October 11, 2025
Source: drugdu
145
Recently, Nuocheng Jianhua and global biopharmaceutical company Zenas jointly announced a global authorization cooperation agreement, with a potential total transaction amount of over 2 billion US dollars, adding another heavyweight footnote to China's innovative drugs going global. Since 2025, the trend of innovative drugs going global has continued to heat up. Previously, leading pharmaceutical companies such as Hengrui Pharmaceutical and Xinda Biotechnology have successively achieved international breakthroughs in technology and market through overseas authorization.
Analysts believe that the continuous increase in the amount and quantity of foreign authorizations for innovative drugs in China is an inevitable trend after the research and development capabilities in this field are globally recognized. In the past few years, the product data of domestic innovative pharmaceutical companies has continuously verified their clinical value, from early individual enterprise breakthroughs to collective global cooperation today. Essentially, it is the global market's recognition of Chinese pharmaceutical companies' "efficient research and development+cost advantages".
Accelerate the global development process of products
The overseas authorization agreement reached by domestic enterprises is expected to accelerate the global development and commercialization process of products.
According to the announcement from Nuocheng Jianhua, the signing of this agreement will accelerate the development and commercialization of Obutinib and other pipeline products globally, providing high-quality treatment options for patients worldwide. It is also an important milestone in the internationalization strategy of the listed company, which will help further enhance its international competitiveness and influence.
In September, multiple pharmaceutical companies reached overseas authorization cooperation agreements. Among them, Hengrui Pharmaceutical reached two overseas authorization transactions within one month. On September 24th, Hengrui Pharmaceutical reached an agreement with Glenmark Specialty to license the company's Class 1 innovative drug, Ruikangtrastuzumab (SHR-A1811), with independent intellectual property rights, to Glenmark Specialty for a fee. Hengrui Pharmaceutical will receive a down payment of 18 million US dollars, milestone payments related to registration and sales up to 1.093 billion US dollars, and corresponding sales commissions.
Hengrui Pharmaceutical stated that the signing of the agreement will help expand the overseas market of Ruikang Trastuzumab, provide high-quality treatment options for patients worldwide, and further enhance the company's innovative brand and overseas performance. The company adheres to both independent research and development and open cooperation, strengthens international cooperation on the basis of endogenous development, achieves rapid transformation of research and development results, covers overseas markets with leading international partners, accelerates integration into the global drug innovation network, and maximizes product value.
On September 5th, Hengrui Pharmaceutical also announced that the company had reached an agreement with Braveheart Bio in the United States to license the Class 1 innovative drug HRS-1893 project with independent intellectual property rights to Braveheart Bio for a fee. Hengrui Pharmaceutical stated that the signing of the agreement will help expand the overseas market of HRS-1893, provide high-quality treatment options for patients worldwide, and further enhance the company's overseas performance.
Core competitiveness recognized overseas
In the first half of 2025, the total amount of foreign authorization for innovative drugs in China has approached 66 billion US dollars, and the global market's recognition of Chinese innovative drugs is constantly increasing.
Hu Xubo, the managing partner of Qiming Venture Capital, recently stated in an interview with China Securities Journal that in recent years, the core driving force behind China's innovative pharmaceutical companies' overseas authorization mainly lies in two aspects: verifying value and building trust. The large-scale development of innovative drugs in China has only been more than ten years, and it takes time for the global research and development system to understand it. Overseas authorization is the most direct proof of strength, especially for international pharmaceutical companies that obtain authorization to conduct clinical research in overseas markets, further consolidating the trust foundation. The second is to efficiently recover funds. The research and development cycle of innovative drugs is long and the investment is large. Overseas authorization can be quickly realized, injecting cash flow into subsequent research and development. At the same time, enterprises can also participate in the global research and development system through cooperation, and long-term enhance their positioning in the global value chain.
From the demand side, the industry generally believes that the upcoming patent cliff may lead to a significant decline in revenue for large overseas companies. Due to the long research and development cycle of innovative varieties and the relatively low internal decision-making efficiency of multinational pharmaceutical companies, it has been difficult for them to make up for this loss through endogenous varieties in recent years. Therefore, multinational pharmaceutical companies are searching for innovative drug assets globally and acquiring them into their own pipelines.
The continuous increase in the amount and quantity of foreign authorizations for innovative drugs in China is an inevitable trend after the global recognition of China's innovative drug research and development capabilities, "said Hu Xubo. In the past few years, the products of Chinese innovative drug companies have been repeatedly validated for value through clinical data, coupled with the outstanding characteristics of" efficient research and development+cost advantage ". The industry has moved from early overseas breakthroughs of individual enterprises to collective global cooperation, and the acceptance of Chinese innovative drugs in the global market has significantly increased.
Hu Xubo further analyzed that in the long run, the positive impact of this trend on industrial innovation capability is worthy of recognition: on the one hand, high authorization income can form a virtuous cycle of "research and development authorization reinvestment", providing financial support for sustained innovation; On the other hand, Chinese innovative pharmaceutical companies have also deeply integrated into the global R&D ecosystem, becoming an important part of it. However, he also cautioned that some companies should be wary of excessively pursuing short-term licensing benefits and neglecting the long-term independent research and development strategy and the construction of the company's core values. Overall, the core competitiveness of China's innovative drugs has been confirmed, and the overseas authorization model will provide strong support for sustained innovation in the industry.
Increased policy support
The development of innovative drugs in our country cannot be separated from policy support. In September, the State Administration of Financial Supervision and Administration of China issued the "Guiding Opinions on Promoting the High Quality Development of Health Insurance". The suggestion is to strengthen the construction of the health service network of insurance companies and promote the coordinated development of the big health industry. Promote the deep integration of health insurance with medical and pharmaceutical industries, and assist in the breakthrough development of the healthcare sector and the biopharmaceutical industry. Support the establishment of a linkage and cooperation mechanism with pharmaceutical and medical equipment enterprises, explore innovative diversified payment methods for pharmaceutical and medical equipment such as independent negotiation and payment based on efficacy in accordance with market-oriented principles.
Zhongtai Securities stated that in July of this year, the National Healthcare Security Administration and the National Health Commission jointly issued the "Several Measures to Support the High Quality Development of Innovative Drugs", adding a catalog of innovative drugs for commercial health insurance, opening up broader development space for the development of commercial health insurance. The institutional positioning of the commercial health insurance innovative drug catalog is very clear, which focuses on covering those varieties with high innovation level, significant clinical value, and significant patient benefits that have not yet been included in basic medical insurance. The total compensation amount for innovative drugs and devices in commercial health insurance in 2024 is approximately 12.4 billion yuan, accounting for 7.7% of the market size of innovative drugs, and there is still room for improvement in the future.
Commercial medical insurance will play an increasingly important role in the payment of innovative drugs. The more patients realize the value of innovative drugs, the more motivated commercial insurance institutions are to include them in the commercial insurance system, which will form a positive cycle, "said Hu Xubo.
Xiangcai Securities believes that while the innovative pharmaceutical industry is embarking on a global market journey, the construction of a diversified payment system in China is further improved. The innovative pharmaceutical industry has formed a good trend of internal and external dual wheel drive, and the development logic of the industry has shifted from R&D investment driven to R&D and commercialization dual wheel drive. Top enterprises are gradually entering the profit realization window with the advantages of pipeline differentiation and commercialization capabilities.
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