Core Viewpoint - Sichuan Kelun Pharmaceutical Co., Ltd. announced that its subsidiary, Sichuan Kelun Botai Biopharmaceutical Co., Ltd., has received acceptance from the National Medical Products Administration (NMPA) for a New Drug Application (NDA) for the RET small molecule kinase inhibitor A400 (also known as EP0031) for the treatment of RET fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) in adult patients [1][2]. Drug Overview - The KL400-I/II-01 study includes two key Phase II cohorts assessing the efficacy and safety of A400/EP0031 at a dosage of 90 mg orally once daily for treating RET fusion-positive locally advanced or metastatic NSCLC patients, both treatment-naive and previously treated [1]. - The primary efficacy endpoints of the two key clinical study cohorts have been met, demonstrating good efficacy of A400/EP0031 in NSCLC patients, including those previously treated with immunotherapy or with brain metastases [1]. - A400 is a next-generation selective RET inhibitor aimed at treating NSCLC, medullary thyroid carcinoma (MTC), and other solid tumors with high prevalence of RET mutations [2]. Clinical Development - Kelun Botai is currently conducting a Phase 1b/2 clinical study in China targeting RET+ MTC and solid tumors [2]. - The Phase I study results for A400/EP0031 in advanced RET-mutant MTC patients were presented at the 2025 ASCO Annual Meeting [2]. - In March 2024, A400/EP0031 received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of RET fusion-positive NSCLC, and in April 2024, it was approved to enter Phase 2 clinical development, with trials ongoing in the U.S., U.K., EU, and UAE [2].

Company Overview - Sichuan Kelun Pharmaceutical Co., Ltd. is located in Chengdu, Sichuan Province, established on May 29, 2002, and listed on June 3, 2010. The company specializes in the development, production, and sales of large-volume parenteral solutions [1][2] - The main business revenue composition includes: non-infusion products 48.37%, infusion products 41.28%, R&D projects 7.01%, and others 3.33% [1] Financial Performance - For the first half of 2025, Kelun Pharmaceutical achieved operating revenue of 9.083 billion yuan, a year-on-year decrease of 23.20%. The net profit attributable to shareholders was 1.001 billion yuan, down 44.41% year-on-year [2] - Since its A-share listing, the company has distributed a total of 6.697 billion yuan in dividends, with 3.386 billion yuan distributed in the last three years [3] Stock Market Activity - On September 24, Kelun Pharmaceutical's stock price increased by 2.00%, reaching 37.69 yuan per share, with a trading volume of 1.05 billion yuan and a turnover rate of 0.22%. The total market capitalization is 60.231 billion yuan [1] - Year-to-date, the stock price has risen by 28.07%, with a 2.03% increase over the last five trading days, 2.14% over the last twenty days, and 6.14% over the last sixty days [1] - The company has appeared on the "Dragon and Tiger List" twice this year, with the most recent appearance on April 30, where the net buying amount was 31.8792 million yuan [1] Shareholder Structure - As of June 30, 2025, the number of shareholders is 34,200, an increase of 2.55% from the previous period. The average circulating shares per person decreased by 2.49% to 38,138 shares [2] - The top ten circulating shareholders include notable funds such as China Europe Medical Health Mixed A and Hong Kong Central Clearing Limited, with varying changes in their holdings [3]

Group 1: Market Performance - The Hong Kong Innovation Drug ETF (159570) experienced a decline of 1.48% with a trading volume of nearly 2 billion CNY on September 23, 2025, and has seen a net inflow of over 15 billion CNY in the past 10 days [1] - As of September 22, 2025, the total size of the Hong Kong Innovation Drug ETF (159570) exceeded 21.6 billion CNY, leading its peers in both size and liquidity [1] - The underlying index components of the ETF mostly showed negative performance, with notable declines in China Biologic Products and CSPC Pharmaceutical Group, while Kangfang Biotech rose over 4% due to positive research news [1] Group 2: Industry Trends - Morgan Stanley noted that the total market capitalization of Chinese biotech stocks listed in Hong Kong has increased by 154% year-to-date, significantly outperforming the Hang Seng Index's 34% increase, indicating a major shift in market recognition of local pharmaceutical innovation capabilities [2] - The pharmaceutical sector is entering a new development phase driven by innovation, with major companies showing stable growth and transitioning from generic to innovative drugs [3][4] - The pharmaceutical industry is expected to benefit from ongoing policy support for innovative drugs, with recent announcements from the National Medical Insurance Bureau indicating a focus on optimizing drug procurement and supporting innovative products [5] Group 3: Company Performance - Hengrui Medicine reported a revenue of 15.76 billion CNY for H1 2025, a year-on-year increase of 15.88%, with a net profit of 4.45 billion CNY, up 29.67% [4] - China Biologic Products achieved a revenue of 17.58 billion CNY in H1 2025, reflecting a year-on-year growth of 9.8%, with a net profit increase of 13.10% [4] - Innovent Biologics demonstrated significant growth in innovative drug revenue, with a 26% increase in H1 2025, contributing to a 32% rise in net profit [4] Group 4: Future Outlook - The pharmaceutical sector is expected to continue benefiting from improved global liquidity and supportive national policies for innovation, with a focus on emerging technologies and international competitiveness [7] - The industry is anticipated to see long-term growth opportunities, particularly in innovative drugs and medical devices, as well as potential challenges associated with international expansion [7] - The recent adjustments in the national drug procurement policy are expected to stabilize the market for generic drugs, reducing the impact of price competition on the sector [5]

Company Overview - Sichuan Kelun Pharmaceutical Co., Ltd. is located in Chengdu, Sichuan Province, and was established on May 29, 2002. The company was listed on June 3, 2010. Its main business involves the development, production, and sales of large-volume infusion products. The revenue composition is as follows: non-infusion products 48.37%, infusion products 41.28%, R&D projects 7.01%, and others 3.33% [1]. Financial Performance - For the first half of 2025, Kelun Pharmaceutical achieved operating revenue of 9.083 billion yuan, a year-on-year decrease of 23.20%. The net profit attributable to the parent company was 1.001 billion yuan, down 44.41% year-on-year [2]. - Since its A-share listing, Kelun Pharmaceutical has distributed a total of 6.697 billion yuan in dividends, with 3.386 billion yuan distributed in the last three years [3]. Stock Market Activity - As of September 23, Kelun Pharmaceutical's stock price was 36.54 yuan per share, with a market capitalization of 58.393 billion yuan. The stock has increased by 24.16% year-to-date, but has seen a decline of 0.90% over the last five trading days and 4.35% over the last 20 days [1]. - The company has appeared on the "Dragon and Tiger List" twice this year, with the most recent appearance on April 30, where it recorded a net purchase of 31.8792 million yuan [1]. Shareholder Information - As of June 30, 2025, the number of shareholders for Kelun Pharmaceutical was 34,200, an increase of 2.55% from the previous period. The average circulating shares per person were 38,138, a decrease of 2.49% [2]. - Among the top ten circulating shareholders, notable changes include an increase in holdings by China Europe Medical Health Mixed A and a decrease in holdings by Hong Kong Central Clearing Limited [3].

Core Viewpoint - Kolun Pharmaceutical's subsidiary, Sichuan Kolun Botai Biopharmaceutical Co., Ltd., has received acceptance for a new drug application (NDA) for its RET small molecule kinase inhibitor project A400 (also known as EP0031) from the National Medical Products Administration (NMPA) in China, aimed at treating RET fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) in adult patients [1] Group 1 - The NDA acceptance is based on positive results from the KL400-I/II-01 study, which included two key Phase II cohorts (1L and 2L and above) for treating RET fusion-positive NSCLC [1] - The Phase II stage of the KL400-I/II-01 study evaluated the efficacy and safety of A400/EP0031 administered orally at a dose of 90mg once daily (QD) for both previously treated and treatment-naive patients with RET fusion-positive locally advanced or metastatic NSCLC [1] - The primary efficacy endpoints of the two key clinical study cohorts have been met, demonstrating good efficacy of A400/EP0031 in both previously treated and treatment-naive NSCLC patients, including those previously treated with immunotherapy or with brain metastases [1] Group 2 - A400/EP0031 has also shown manageable tolerability and safety profiles [1]

Core Viewpoint - The company has received acceptance for a new drug application (NDA) for its RET small molecule kinase inhibitor A400 (also known as EP0031) from the National Medical Products Administration (NMPA) in China, aimed at treating RET fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) in adult patients [1] Group 1 - The NDA acceptance is based on positive results from the KL400-I/II-01 study, which included two key Phase II cohorts assessing the efficacy and safety of A400/EP0031 [1] - The Phase II study consists of two cohorts, evaluating A400/EP0031 administered once daily at 90mg for treating both previously treated and treatment-naive RET fusion-positive locally advanced or metastatic NSCLC patients [1] - The primary efficacy endpoints of both key clinical study cohorts have been met, demonstrating good efficacy of A400/EP0031 in NSCLC patients, including those previously treated with immunotherapy or with brain metastases [1] Group 2 - A400/EP0031 has shown manageable tolerability and safety profiles during the clinical trials [1]

证券代码：002422 证券简称：科伦药业 公告编号：2025-072 四川科伦药业股份有限公司 关于子公司 A400/ EP0031 新药上市申请 获国家药品监督管理局受理的公告 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"）开发的转染过 程中重排(RET)小分子激酶抑制剂项目 A400(亦称 EP0031)的一项新药上市申请 (NDA)已获中国国家药品监督管理局(NMPA)药品审评中心(CDE)受理，用于治疗 RET 融合阳性局部晚期或转移性非小细胞肺癌(NSCLC)成人患者。本次受理是基 于 KL400-I/II-01 研究中两个关键 2 期队列（1L 和 2L 及以上）治疗 RET 融合阳 性 NSCLC 的积极结果。 一、药品基本情况 KL400-I/II-01 研究中 2 期阶段包含队列 1 和队列 2，分别评估 A400/EP0031 每天一次(QD) 90mg 口服用于治疗经治和初治的 RET 融合阳性局部晚期或转移 ...

Core Viewpoint - Kelun Pharmaceutical has significant ownership in Kelun Biotech and is actively developing a diverse pipeline of innovative drugs targeting various diseases [2] Company Summary - As of June 30, 2025, Kelun Pharmaceutical directly holds 51.45% of Kelun Biotech and indirectly holds 4.97% [2] - Kelun Biotech has over 30 innovative drug candidates in its research pipeline, focusing on oncology and non-oncology diseases such as autoimmune and metabolic disorders [2]

Group 1 - The chemical pharmaceutical sector increased by 0.22% on September 22, with Sunflower leading the gains [1] - The Shanghai Composite Index closed at 3828.58, up 0.22%, while the Shenzhen Component Index closed at 13157.97, up 0.67% [1] - Notable gainers in the chemical pharmaceutical sector included Sunflower, which rose by 19.96% to a closing price of 5.95, and Frontier Biotech, which increased by 5.84% to 15.76 [1] Group 2 - The sector experienced a net outflow of 1.368 billion yuan from institutional investors, while retail investors saw a net inflow of 908 million yuan [2] - Major stocks with significant net inflows from retail investors included Sunflower, which had a net inflow of 55.9352 million yuan [3] - Conversely, stocks like Hengrui Medicine experienced a net outflow of 62.0948 million yuan from retail investors [3]

Core Insights - The report indicates a 2.07% week-on-week decline in the Shenwan Pharmaceutical Index, underperforming both the CSI 300 Index and the ChiNext Index during the week of September 15-19, 2025 [1][12] - The focus for the upcoming 1-2 quarters includes significant global conferences related to innovative drugs and the business development (BD) spending rhythm of multinational corporations (MNCs) [1][18] Recent Market Review - The market experienced fluctuations, with a notable rise in coal, electricity, electronics, and real estate sectors, while the pharmaceutical index showed similar volatility, particularly with a larger adjustment on Thursday and Friday [2][13] - The innovative drug sector is currently in a state of adjustment, reflecting a digestion of trading structures and a lack of short-term catalysts [3][14] Future Outlook - The report emphasizes a positive outlook for the pharmaceutical sector in 2025, driven by innovative drugs, with a focus on overseas major pharmaceuticals, small and medium-sized technology revolutions, and the revaluation of generic pharmaceuticals [4][15] - The report suggests that the innovative drug sector is entering a second wave of growth over the next 5-10 years, with the keyword being "disruption" [3][14] Investment Strategy - The report outlines specific investment strategies in the innovative drug sector, highlighting key companies such as Innovent Biologics, BeiGene, and others in various therapeutic areas including oncology and chronic diseases [7][16] - It also identifies emerging technologies such as brain-computer interfaces and AI in medicine as potential investment opportunities [8][16] Upcoming Conferences - Key upcoming global conferences include the ESMO Congress and SABCS, which are expected to influence BD activities and provide insights into the latest advancements in oncology [18][19] Performance Metrics - The report notes that the CSI Innovative Drug Index has increased by 38.55% since the beginning of 2025, outperforming both the Shenwan Pharmaceutical Index and the CSI 300 Index [23][26]