Mastodon Skip to main content

Posts

Showing posts with the label China

China Biotech License-out Deals with Upfront Above $100M+

An increasing number of drug candidates made in China have been out-licensed. Here are the ones aimed for approval in foreign countries. Shanghai Night ★ BL-B01D1, anti-EGFRxHER3 ADC,  SystImmune 2023.12  Announced in Ph3, BMS " $800 million in an upfront payment and up to $500 million in contingent near-term payments. SystImmune is eligible to receive additional payments of up to $7.1 billion contingent upon the achievement of certain development, regulatory and sales performance milestones for a total potential consideration of up to $8.4 billion. The companies will share certain global development expenses and profits and losses in the United States. Through its affiliates, SystImmune will retain exclusive development and commercialization rights in Mainland China, where Bristol Myers Squibb will receive a royalty on net sales. Outside the United States and Mainland China, SystImmune will receive a tiered royalty on net sales. The agreement is subject to customary clearanc...

How to get the latest info of new drugs in China

In this section, we will outline various methods for keeping track of new drug updates in China.: 1. Approval Information of Drugs This section will explain how to obtain the latest updates from the Chinese National Medical Products Administration ( NMPA ) website, including information on new drug approvals. Drug search page On the  drug search page , you can enter the name of a drug (either in Chinese or English) to view the list of approved domestic and imported drugs. For full details about a specific approval, click the product link. Drug list Details 2. IND Updates of New Drugs Here we will explain how to search for updates on new drug Investigational New Drug Applications (INDs) in China. Where to find the NEW DRUG IND data Navigation bar We can find that information on the China Center for Drug Evaluation (CDE)  website . Please select the 受理品种信息 option on the navigation bar. The new IND updates are available for you here. You can search for specific products by enteri...