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]

Core Insights - The completion of over $110 million in Series B financing marks a significant milestone in the company's development, with support from top global investment institutions, indicating trust in the company's R&D capabilities and long-term vision [1][2] Group 1: Financing Details - The Series B financing was led by a well-known industry institution, with participation from a sovereign wealth fund, China National Pharmaceutical Group, and several venture capital firms [1] - Existing shareholders, including Hillhouse Capital, Qiming Venture Partners, and others, continued to support the financing round [1] Group 2: Company Development and Pipeline - Since its establishment in 2021, the company has focused on developing innovative RNAi therapies targeting liver and extrahepatic tissues, with a diverse product pipeline covering autoimmune diseases, cardiovascular diseases, metabolic diseases, and obesity [1] - Several products in the pipeline have already entered clinical stages, and the successful financing will enhance clinical development and global expansion efforts [1] Group 3: Strategic Partnerships - The company recently announced a global R&D collaboration and licensing agreement with Eli Lilly, aimed at developing RNAi candidates for metabolic diseases based on the company's proprietary LEAD platform [2] - The agreement includes an upfront payment and equity investment, with potential milestone payments of up to $1.2 billion and tiered royalties on commercial sales [2]

Core Insights - The completion of over $110 million in Series B financing marks a significant milestone in the company's development journey [1][2] - The financing round was led by a prominent industry institution, with participation from various global investment firms and strategic investment from Eli Lilly [1] - The company aims to leverage its proprietary RNAi drug development platform to create innovative therapies targeting liver and extrahepatic tissues [1] Financing Details - The Series B financing was supported by notable investors including a sovereign wealth fund, China National Pharmaceutical Group, and several venture capital firms [1] - Existing shareholders such as Hillhouse Capital, Qiming Venture Partners, and others continued to support the financing round [1] Product Pipeline and Development - Since its establishment in 2021, the company has developed a diverse product pipeline addressing autoimmune diseases, cardiovascular diseases, metabolic disorders, and obesity, with several candidates already in clinical stages [1] - The successful completion of this financing will enhance the clinical development and global expansion of the company's pipeline [1] Strategic Partnerships - The company recently entered into a global research collaboration and licensing agreement with Eli Lilly to develop RNAi candidates for metabolic diseases [2] - Under the agreement, the company will receive upfront payments and equity investments, with potential milestone payments of up to $1.2 billion and tiered royalties on commercial sales [2] Future Directions - The company is committed to continuous innovation to expand the applications of RNAi technology and address unmet clinical needs globally [2] - Future efforts will focus on advancing late-stage clinical development of its drug candidates and utilizing the LEAD platform to bring more transformative candidates into clinical stages [2]

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- ...

中国生物制药(01177)发布公告，集团开发的"罗替高汀贴片"(商标名：罗菲定)已获得中国国家药品监督 管理局的上市批准，用于早期特发性帕金森病症状及体征的单药治疗，或与左旋多巴联合用于病程中的 各个阶段。 帕金森病是中老年常见的神经退行性疾病，《中国帕金森病报告2025》显示，国内现存帕金森病患病人 数超过500万例。除动作迟缓、肌强直、静止性震颤、姿势平衡障碍等运动症状外，疾病表现常伴有嗅 觉障碍、睡眠行为异常、抑郁焦虑、便秘等多种非运动症。 帕金森病的发病根源是脑内黑质区域制造多巴胺的神经细胞逐渐凋亡，目前无法治愈。随着病情进展， 患者需完全依赖药物补充多巴胺，当药物浓度出现波动时，便会出现"开关效应"："开期"指药物起效 时，患者的运动功能得到改善，身体活动相对自如。"关期"指药效减弱或消失时，患者迅速出现肢体僵 直、行动困难，如同断电一般。 罗替高汀贴片是一种非麦角类多巴胺受体激动剂，采用透皮给药方式，不仅避免了肝脏首过效应，更具 备长效缓释的特性，能够维持24小时稳定的血药浓度。对于存在"开关现象"的帕金森病患者，该药物可 显着减少"关期"发作、延长"开期"时间，同时降低脉衝式刺激多巴胺受体引发的 ...

智通财经APP讯，中国生物制药(01177)发布公告，集团开发的"罗替高汀贴片"(商标名：罗菲定®)已获 得中国国家药品监督管理局的上市批准，用于早期特发性帕金森病症状及体征的单药治疗，或与左旋多 巴联合用于病程中的各个阶段。 帕金森病是中老年常见的神经退行性疾病，《中国帕金森病报告2025》显示，国内现存帕金森病患病人 数超过500万例。除动作迟缓、肌强直、静止性震颤、姿势平衡障碍等运动症状外，疾病表现常伴有嗅 觉障碍、睡眠行为异常、抑郁焦虑、便秘等多种非运动症。 帕金森病的发病根源是脑内黑质区域制造多巴胺的神经细胞逐渐凋亡，目前无法治愈。随着病情进展， 患者需完全依赖药物补充多巴胺，当药物浓度出现波动时，便会出现"开关效应"："开期"指药物起效 时，患者的运动功能得到改善，身体活动相对自如。"关期"指药效减弱或消失时，患者迅速出现肢体僵 直、行动困难，如同断电一般。 罗替高汀贴片是一种非麦角类多巴胺受体激动剂，采用透皮给药方式，不仅避免了肝脏首过效应，更具 备长效缓释的特性，能够维持24小时稳定的血药浓度。对于存在"开关现象"的帕金森病患者，该药物可 显着减少"关期"发作、延长"开期"时间，同时降低脉衝式 ...

帕金森病的发病根源是脑内黑质区域制造多巴胺的神经细胞逐渐凋亡，目前无法治癒。随着病情进展， 患者需完全依赖药物补充多巴胺，当药物浓度出现波动时，便会出现「开关效应」：「开期」指药物起 效时，患者的运动功能得到改善，身体活动相对自如。「关期」指药效减弱或消失时，患者迅速出现肢 体僵直、行动困难，如同断电一般。 罗替高汀贴片是一种非麦角类多巴胺受体激动剂，采用透皮给药方式，不仅避免了肝脏首过效应，更具 备长效缓释的特性，能够维持24小时稳定的血药浓度。对于存在「开关现象」的帕金森病患者，该药物 可显着减少「关期」发作、延长「开期」时间，同时降低脉冲式刺激多巴胺受体引发的运动并发症风 险，从而实现更平稳的症状控制。此外，每日一贴的简便用药方式有望极大的提升患者的用药依从性， 在伴有吞咽困难、需择期手术或高龄体弱的患者人群中具有显着优势。罗替高汀贴片已被纳入《中国帕 金森病治疗指南》等多部指南及共识，成为早发型帕金森病的初期治疗推荐用药。 罗菲定®依托集团自主研发的溶剂胶技术平台，是继老年痴呆治疗药物利斯的明透皮贴剂(苏乐达®) 后，集团在神经系统疾病透皮治疗领域的又一重磅成果。近年来，集团持续升级透皮贴剂技术平台， ...

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 羅替高汀貼片是一種非麥角類多巴胺受體激動劑，採用透皮給藥方式，不僅避免了肝臟首過效應， 更具備長效緩釋的特性，能夠維持24小時穩定的血藥濃度。對於存在「開關現象」的帕金森病患者， 該藥物可顯著減少「關期」發作、延長「開期」時間，同時降低脈衝式刺激多巴胺受體引發的運動併發 症風險，從而實現更平穩的症狀控制。此外，每日一貼的簡便用藥方式有望極大的提升患者的用藥 依從性，在伴有吞嚥困難、需擇期手術或高齡體弱的患者人群中具有顯著優勢。羅替高汀貼片已被 納入《中國帕金森病治療指南》等多部指南及共識[2]，成為早發型帕金森病的初期治療推薦用藥。 羅菲定®依托本集團自主研發的溶劑膠技術平台，是繼老年癡呆治療藥物利斯的明透皮貼劑（蘇樂達® ） 後，本集團在神經系統疾病透皮治療領域的又一重磅成果。近年來，本集團持 ...