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港股概念追踪 |国家药监局关于同意在北京上海开展优化创新药临床试验审评审批试点的批复 创新药有望跑赢医药其他细分领域(附概念股)

Hong Kong stock concept tracking | National Medical Products Administration approved the pilot program of optimizing the clinical trial review and approval of innovative drugs in Peking and Shanghai, and innovative drugs are expected to outperform other s

Zhitong Finance ·  Aug 2 09:03

The pharmaceutical industry is expected to see overall year-on-year improvement and sequential growth in the second half of this year.

The Beijing and Shanghai Municipal Drug Administration has received the "Beijing Municipal Drug Administration's Request for the Launch of Clinical Trial Approval Pilot for Optimizing and Innovating Drugs" and the "Shanghai Municipal Drug Administration's Request for the Pilot Work of Applying for Clinical Trial Approval for Optimized and Innovative Drugs" (Hu Drug Supervision Drug Note [2024] No. 192). The following approval is now given: The pilot program for optimizing and innovating drug clinical trials will be conducted in Beijing and Shanghai, and your bureau is requested to strictly follow the "Working Plan for Pilot Program of Optimized and Innovative Drug Clinical Trial Approval" to organize the pilot program.

On July 30th, Li Li, Party Secretary and Director of the National Medical Products Administration, presided over a meeting to discuss and deploy the reform of clinical trial approval for innovative drugs, and to deliberate and approve the "Working Plan for Pilot Program of Optimized and Innovative Drug Clinical Trial Approval". The meeting pointed out that this pilot work is aimed at the key process of limiting the speed of clinical trials for innovative drugs, and exploring the establishment of a working system and mechanism to improve the quality and efficiency of drug clinical trials, to achieve the goal of completing the evaluation and approval of innovative drug clinical trial applications within 30 working days, and to promote the target of shortening the time taken to start drug clinical trials in pilot areas.

In addition, the Shanghai Municipal People's Government recently issued "Several Opinions on Supporting the Full Chain Innovation and Development of the Biomedical Industry", focusing on key areas such as research and development, clinical trials, evaluation and approval, application promotion, industrialization and financing. Full-chain innovation, full-chain reform, and full-chain empowerment are insisted on.

Sinolink Securities believes that as national policies supporting the innovation chain of pharmaceuticals and other industries are successively launched, the innovative drug industry will usher in faster development.

The bank stated that after passing the semi-annual report window, the pharmaceutical industry is expected to see overall year-on-year improvement and sequential growth in the second half of this year. Considering that the public fund's pharmaceutical allocation ratio has continuously decreased compared with the previous period, the bank suggests that the golden opportunity of increasing the allocation of pharmaceutical sector has already opened.

Sealand Securities research believes that the future policy support for the entire industry chain of innovative drugs will help enhance market confidence and be bullish on investment opportunities in high-value innovative drugs (FIC/unmet/BIC/me better) with original innovation and international competitiveness, as well as industry chain. The innovative drug sector is expected to perform strongly and outperform other sub-sectors of the pharmaceutical industry, and is a promising opportunity for medium- to long-term investment.

Innovative drug-related companies:

Innovent Bio (01801), Cellon Biotech (6990), Akeso (09926), Hutchmed (China) (00013), Beigene (06160), Consun Pharma (02162), Remegen (09995), Frontage (01521), Innocare (09969), etc.

The translation is provided by third-party software.


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