股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2026年2月28日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 中國生物製藥有限公司 呈交日期: 2026年3月2日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 01177 | 說明 - | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 30,000,000,000 | HKD | | 0.025 HKD | | 750,000,000 | | 增加 / 減少 (-) | | | 0 | | | HKD | | | | 本月底結存 | | | 30,000,000,000 | HKD | | 0.025 HKD | | 750,000,000 | 本月底法定/註冊股本總額： HKD ...

Core Insights - The healthcare sector is entering a promising phase in 2025 after four years of "de-bubbling" and "restructuring," with a significant increase in IPO activities and a shift towards innovative drug companies [1] Group 1: Market Trends - In 2025, 39 healthcare companies successfully issued IPOs, raising a total of 35.9 billion yuan, with over 100 companies experiencing annual growth exceeding 100% [1] - The market capitalization of 14 companies, including China Biologic Products and Innovent Biologics, surpassed 100 billion yuan, indicating a shift in the top 10 healthcare companies from traditional pharmaceutical firms to innovative drug concept enterprises [1] Group 2: BD Transactions and Opportunities - The total amount for BD transactions in China's innovative drug sector reached 130 billion USD in 2025, with no significant decline in BD transaction enthusiasm observed [3] - The focus of BD transactions is diversifying beyond oncology to include various disease areas, such as obesity and respiratory diseases, with notable acquisitions by major pharmaceutical companies [3][4] Group 3: Investment Focus and Strategies - China Biologic Products is concentrating on four key areas: oncology immunotherapy, liver disease metabolism, respiratory antiviral treatments, and topical medications, while also planning to expand into cardiovascular and central nervous system products [4] - The company is also investing in AI drug development, believing that AI-designed molecules will inevitably gain regulatory approval, emphasizing the importance of data in clinical advancement [4] Group 4: IPO Market Dynamics - The secondary market has matured, with investors demanding higher standards for IPO projects, leading to over 400 companies queued for IPOs in Hong Kong [5] - The 2026 IPO performance is expected to be differentiated, with funds likely to flow towards companies with successful BD cases and clear product launch timelines, while those lacking competitive advantages may face significant IPO pressure [5]

Core Viewpoint - China Biologic Products (01177.HK) has received approval from the National Medical Products Administration (NMPA) for its self-developed innovative drug, Rovaxitinib Tablets (brand name: Anxu®), for 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 is a globally innovative small molecule inhibitor targeting both JAK and ROCK pathways, providing dual effects of anti-inflammation and anti-fibrosis [1] - The drug works by inhibiting the JAK1/2-STAT3/5 signaling pathway, reducing high levels of inflammatory cytokines produced by myeloid cells, thus improving splenomegaly and systemic symptoms [1] - Additionally, it suppresses ROCK1/2 to lower the polarization level of T helper cells and the burden of inflammatory cytokines in patients with myelofibrosis, further enhancing anti-inflammatory effects and supporting long-term disease control [1]

Core Viewpoint - China National Pharmaceutical Group's innovative drug, Rovaxitinib (brand name: Anxu), has received approval from the National Medical Products Administration (NMPA) for the treatment of intermediate-2 or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF) in adult patients as a first-line therapy [1] Group 1: Drug Efficacy - Rovaxitinib is a first-in-class JAK/ROCK dual-target small molecule inhibitor that provides dual effects of anti-inflammation and anti-fibrosis through the inhibition of the JAK1/2-STAT3/5 signaling pathway and ROCK1/2 [1] - In a Phase II clinical study (TQ05105-II-01) involving 107 patients, Rovaxitinib demonstrated superior efficacy compared to hydroxyurea, with 58.33% of patients achieving a spleen volume reduction of ≥35% (SVR35) at week 24 [2] - The average duration of SVR35 was reported to be 8.31 months, and the total symptom score improvement of ≥50% (TSS50) was achieved by 77.78% of patients [2] Group 2: Safety Profile - Rovaxitinib exhibited good overall tolerability, with a ≥ grade 3 adverse reaction rate of approximately 40% and an anemia occurrence rate of about 40% [2] - The treatment discontinuation rate was only 6.7%, significantly lower than that of ruxolitinib [2] Group 3: Future Development - Beyond myelofibrosis, Rovaxitinib shows promising potential in the treatment of chronic graft-versus-host disease (cGVHD), currently in Phase III clinical trials in China and has been included in the breakthrough therapy program by the NMPA [2] - In the United States, Rovaxitinib has been approved to initiate Phase II clinical research for cGVHD [2]

Core Viewpoint - China National Pharmaceutical Group's innovative drug, Rovaxitinib (brand name: Anxu®), has received approval from the National Medical Products Administration (NMPA) for the treatment of intermediate-2 or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF) in adult patients as a first-line therapy [1][2] Group 1: Drug Approval and Mechanism - Rovaxitinib is a globally first-in-class JAK/ROCK dual-target small molecule inhibitor that achieves dual efficacy through anti-inflammatory and anti-fibrotic effects [1] - The drug works by inhibiting the JAK1/2–STAT3/5 signaling pathway to reduce high levels of inflammatory cytokines produced by myeloid cells, improving splenomegaly and systemic symptoms [1] - Additionally, it inhibits ROCK1/2 to lower the polarization level of T helper cells and inflammatory cytokine load in patients with myelofibrosis, further enhancing anti-inflammatory effects [1] Group 2: Clinical Trial Results - In a Phase II clinical study (TQ05105-II-01), Rovaxitinib demonstrated superior efficacy and good safety compared to hydroxyurea in treating intermediate-2 and high-risk myelofibrosis patients [2] - The study included 107 patients, randomized in a 2:1 ratio to receive either Rovaxitinib 15mg or hydroxyurea 0.5g, administered orally twice daily [2] - Efficacy results showed that 58.33% of patients in the Rovaxitinib group achieved a ≥35% reduction in spleen volume (SVR35) at week 24, with an average duration of SVR35 lasting 8.31 months and a total symptom score improvement rate of 77.78% [2] - The overall tolerability of Rovaxitinib was good, with a ≥ grade 3 adverse reaction rate of approximately 40% and a treatment discontinuation rate of only 6.7%, significantly lower than that of ruxolitinib [2] Group 3: Future Development - Beyond myelofibrosis, Rovaxitinib shows breakthrough potential in treating chronic graft-versus-host disease (cGVHD) [2] - The product is currently in Phase III clinical trials for cGVHD in China and has been included in the breakthrough therapy program by the NMPA, with plans for a Phase II clinical study approved in the United States [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 「羅伐昔替尼片」獲批上市 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」）宣佈，本集團自 主研發的國家1類創新藥羅伐昔替尼片（商品名：安煦® ）已獲得中國國家藥品監督管理局(NMPA)的上 市批准，用於中危-2或高危的原發性骨髓纖維化(PMF)、真性紅細胞增多症後骨髓纖維化(PPV-MF) 或原發性血小板增多症後骨髓纖維化(PET-MF)成年患者的一線治療。 羅伐昔替尼是一款全球首創的JAK/ROCK雙靶點小分子抑制劑，通過JAK/ROCK雙通路協同作用， 實現抗炎與抗纖維化的雙重療效。該藥物一方面通過抑制JAK1/2–STAT3/5信號通路，減少髓系細 胞產生的高水平炎症細胞因子，發揮抗炎作用，改善脾臟腫大及全身症狀；另一方面，通過抑制 ROCK1/2 ...

Core Viewpoint - China National Pharmaceutical Group (01177.HK) has received approval from the National Medical Products Administration (NMPA) for its self-developed Class 1 innovative drug, Bemosituzumab (brand name: Andevate®), for a new indication in treating patients with unresectable stage III non-small cell lung cancer (NSCLC) who do not have known epidermal growth factor receptor (EGFR) sensitive mutations or anaplastic lymphoma kinase (ALK) rearrangements after platinum-based chemoradiotherapy without disease progression [1]. Group 1 - The drug Bemosituzumab has been approved for a specific patient population, which includes those with unresectable stage III NSCLC [1]. - The approval is significant as it addresses a critical need for treatment options in patients who have not progressed after receiving platinum-based therapies [1]. - The indication specifically targets patients without known EGFR sensitive mutations or ALK rearrangements, highlighting a niche market for the drug [1].

Core Viewpoint - China National Pharmaceutical Group's innovative drug Bemosituzumab (brand name: Andevate) has received approval from the National Medical Products Administration (NMPA) for a new indication in treating unresectable stage III non-small cell lung cancer (NSCLC) patients who have not progressed after platinum-based chemotherapy [1] Group 1 - The approval is based on positive results from the R-ALPS study, which was presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting [1] - The study included patients with locally advanced or unresectable stage III NSCLC who had not progressed after synchronous/sequential chemoradiotherapy, comparing Bemosituzumab to a placebo [1] Group 2 - The median follow-up time was 19.4 months, with a median progression-free survival (PFS) of 9.69 months for the Bemosituzumab group compared to 4.17 months for the placebo group (HR=0.53, 95% CI 0.39-0.72, p<0.0001), indicating a 47% reduction in the risk of disease progression or death [2] - Subgroup analyses showed consistent benefit trends across various groups, demonstrating the broad applicability of this treatment [2] - Overall survival (OS) data is not yet mature, with median OS not reached, but a trend towards OS benefit was observed (HR=0.76, 95% CI 0.50-1.14) [2] Group 3 - The incidence of grade 3 or higher treatment-related adverse events (TRAEs) was 29.4% in the Bemosituzumab group compared to 19.7% in the placebo group [2] - Bemosituzumab is the third PD-L1 inhibitor approved in China for consolidation therapy after radical chemoradiotherapy for locally advanced or unresectable NSCLC [2] - The company aims to continue focusing on innovation in lung cancer treatment, developing a pipeline that covers multiple molecular subtypes and treatment scenarios to enhance patient survival benefits [2]

Core Viewpoint - China National Pharmaceutical Group's innovative drug Bemosituzumab (brand name: Andevate®) has received approval from the National Medical Products Administration (NMPA) for a new indication in treating unresectable stage III non-small cell lung cancer (NSCLC) patients who have not experienced disease progression after platinum-based chemoradiotherapy [1] Group 1 - The approval is based on positive results from the R-ALPS study, which was presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting [1] - The study included patients with locally advanced or unresectable stage III NSCLC who received either Bemosituzumab or a placebo as consolidation treatment until disease progression, with the primary endpoint being progression-free survival (PFS) assessed by blinded independent central review (BICR) [1] Group 2 - The median follow-up time was 19.4 months, with a median PFS of 9.69 months for the Bemosituzumab group compared to 4.17 months for the placebo group (HR=0.53, 95% CI 0.39-0.72, p<0.0001), indicating a 47% reduction in the risk of disease progression or death [2] - Subgroup analyses showed consistent benefit trends across various groups, demonstrating the broad applicability of this treatment [2] - Overall survival (OS) data is not yet mature, with median OS not reached, but a trend towards OS benefit was observed (HR=0.76, 95% CI 0.50-1.14) [2] Group 3 - The incidence of grade 3 or higher treatment-related adverse events (TRAEs) was 29.4% in the Bemosituzumab group compared to 19.7% in the placebo group [2] - Bemosituzumab is the third PD-L1 inhibitor approved in China for consolidation treatment after radical chemoradiotherapy for locally advanced or unresectable NSCLC [2] - The company aims to continue focusing on innovation in lung cancer treatment, developing a pipeline that covers multiple molecular subtypes and treatment scenarios to enhance patient survival benefits [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 • 中位隨訪時間19.4個月，貝莫蘇拜單抗組中位PFS為9.69個月，安慰劑組為4.17個月（HR=0.53， 95% CI 0.39-0.72， p<0.0001 ），患者疾病進展或死亡風險降低47%； • 預設的亞組分析（是否吸煙、前序治療方式為同步╱序貫）結果顯示，各亞組與意向性治療(ITT) 人群獲益趨勢一致，展現出該治療方案的廣泛適用性； 貝莫蘇拜單抗注射液非小細胞肺癌放化療後維持適應症獲批上市 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」）宣佈，本集團自 主研發的國家1類創新藥貝莫蘇拜單抗（商品名：安得衛® ）新適應症已獲得中國國家藥品監督管理局 (NMPA)的上市批准，用於在接受鉑類藥物為基礎的同步或序貫放化療後未出現疾病進展的未攜帶已 ...