novo Nordisk's semaglutide injection for treating metabolic-associated steatotic liver disease is proposed for priority review by the National Medical Products Administration [14]

中国生物制药董事会主席谢其润表示："我们很高兴与赛诺菲携手，将公司首创JAK/ROCK抑制剂惠及 全球患者。此次合作是公司全球化布局的重要里程碑，中国生物制药始终致力于成为跨国制药企业的首 选中国合作伙伴。我们坚信，依托赛诺菲在全球研发与商业化优势，公司将进一步提速创新产品落地， 为全球患者带来更多突破性疗法。" 本报讯 （记者金婉霞）3月4日，港股制药龙头中国生物制药有限公司（以下简称"中国生物制药"）与 全球跨国制药巨头赛诺菲联合宣布，双方就全球首创JAK/ROCK双靶点抑制剂罗伐昔替尼达成独家全球 许可协议。根据协议，中国生物制药及子公司正大天晴药业集团股份有限公司（以下简称"正大天晴"） 将授予赛诺菲该产品在全球范围内开发、生产与商业化的独家权利，同时将获得1.35亿美元的首付款以 及最高13.95亿美元的潜在开发、监管及销售里程碑付款，及最高双位数的销售分成。这是中国药企在 移植领域创下的最大规模对外授权交易。 作为正大天晴自主研发的首创新药，罗伐昔替尼是全球首款JAK/ROCK双靶点小分子抑制剂。它通过双 通路协同作用，实现抗炎与抗纤维化双重药理作用，是全球同靶点药物中研发进度领先、临床数据亮眼 ...

Core Viewpoint - China National Pharmaceutical Group announced a global exclusive licensing agreement with Sanofi for the JAK/ROCK inhibitor, Rovaxtinib, which could yield up to $1.53 billion in payments, including an upfront payment of $135 million and potential milestone payments of up to $1.395 billion [1] Group 1 - The agreement allows China National Pharmaceutical Group to receive a tiered royalty based on annual net sales of Rovaxtinib, which is a first-in-class oral small molecule JAK/ROCK inhibitor with dual pathways for anti-inflammatory and anti-fibrotic effects [1] - Rovaxtinib has recently been approved by the National Medical Products Administration for first-line treatment of intermediate-2 or high-risk primary myelofibrosis and PPV-MF in adult patients [1] - The drug has shown excellent efficacy in treating chronic graft-versus-host disease (cGVHD), significantly outperforming existing therapies, and has been recognized as a breakthrough therapy by China's CDE, with clinical trials entering Phase III domestically and FDA approval for Phase II trials in the U.S. [1] Group 2 - Sanofi, a leading multinational pharmaceutical company focused on vaccines, autoimmune diseases, and rare diseases, aligns well with Rovaxtinib's strong performance in the cGVHD treatment area [2] - This collaboration marks a significant step for China National Pharmaceutical Group in its transformation towards becoming an innovative pharmaceutical company, especially following the implementation of centralized procurement policies [3] - The company has been actively expanding its innovative drug business, acquiring companies like Hegia Biotech for $1.2 billion and integrating various innovative drug pipelines across oncology, liver diseases, respiratory, and cardiovascular metabolism [3] Group 3 - The financial performance indicates that the transformation towards innovation is yielding results, with revenue reaching 17.57 billion yuan in the first half of 2025, a year-on-year increase of 10.7%, and innovative product revenue of 7.8 billion yuan, up 27.2%, accounting for over 40% of total revenue [3] - The net profit for the same period was 3.39 billion yuan, reflecting a 140% year-on-year growth, and the company's gross margin has improved to 82.5% [3]

（正大天晴药业集团公众号） (编辑：杨燕 林辰) 3月4日，中国生物制药宣布，与赛诺菲就罗伐昔替尼，一款全球首创（First-in-Class）的新型、强效口 服小分子JAK/ROCK抑制剂达成独家授权协议。 根据协议，中国生物制药子公司正大天晴授予赛诺菲在全球范围内开发、生产及商业化罗伐昔替尼的独 家许可。中国生物制药有权获得最高15.3亿美元的付款，其中包括1.35亿美元的首付款以及潜在开发、 监管及销售里程碑付款，另外还将获得基于罗伐昔替尼年度净销售额的最高双位数的阶梯式特许权使用 费。协议的生效以惯常的交割条件为前提，包括取得相关监管部门的批准。 ...

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 has received approval from the National Medical Products Administration (NMPA) for its self-developed innovative drug, Rovaxitinib tablets (brand name: Anxu), for the first-line treatment of adult patients with intermediate-2 or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF) [1] Group 1 - Rovaxitinib demonstrated excellent efficacy and safety in a Phase II clinical study compared to hydroxyurea in treating intermediate-2 and high-risk myelofibrosis patients [1] - The study results indicated that 58.33% of patients in the Rovaxitinib group achieved a spleen volume reduction of ≥35% (SVR35) at week 24, with 63.89% achieving SVR35 at any time point [1] - The average duration of SVR35 was 8.31 months, and the total symptom score improvement of ≥50% (TSS50) rate reached 77.78% [1] Group 2 - The overall tolerability of the drug was good, with an incidence rate of adverse reactions of grade ≥3 at approximately 40%, and anemia occurrence also around 40% [1] - The treatment discontinuation rate was only 6.7% [1]