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].

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]

格隆汇9月23日丨科伦博泰生物-B(06990.HK)宣布，公司转染过程中重排(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期队列治疗1L和2L及以上RET融合阳性NSCLC的积极结果。 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性NSCLC患者的有效性和安全性。两个关键临床研究队 列的主要有效性终点已达到，A400/EP0031在经治和初治的NSCLC患者中（包括既往经免疫疗法治疗或 脑转移患者）展示出良好的疗效。A400/EP0031亦显示出令人鼓舞的、可管理的耐受性和安全性。 ...

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性NSCLC患者的有效性和安全性。两个关键临床研究队 列的主要有效性终点已达到，A400/EP0031在经治和初治的NSCLC患者中(包括既往经免疫疗法治疗或 脑转移患者)展示出良好的疗效。A400/EP0031亦显示出令人鼓舞的、可管理的耐受性和安全性。 科伦博泰生物-B(06990)发布公告，公司转染过程中重排(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期队列治疗1L和2L及以上RET融合阳性NSCLC的积极结果。 ...

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。 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. 四川科倫博泰生物醫藥股份有限公司 （於中華人民共和國註冊成立的股份有限公司） – 1 – （股份代號：6990） 自願公告 A400/EP0031新藥上市申請獲國家藥品監督管理局受理 四 川 科 倫 博 泰 生 物 醫 藥 股 份 有 限 公 司（「本公司」）董 事（「董 事」）董 事 會（「董 事 會」）欣 然 宣 佈，本 公 司 轉 染 過 程 中 重 排(RET)小分子激酶抑制劑項目A400（亦 稱 EP0031）的 一 項 新 藥 上 市 申 請(NDA)已獲中國國家藥品監督管理局(NMPA)藥 品 審評中心(CDE)受 理，用 於 治 療RET融合陽性局部晚期或轉移性非小細胞肺癌 (NSCLC)成 人 患 者。本 次 受 理 是 基 於KL ...

Group 1: Key Recommendations - Key recommendation for Kelun Pharmaceutical (002422): Short-term performance under pressure, but continuous innovation results are being realized [5][6][7][8] - Key recommendation for Huaxia Eye Hospital (301267): Good growth in refractive business, with performance stabilizing and improving [10][11][12][14] - Key recommendation for Pumen Technology (688389): Domestic business short-term decline, but international business shows steady growth [15][16][17][19] Group 2: Financial Performance - Kelun Pharmaceutical reported H1 2025 revenue of 9.083 billion yuan, down 23.20% year-on-year, and net profit of 1.001 billion yuan, down 44.41% year-on-year [5][6] - Huaxia Eye Hospital achieved H1 2025 revenue of 2.139 billion yuan, up 4.31% year-on-year, and net profit of 282 million yuan, up 6.20% year-on-year [10][11] - Pumen Technology's H1 2025 revenue was 507 million yuan, down 14.1% year-on-year, with a net profit of 122 million yuan, down 29.3% year-on-year [16][17] Group 3: Business Segments - For Kelun Pharmaceutical, the infusion segment saw revenue of 3.750 billion yuan, down 19.65% year-on-year, while innovative drug sales reached 310 million yuan, with SKB264 accounting for 97.65% of this [6][7] - Huaxia Eye Hospital's refractive project revenue was 789 million yuan, up 13.75% year-on-year, while cataract project revenue declined by 7.33% to 431 million yuan [12][13] - Pumen Technology's domestic revenue was 332 million yuan, down 22.74% year-on-year, while international revenue was 175 million yuan, up 9.01% year-on-year [17][18] Group 4: Investment Recommendations - Kelun Pharmaceutical's revenue forecasts for 2025-2027 are 19.471 billion, 22.371 billion, and 24.487 billion yuan, with net profits of 2.265 billion, 2.876 billion, and 3.418 billion yuan respectively, maintaining a "buy" rating [8] - Huaxia Eye Hospital's net profit forecasts for 2025-2027 are 515 million, 605 million, and 697 million yuan, also maintaining a "buy" rating [14] - Pumen Technology's net profit forecasts for 2025-2027 are 407 million, 471 million, and 537 million yuan, maintaining a "buy" rating [19]

Core Viewpoint - The company reported a significant decline in revenue and net profit for the first half of 2025, with a focus on the challenges faced in its infusion, generic drugs, and raw materials segments, while highlighting growth opportunities from innovative product launches [1][2]. Revenue and Profit Summary - The company’s total revenue for the first half of 2025 was 9.083 billion yuan, a decrease of 23.2% year-on-year, with a net profit attributable to the parent company of 1.001 billion yuan, down 44.41% [1]. - In Q2 alone, revenue was 4.693 billion yuan, reflecting a year-on-year decline of 16.3%, and net profit was 416 million yuan, down 46.2% [1]. Business Segment Performance - **Infusion Segment**: Revenue was 3.750 billion yuan, a decline of 19.65% year-on-year. The company is transitioning to fully closed infusion systems, with the market share of closed infusion products increasing by 0.39 percentage points [2]. - **Non-Infusion Formulations**: Revenue reached 1.955 billion yuan, down 3.18% year-on-year. The sales of plastic water injections decreased by 11.96% due to reduced demand for glucose injections and the failure to win bids in national procurement [2]. - **Intermediate and Raw Materials**: Revenue from antibiotic intermediates and raw materials was 2.282 billion yuan, down 30.29% year-on-year, primarily due to market demand fluctuations [2]. International Business - The company achieved overseas revenue of 1.130 billion yuan, a decline of 39.69% year-on-year, mainly due to a decrease in overseas licensing income [3]. R&D and Innovation - The company is advancing its R&D pipeline with a dual focus on core business and innovative exploration. The innovative product Jiatailai has been launched, and further exploration for its use in treating various solid tumors is ongoing [3]. - Collaborations with Merck are progressing on 14 clinical studies for sac-TMT as a monotherapy or in combination with other drugs for multiple cancer types [3]. Investment Outlook - The company’s infusion and raw material intermediate businesses are expected to reach a bottom, with ongoing progress in the pipeline and accelerated sales of innovative products. Projected net profits for 2025-2027 are 1.675 billion, 2.248 billion, and 2.716 billion yuan, with year-on-year growth rates of -43%, 34%, and 21% respectively [4].