Four Special Channels for FDA to Review Drugs

1. Four Special Channels for FDA to Review Drugs www.creative-biolabs.com/adc

2. 01 Fast Track 02 Priority Review Content 03 Accelerated Approval 04 Breakthrough Therapies

3. Backgournd Recently, the FDA awarded the patent-based enfortumab vedotin antibody-conjugated drug developed jointly by Seattle Genetics and its partner Astellas. The drug is currently in a phase II study of a key metastatic transitional cell carcinoma. This is undoubtedly a good news for Seattle Genetics. They have also marked the project with a "breakthrough therapy" label. After the first commercial product, Adcetris, this is the company's most promising ADC drug. Enfortumab vedotin consists of an anti-Nectin-4 monoclonal antibody and Seattle's own synthetic cytotoxin monomethyl auristatin E (MMAE), which is the first ADC drug to target solid tumor Nectin-4, targeting bladder cancer.

4. 01 Fast Track Fast-track refers to an accelerated review of drugs for the treatment of serious illnesses and to fill in unmet medical needs. Its purpose is to enable patients to acquire important new drugs as soon as possible. Fast-track access must be initiated by pharmaceutical companies and can be made at any stage of drug development. The FDA will give a response within 60 days by judging whether the drug meets the requirements.

5. 02 Priority Review A Priority Review designation will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.

6. 03 Accelerated Approval When studying a new drug, it can sometimes take many years to learn whether a drug actually provides a real effect on how a patient survives, feels, or functions. A positive therapeutic effect that is clinically meaningful in the context of a given disease is known as “clinical benefit”. Mindful of the fact that it may take an extended period of time to measure a drug’s intended clinical benefit, in 1992 FDA instituted the Accelerated Approval regulations. These regulations allowed drugs for serious conditions that filled an unmet medical need to be approved based on a surrogate endpoint. Using a surrogate endpoint enabled the FDA to approve these drugs faster.

7. 04 Breakthrough Therapy Breakthrough therapies are generally filed by pharmaceutical companies. FDA can also consider proposals based on initial clinical results of drugs and promotion of project promotion. Applications for breakthrough therapies are usually no later than the end of the second phase, and the FDA will respond within 60 days. Once a drug is approved for breakthrough therapies, it will receive all rapid approval policy benefits, and at the same time, it will receive enhanced guidance from the FDA's higher-level review team from the beginning of the first phase of clinical trials.

8. Established in 2004, Creative Biolabs is highly specialized in advanced antibody biochemistry and engineering. With more than a decade of exploration and expansion, our current research and service capacity covers the entire new drug discovery and development pipeline, ranging from early discovery, antibody design, pre-clinical evaluations, cGMP manufacturing, to clinical trials. As an international cooperation, we have established offices all around the globe with more than 200 well-trained full-time scientists and technicians, who work closely with our customers and research partners to develop new medicines for a better, healthier world. After years of pursuit for perfection, Creative Biolabs has established our leadership in targeted immunotherapy and antibody-drug conjugate (ADC) development. Creative Biolabs

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