Recently, Shiyao Group announced that its subsidiary Shiyao Jushi has signed an exclusive authorization agreement with Radiance Biopharma for the antibody conjugate drug SYS6005. Since 2025, several pharmaceutical companies, including Xinda Biotechnology and Xiansheng Pharmaceutical, have signed large orders with potential amounts of up to 1 billion US dollars. Industry insiders believe that the overall progress of domestic new drug research and development is commendable, and Chinese pharmaceutical companies with strong research and development capabilities are expected to compete with foreign-funded enterprises in the global market. They are optimistic about the prospects of domestic new drug research and development and going global in 2025.

Multiple products achieve overseas authorization

According to the announcement from Shiyao Group, Shiyao Giant Stone has agreed to grant Radiance Biopharma exclusive authorization to develop and commercialize SYS6005 in the United States, European Union, United Kingdom, Switzerland, Norway, Iceland, Liechtenstein, Albania, Montenegro, North Macedonia, Serbia, Australia, and Canada. Shiyao Giant Stone will receive a down payment of $15 million and has the right to receive up to $150 million in potential development and regulatory milestone payments and up to $1.075 billion in potential sales milestone payments. It will also receive tiered sales commissions based on the annual net sales of the product in the local area.

Antibody conjugated drugs (ADCs) have become one of the main areas of overseas authorization for domestic innovative pharmaceutical companies in recent years. On January 2nd, Xinda Biotechnology announced a global exclusive cooperation and licensing agreement with Roche Pharmaceuticals for IBI3009, granting Roche exclusive rights to the global development, production, and commercialization of IBI3009. IBI3009 is a new generation ADC candidate product targeting Delta like ligand 3 (DLL3), with potential milestone payments of up to $1 billion in this transaction; On January 8th, Yingen Biotechnology and Avenzo Therapeutics, Inc. (Avenzo) jointly announced that they have signed an exclusive licensing agreement. According to the agreement, Avenzo will obtain exclusive rights to develop, manufacture, and commercialize DB-1418/AVZO-1418 globally (excluding Greater China), which is an EGFR/HER3 bispecific ADC developed by Yingen Biotech.

In terms of cooperation in other fields, on January 13th, Xiansheng Zaiming, an innovative anti-tumor drug company under Xiansheng Pharmaceutical Group, and AbbVie, a global biopharmaceutical company, announced that they have reached a license selection agreement for Xiansheng Zaiming's investigational candidate drug SIM0500. Xiansheng Zaiming will receive a down payment from AbbVie, as well as up to $1.055 billion in optional equity payments and milestone payments.

Baiaotai recently announced that the company has signed an authorization license and commercialization agreement with Intas Pharmaceuticals (Intas), granting a paid license to Intas for the exclusive product commercialization rights of the company's BAT2506 (Golimumab) injection in the US market. Baiaotai will be responsible for research and development, production, and commercial supply, while Intas will be responsible for the commercial activities of BAT2506 in the US market through its US subsidiary Accord BioPharma. The total amount of down payment and milestone payments for this transaction is up to $164.5 million.

According to a research report by Ping An Securities, there were over 100 authorized transactions among domestic biopharmaceutical companies in 2024, with a total disclosed transaction amount of nearly 50 billion US dollars, setting a new historical high. Among them, there were 88 overseas authorization transactions, which is twice the number of external introduction transactions. Innovative drugs are accelerating their overseas expansion. These data reflect the strong growth of China's biopharmaceutical industry in terms of transaction volume and innovation.

Continuously increasing innovation

In recent years, Chinese pharmaceutical companies have continued to increase innovation. According to statistics from the National Medical Products Administration, a total of 48 innovative drugs have been approved for market in 2024.

By 2025, multiple innovative drugs have been approved for market launch. On January 2nd, the National Medical Products Administration conditionally approved the listing of Amimatosa Injection (Ruibosheng) submitted by Bosheng Excellent Biotechnology (Beijing) Co., Ltd. through the priority review and approval process.

Recently, Guangdong Hengrui Pharmaceutical Co., Ltd., a subsidiary of Hengrui Pharmaceutical, received the "Drug Registration Certificate" approved by the National Medical Products Administration, approving the company's independently developed Class 1 innovative drug and the world's first ultra long acting PCSK9 monoclonal antibody, Recasemab (Aixin'an), to be launched. This product is the first Class 1 innovative drug launched by the company in the field of cardiovascular disease. So far, Hengrui Pharmaceutical has approved 18 Class 1 innovative drugs for market, and 4 other innovative drugs have been approved for market. The company has over 90 independently innovated products under clinical development, with about 400 clinical trials conducted both domestically and internationally, and its innovative achievements firmly occupying a leading position in the industry. In terms of R&D investment, Hengrui Pharmaceutical's R&D expenses reached 4.549 billion yuan in the first three quarters of this year, a year-on-year increase of 22%, ranking among the top in the national pharmaceutical industry. At present, the company has established 14 R&D centers in Lianyungang, Shanghai, the United States, and Europe, with a global R&D team of over 5000 people.

On January 6th, Xiansheng Zaiming announced that its independently developed CDH6 antibody coupled drug (ADC) SIM0505 received a clinical trial approval notice from the National Medical Products Administration on January 2nd, 2025, and plans to conduct clinical trials for advanced solid tumors.

Some listed companies are actively expanding their product indications, and with the steady progress of product commercialization layout, their performance has been boosted. For example, Junshi Biotech's core product, Triprolizumab (Tuoyi), was conditionally approved for market by the National Medical Products Administration in December 2018, becoming the first domestically produced PD-1 monoclonal antibody drug to be approved for market. In October 2023, Tuoyi's indication for nasopharyngeal carcinoma was approved by the US Food and Drug Administration. Junshi Biology's recently released 2024 performance forecast shows that the company's research and development expenses are expected to be around 1.274 billion yuan in 2024; By 2024, the operating revenue will reach about 1.949 billion yuan, a year-on-year increase of about 29.71%. Junshi Biotechnology stated that during the reporting period, the company's operating revenue increased mainly due to the growth in sales revenue of commercial drugs compared to the same period in 2023. The company continues to expand its global commercial network. As of the announcement disclosure date, Terizumab has been approved for listing in countries and regions such as the United States, the European Union, India, the United Kingdom, Jordan, and Australia. At the same time, the listing authorization application in Singapore has been accepted. The company and its partners will actively promote the listing application and commercialization process of Triprolizumab in the cooperation area.

Empowered by AI technology

Recently, several medical listed companies have announced new application scenarios for AI in their own businesses, and companies have also deepened cooperation in AI pharmaceuticals, data sharing, and scenario expansion.

The relevant person in charge of Junshi Biotechnology stated in an interview with China Securities Journal that the company ensures that each digital investment corresponds to quantifiable business value output, and achieves the dual goals of cost reduction, efficiency improvement, and business innovation through the strategic deployment of AI technology. After the company officially joined DeepSeek on February 10th, it will further pilot the following scenario applications: marketing employee training and virtual training; AI quality review, deviation analysis, and prediction based on QMS and external quality databases; Batch processing of data; Automated collection and archiving of clinical CRA files; Statistical programming assistant, etc. At the same time, we will explore lightweight AI research and development assistance such as clinical and application document writing, scientific literature retrieval and summarization, information collection, organization, and analysis, to continuously improve research and development efficiency and operational quality. The company also plans a medium - to long-term strategy, gradually building and improving multiple omics data platforms, constructing enterprise knowledge graphs, governing research and development data, and consolidating data foundations. Actively cooperating with academic institutions and AI pharmaceutical companies, exploring the use of AI to tackle research and development cores, accelerate target discovery and validation, molecular design, toxicity prediction, and other links, and accelerate drug discovery

On January 17th, Xiansheng Pharmaceutical and Feimizi Technology jointly announced that they have reached a cooperation on a clinical stage analgesic candidate drug FZ002-037 targeting SSTR4. Fermi Technology is a small molecule AI biotechnology company that has entered the clinical validation stage.

Xinda Securities believes that while AI empowers innovation and efficiency, it is expected to promote the commercialization of innovative drugs and changes in payment expectations in China, and promote the revaluation of related asset values. Caitong Securities believes that it is optimistic about the medium to long-term impact of AI on the pharmaceutical industry, and pharmaceutical companies with high-tech attributes will be more favored by the market. China Post Securities believes that "AI+healthcare" is expected to be applied in fields such as drug research and development, cancer diagnosis, medical imaging, surgical robots, etc., and the industry may undergo tremendous changes.