四川科伦药业股份有限公司 证券代码：002422 证券简称：科伦药业 公告编号：2025-050 关于公司注射用头孢唑林钠/氯化钠注射液获得药品注册批准的公告 本公司及董事会全体成员保证公告内容的真实、准确和完整，对公告的虚假记载、误 导性陈述或者重大遗漏负连带责任。 四川科伦药业股份有限公司（以下简称"公司"）子公司湖南科伦制药有限 公司的化学药品"注射用头孢唑林钠/氯化钠注射液"于近日获得国家药品监督 管理局的药品注册批准，现将相关情况公告如下： 一、 药品基本情况 1. 药品名称：注射用头孢唑林钠/氯化钠注射液 剂型：注射剂 规格：粉体室：按头孢唑林（C14H14N8O4S3）计1.0g；液体室：氯化钠注射液 100ml：0.9 g 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本品 符合药品注册的有关要求，批准注册，发给药品注册证书。 2. 药品相关情况 粉液双室袋是国际上先进的输液产品，其中粉体和液体分别位于两个独立的 腔室，保证混合前各腔室药品的稳定性，临床使用时即开、即混、即用，可有效 避免配制过程中的错配和污染风险，同时节约配制时间、减少配制工作量并降低 医护人员暴露风险，尤其 ...

Core Viewpoint - Kolun Pharmaceutical (002422) announced that its subsidiary, Hunan Kolun Pharmaceutical Co., Ltd., has received drug registration approval from the National Medical Products Administration for its chemical drug "Cefazolin Sodium/Sodium Chloride Injection" [1] Group 1 - The drug is packaged in a dual-chamber bag, containing 1.0g of cefazolin and 0.9g of sodium chloride in 100ml of injection solution [1] - The dual-chamber bag design helps to avoid mismatching and contamination risks during the preparation process, making it suitable for rapid treatment in emergency situations [1] - Cefazolin sodium is a classic medication for infection treatment, with projected sales of 1.35 billion yuan for injection forms in China in 2024 [1] Group 2 - Kolun Pharmaceutical is the second company in China to receive approval for the dual-chamber bag packaging format [1]

四川科伦药业股份有限公司（以下简称"公司"）于2025年6月5日发布了《四 川科伦药业股份有限公司关于控股子公司科伦博泰根据一般性授权配售股份的 公告》（公告编号：2025-046，以下简称"配售公告"），内容有关公司控股子 公司四川科伦博泰生物医药股份有限公司（以下简称"科伦博泰"）与配售代理 签订配售协议及根据配售协议进行H股配售（以下简称"本次配售"）。本公告 中所用词汇的含义除另有定义外，与配售公告所界定者相同。 公司获悉，本次配售已于2025年6月12日完成，科伦博泰按331.8港元/股的配 售价格向不少于6名的承配人配售合计5,918,000股H股，配售所得款项净额约为 19.43亿港元，资金用途见配售公告披露内容。 本次配售完成后，科伦博泰的股份总数为233,185,969股，其中公司及全资子 公司科伦国际发展有限公司合计直接持有科伦博泰约53.41%股份，公司仍为科伦 博泰的控股股东。本次配售不存在损害公司及全体股东利益的情形。 特此公告。 证券代码：002422 证券简称：科伦药业 公告编号：2025-049 四川科伦药业股份有限公司 关于控股子公司科伦博泰完成根据一般性授权配售股份的公告 ...

Core Viewpoint - Sichuan Kelun Pharmaceutical Co., Ltd. announced that its subsidiary, Sichuan Kelun Botai Biopharmaceutical Co., Ltd., received breakthrough therapy designation from the National Medical Products Administration (NMPA) for its TROP2 ADC product, sac-TMT, in combination with PD-L1 monoclonal antibody, Tagolizumab, for the first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without driver gene mutations [2][3]. Group 1: Product and Clinical Development - Sac-TMT is a novel TROP2 ADC developed by Kelun Botai, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), and gynecological tumors [3][5]. - The drug utilizes a new linker and has a drug-antibody ratio (DAR) of 7.4, employing a topoisomerase I inhibitor as an effective payload to induce DNA damage in tumor cells [3][5]. - Sac-TMT has previously received four other breakthrough therapy designations for various indications, including triple-negative breast cancer (TNBC) and EGFR mutation-positive NSCLC [3][4]. Group 2: Regulatory and Market Position - Sac-TMT is the first domestically developed ADC with global intellectual property rights and the first TROP2 ADC approved for lung cancer indications globally [5]. - The drug has already been approved for two indications in China, including treatment for advanced TNBC and EGFR mutation-positive NSCLC after prior treatment [4][5]. - Kelun Botai has initiated eight registration clinical studies in China, while Merck has started 14 ongoing global Phase III clinical studies for sac-TMT in various cancer types [5]. Group 3: Collaborations and Partnerships - In May 2022, Kelun Botai granted Merck exclusive rights to develop, use, manufacture, and commercialize sac-TMT outside Greater China [4]. - Tagolizumab, the PD-L1 monoclonal antibody used in combination with sac-TMT, is the first approved PD-L1 antibody for first-line treatment of nasopharyngeal carcinoma in China [6].

Investment Rating - The report recommends a "Buy" rating for multiple companies in the pharmaceutical sector, including Junshi Biosciences, Hualing Pharmaceutical-B, and others [3]. Core Insights - The pharmaceutical sector has outperformed the market, with a focus on the potential of innovative drugs and the CD73 target in cancer immunotherapy [4][5]. - The report highlights the promising clinical progress of CD73 inhibitors, with several products in various stages of clinical trials [21][25]. Summary by Sections Industry Investment Rating - The report provides a list of recommended companies with "Buy" and "Hold" ratings, indicating strong investment potential in the pharmaceutical sector [3]. Industry Performance - The pharmaceutical sector rose by 1.13%, outperforming the CSI 300 index by 0.25 percentage points, with innovative drugs and vaccines leading the performance [5][32]. Company Dynamics - Companies such as Lepu Medical and Sunshine Nuohua have made significant announcements regarding new product approvals and clinical trial progress, indicating a robust pipeline and growth potential [33][34]. Industry Trends - The report discusses the increasing focus on innovative drugs and the impact of regulatory changes on the pharmaceutical landscape, suggesting a shift towards high-efficiency business models in the industry [31][40].

Group 1 - Libet has received approval from the China Securities Regulatory Commission for the issuance of convertible bonds, valid for 12 months [1] - Dinglong plans to acquire an additional 8% stake in its subsidiary, increasing its ownership from 91.35% to 99.35% for a total price of 240 million yuan [1] - Longyuan Donggu has been designated as a supplier for a major automotive project, with an expected total sales amount of 450 to 500 million yuan over five years [14] Group 2 - Luoniushan reported a sales revenue of 100 million yuan in May, a year-on-year decrease of 11.45% [2] - Baoming Technology has secured a loan commitment of up to 7 million yuan for stock repurchase [2] - Xinhua Pharmaceutical has received approval for the listing of a new chemical raw material used in treating chronic heart failure and hypertension [3] Group 3 - China Minmetals announced a new contract amount of 396 billion yuan for the first five months of the year, a decrease of 22.2% year-on-year [7] - Zhongbei Communication's application for a specific stock issuance has been accepted by the Shanghai Stock Exchange [8] - Rongfa Nuclear Power plans to issue bonds not exceeding 1 billion yuan to repay debts and supplement working capital [9] Group 4 - Phoenix Optical plans to invest 8.5 million USD to establish a wholly-owned subsidiary in Vietnam for manufacturing optical products [11] - Xiamen Airport reported a passenger throughput of 2.4752 million in May, a year-on-year increase of 8.34% [12] - Weilan Biological has received a new veterinary drug registration certificate for a product aimed at treating canine allergies and inflammation [13] Group 5 - Shouxiangu has completed the registration of a health food product that claims to enhance immunity [13] - Xingye Yinxin's subsidiary has passed a resource reserve verification report, confirming significant mineral reserves [16] - Shaanxi Construction has won two major projects with a total contract value exceeding 2.8 billion yuan [18] Group 6 - Huari received a cash dividend of 50 million yuan from its subsidiary [20] - Zhongchu's deputy general manager has resigned due to governance arrangements [21] - Kexin Pharmaceutical's core product has received breakthrough therapy designation from the National Medical Products Administration [39]

证券代码：002422 证券简称：科伦药业 公告编号：2025-048 四川科伦药业股份有限公司 关于子公司核心产品 TROP2 ADC 芦康沙妥珠单抗(sac -TMT) 联合 PD-L1 单抗塔戈利单抗一线治疗无驱动基因突变的局部晚期 或转移性非鳞状非小细胞肺癌 获国家药品监督管理局突破性疗法认定的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚假记载、误 导性陈述或重大遗漏。 四川科伦药业股份有限公司（以下简称"公司"）近日获悉，公司控股子公 司四川科伦博泰生物医药股份有限公司（以下简称"科伦博泰"）靶向人滋养细 胞表面抗原 2(TROP2)的抗体偶联药物(ADC)芦康沙妥珠单抗(sac-TMT)(佳泰莱®) 联合抗程序性细胞死亡配体 1(PD-L1)单克隆抗体塔戈利单抗(科泰莱®)一线治疗 无驱动基因突变的局部晚期或转移性非鳞状非小细胞肺癌(NSCLC)获中国国家 药品监督管理局(NMPA)药品评审中心(CDE)授予突破性疗法认定。突破性疗法 认定是针对与现有治疗手段相比具有明显临床优势的药物，旨在加速满足临床急 需医疗需求的创新药的研发和产品上市。 这是芦康沙妥珠单抗(sac- ...

Core Viewpoint - The ongoing public dispute between Kelong Pharmaceutical's chairman Liu Gexin and Peking University professor Rao Yi has inadvertently boosted the market value management of Kelong, particularly through the promotion of its product, ergothioneine capsules, despite the product facing allegations of being a "fake drug" [1][2][11]. Group 1: Product and Market Performance - Ergothioneine is a natural sulfur-containing amino acid, currently not classified as a health product or food, with plans for gradual approval in China [2][5]. - Following the controversy, Kelong's stock price experienced a slight decline of approximately 4.98% over two days but later rebounded, with sales of ergothioneine capsules increasing significantly by 14.82 million yuan in just two days [2][10]. - Kelong's first-quarter revenue and profit both declined, yet the stock price surged by 20%, reaching a historical high during the publicity surrounding the "muscle show" [3][15]. Group 2: Regulatory and Scientific Context - The ergothioneine capsules are marketed as dietary supplements imported from Japan, with a minimum price of 1,199 yuan for a bottle of 60 capsules [5][12]. - Kelong has not yet registered or filed for the ergothioneine capsules with the National Health Commission, which is necessary for health product approval in China [8][9]. - The product's promotion has raised concerns about misleading advertising, as Kelong has been accused of implying health benefits that have not been scientifically validated [9][12]. Group 3: Company Background and Strategic Shift - Kelong Pharmaceutical, founded in 1996, has seen a significant decline in its traditional intravenous infusion business, which previously contributed over 10 billion yuan in revenue [14][15]. - The company is pivoting towards the health sector, with ergothioneine being a key focus, as it seeks to adapt to changing market conditions and regulatory environments [11][14]. - Despite the controversies, Kelong and its subsidiaries have seen stock price increases, indicating a potential market advantage from the heightened visibility [15][16].

Core Viewpoint - The Chinese pharmaceutical industry is transitioning from "generic drugs" to "innovative drugs," creating a golden development period for companies with core R&D capabilities, driven by policy support, capital influx, and market demand [1] Group 1: Reasons for Optimism in the "Innovative Drug" Sector - Policy Benefits: National strategic support for the shift from "generic" to "innovative" drugs [1] - Market Demand: Aging population and consumption upgrades ensure strong long-term growth [1] - Technological Breakthroughs: Chinese innovative drugs are gradually moving towards global markets, with companies like BeiGene achieving overseas licensing [1] Group 2: Notable A-Share Innovative Drug Companies - Hengrui Medicine (600276): Leading innovative drug company with the highest R&D investment in China, exceeding 6 billion in 2023, covering oncology, autoimmune diseases, and metabolic diseases [3] - BeiGene (688235): A benchmark for Chinese innovative drugs going global [5] - Innovent Biologics (01801.HK): One of the "PD-1 Four Little Dragons" with a rich pipeline [5] - Rongchang Biologics (688331): Leader in the ADC sector [7] - Kelun Pharmaceutical (002422): Transitioning from an infusion leader to innovative drugs [7] - East China Pharmaceutical (000963): Driven by both medical aesthetics and innovative drugs [7] - Kangfang Biologics (09926.HK): Leader in the dual antibody sector [7] Group 3: Market Trends and Dynamics - Accelerated inclusion of innovative drugs in medical insurance, leading to explosive sales growth [4] - New listing regulations for the Sci-Tech Innovation Board/B-shares allow unprofitable biotech companies to go public, improving the financing environment [4] - The aging population in China exceeds 280 million, with increasing treatment demands for diseases like cancer, diabetes, and cardiovascular issues [4] - Rising per capita medical expenditure and enhanced patient payment capabilities for high-end innovative drugs [4] Group 4: Investment Recommendations - Long-term holding of core leaders like Hengrui and BeiGene is advised [9] - Attention to emerging players in niche sectors such as ADC, dual antibodies, and GLP-1 drugs [9] - Monitoring of R&D risks, including clinical failures and price reductions in medical insurance [9]

Core Viewpoint - The pharmaceutical sector, particularly innovative drugs, experienced a significant surge on June 9, with related ETFs in the Hong Kong market rising collectively by over 4% in half a day, indicating high trading activity and investor interest [1]. Group 1: ETF Performance - The Hong Kong innovative drug ETFs saw substantial gains, with the following notable performances: - Guotai Innovative Drug ETF (517110) increased by 4.7%, with a trading volume of 814.38 million yuan and a scale of 4.29 million units [2][3]. - Hong Kong Innovative Drug ETF Fund (520700) rose by 4.65%, with a trading volume of 4.32 billion yuan and a scale of 2.18 million units [5]. - Hong Kong Innovative Drug 50 ETF (513780) gained 4.63%, with a scale of 4.2 million units [5]. - Hong Kong Innovative Drug ETF (513120) increased by 4.44%, with a trading volume of 49.82 billion yuan and a scale of 91.57 million units [6]. Group 2: Investment Logic - The investment logic for innovative drugs is driven by both domestic and international factors: - Domestic policies, such as the "腾笼换鸟" (Tenglong Huanniao) policy, are creating more payment space for innovative drugs, facilitating the import substitution process and providing better service and policy support for domestic innovative drugs [2]. - A significant number of innovative drug companies are expected to reach profitability this year, as high R&D investments begin to translate into revenue growth, leading to profit elasticity [2]. Group 3: Market Dynamics - Prior to Q3 2022, innovative drugs were largely overlooked by the market, with minimal research and trading activity, resulting in a bottoming out of asset prices and industry cycles [3]. - It is anticipated that innovative drugs will become a standard allocation for active pharmaceutical fund managers in the next two years, potentially attracting an additional 30-50 billion yuan in investment, while the current circulating market cap for innovative drugs is around 30 billion yuan [3]. Group 4: Index Composition - The CSI Hong Kong Innovative Drug Industry Index selects up to 50 publicly listed companies involved in innovative drug R&D in the Hong Kong market, reflecting the overall performance of these companies [7]. - Major weighted stocks in the index include: - BeiGene (6160.HK) with a weight of 11.99% - Heng Rui Medicine (600276) with a weight of 9.35% - WuXi AppTec (603259) with a weight of 9.31% [4][8].