Core Viewpoint - Beida Pharmaceutical's subsidiary, Hangzhou Jingyao Biotechnology, has received approval from the National Medical Products Administration (NMPA) for clinical trials of BPI-572270 capsules aimed at treating patients with advanced malignant solid tumors [1][2]. Group 1: Company Developments - Beida Pharmaceutical's subsidiary, Hangzhou Jingyao Biotechnology, has been granted a clinical trial approval notice by NMPA for BPI-572270 [1]. - BPI-572270 is a novel compound developed by the company, possessing complete independent intellectual property rights [2]. Group 2: Product Details - BPI-572270 is a new type of potent pan-RAS non-degradable molecular glue inhibitor [2]. - The mechanism of action involves inducing the binding of the chaperone protein Cyclophilin A (CYPA) to activated RAS mutant proteins, leading to conformational changes that prevent RAS from interacting with downstream signaling proteins, thereby blocking tumor growth pathways like MAPK [2]. - Preclinical studies indicate that BPI-572270 effectively inhibits various tumor cells with different RAS mutations, including pancreatic cancer, non-small cell lung cancer, and colorectal cancer, while also demonstrating excellent pharmacokinetic properties and good safety [2]. - The compound shows promise for single-agent treatment of multiple RAS-mutant cancers or for achieving more comprehensive disease control through combination therapy [2].

Core Viewpoint - Beida Pharmaceutical's subsidiary, Hangzhou Jingyao Biotechnology, has received approval from the National Medical Products Administration (NMPA) for clinical trials of BPI-572270 capsules aimed at treating patients with advanced malignant solid tumors [1][2]. Group 1 - BPI-572270 is a novel compound developed by the company, possessing complete intellectual property rights, and is classified as a new type of potent pan-RAS non-degradable molecular glue inhibitor [2]. - The mechanism of action involves inducing the chaperone protein Cyclophilin A (CYPA) to bind to activated RAS mutant proteins, causing conformational changes that prevent RAS from interacting with downstream signaling proteins, thereby blocking MAPK signaling pathways responsible for tumor growth [2]. - Preclinical studies indicate that BPI-572270 exhibits strong inhibitory effects on various tumor cells harboring RAS mutations (including KRAS, NRAS, HRAS) across multiple cancer types such as pancreatic cancer, non-small cell lung cancer, and colorectal cancer, while also demonstrating excellent pharmacokinetic properties and good safety [2]. Group 2 - The drug has the potential to treat multiple RAS-mutant cancers as a monotherapy or in combination with other treatments for more comprehensive disease control [2].

Core Viewpoint - The announcement indicates that the drug candidate BPI-572270, developed by the company's wholly-owned subsidiary Jingyao Biotech, has received approval from the National Medical Products Administration for clinical trials in patients with advanced malignant solid tumors [1] Group 1: Drug Development - BPI-572270 is a new molecular entity that the company has independently developed and holds complete intellectual property rights [1] - It is characterized as a novel and potent pan-RAS non-degradable molecular glue inhibitor [1] Group 2: Mechanism of Action - The mechanism of action involves inducing the chaperone protein Cyclophilin A (CYPA) to bind to activated mutant RAS proteins, leading to conformational changes in RAS proteins [1] - This process prevents RAS proteins from binding to downstream signaling proteins, such as cRAF, thereby blocking the MAPK signaling pathways responsible for tumor growth [1]

证券代码：300558 证券简称：贝达药业 公告编号：2026-002 贝达药业股份有限公司 产品名称：BPI-572270 胶囊 受理号：CXHL2501284、CXHL2501285、CXHL2501286、CXHL2501287 通知书编号：2026LP00244、2026LP00245、2026LP00246、2026LP00247 注册分类：化学药品 1 类 申请事项：境内生产药品注册临床试验 申请人：杭州景曜生物科技有限责任公司 结论：根据《中华人民共和国药品管理法》及有关规定，经审查，2025 年 11 月 21 日受理的 BPI-572270 胶囊符合药品注册的有关要求，同意本品单药在晚期恶 性实体瘤患者中开展临床试验。 二、该临床试验用药的研究情况 BPI-572270 是由公司自主研发并拥有完全自主知识产权的新分子实体化合物， 是一种新型强效的泛 RAS"非降解型分子胶"抑制剂。其作用机制是诱导肿瘤细 胞中广泛表达的伴侣蛋白 Cyclophilin A（CYPA）结合到激活状态的 RAS 突变蛋 关于 BPI-572270 胶囊获得临床试验批准通知书的公告 本公司及董事会全体成员保证信息披 ...

Core Viewpoint - Yifang Biotechnology has submitted an application for a mainboard listing on the Hong Kong Stock Exchange, amid a wave of License-out deals in the domestic innovative drug sector, but faces significant challenges including ongoing losses, business model risks, and governance concerns [1][7]. Business Model and Financial Performance - Yifang Biotechnology relies heavily on the License-out model, with its two marketed products, Beifuzi and Goresir, exclusively licensed to leading companies, BeiGene and Zhenhua Tianqing [2][8]. - Revenue figures show that from 2023 to the first three quarters of 2025, the company generated revenues of CNY 186 million, CNY 169 million, and CNY 30.89 million, all from licensing agreements [2][8]. - In 2023, over 96% of revenue came from a CNY 180 million milestone payment for Beifuzi, while in 2024, the focus shifted to a CNY 151 million milestone payment for Goresir [2][8]. - Despite these revenues, the company has not achieved profitability, reporting net losses of CNY 284 million, CNY 240 million, and CNY 181 million for 2023, 2024, and the first three quarters of 2025, respectively [2][8]. Accounts Receivable Issues - A significant issue arose when BeiGene delayed a CNY 180 million milestone payment for Beifuzi, leading to a nearly two-year overdue situation [3][9]. - Although the revenue was recognized in 2023, cash flow was delayed, resulting in a CNY 18 million bad debt provision in 2024 [3][9]. Financial Position and Fundraising - As of September 30, 2025, Yifang Biotechnology had CNY 670 million in cash and cash equivalents, CNY 700 million in time deposits, and CNY 153 million in financial assets, totaling CNY 1.523 billion in liquid assets [4][10]. - The company has CNY 1 billion of unutilized funds from its previous fundraising round and has invested CNY 761 million in cash management [4][10]. - Despite a strong cash position, the rationale for seeking additional fundraising is questioned [4][10]. Governance and Shareholding Structure - The company's governance structure is under scrutiny, with a trend of shareholding dilution following the expiration of a joint action agreement among key executives [5][11]. - The combined shareholding of the founders decreased from 28.58% to 27.26% after the agreement ended, raising concerns about control [5][11]. - A significant number of shares (approximately 161 million, or 27.79% of total shares) will be unlocked in January 2026, potentially leading to market pressure [5][11]. Executive Compensation - The total annual salary for key executives exceeded CNY 25 million from 2023 to 2024, which is considered high relative to the company's ongoing losses [6][12]. - Balancing executive incentives with shareholder returns and sustainable development remains a governance challenge [6][12].

Core Insights - The report emphasizes the importance of discovering investment opportunities with a proactive attitude rather than merely relaying information [1] Macro News Summary - The Ministry of Industry and Information Technology (MIIT) supports local governments in building future industries and increasing government investment fund efforts [4] - MIIT will promote collaborative innovation across the entire supply chain for advanced materials [4] - The Ministry of Housing and Urban-Rural Development supports reasonable financing needs of real estate companies and addresses both rigid and improved housing demands of residents [4] Industry Developments - Glass substrates are expected to become the next generation of core materials for advanced packaging, replacing traditional organic substrates, with related stocks including Di'er Laser (300776) and Hongtian Co., Ltd. (603800) [5] - Six departments have extended tax and fee incentives for the childcare industry, indicating a potential boom for the maternal and infant sector, with related stocks including Kidswant (301078) and Aiyingshi (603214) [5] - Several banks have recently launched satellites, accelerating the operational value of the satellite industry, with related stocks including Hangyu Micro (300053) and Aerospace Hongtu (688066) [5] Company Focus - Ruike Laser (300747) is taking measures to resist malicious low-price sales and irregular channel sales that disrupt market pricing [6] - Betta Pharmaceuticals (300558) is progressing steadily with multiple clinical studies for MCLA-129 [6] - Zhongke Chuangda (300496) has reached a strategic cooperation with the Beijing Humanoid Robot Innovation Center through its subsidiary Xiaowu Intelligent [6] - Ningbo Bank (002142) is continuously accumulating differentiated competitive advantages, with a steady expansion of profit scale expected by 2025 [6] Market Review and Outlook - On January 21, the market experienced a pullback after a rise, with the Shanghai Composite Index closing at 4116.94, up 0.08%, and the Shenzhen Component Index at 14255.13, up 0.70% [7] - The total trading volume in the Shanghai and Shenzhen markets was 2.6 trillion, a decrease of 177.1 billion from the previous trading day [7] - The market is expected to shift from a "fund-driven" rapid growth model to a "performance-driven" slow bull market, with macroeconomic improvements and corporate profit recoveries as key drivers for mid-term upward trends [7] - It is advised to maintain balanced allocations across sectors, focusing on non-ferrous metals, technology growth, new energy, and dividend stocks [7]

证券日报网讯 1月21日，贝达药业在互动平台回答投资者提问时表示，基于国外临床进展、国内商业化 规划，公司将统筹推进EYP-1901的国内临床研究及上市申报工作。公司合作伙伴EYEPOINT公司已在 2025年完成wAMD适应症的两项III期临床入组，并计划在2026年一季度实现DME适应症的III期临床的 首例病人入组，相关临床工作正在顺利推进当中。 （文章来源：证券日报） ...

Group 1 - The company, Betta Pharmaceuticals, announced a commercial cooperation with Wuhan Heyuan Biotechnology Co., Ltd. for the regional commercialization of recombinant human albumin injection (rice-based) [1] - The recombinant human albumin product is considered groundbreaking, with clinical research showing efficacy comparable to human plasma albumin while overcoming safety risks associated with blood sources [1] - The company holds a 5.6% stake in Heyuan Biotechnology, which is currently under a lock-up period lasting one year post-IPO [1]

Group 1 - The company, BeiGene, stated that its investment in Wuhan Heyuan Biotechnology Co., Ltd. is accounted for under other equity instruments, and the fair value changes are recorded in other comprehensive income, which does not affect the company's net profit [1]

| 交易日期 | 证券代码 | 证券简称 | 成交价格 | 成交量 | 成交金额 买方营业部 (万元) | 卖方营业部 | | --- | --- | --- | --- | --- | --- | --- | | | | | (元) | (万股/万份) | | | | 2026-01-21 | 300558 | 贝达药业 | 38.62 | 12.68 | 489.70 中信建投证券股份 | 中信建投证券股份 | | | | | | | 有限公司北京朝阳 | 有限公司北京朝阳 | | | | | | | 分公司 | 分公司 | 1月21日，贝达药业大宗交易成交12.68万股，成交额489.7万元，占当日总成交额的1.81%，成交价38.62 元，较市场收盘价48.77元折价20.81%。 ...