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 standardization of selection procedures. However, the policies for including domestic new drugs into the reference formulation catalog are 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 the inclusion of domestic new drugs into the reference formulation catalog, using this as a strategy to delay product lifecycle and maintain long-term market monopoly to gain higher pricing power and more profit margins. Second, some ineffective proprietary products, due to lack of reference formulations, have long monopolized the market, resulting in a phenomenon where inferior products drive out better ones.

Chen Baohua suggested that for domestic new drugs with expired patents, strong measures combining administrative and legal approaches should be adopted. It should be clearly stipulated that they be included as reference formulations, or relevant products should be ordered to complete re-evaluation within a specified time limit. If re-evaluation shows that their quality and efficacy cannot meet clinical needs, they should be eliminated 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 unified benchmark for the development and evaluation of generics, ensuring that generics are highly consistent with original research drugs in quality and efficacy. Therefore, reference formulations should not be distorted into special tools for protecting drug intellectual property but should return to their fundamental function—focusing on promoting drug quality improvement and increasing accessibility. This is of great significance for breaking market monopolies, promoting market competition, and enhancing patient access to medications, and should be highly valued.

Meanwhile, Chen Baohua also proposed a “Proposal for Amending 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 institutional imbalance between incentivizing innovation, promoting competition, and safeguarding public health in the pharmaceutical industry, with the rule of law supporting high-quality development of the pharmaceutical industry.

Chen Baohua put forward four specific suggestions: first, to add relevant provisions on “export exemptions” during the patent compensation period for drugs; second, to add provisions on “waiver at the end of the period”; third, to improve the “BOLAR exception” provisions; and fourth, to further improve the early resolution mechanism for drug patent disputes, regulating the behavior of patent holders and generic drug applicants.

(Edited by: Wen Jing)

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