Adjustments to medical device classification rules

Pharmaceutical Industry Receives Double Benefits from Policy and Technology 
In April 2025, the pharmaceutical industry received a series of significant updates: the National Medical Products Administration (NMPA) publicly solicited opinions on medical device classification rules and simultaneously supported the early clinical use of drugs already approved overseas; the FDA announced a phased elimination of animal testing; the first gene replacement therapy drug in China was launched, with Jinbo Biology's recombinant type III collagen filler approved; Mitouke Biology and Ruijian Pharmaceuticals completed financing rounds... These events not only mark a dual breakthrough in policy and technology, but also signal that the pharmaceutical industry is about to enter a new development stage.

For investors and industry professionals, how can they seize the opportunities presented by this dual-engine drive of policy and technology? This article will delve into the logic behind these events and look forward to future investment directions in the pharmaceutical industry.

I. Policy Side: Adjustment of Medical Device Classification Rules and Accelerated Introduction of Overseas Drugs 
1. Adjustment of Medical Device Classification Rules: Accelerating Industry Standardization 
The NMPA recently publicly solicited opinions on medical device classification rules, aiming to further optimize medical device management. The core of this adjustment is:

• More precise classification: Refining the classification standards of medical devices based on risk levels and technical characteristics, avoiding a "one-size-fits-all" approach. 
• Improved approval efficiency: Reducing the approval burden for low-risk products through classification optimization and accelerating the market launch of innovative medical devices. 
Impact Analysis:

• For medical device companies, the adjustment of classification rules will reduce the compliance costs of some products, with smaller companies potentially benefiting more. 
• Innovative medical device companies will have access to faster approval channels, accelerating the commercialization process of their products. 
2. Accelerated Introduction of Overseas Drugs: Meeting Urgent Clinical Needs 
The NMPA issued a document supporting the early clinical use of drugs already approved overseas. The core objective of this policy is:

• Filling domestic gaps: Rapidly introducing mature overseas drugs to address unmet needs in areas such as rare diseases and tumors. 
• Promoting domestic innovation: Driving domestic pharmaceutical companies to improve their R&D capabilities by introducing internationally advanced drugs. 
Investment Opportunities:

• Focus on domestic agents or distributors cooperating with overseas pharmaceutical companies. 
• Domestic pharmaceutical companies may quickly deploy cutting-edge fields through the License-in model. 
II. Technology Side: Breakthrough in Gene Therapy and Alternatives to Animal Testing 
1. Breakthrough in Gene Therapy: The First Domestic Gene Replacement Therapy Drug Launched 
Recently, the first domestic gene replacement therapy drug was approved for market launch, marking the transition of gene therapy from the laboratory to the clinic. The significance of this breakthrough lies in:

• Improved technological maturity: Advances in gene editing technology have provided new solutions for the treatment of rare diseases. 
• Commercialization: The high pricing model of gene therapy may bring substantial returns to pharmaceutical companies. 
Case Extension: 
Jinbo Biology's approval of its recombinant type III collagen filler is another milestone in China's medical aesthetics field. Collagen, as a high-end medical aesthetic material, has enormous market potential.

2. FDA Gradually Eliminates Animal Testing: Rise of Alternative Technologies 
The FDA announced a phased elimination of animal testing, shifting towards alternative technologies such as computer simulation and organ-on-a-chip. The underlying logic of this trend is:

• Ethics and efficiency: Animal testing is costly and time-consuming, while alternative technologies can significantly shorten the R&D cycle. 
• Technological iteration: The maturity of AI and bioprinting technologies has made alternative solutions possible. 
Investment Directions:

• Focus on companies developing organ-on-a-chip and AI drug screening technologies. 
• Traditional CRO (Contract Research Organization) companies may face transformation pressures. 
III. Capital Side: Active Financing, Accelerated Growth of Innovative Pharmaceutical Companies 
Recently, innovative pharmaceutical companies such as Mitouke Biology and Ruijian Pharmaceuticals have completed financing rounds, reflecting the continued optimism of capital towards the pharmaceutical industry. The common characteristics of these companies are:

• High technological barriers: Focusing on cutting-edge fields such as gene therapy and cell therapy. 
• High commercialization potential: Product pipelines cover unmet clinical needs. 
Investment Logic:

• The financing capacity of innovative pharmaceutical companies is an important indicator for evaluating their R&D capabilities. 
• Focus on Biotech companies with an international perspective. 
IV. Future Outlook: Three Major Trends in the Pharmaceutical Industry 
1. Policy and technology resonance: Optimization of medical device and drug approvals will continue to unleash industry vitality. 
2. Commercialization of gene therapy: As more products are launched, gene therapy will become a new growth point for the pharmaceutical industry. 
3. Capital concentration towards leading companies: Innovative pharmaceutical companies with core technologies will receive more capital favor. 
Conclusion: The "Golden Decade" of the Pharmaceutical Industry Has Just Begun 
From policy adjustments to technological breakthroughs and capital support, the pharmaceutical industry is experiencing unprecedented development opportunities. For investors, the key lies in seizing leading companies in niche segments and cutting-edge technologies.

Interactive Topic: 
Where do you think the greatest opportunities lie in the future pharmaceutical industry? Is it gene therapy, medical aesthetic materials, or AI drug development? Welcome to share your views in the comments section!