China NMPA Approved Tracker: Jan 2021
Writer: Minhua Chu
Editor: Howard Fields
Takeda China launched a new treatment in January that is considered potentially valuable for the company. It is Edarbi (azilsartan medoxomil) an oral angiotensin II receptor blocker (ARB) that was approved by China’s National Medical Products Administration (NMPA) for treating hypertension.
Another notable approval was Beigene (NASDAQ: BGNE, SEHK: 6160.HK) ’s PD-1 monoclonal antibody, tislelizumab, a new indication for first-line treatment of advanced squamous non-small cell lung cancer (NSCLC), in combination with chemotherapy. Just the day before that approval, Novartis got the exclusive global rights (but not Japan) for tislelizumab, for $650 million USD upfront.
Also, the Chinese biotech Antengene (SEHK: 6996.HK) has acquired exclusive development and commercial rights in several Asia Pacific markets for Xpovio (selinexor), the only oral selective nuclear export inhibitor (SINE) compound of its kind, developed by Karyopharm Therapeutics. Selinexor is also the first NDA for a SINE compound in China.
