Core Viewpoint - China Biologic Products (01177.HK) has announced the completion of Phase II clinical trials for its self-developed innovative drug TQH3906, a TYK2/JAK1 JH2 allosteric inhibitor, targeting moderate to severe plaque psoriasis, demonstrating good safety and tolerability across all dosage groups and achieving the primary endpoint of the study [1] Group 1: Clinical Trial Details - The study is a randomized, double-blind, placebo-controlled, multi-center Phase II trial (NCT06542614) aimed at evaluating the efficacy and safety of TQH3906 in patients with moderate to severe plaque psoriasis [1] - A total of 209 patients were enrolled in the study, which included a placebo group and five different dosage groups of TQH3906 [1] - The drug was administered orally once daily throughout the trial [1]

TQH3906「TYK2/JAK1 JH2變構抑制劑」 斑塊狀銀屑病二期取得積極進展 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TQH3906「TYK2/JAK1 JH2變構抑制劑」已於近日完成針對中重度斑塊狀銀屑 病(PsO)的二期臨床試驗。研究結果顯示，TQH3906所有劑量組均表現出良好的安全性與耐受性，並 達到二期研究的主要終點。 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 在安全性方面，TQH3906整體安全性良好，總體不良事件發生率與安慰劑組相當，且絕大部分治療 期間出現的不良事件(TEAE)嚴重程度為1-2級。其安全性特徵與同類TYK2抑制劑的表現相似，未出 現新的安全性信號。 相比抗體類生物制劑，口服小分子靶向藥物具有給藥便捷、耐受性高及 ...

智通财经APP获悉，香港联交所最新资料显示，12月24日，副总裁兼执行董事谢炘增持中国生物制药 (01177)100万股，每股作价6.4068港元，总金额为640.68万港元。增持后最新持股数目约为3.61亿股，最 新持股比例为1.92%。 ...

香港联交所最新资料显示，12月24日，副总裁兼执行董事谢炘增持中国生物制药(01177)100万股，每股 作价6.4068港元，总金额为640.68万港元。增持后最新持股数目约为3.61亿股，最新持股比例为1.92%。 ...

Core Viewpoint - The report from Bank of America indicates a significant decline in the sales of the pharmaceutical industry in mainland China for October, with a year-on-year decrease of 3%, contrasting sharply with a 6.8% increase in September [1] Industry Summary - The hospital channel experienced a year-on-year decline of 3.3%, down from a previous growth of 7.1% [1] - The retail channel remained nearly flat year-on-year, showing a notable slowdown from a 2.4% increase in September [1] Company Performance - The performance of China's biopharmaceutical products in October showed a mixed trend, with core products anlotinib and glycyrrhizic acid seeing year-on-year sales growth of 6.5% and 4.4%, respectively [1] - Conversely, sales of budesonide and esomeprazole fell significantly, with year-on-year declines of 28.5% and 39.4%, respectively [1] Revenue Forecast Adjustments - Based on the sales performance, the company has revised its revenue forecasts for 2026 and 2027 downwards by 0.2% and 0.4%, respectively [1] - The target price has been adjusted from HKD 9.4 to HKD 8.3, while maintaining a "Buy" rating due to the substantial licensing potential of pipeline products [1] Specific Company Ratings - For CSPC Pharmaceutical, the report notes continued poor sales performance of several key drugs in October, leading to a maintained "Underperform" rating with a target price of HKD 7.2 [1]

中国生物制药(01177.HK)公布，集团自主研发的国家1类创新药库莫西利胶囊 (商品名：赛坦欣®) 已获 得中国国家药品监督管理局 (NMPA) 的上市批准，用于与氟维司群联合治疗既往接受内分泌治疗后出现 疾病进展的激素受体 (HR) 阳性、人表皮生长因子受体2 (HER2) 阴性的局部晚期或转移性乳腺癌患者。 本文源自：金融界AI电报 ...

Group 1 - The core point of the news is that China National Pharmaceutical Group has received approval from the National Medical Products Administration (NMPA) for its self-developed innovative drug, Kumosili Capsule (brand name: Saitanxin), for use in combination with Fulvestrant to treat hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer patients who have previously undergone endocrine therapy [1][2] - Kumosili is a world-first triple inhibitor targeting CDK2/4/6, showing varying degrees of inhibition on CDK2, CDK4, and CDK6 kinases, with a strong selective inhibition capability on CDK4 kinase [1] - The unique mechanism of action of Kumosili helps delay the resistance issues associated with CDK4/6 inhibitors in clinical settings and reduces the risk of bone marrow suppression [1] Group 2 - In the pivotal Phase III clinical trial (TQB3616-III-01), the combination of Kumosili and Fulvestrant demonstrated encouraging efficacy, with a median progression-free survival (mPFS) of 16.62 months, significantly extending the mPFS by 9.16 months compared to the Fulvestrant group (7.46 months), and reducing the risk of disease progression or death by 64% (HR=0.36, p<0.0001) [2] - The objective response rate (ORR) significantly improved to 40.21% compared to 12.12% in the Fulvestrant group (p<0.0001) [2] - The most common treatment-related adverse events (TRAEs) were mostly grade 1-2 and manageable; grade 3 or higher hematological toxicities, such as bone marrow suppression, were low; no TRAEs led to treatment discontinuation or death, indicating overall safety and tolerability [2] - In addition to the approved second-line treatment indication, a first-line HR+/HER2- breast cancer indication for Kumosili in combination with Fulvestrant has been submitted to NMPA for approval in July 2025, and the Phase III clinical trial for its adjuvant treatment indication has completed patient enrollment, with gradual approvals expected in the next two years [2]

Core Viewpoint - China Biologic Products (01177.HK) has received approval from the National Medical Products Administration (NMPA) for its self-developed innovative drug, Kumosily, for the treatment of HR-positive, HER2-negative locally advanced or metastatic breast cancer patients who have experienced disease progression after endocrine therapy [1][2]. Group 1: Drug Approval and Mechanism - Kumosily is a globally first-in-class triple inhibitor targeting CDK2/4/6, showing selective inhibition of CDK4 kinase, which helps delay resistance to CDK4/6 inhibitors and reduces the risk of bone marrow suppression [1]. - The drug has been approved for use in combination with Fulvestrant for second-line treatment [1]. Group 2: Clinical Trial Results - In the pivotal Phase III clinical trial (TQB3616-III-01), the combination of Kumosily and Fulvestrant demonstrated a median progression-free survival (mPFS) of 16.62 months, significantly extending the mPFS by 9.16 months compared to the Fulvestrant group (7.46 months) [2]. - The risk of disease progression or death was reduced by 64% (HR=0.36, p<0.0001), and the objective response rate (ORR) increased significantly to 40.21% compared to 12.12% (p<0.0001) [2]. - Most treatment-related adverse events (TRAEs) were manageable and of grade 1-2, with minimal grade ≥3 hematological toxicity, and no TRAEs leading to treatment discontinuation or death [2]. Group 3: Future Development and Pipeline - Besides the approved second-line indication, a first-line application for HR+/HER2- breast cancer has been submitted to NMPA, with expectations for approval by July 2025 [3]. - The company has completed patient enrollment for the Phase III clinical trial for the adjuvant treatment indication, aiming for gradual approvals in the next two years [3]. - The company is focused on the breast cancer field, developing a pipeline that covers all molecular subtypes, including HR-positive, HER2-positive, low HER2 expression, and triple-negative breast cancer, with a comprehensive treatment strategy from new adjuvant to later lines [3].

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 「庫莫西利膠囊」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類創新藥庫莫西利膠囊 (商品名：賽坦欣®) 已獲得中國國家藥品監督管理局 (NMPA) 的上市批准，用於與氟維司群聯合治療既往接受內分泌治療後出現疾病進展的激素受體 (HR) 陽性、 人表皮生長因子受體2 (HER2) 陰性的局部晚期或轉移性乳腺癌患者。 參考文獻： 承董事會命 庫莫西利是全球首創的同時靶向CDK2/4/6的三重抑制劑，對CDK2、CDK4、CDK6激酶有不同程度 的抑制效果，且對CDK4激酶有較強的選擇性抑制能力。基於其獨特的作用機制，庫莫西利不僅有助 於延緩臨床中CDK4/6抑制劑的耐藥問題，還可以減輕骨髓抑制風險[1]。 在關鍵I ...

Core Viewpoint - The approval of the first global CDK2/4/6 inhibitor, Kumosiliz, by China National Pharmaceutical Group's subsidiary, marks a significant advancement in targeted therapy for HR+/HER2- advanced or metastatic breast cancer in China, positioning the country in the international arena of breast cancer treatment [1][4]. Group 1: Product Approval and Efficacy - Kumosiliz's approval is based on the CULMINATE-1 study, which demonstrated significant improvement in median progression-free survival (PFS) when combined with Fulvestrant compared to Fulvestrant alone, reducing the risk of disease progression or death in HR+/HER2- advanced breast cancer [1][2]. - The unique molecular design of Kumosiliz allows for precise targeting of CDK4 while enhancing binding to CDK2, with a weaker inhibitory effect on CDK6, thereby reducing the risk of bone marrow suppression associated with traditional CDK4/6 inhibitors [1]. Group 2: Market Potential and Strategic Positioning - Analysts have identified Kumosiliz as a potential "blockbuster" drug, with peak sales in China projected to exceed 2 billion yuan [3]. - China National Pharmaceutical Group is expanding Kumosiliz's indications, including first-line treatment for HR+/HER2- advanced breast cancer and adjuvant therapy for HR+ early breast cancer, indicating a strategic approach to capture a larger market share [3]. - The breast cancer treatment market is rapidly growing, and the company is not relying solely on Kumosiliz but is also developing a comprehensive portfolio of therapies across various breast cancer subtypes and treatment stages [3][4]. Group 3: Comprehensive Product Portfolio - The company has established a robust portfolio of foundational drugs for breast cancer, including already marketed products such as Fulvestrant injection and Trastuzumab injection, positioning itself to leverage the launch of Kumosiliz [4]. - With the launch of Kumosiliz, the company is expected to transition from a single product focus to a cluster of breakthrough products in the breast cancer treatment space, supported by a full-spectrum product matrix covering all molecular subtypes and treatment cycles [4].