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].

Core Viewpoint - China National Pharmaceutical Group announced that its subsidiary, Chengdu Tianqing, received approval for the CDK2/4/6 inhibitor, Kemosir Capsule (brand name: Saitanxin), for the treatment of HR+/HER2- locally advanced or metastatic breast cancer previously treated with endocrine therapy [1] Group 1: Product Development and Market Position - The company is expanding the indications for Kemosir, including first-line treatment for HR+/HER2- advanced breast cancer in combination with Fulvestrant and adjuvant therapy for HR+ early breast cancer [1] - The breast cancer treatment market is growing, becoming one of the most competitive areas for innovative drugs globally [1] - The company has established a comprehensive portfolio in the breast cancer field, covering various molecular subtypes such as HER2 positive (HER2+), low HER2 expression, HR positive (HR+/HER2-), and triple-negative breast cancer (TNBC) [1] Group 2: Comprehensive Treatment Coverage - The company systematically covers the entire treatment cycle for breast cancer, including adjuvant therapy, first-line, second-line, and neoadjuvant treatment scenarios, aiming to provide new treatment options for more patients [1] - In addition to Kemosir in the HR+/HER2- field, the company has differentiated products such as TQB2102 (HER2 dual antibody ADC), TQB3126 (ER-PROTAC), and TQB3202 (PI3Kα) [1] - The company has fully established a portfolio of mainstream foundational drugs for breast cancer, including already marketed products such as Qingkeyi (Fulvestrant injection), Qingweishi (Everolimus tablets), Saituo (Trastuzumab injection), Paletan (Pertuzumab injection), and Qingweiyi (Palbociclib capsules) [2]

"B轮融资完成是公司发展历程中的重要里程碑。"圣因生物创始人、CEO王为民博士表示，获得多家全 球顶尖投资机构的支持，不仅是对公司研发实力与企业愿景的信任与认可，也为公司的长远发展注入了 关键资源。圣因生物始终致力于通过持续创新来拓宽RNAi技术的应用边界，从而解决全球未满足的临 床需求。未来，公司将全力推进在研药物的全球后期临床开发，同时依托LEAD平台推动更多变革性候 选药物进入临床阶段。 就在上个月，圣因生物宣布与礼来制药公司达成一项全球研发合作与许可协议，双方将基于圣因生物专 有的LEAD平台共同推动针对代谢性疾病的RNAi候选药物的开发。根据协议条款，圣因生物将获得包 括首付款和股权投资的近期付款。此外，圣因生物还有权收取后续高达12亿美元的开发、监管和销售里 程碑付款，以及商业销售的分级特许权使用费。 近日，圣因生物宣布已完成超1.1亿美元B轮融资，本轮融资由一家知名产业机构领投，一家国际主权基 金、中国生物制药集团、君联资本、维梧资本、Invus、SymBiosis、苏创投、真脉投资、清池资本跟 投，并获礼来制药公司战略投资。同时，现有股东高瓴创投、启明创投、险峰淇云、泰福资本、元禾控 股、北极 ...

近日，圣因生物宣布已完成超1.1亿美元B轮融资，本轮融资由一家知名产业机构领投，一家国际主权基 金、中国生物制药集团、君联资本、维梧资本、Invus、SymBiosis、苏创投、真脉投资、清池资本跟 投，并获礼来制药公司战略投资。同时，现有股东高瓴创投、启明创投、险峰淇云、泰福资本、元禾控 股、北极光创投等继续支持。 自2021年成立以来，圣因生物凭借其专有的RNAi药物研发平台，致力于开发出靶向肝脏及肝外组织的 同类首创/同类最佳RNAi疗法。基于该平台，公司已构建了涵盖自身免疫疾病、心血管疾病、代谢性疾 病及肥胖等不同治疗领域的多元化产品管线，其中多款已进入临床阶段。此次B轮融资的顺利完成，将 有力推动公司在研及规划中管线的临床开发及全球化布局，并助力公司在RNAi领域持续实现新突破。 "B轮融资完成是公司发展历程中的重要里程碑。"圣因生物创始人、CEO王为民博士表示，获得多家全 球顶尖投资机构的支持，不仅是对公司研发实力与企业愿景的信任与认可，也为公司的长远发展注入了 关键资源。圣因生物始终致力于通过持续创新来拓宽RNAi技术的应用边界，从而解决全球未满足的临 床需求。未来，公司将全力推进在研药物的全球 ...

Group 1 - The core announcement is that China Biologic Products (01177) has received clinical trial approval from both the National Medical Products Administration (NMPA) in China and the U.S. Food and Drug Administration (FDA) for its innovative drug TQF3250 capsules, which are intended for weight loss [1] - TQF3250 is an oral small molecule GLP-1 receptor agonist that selectively activates the cAMP-biased GLP-1 receptor signaling pathway, promoting insulin secretion while reducing β-arrestin recruitment and receptor internalization, thus extending the duration of action [1] - Compared to traditional injectable GLP-1 drugs, TQF3250's oral administration method significantly enhances patient convenience and long-term treatment adherence [1] Group 2 - Obesity and overweight have become one of the most severe public health challenges of the 21st century, with the global prevalence expected to rise from 36% in 2000 to 50% by 2030, affecting nearly 3 billion people [2] - In China, the trend is particularly pronounced, with an estimated 41% of adults projected to have a high BMI (≥25 kg/m²) by 2025, and 9% classified as obese (BMI ≥30 kg/m²) [2] - The clinical trial application for TQF3250 to treat type 2 diabetes has also been approved by NMPA, indicating that metabolic diseases are a core focus area for the company, which aims to provide a diverse product pipeline for patients [2]

Group 1 - The core point of the article is that China Biologic Products (01177.HK) has received approval from the NMPA and FDA for its innovative oral GLP-1 receptor agonist TQF3250, aimed at weight loss [1] - TQF3250 is a small molecule oral GLP-1 receptor agonist that selectively activates the cAMP pathway, promoting insulin secretion while reducing gastrointestinal side effects compared to traditional GLP-1 drugs [1] - The oral administration of TQF3250 enhances patient convenience and long-term treatment adherence compared to injectable GLP-1 medications [1] Group 2 - Obesity and overweight are significant public health challenges, with global adult obesity rates expected to rise from 36% in 2000 to 50% by 2030, affecting nearly 3 billion people [2] - In China, the trend is particularly pronounced, with an estimated 41% of adults projected to have a high BMI (≥25 kg/m²) by 2025, and 9% classified as obese (BMI ≥30 kg/m²) [2] - TQF3250 has also received NMPA approval for clinical trials targeting type 2 diabetes, aligning with the company's focus on metabolic diseases and diverse product pipeline [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） 1 除減重適應症外，TQF3250用於治療2型糖尿病的臨床試驗申請已獲NMPA批准。代謝性疾病是本集 團聚焦的核心治療領域之一，本集團將通過多元化的產品管線，為患者提供更豐富的治療選擇。 參考文獻： 自願公告 TQF3250「口服偏向型GLP-1受體激動劑」臨床試驗申請獲NMPA、FDA批准 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 主研發的創新藥TQF3250膠囊「口服偏向型GLP-1受體激動劑」的臨床試驗申請已獲得中國國家藥品監 督管理局(NMPA)和美國食品藥品監督管理局(FDA)的批准，擬用於減重。 TQF3250是一款口服小分子偏向型GLP-1受體激動劑。與傳統GLP-1藥物相比，TQF3250通過選擇性 激活cAMP偏向的GLP- ...