Core Insights - Yahui Pharmaceutical (688176) is accelerating the review process for its product APL-1702, a photodynamic therapy system for treating high-grade squamous intraepithelial lesions (HSIL), aiming for swift market approval [1] - The company reported a revenue of 202 million yuan in 2024, achieving its commercial operation breakeven target, and a 151.24% year-on-year revenue growth in Q1 2025 [2] - APL-2501, an antibody-drug conjugate for treating various advanced tumors, is progressing well, with plans to complete CMC and GLP toxicology studies in 2025 [2] - APL-2302, a novel oral small molecule inhibitor targeting USP1, has received approval for clinical trials in the US and China, with the first patient enrolled in March 2025 [3] Group 1 - APL-1702 is the first product to show positive results in international Phase III trials for HSIL, with a target population of approximately 2.1 million patients in China [1] - The company is conducting systematic research on market accessibility and payment assurance, and is advocating for policies to support cervical cancer prevention [1] Group 2 - The company has exceeded its initial revenue target for 2024, achieving 202 million yuan, and reported a significant increase in Q1 2025 revenue [2] - APL-2501 has shown superior characteristics compared to competitors, with plans for further development and clinical trial submissions in 2026 [2] Group 3 - APL-2302 is designed to induce synthetic lethality in tumors by inhibiting USP1, with ongoing clinical trials expected to advance in 2025 [3] - The company has received regulatory approvals for APL-2302 trials in both the US and China, indicating strong progress in its clinical development pipeline [3]

Financial Data and Key Metrics Changes - For Q1 2025, total revenue was $2.7 million, a significant decrease from $25.4 million in the same period in 2024 [28] - Total operating costs and expenses for Q1 2025 were $17.7 million, down from $74.5 million in Q1 2024, representing a 76% year-over-year decrease [29] - The net loss from continuing operations for Q1 2025 was $16.8 million, or $0.16 per share, compared to a net loss of $49 million, or $0.49 per share, in Q1 2024 [29] Business Line Data and Key Metrics Changes - R&D expenses for Q1 2025 were $9.2 million, down from $36.5 million in Q1 2024, a decrease of 75% year-over-year [29] - SG&A expenses for Q1 2025 were $8.1 million, compared to $16.7 million in Q1 2024, a decrease of 51% year-over-year [29] Market Data and Key Metrics Changes - The total addressable market for FG3246 in metastatic castration-resistant prostate cancer (mCRPC) is estimated to be over $5 billion in annual sales [10] - Approximately 290,000 men are diagnosed with prostate cancer each year in the U.S., with 65,000 being drug-treatable patients in the metastatic castration-resistant stage [9] Company Strategy and Development Direction - The company is focused on advancing its U.S. pipeline opportunities, particularly FG3246 and FG3180, while divesting FibroGen China to simplify operations and extend cash runway [5][6] - The sale of FibroGen China to AstraZeneca is expected to close in Q3 2025, with total consideration now estimated at approximately $185 million, an increase from the initial guidance [5][6][27] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in the refined focus and multiple near-term catalysts across clinical programs, positioning the company well for shareholder value creation [9] - The company anticipates FDA feedback on roxadustat's development for anemia associated with lower-risk myelodysplastic syndromes (MDS) in Q3 2025 [8] Other Important Information - The company reported cash flow positive results in Q1 2025, generating $7.3 million in cash flow on a consolidated basis [30] - Upon closing the China transaction, the company plans to pay off its senior secured term loan, resulting in a cash outflow of approximately $80 million [30] Q&A Session Summary Question: Regarding clinical development on FG3246 and market dynamics after Pluvicto approval - Management confirmed that Pluvicto experienced patients will be allowed in the Phase II monotherapy trial to mitigate enrollment challenges [39][40] Question: Comments on recent FDA correspondence regarding roxadustat - Management reported favorable interactions with the FDA, including timely responses for IND filings and Type C meeting requests [41][42][43] Question: Feasibility studies in colorectal cancer given cash infusion from AstraZeneca - Management indicated that they will hold off on colorectal cancer studies for now, focusing on initiating the Phase II monotherapy trial [44][45] Question: Rate limiting steps ahead of the upcoming Phase II monotherapy study - The close of the China transaction is the primary rate limiter for starting the Phase II monotherapy trial [50] Question: Evolving commercial opportunity for FG3180 - Management highlighted the importance of the Phase II trial in assessing the commercial potential of FG3180 as a diagnostic tool [52][54]

江苏恒瑞医药股份有限公司 关于获得药物临床试验批准通知书的公告 阿得贝利单抗注射液是公司自主研发的人源化抗 PD-L1 单克隆抗体，能通过 特异性结合 PD-L1 分子从而阻断导致肿瘤免疫耐受的 PD-1/PD-L1 通路，重新激 活免疫系统的抗肿瘤活性，从而达到治疗肿瘤的目的。国外有同类产品 Atezolizumab （ 商 品 名 ： Tecentriq ） 、 Avelumab( 商品名： Bavencio) 和 Durvalumab(商品名：Imfinzi)于美国获批上市销售，其中 Atezolizumab 和 Durvalumab 已在中国获批上市。国内有康宁杰瑞/思路迪药业的恩沃利单抗、基 石药业的舒格利单抗和正大天晴药业的贝莫苏拜单抗等同类产品获批上市。公司 阿得贝利单抗注射液（商品名：艾瑞利）已于 2023 年 3 月获批上市，获批的适 应症为与卡铂和依托泊苷联合用于广泛期小细胞肺癌患者的一线治疗。经查询， 2023 年 Atezolizumab、Avelumab 和 Durvalumab 全球销售额合计约为 89.85 亿 美元。截至目前，阿得贝利单抗注射液相关项目累计研发投入约 78,47 ...