China's innovative drugs are facing a "highlight moment" and Zhejiang's innovative drugs industry is experiencing "acceleration"

China News Service, Hangzhou, October 4 (Pan Qinwen) China's innovative drugs are ushering in a "highlight moment": At present, China's pipeline of new drugs under development accounts for about 30% of the global total, ranking second in the world; since this year, 59 domestic innovative drugs have been approved for marketing, 13 of which are first-in-class innovative drugs with new mechanisms and new targets. In this wave of domestic innovative drugs, Zhejiang has performed well - so far this year, 8 varieties and 12 specifications of innovative drugs have been approved, ranking second in the country; since the "14th Five-Year Plan", a total of 22 varieties and 25 specifications of innovative drugs have been approved, ranking third in the country.

Hangzhou Bangshun Pharmaceutical Co., Ltd., established in 2020, received its first innovative drug approved for marketing in April this year. Its independently developed Class 1 innovative drug, Bezixitinib Tablets, is used for the first-line treatment of adult patients with intermediate-risk-2 or high-risk primary myelofibrosis (PMF), myelofibrosis secondary to polycythemia vera (PPV-MF), or myelofibrosis secondary to essential thrombocythemia (PET-MF). It is the first highly selective JAK2 single-target inhibitor approved in China.

"Bezexitinib tablets received on-site support and professional guidance from the drug regulatory department from the submission of the application in August 2024 to the approval in April 2026, which helped us greatly improve the review efficiency." Hu Qunyan, assistant general manager of the company, said that currently, the drug's second indication has completed phase three clinical trials and will soon submit a new drug marketing application; another new drug in the field of autoimmunity is in the phase three clinical trial stage.

Bangshun Pharmaceutical's "accelerated run" is a vivid footnote to the overall acceleration of Zhejiang's innovative pharmaceutical industry. Behind this is the concentrated release of the province's system layout for many years.

“The research and development cycle of innovative drugs is long and the investment is large, which requires continuous support from the entire policy chain.” Xu Weihong, director of the Drug Registration and Monitoring and Evaluation Division of the Zhejiang Provincial Food and Drug Administration (hereinafter referred to as the “Zhejiang Provincial Food and Drug Administration”), introduced that the province will issue at the end of 2024 “Zhejiang Province’s Full Chain Support for High-Quality Development of Innovative Drug Devices” "Several Measures for Development", which proposes 21 measures from 7 aspects including research and development, review, and application; in 2026, the "Guiding Opinions of the General Office of the Zhejiang Provincial People's Government on Promoting the High-Quality Development of the Biomedical Industry" was issued, clarifying that the operating income of the biomedical industry cluster will exceed 500 billion yuan by 2030.

The reform of review and approval is particularly significant. The Zhejiang Provincial Food and Drug Administration actively undertook the reform of the review and approval process for drug supplement applications from the National Medical Products Administration, and the review speed was increased by 74%; the review and approval of drug production licenses and production enterprise relocation changes were accelerated by 63% and 67% respectively, the number of provincial enterprise-related inspections was reduced by 30%, and the sampling verification and compliance inspection of innovative drugs were accelerated by more than 25%.

"We implement 'one product, one policy' special service for key innovative varieties to help companies avoid detours." Xu Weihong said that at present, the province has many products included in the key service targets of the State Food and Drug Administration.

In Zhejiang, the increase in speed not only gives companies a real sense of gain, but also strengthens their confidence in developing new drugs. For example, Xianweida Biotech's Enoglutide Injection, Borui Biotech's Zebetuzumab Injection, and Hisun Pharmaceutical's Haibo Maibu Tablets have all made innovative breakthroughs across the country and even around the world.

At present, Zhejiang has sorted out a pipeline of more than 200 varieties under research, forming an innovative drug research and development pattern in which "Hangzhou takes the lead and various places fill in the gaps". The provincial Food and Drug Administration will focus on its drug approval responsibilities and launch a series of measures to specifically support innovative drugs from the three dimensions of source cultivation, process tracking, and sprint escort; it will implement "one product, one policy" precise services for 9 varieties under review and 34 phase III clinical varieties, and promote breakthroughs in key tracks such as cell and gene therapy drugs and nuclear drugs. Zhejiang’s innovative drugs are expected to usher in a larger harvest during the “15th Five-Year Plan” period.