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]

Core Viewpoint - The innovation drug sector in China is experiencing significant growth due to favorable policy developments, with the introduction of new drug listings in the national medical insurance catalog and commercial insurance, providing a stable policy outlook for innovative drug companies [1][2]. Group 1: Industry Trends - The China Hong Kong Stock Connect Innovation Drug Index increased by 0.30% as of December 11, 2025, with notable gains from companies such as Zhaoyan New Drug (+4.15%) and Rongchang Bio (+2.85%) [1]. - The national medical insurance catalog for 2025 successfully added 114 new drugs, including 50 innovative drugs, achieving a historical high success rate of 88% [1]. - The introduction of dual catalogs for medical insurance and commercial insurance is expected to directly benefit innovative drug companies, indicating a positive industry outlook [1]. Group 2: Market Opportunities - The top ten weighted stocks in the China Hong Kong Stock Connect Innovation Drug Index account for 72.68% of the index, highlighting the concentration of investment in leading innovative drug companies [2]. - The Harvest Innovation Drug ETF (520970) closely tracks the index, providing investors with access to leading companies involved in drug research, development, and production [2]. - Investors without stock accounts can leverage the Hong Kong Stock Connect Innovation Drug ETF linked fund (024700) to capitalize on the growth opportunities in the innovative drug sector [2].

Core Insights - The report from CMB International indicates a leading rating for the mainland pharmaceutical industry, following the National Healthcare Security Administration's announcement of the results from the 2025 Innovative Drug High-Quality Development Conference [1] Group 1: Industry Developments - The recent negotiations for the medical insurance and commercial insurance innovative drug catalog have resulted in many innovative pharmaceutical companies covered by CMB International having products newly included or successfully renewed in the insurance coverage [1] - Companies such as Heng Rui Medicine (600276), Innovent Biologics (01801), CanSino Biologics (09926), and China National Pharmaceutical Group (01177) have more than five products that received new coverage or new indications [1] Group 2: Market Outlook - The inclusion of more new drugs in the catalog is expected to enhance clinical medication levels and improve the overall R&D return rates in the innovative drug industry [1] - The introduction of commercial insurance funds is anticipated to provide significant incremental funding for innovative drug payments, paving the way for a diversified payment system alongside basic medical insurance [1] Group 3: Future Growth Potential - CMB International is optimistic about the sales growth potential of newly included products/indications in 2026, particularly for potential blockbuster products from companies like CanSino Biologics [1] - The report emphasizes the importance of monitoring the actual execution and payment situations of the first batch of commercial insurance catalog, as well as the dynamic adjustments in the list and pricing, and the long-term development opportunities arising from real-world data accumulation [1]

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]

Core Viewpoint - The release of the 2025 version of the basic medical insurance directory and the first commercial insurance directory is expected to support innovation in the CXO industry, leading to a potential performance recovery in the second half of the year [1] Summary by Categories Industry Outlook - The report indicates that several companies' core innovative products have been included in the medical insurance directory [1] - Despite ongoing pressures on medical insurance revenue due to macroeconomic conditions and aging populations, attention is drawn to the renewal of national centralized procurement [1] Commercial Insurance - The initial commercial insurance directory is expected to have limited short-term impact on product sales due to the small scale of commercial insurance [1] - However, the significance of the commercial insurance directory is highlighted as it may pave the way for the expansion of commercial medical insurance in China, marking the beginning of a diversified payment system development [1] Company Recommendations - The report recommends buying shares in the following companies: - Sanofi (01530) - Genscript Biotech (02273) - WuXi AppTec (02268) - Genor Biopharma (02367) - Innovent Biologics (01801) - China Biologic Products (01177) [1]

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]