从盈利37亿元到亏损5.3亿元，百利天恒继续融资好消息。 主要收入过分依赖知识产权授权合作，导致业绩不稳定。根据未来三年研发及经营活动的资金需求测 算，未来三年该公司资金缺口为48.19亿元。 除了在A股定增募资，百利天恒还推进了赴港上市。2024年6月，百利天恒表示，为了进一步助力公司 国际化业务的发展，更好利用境外融资平台，支持公司创新产品在欧美日等市场的全球开拓，公司向港 交所首次递交IPO申请，于7月份在港交所主板递交上市申请；同年12月，获中国证监会境外发行上市 备案通知书；今年1月，因文件期满失效，百利天恒第二次递交港股上市文件。 在准备港股上市的同时，还不放弃着手定增计划，可见该公司资金需求极大。 管线方面，2023年12月，百利天恒凭借创新药BL-B01D1拿下了交易额84亿美元的合作协议。目前"以仿 养创"的模式难以为继。当ADC已经成为癌症治疗的关键方式，BL-B01D1是全球首创也是唯一进入临 床阶段的靶向EGFRxHER3的双特异性抗体ADC，主要靶向非小细胞肺癌和乳腺癌。虽然百利天恒占据 了先机，但这两大领域的竞争者较多。如果该公司因为资金缺乏不能率先上市占据定价权和市场份额的 优势 ...

Core Insights - The total transaction amount for Chinese innovative drugs going abroad reached $48.4 billion in the first half of this year, nearing the total for the entire year of 2024 and setting a historical record [1] - The innovative drug sector is becoming a typical representative of China's breakthroughs in high-tech fields, alongside industries like electric vehicles and artificial intelligence [1] Group 1: Industry Evolution - The journey of Chinese innovative drugs began over 20 years ago, with significant milestones including the establishment of early companies like Betta Pharmaceuticals and the introduction of targeted cancer therapies [5][6] - The reform of drug approval processes initiated by the former National Medical Products Administration in 2015 aligned domestic standards with international ones, encouraging new drug development and expediting approvals [6][8] - The introduction of the STAR Market in 2019 allowed unprofitable biotech companies to go public, providing a boost to the nascent innovative drug sector [8][9] Group 2: Recent Developments - Major transactions in the past six months include a record $12.5 billion upfront payment by Pfizer for a dual-antibody innovative drug from 3SBio, along with other significant deals exceeding $1 billion by companies like Innovent Biologics and Hengrui Medicine [4] - The recent issuance of supportive measures by the National Healthcare Security Administration and the National Health Commission indicates a favorable regulatory environment for innovative drug companies [4] Group 3: R&D and Market Dynamics - The Chinese innovative drug industry has shifted from a follow-the-leader strategy to focusing on original innovations, with companies like Akeso developing competitive PD-1 dual antibodies that outperform established products [15][17] - The number of clinical trials in China has increased significantly, with a compound annual growth rate of 15% from 2019 to 2024, reflecting a growing commitment to R&D [20] - The successful approval of innovative drugs like Zepzelca and CAR-T therapies in the U.S. demonstrates the potential of Chinese companies to compete on a global scale [17] Group 4: International Collaboration and Trust - Chinese innovative drug companies are increasingly seeking partnerships with international firms to enhance their credibility and market presence, as seen in the collaboration between Bai Li Tianheng and Bristol-Myers Squibb [23][24] - The shift towards internationalization is evident, with Chinese companies aiming to develop and commercialize their own drugs while adhering to local regulations in new markets [28][30] - The successful navigation of international partnerships has led to improved perceptions of the quality of Chinese clinical data, as demonstrated by the rigorous evaluations conducted by foreign partners [23][24]

撰文丨王聪 编辑丨王多鱼 排版丨水成文 食管癌 是癌症相关死亡的第七大常见原因，其中， 食管鳞状细胞癌 （ESCC） 是全球最常见的食管癌类型。免疫检查点抑制剂 （例如抗 PD-1、PD-L1 和 CTLA-4 单抗） 与基于铂类药物的化疗相结合，已成为晚期食管鳞状细胞癌的标准治疗方法，并带来了显著的生存获益。然而，仅有 10%-20% 的食管鳞状细 胞癌患者能长期存活，因为大多数患者会对这些药物产生耐药性。 晚期食管鳞状细胞癌的二线治疗采用 伊立替康 （Irinotecan） ，但其疗效也有限，客观缓解率 （ORR） 不超过 10%。 因此，迫切需要开发新的有效治疗策略，以克服当前疗法的局限性，提高食管鳞状细胞癌患者的生存率。 2025 年 7 月 10 日， 北京大学肿瘤医院 鲁智豪 、 沈琳 、 龚继芳 等人在国际顶尖医学期刊 Nature Medicine 上发 表了题为： A bispecific antibody–drug conjugate targeting EGFR and HER3 in metastatic esophageal squamous cell carcinoma: a ph ...

Core Insights - Baili Tianheng's BL-B01D1 has become the world's first dual antibody-drug conjugate (ADC) to complete Phase III clinical trials, targeting recurrent or metastatic nasopharyngeal carcinoma after failure of PD-1/PD-L1 monoclonal antibody treatment and at least two lines of chemotherapy [1][4][5] - The successful Phase III trial may position nasopharyngeal carcinoma as the primary indication for BL-B01D1, with potential for additional indications such as esophageal cancer to be analyzed in mid-2025 [1][2][5] Company Developments - Baili Tianheng's BL-B01D1 achieved a major clinical endpoint in its Phase III trial, marking a significant milestone for the company and the dual ADC category [2][3] - The company has over 30 ongoing clinical trials for BL-B01D1, including 9 Phase III trials, with the nasopharyngeal carcinoma indication being recognized as a breakthrough therapy by the National Medical Products Administration (NMPA) in April 2024 [2][5] - In 2023, Baili Tianheng entered a partnership with BMS, which included a total transaction value of $8.4 billion for the rights to BL-B01D1, making it the first dual ADC licensed from China [3][5] Industry Context - The success of BL-B01D1 in Phase III trials is seen as a validation of the quality and potential of dual ADCs globally, highlighting the strength of Chinese innovative drug assets [1][5] - The number of dual ADCs entering clinical stages globally remains limited, with only a few others, such as TQB2102 and JSKN003, also in Phase III trials [5][6] - The dual targeting nature of BL-B01D1, which targets EGFR and HER3, positions it favorably in the competitive landscape, with broad anti-tumor activity demonstrated across multiple cancer types [5]

生物医药 创新药动态更新 领先大市-B(维持) iza-bren 肺癌更新：EGFR 野生型、EGFR 突变等 NSCLC 疗效突出，SCLC 后线 OS 疗效显著 2025 年 6 月 25 日 行业研究/行业快报 生物医药行业近一年市场表现 药物点评： 首选股票 评级 iza-bren（BL-B01D1）是百利天恒自主研发的 EGFR×HER3 双抗 ADC。 iza-bren 由 EGFR×HER3 双特异性抗体组成，通过可裂解连接子连接至新型 TOP-1 抑制剂 Ed-04。DAR 为 8。iza-bren 与在肿瘤细胞上共表达的 EGFR 及 HER3 结合来缓解抗药性，喜树硷类衍生物 Ed-04 被内化并转运至溶酶体释 放促使细胞凋亡。iza-bren 正在中美进行约 30 项肿瘤临床试验，进行 10 项 III 期临床，并和合作伙伴 BMS 推进美国 III 期临床。iza-bren 在 EGFR 野生 型、EGFR 突变型、经典 EGFR 突变外的驱动基因突变 NSCLC 及 SCLC 患 者中均有良好安全性和抗肿瘤活性。 相关报告： iza-bren 在 EGFR 野生型、EGFR 突变 N ...

6月18日，《关于深化科创板改革 服务科技创新和新质生产力发展的八条措施》（以下简称"科创板八 条"）发布满一周年。 一年来，监管部门持续提升科创板服务未盈利科技企业的制度包容性与精准性，发行承销、再融资等制度创新 落地实施，为未盈利科技型企业进一步构建适配发展路径。 记者获悉，监管部门从政策制定与审核执行两个维度同步发力，着力提升对未盈利企业"含科量"的精准识别能 力，严把发行上市准入关。 如在政策方面，证监会持续完善科创板科创属性评价标准，2024年进一步将研发投入门槛由6000万元提升至 8000万元，发明专利要求增至7项并强调产业化能力，以"硬科技"标尺引导企业夯实创新根基。 数据显示，"科创板八条"发布以来，先后有4家未盈利企业申报科创板IPO获得受理，6家上市时未盈利的科创 板公司再融资时适用"轻资产、高研发投入"标准，28单科创板并购交易涉及收购未盈利标的。 未盈利企业科创板IPO受理有序推进 去年6月19日，证监会发布的"科创板八条"明确提出，支持具有关键核心技术、市场潜力大、科创属性突出的 优质未盈利科技型企业在科创板上市，提升制度包容性。 "科创板八条"发布后，未盈利企业科创板IPO受理有 ...

Core Viewpoint - The implementation of the "Eight Measures for Deepening the Reform of the Sci-Tech Innovation Board" has significantly enhanced the support for unprofitable technology companies, facilitating their listing and financing opportunities on the Sci-Tech Innovation Board [1][2][3]. Group 1: Unprofitable Companies and IPOs - Since the release of the "Eight Measures," four unprofitable companies have successfully submitted their IPO applications to the Shanghai Stock Exchange [3][6]. - The recent acceptance of the IPO application from Zhaoxin Integrated, a leading domestic CPU manufacturer, marks another step forward in the orderly progress of unprofitable companies' IPOs on the Sci-Tech Innovation Board [2][3]. Group 2: Policy Enhancements and Standards - The China Securities Regulatory Commission (CSRC) has emphasized the importance of focusing on sectors with active technological innovation and has improved the evaluation standards for the Sci-Tech attributes of companies [3][4]. - In 2024, the R&D investment threshold for companies will be raised from 60 million to 80 million yuan, and the requirement for invention patents will increase to seven, emphasizing the need for industrialization capabilities [3][4]. Group 3: Support for R&D and Financing - The Shanghai Stock Exchange has introduced a "light asset, high R&D investment" standard to enhance transparency and predictability in refinancing for technology companies, with nine companies already disclosing refinancing plans totaling nearly 25 billion yuan [4][6]. - Dize Pharmaceutical became the first company to successfully complete refinancing under the new standard, highlighting the importance of this policy for sustaining R&D investments [4]. Group 4: Performance of Unprofitable Companies - As of May 2025, the Sci-Tech Innovation Board has supported 54 unprofitable companies, with a total revenue exceeding 170 billion yuan, reflecting a 24% year-on-year growth [6]. - Among these companies, 22 have achieved their first profit post-IPO, indicating a significant improvement in operational efficiency [6]. Group 5: Future Outlook - The continued implementation of the "Eight Measures" is expected to enable more unprofitable companies with core technologies to overcome capital constraints, thereby enhancing China's strategic position in the new technological revolution [7].

2025ASCO 大会国内重点研究总结报告 | [Tabl 分析师： | 罗佳荣 | 分析师： | 李安飞 | | --- | --- | --- | --- | | e_Author] | SAC 执证号：S0260516090004 | | SAC 执证号：S0260520100005 | | | SFC CE.no: BOR756 | | | | | 021-38003671 | | 021-38003669 | | | luojiarong@gf.com.cn | | lianfei@gf.com.cn | | | 请注意，李安飞并非香港证券及期货事务监察委员会的注册持牌人，不可在香港从事受监管活动。 | | | [Table_Summary] 核心观点： 相关研究 [Table_Report ： ] 医药生物非药行业 2024 年报及 2025 年 1 季报总结:蓄势待发，看好国内创新优势与制造优势 2025-05-05 识别风险，发现价值 请务必阅读末页的免责声明 [本报告联系人： Table_C ontacter] 龙雪芳 021-38003558 longxuefang@gf.com.cn 王 ...

Core Insights - The "Eight Articles" of the Sci-Tech Innovation Board have revitalized the capital market ecosystem, with significant growth in M&A activities and IPOs for unprofitable companies [1] - Since the release of the "Eight Articles," there have been 106 new M&A transactions on the Sci-Tech Innovation Board, with 60 completed and a total transaction value exceeding 140 billion yuan [1] - Institutional innovations are strengthening the connection between "hard tech" companies and the capital market, enhancing the flexibility of capital to promote technological advancements [1] Group 1: Company Responses to "Eight Articles" - Baili Tianheng's chairman highlighted that the "Eight Articles" have deepened reforms and increased support for high-quality development of unprofitable companies, allowing for successful IPOs even before profitability [1] - Jinghe Integrated's chairman noted that the "Eight Articles" have improved financing efficiency and innovation mechanisms, enabling the company to issue 2 billion yuan in technology innovation bonds [2] - Chip Origin's chairman mentioned that the "Eight Articles" support refinancing for R&D, allowing the company to accelerate its strategic layout in Chiplet technology [3] Group 2: Recommendations for Future Reforms - Tianyue Advanced's chairman expressed the need for more long-term capital to focus on outstanding Sci-Tech Innovation Board companies and suggested enhancing the inclusivity of capital operations for hard tech companies [7] - Du Jinhao from Ailis proposed increasing liquidity by attracting more long-term funds and promoting international connectivity for quality Sci-Tech enterprises [7] - The emphasis on improving corporate governance and enhancing profitability through cash dividends was also highlighted as a key area for development [4]

Core Viewpoint - The launch of the "Eight Measures for the Sci-Tech Innovation Board" marks a new phase in the reform of the capital market, focusing on enhancing the inclusiveness and adaptability of the market to technological innovation [1] Group 1: Financing Standards and Innovations - The "light asset, high R&D investment" standard has been established to facilitate financing for innovative companies, allowing them to raise funds more flexibly without being restricted by traditional financing limitations [2][3] - The first successful fundraising under this standard was achieved by Dize Pharmaceutical, which raised 1.796 billion yuan for core product development and establishing a self-research production base [2] - The introduction of this standard is seen as a significant step in alleviating the financing difficulties faced by innovative companies, enabling them to maintain their R&D momentum and competitive edge [4] Group 2: Impact on Specific Companies - Chiplet technology company Chipyuan is advancing its refinancing project under the new standard, which is expected to accelerate its strategic layout in the AIGC and intelligent driving systems [4] - China National Railway Group successfully issued the first central enterprise sci-tech bond, raising 4.5 billion yuan, which reflects strong market recognition of its technology in the rail transportation sector [5][6] - Crystal Integration has also benefited from the new financing measures, raising 2 billion yuan through a technology innovation bond to support its ongoing R&D efforts [7] Group 3: Broader Market Implications - The introduction of the "Eight Measures" and the supportive policies for sci-tech bonds are expected to create a more inclusive financing environment for technology enterprises, enhancing their ability to innovate and grow [8] - The collaboration between the capital market and technology sectors is anticipated to foster a positive cycle of development, where financing supports technological advancements and vice versa [8]