A-share purchase | He Yuan Biology(688765.SH) opens up subscriptions with a total of 8 drug pipelines under research.

On October 14, He Yuan Biology (688765.SH) initiated its IPO with an issue price of 29.06 yuan per share and a maximum subscription limit of 14,000 shares. It is listed on the Shanghai Stock Exchange, with Guotai Haitong serving as its sponsor institution. According to the prospectus, He Yuan Biology is an innovative biopharmaceutical company with a globally-leading plant bio-reactor technology platform. It has developed a rice endosperm cell bio-reactor expression system with independent intellectual property rights and established a complete industrial system for plant molecular pharming. The company has developed multiple drugs, pharmaceutical excipients, and research reagents based on the rice endosperm cell bio-reactor expression system. As of the signing date of this prospectus, the company has 8 drug pipelines under research and development. The drug with the fastest progress, recombinant human serum albumin injection (OsrHSA, HY1001), has completed most of the review procedures for its new drug application (NDA) and is expected to be approved for marketing in the near future. The company has 2 drugs in Phase II clinical trials, 2 drugs in Phase I clinical trials, and 1 drug approved for clinical trials. The company currently has no approved drugs on the market and is not yet profitable. Its core product, HY1001, has completed a Phase III clinical trial for the indication of hypoalbuminemia in liver cirrhosis in China, with results showing good safety and meeting predetermined primary and secondary clinical research endpoints. Information shows that at the end of May 2025, He Yuan Biology held a communication meeting with the US FDA on the design of an international multicenter Phase III clinical trial for HY1001. The FDA has agreed that once the international multicenter Phase III clinical study is completed and achieves the expected results, HY1001 can be approved for all current indications for human serum albumin from plasma. Based on the results of the communication meeting mentioned above, the company plans to further communicate with the US FDA, China CDE, and the European Medicines Agency (EMA) on specific clinical design and reach an agreement, then conduct a global multicenter Phase III clinical study that includes Chinese patients. Upon completion of the study, the company will simultaneously apply for drug marketing approval from the US FDA and EMA, and apply for an expansion of indications for HY1001 from China CDE. It is expected that after approval, HY1001 will be marketed and sold in China, the US, and Europe, and will include all current indications for human serum albumin from plasma. Financially, in the years 2022, 2023, and 2024, the company achieved operating revenues of approximately 13.3997 million yuan, 24.2641 million yuan, and 25.2161 million yuan respectively, and net profits of approximately -144 million yuan, -187 million yuan, and -152 million yuan respectively.