Core Insights - The article highlights the long-term value of Yifang Biotech, a leading domestic small molecule drug development company, focusing on high-barrier targeted therapies in oncology, autoimmune diseases, and metabolism [1][2]. Group 1: Product Pipeline and Approvals - As of March 2025, the company has two drugs approved for market: the third-generation EGFR-TKI, Befotnib, and the KRAS G12C inhibitor, Gsorese [1]. - Befotnib is the fourth approved third-generation EGFR-TKI in China, indicated for EGFR mutation-positive NSCLC in 1st and 2nd line treatments, with mPFS of 22.1 months, significantly extending the duration compared to the control group [1][2]. - Gsorese is the second KRAS G12C inhibitor in China, expected to be approved in November 2024 for treating KRAS G12C mutation NSCLC patients, with an ORR of 52% and DCR of 88.6% in Phase II trials [2]. Group 2: Strategic Collaborations - The company has partnered with Betta Pharmaceuticals for the commercialization of Befotnib, leveraging Betta's established operational and sales capabilities to enhance market penetration [1]. - An exclusive licensing agreement was signed with Zhengda Tianqing for Gsorese, which may accelerate its growth potential in the market [2]. Group 3: Research and Development Potential - The company is advancing several promising candidates, including the oral TYK2 inhibitor D-2570, which has shown strong efficacy in treating moderate to severe plaque psoriasis with a PASI75 response rate of 85.0%-90.0% [2][3]. - The oral SERD D-0502 for HR+/HER2- breast cancer is in critical Phase III clinical trials, indicating its potential to be a best-in-class (BIC) therapy [3]. - The URAT1 inhibitor D-0120 for hyperuricemia and gout has completed Phase IIb clinical trials, showcasing its promising drug development potential [3]. Group 4: Financial Projections - The company forecasts revenues of 191 million yuan, 255 million yuan, and 399 million yuan for the years 2025, 2026, and 2027, respectively, indicating a positive growth trajectory [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，並明確表示概不就因本公告全部或任何部分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。 Shanghai Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2696) 自願公告 小分子創新藥HLX99 的臨床試驗申請獲美國食品藥品管理局(FDA)批准 A. 緒言 本公告由上海復宏漢霖生物技術股份有限公司（「本公司」）自願作出，以告知 本公司股東及潛在投資者本公司最新業務更新。 本公司董事會（「董事會」）欣然宣佈，近日，本公司自主研發的小分子創新 藥HLX99（「HLX99」）的臨床試驗申請獲美國食品藥品管理局(FDA)批准。 HLX99擬用於治療肌萎縮側索硬化(ALS）。 B. 關於HLX99 HLX99是本公司自主研發的創新型小分子偶聯化學藥物，擬用於治療肌萎縮 側索硬化(ALS)。肌萎縮側索硬化(ALS)，又稱「漸凍症」，是一種神經系統退 行性疾病，影響大腦運動皮層、腦干和脊髓的運動神經元細胞群，導致肌肉 ...