2026 年 01 月 09 日 贝达药业(300558.SZ) 海外即将读出重磅数据，国内进入新品 种放量周期 核心逻辑：海外存在超长效眼药 EYP-1901 海外 3 期临床数据读 出催化，国内多个新品种进入放量周期。海外市场创新布局进入 兑现阶段，超长效 6 个月给药一次潜在大品种眼药 EYP-1901 首个 wAMD 3 期临床数据有望 2026 年中读出，恩沙替尼已开启美国销 售；国内市场上植物源重组白蛋白、恩沙替尼、贝福替尼、泰贝 西利、伏罗尼布等多个新品种进入放量增长新周期，另有长效八 因子、MCLA-129 等多个新品种蓄势待发。 海外潜在大品种超长效 6 个月给药一次眼药 EYP-1901 存在 3 期数据读出催化，海外市场创新布局开始逐步兑现。公司海外布 局的核心产品 VEGF 小分子眼药 EYP-1901 已进入 3 期临床，有望 2026 年中读出 wAMD 3 期临床数据；竞争格局方面，VEGF 小分子 眼药竞争格局良好，EYP-1901 进度领先；差异化优势方面，EYP- 1901 为超长效制剂，可实现 6 个月给药一次，相对当前主流用药 阿柏西普（2 个月给药一次）等有望大幅提升 ...

1月4日晚，科创板创新药企益方生物(688382.SH)公告披露，公司于2026年1月1日向香港联合交易所递 交了发行H股股票并在香港联交所主板挂牌上市的申请，并于同日在香港联交所网站刊登了本次发行上 市的申请资料。 益方生物主要聚焦肿瘤、代谢及自身免疫性疾病等重大疾病领域，专注于研发创新型靶向药物。据港交 所招股书，公司目前产品及研发管线包括两款对外授权的上市产品贝福替尼(BPI-D0316)、格索雷塞(D- 1553)；两款临床阶段核心产品D-2570、泰瑞司群(D-0502)；一款临床阶段候选产品达比诺雷(D-0120)； 及三个临床前候选产品(YF087、YF550及YF057)。 值得注意的是，此前益方生物申报科创板IPO时，虽无商业化产品，但市场仍押注其创新药管线上市后 的收益，然而，公司旗下贝福替尼上市纳入医保后大幅降价，在一定程度上影响了益方生物的收益。 据公开信息，治疗肺癌的贝福替尼于2023年首次纳入国家医保目录，通过谈判显著降低价格。纳入医保 前，每盒(25mg×40粒)价格约为6000元；纳入后，谈判价格降至约2800—2862元/盒，降幅约为52%— 53%。一般而言，创新药进入国家 ...

流动性方面，科创创新药ETF汇添富盘中换手5.27%，成交2366.22万元。拉长时间看，截至12月18日，科创创新药ETF汇添富近1年日均成交3756.23万元。 截至2025年12月19日 10:14，上证科创板创新药指数(950161)强势上涨3.26%，成分股成都先导(688222)上涨10.44%，益方生物(688382)上涨9.82%，悦康药业 (688658)上涨6.82%，阳光诺和(688621)，泽璟制药(688266)等个股跟涨。科创创新药ETF汇添富(589120)上涨3.02%，最新价报0.85元。（以上所列股票仅为 指数成份股，无特定推荐之意） 12月18日，益方生物在互动平台回答投资者提问时表示，目前公司主要有2款对外授权产品，其中就贝福替尼产品，公司已与贝达药业在合作区域内（包括 中国内地和香港、台湾地区）达成授权合作。 从资金净流入方面来看，科创创新药ETF汇添富近4天获得连续资金净流入，最高单日获得1415.88万元净流入，合计"吸金"3017.86万元，日均净流入达 754.46万元。（数据来源：Wind） 消息面上，近日，国家医保局、人力资源社会保障部公布《国家基本医疗保 ...

（文章来源：证券日报） 证券日报网讯 12月18日，益方生物在互动平台回答投资者提问时表示，目前公司主要有2款对外授权产 品，其中就贝福替尼产品，公司已与贝达药业在合作区域内（包括中国内地和香港、台湾地区）达成授 权合作。就格索雷塞（D-1553）产品，公司授予正大天晴对D-1553产品在中国大陆地区开发、注册、 生产和商业化的独家许可权。 ...

公示显示，该药的临床试验申请由一家名不见经传的"杭州景曜生物科技有限公司"（简称"景曜生物"） 提交。这与该药品广为人知的研发主体——上市公司贝达药业产生了令人费解的"署名冲突"。 这究竟是两家公司针对同名药物的独立竞争，还是贝达药业管线布局中尚未披露的权益安排？南都N视 频记者就此发函并致电贝达药业，但截至发稿前并未得到回复。 近日，国家药品监督管理局药品审评中心（CDE）的一则受理公示，让不少关注贝达药业股份有限公司 （简称"贝达药业"300558.SZ）的投资者的目光聚焦在抗癌新药"BPI-572270"上。 "双生花"：从科学源头到申报主体 "BPI-572270"项目的科学本源如何？ 追溯至今年4月，贝达药业BPI-572270等四项研究成果亮相2025第116届美国癌症研究协会（AACR）年 会。 贝达药业介绍，"BPI-572270"针对的是非常具有挑战性的靶点，即KRAS突变。这是导致多种癌症发生 （如胰腺癌，非小细胞肺癌和结直肠癌）的致癌驱动因素，在所有癌症中的突变频率为20%-30%。 | | | | | | | | P. B.J 402V 230 WE TI-S | | 11.000 | ...

Core Viewpoint - The company has stated that there are currently no global multicenter clinical plans for Beifu Tini and Tairisili, and any significant collaborations or transactions will be disclosed in a timely manner [1] Group 1 - The company is actively engaging with investors through an interactive platform [1] - The company emphasizes transparency regarding major collaborations or transactions [1]

Core Viewpoint - Betta Pharmaceuticals has made significant progress in the approval of its oncology drugs in China, with multiple products receiving regulatory approvals for various indications from 2022 to 2025, indicating a strong pipeline and commitment to addressing clinical needs and market potential [2] Group 1: Drug Approvals and Indications - In 2022, Ensartinib was approved in China for first-line treatment of non-small cell lung cancer (NSCLC) [2] - In 2023, Bevacizumab received approval for both second-line and first-line indications in China [2] - Vorolanib was approved in China for use in combination with Everolimus for the treatment of advanced renal cell carcinoma [2] - In 2024, Ensartinib is expected to receive FDA approval for its first-line indication [2] - By 2025, Tarextumab was approved in China for use in combination with Fulvestrant for treating hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer in adults who have previously received endocrine therapy [2] - Ensartinib was also approved for sale in Macau [2] Group 2: Future Development Strategy - The company plans to drive its research and development based on clinical needs and market potential [2] - It aims to leverage its experienced team to identify high-value molecules and advance their preclinical and clinical development [2] - The ultimate goal is to facilitate the commercialization of its products [2]

Core Viewpoint - Bidda Pharmaceutical is planning to issue H-shares and apply for listing on the Hong Kong Stock Exchange to enhance its capital strength and competitiveness, while also advancing its internationalization process [1] Group 1: Financial Performance - For the first half of 2025, Bidda Pharmaceutical reported revenue of 1.731 billion yuan, a year-on-year increase of 15.37%, but the net profit attributable to shareholders dropped by 37.53% to 140 million yuan, marking the first half-year profit decline since 2022 [2] - The company's second-quarter performance showed a revenue of 814 million yuan, a slight increase of 6.39%, while net profit fell significantly by 68.36% to 39.81 million yuan [2] Group 2: Debt and Financial Pressure - Bidda Pharmaceutical is facing financial pressure, with current assets of 1.359 billion yuan against current liabilities of 1.757 billion yuan as of mid-2023, resulting in a cash and cash equivalents balance of 527 million yuan [4] - The company has an outstanding payment of 180 million yuan to Yifang Bio for a milestone payment related to a lung cancer drug project, which has been overdue for nearly two years [3] - As of the first half of 2025, the total accounts payable amounted to 580 million yuan, with 180 million yuan being overdue payments to Yifang Bio [3] Group 3: Research and Development - Bidda Pharmaceutical's R&D investment has been declining, dropping from 700 million yuan in 2022 to 500 million yuan in 2024, with only 255 million yuan spent in the first half of 2025, a slight decrease of 0.63% year-on-year [3]

Core Viewpoint - Bidar Pharmaceuticals is making its third attempt to list on the Hong Kong Stock Exchange, facing significant financial pressures and reliance on its core product, Camrelizumab, for revenue generation [1][2][4]. Group 1: Company Background - Bidar Pharmaceuticals, listed on the Shenzhen Stock Exchange since 2016, has become a representative enterprise in the domestic innovative drug sector [2]. - The company has eight listed drugs, focusing on areas such as lung cancer, kidney cancer, and breast cancer [1]. Group 2: Financial Performance - In the first half of 2025, Bidar achieved revenue of 1.731 billion yuan, a year-on-year increase of 15.37%, but its net profit dropped by 37.53% to 140 million yuan [3]. - Historical revenue growth from 2021 to 2024 shows fluctuations in net profit, with figures of 383 million, 145 million, 348 million, and 403 million yuan respectively [3]. Group 3: Financial Challenges - As of June 30, 2025, the company had cash reserves of 527 million yuan, with current liabilities reaching 1.757 billion yuan, indicating significant short-term debt pressure [4]. - Bidar has overdue payments of 180 million yuan to its partner, Yifang Bio, which has led to the latter recognizing bad debt provisions of 18 million yuan [4]. Group 4: Research and Development - The company has maintained high R&D expenditures, with amounts of 861 million, 977 million, 1.002 billion, and 717 million yuan from 2021 to 2024, often exceeding 40% of revenue [5]. - In the first half of 2025, Bidar invested 299 million yuan in various ongoing projects, including Ensartinib and other candidates [5]. Group 5: Market Context - The push for H-share listing is part of a broader trend among innovative drug companies in China seeking to access international capital markets [5]. - Successful H-share listings can enhance a company's risk resilience and brand influence, as seen with other companies like Hengrui Medicine and Kexing Pharmaceutical [5].

Core Viewpoint - Benda Pharmaceutical's net profit for H1 2025 is projected to be 140 million yuan, a year-on-year decrease of 37.53%, primarily due to increased depreciation and amortization expenses impacting current profits [1] Financial Performance - The company's EBITDA stands at 498 million yuan, reflecting a year-on-year growth of 13.10%, indicating stable growth in core business operations [1] - The decline in net profit is attributed to rising costs, while the core business remains robust [1] Product Development and Market Position - Benda Pharmaceutical's drug sales are steadily increasing, reinforcing its competitive advantage in the lung cancer treatment market [1] - The first-line treatment of the third-generation EGFRTKI, Beifu Tini, is set to benefit from its inclusion in the medical insurance catalog, marking a significant milestone [1] - The company has received approval for postoperative adjuvant therapy indications, further expanding its treatment offerings [1] Future Prospects - Two KRAS-targeted drugs were showcased at the 2025 AACR, indicating promising future developments in the pipeline [1] - The company is actively enhancing its innovative product portfolio in the lung cancer sector and pursuing external collaborations, including the approval of plant-derived albumin for market entry [1] - The investment rating remains "Buy," reflecting confidence in the company's growth trajectory [1]