China Market Approval Tracker: Mar 2021
Writer: Minhua Chu
Editor: Justin Fischer
In March 2021, China NMPA green-lighted three in-licensed kinase inhibitors. Among them were pralsetinib and avapritinib from Blueprint Medicines and CStone, respectively, as well as ripretinib from Deciphera and Zai Lab.
Pralsetinib and avapritinib are the first marketed products from CStone Pharmaceuticals, a Chinese biopharmaceutical company listed on the Hong Kong Stock Exchange. The drugs were granted conditional approval as a second-line treatment for adults with locally advanced and metastatic RET fusion-positive non-small cell lung cancer (NSCLC). The drugs are the first RET inhibitors approved in China. They are also the first drugs approved using real-world data compiled by the Lecheng Administration in Hainan.
The Lecheng Administration (Hainan Boao Lecheng International Medical Tourism Pilot Zone Administration) was established in August 2019 in accordance with regulations issued by the State Council. Following a special review procedure, this designated area on the southern Chinese island of Hainan permits the use of drugs and devices that are not yet licensed in the rest of China but have been approved overseas.
In 2019, a clinical real-world data application pilot was launched in Lecheng. Pratinib arrived in Lecheng shortly after being approved in the US in September 2020. The real-world study results in the Lecheng Administration complement the drug's clinical trial results, providing a valuable aid in regulatory review. This breakthrough reflects a new way of thinking about how we regulate drugs, said Siyuan Zhou, deputy director of the Center for Drug Evaluation (CDE), NMPA.
Telitacicept, an innovative drug from RemeGen also got market approval. The drug was developed to treat active, autoantibody-positive systemic lupus erythematosus (SLE) adult patients who still have high disease activity after standard care. Telitacicept is a novel recombinant TACI-Fc (transmembrane activator and calcium modulator and cyclophilin ligand interactor) fusion protein. It works by binding to the cell-signaling molecules BLyS (B lymphocyte stimulator) and APRIL (a proliferation-inducing ligand).
Two Chinese biotech companies submitted their first New Drug Applications (NDA) as well.
Everest Medicines acquired from Tetraphase Pharmaceuticals the rights to develop and commercialize eravacycline in the Greater China, South Korea and selected Southeast Asia markets. Eravacycline is a fully synthetic tetracycline-class antibiotic indicated for the treatment of complicated intra-abdominal infections (cIAI). It is already marketed in the US and Europe under the brand Xerava.
Also, BeyondSpring announced that it has simultaneously submitted NDAs to the US FDA and the China NMPA for its new drug, plinabulin. The drug's indication is severe neutropenia (CIN). Derived from natural seaweed, plinabulin is a guanine nucleotide exchange factor (GEF-H1) activator, not a G-CSF analog. The molecule can reduce the occurrence of early CIN by reversing the formation of chemotherapy-induced neutrophil blockade in the bone marrow by keeping neutrophil levels within the normal range. The mechanism of action is different from that of G-CSF.