National People's Congress Deputy and President of Huahai Pharmaceutical, Chen Baohua: Improve the policy for selecting reference formulations of domestically produced new drugs

Reporter Nie Yinghao, Securities Times

At the 2026 National Two Sessions, National People’s Congress Deputy and Huahai Pharmaceutical President Chen Baohua proposed suggestions on amending the Patent Law of the People’s Republic of China, accelerating the improvement of the domestic new drug reference formulation selection policy, and speeding up the exemption of some clinical trials for biosimilar drugs.

Chen Baohua stated that currently, the country has a relatively clear framework for the formulation of reference formulation standards and the规范 of selection procedures. However, the current policy for selecting reference formulations and including domestic new drugs into the reference formulation catalog is not yet sound, which not only restricts industry development but also weakens patients’ access to and choice of medications.

In recent years, driven by innovation-led development strategies, Chinese pharmaceutical companies have achieved fruitful results in new drug research and development, making breakthroughs in fields such as oncology and cardiovascular diseases. However, two major issues still exist:

First, some original research drug companies, after patent expiration, have not actively promoted domestic new drugs into the reference formulation catalog, using this as a strategy to延缓 product lifecycle and maintain long-term market monopoly to gain higher pricing power and more profit margins. Second, some ineffective exclusive products, due to lack of reference formulations, have long monopolized the market, leading to a phenomenon of “bad money driving out good.”

Chen Baohua suggested that for domestic new drugs with expired patents, strong measures combining行政 and legal means should be adopted,明确规定 to list them as reference formulations, or require relevant products to complete re-evaluation within a specified time limit. If the re-evaluation shows that their quality and efficacy cannot meet clinical needs, they should be淘汰ed to prevent long-term market monopoly.

Chen Baohua emphasized that the core purpose of selecting and determining reference formulations is to provide a scientific and统一 benchmark for the研发 and evaluation of generics, ensuring that generics have a high degree of一致性 in quality and efficacy with original drugs. Therefore, reference formulations should not be distorted into特殊 tools for protecting drug intellectual property rights but should return to their fundamental function of promoting drug quality improvement and accessibility. This is of great significance for breaking market monopoly, promoting market competition, and enhancing patient access to medications, and should be highly valued.

Meanwhile, Chen Baohua also proposed a “Proposal to Amend the Patent Law of the People’s Republic of China,” suggesting partial revisions and additions to Articles 42, 9, 75, and 76, aiming to systematically address the制度 imbalance between incentivizing innovation, promoting competition, and safeguarding public health in the pharmaceutical industry, ensuring high-quality development of the pharmaceutical sector through rule of law.

Chen Baohua put forward four specific suggestions: first, add relevant provisions on “export exemption” during the patent compensation period for drugs; second, add “waiver at the end of the period”; third, improve the “BOLAR exception” provisions; fourth, further完善 early resolution mechanisms for patent disputes,规范行为 of patent holders and generic applicants.

(Edited by: Wen Jing)

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