Week In Review: Three China In-Licensing Deals Add Up To $662 Million

  • Zai Lab (ZLAB) announced China's NMPA has approved Qinlock® (ripretinib) to launch as a treatment for advanced gastrointestinal stromal tumors (GIST) (see story). The indication is for adult patients who have received prior treatment with three or more kinase inhibitors, including imatinib. In 2019, Zai acquired China rights to Qinlock, which targets a broad spectrum of KIT and PDGFRα mutations known to drive GIST, from Deciphera (DCPH) in a $205 million deal.
  • CStone Pharma (HK: 2616) of Suzhou was approved to launch Ayvakit (avapritinib) tablets, a treatment for unresectable/metastatic gastrointestinal stromal tumor (GIST) harboring a PDGFRA exon 18 mutation (see story). The NMPA approval of Ayvakit was based on an open-label Phase I/II bridging study in China patients with advanced GIST. All eight patients showed anti-tumor activity. One week ago, CStone announced China approval of a RET inhibitor for RET non-small cell lung cancer.  
  • BeyondSpring (BYSI), a New York City cancer biopharma, submitted NDAs to US and China regulators of a novel prevention treatment for chemotherapy-induced neutropenia (CIN) (see story). The company combines plinabulin with granulocyte colony-stimulating factor (G-CSF), the current standard of care. BeyondSpring says G-CSF treatment is most beneficial in Week 2 after chemotherapy, leaving patients vulnerable during Week 1, the so-called “neutropenia vulnerability gap” when over 75% of CIN-related clinical complications occur. 
  • Shanghai Henlius Biotech (HK: 2696) will file for China approval of its PD-1 inhibitor after successful Phase II trials of the candidate (see story). Henlius said HLX10 met its endpoints in a Phase II trial, but it will release the data at a future medical conference. Later this year, it plans to file a China NDA for HLX10 plus chemotherapy as a first-line treatment for sqNSCLC. The Phase II trial tested HLX10 in patients with advanced microsatellite instability-high or mismatch repair-deficient solid tumors that don't respond to standard therapies. 
  • Shanghai's Everest Medicines (HK: 1952) said it is approved to conduct a China Phase II trial of Trodelvy® in patients with cancers that have high TROP-2 expression (see story). Everest plans to enroll 180 patients with esophageal squamous cell carcinoma, gastric cancer, and cervical cancer. In 2019, Everest acquired Greater China rights to Trodelvy in an agreement worth up to $835 million from Immunomedics, which was bought by Gilead (GILD). Last year, Everest began a registrational China Phase IIb trial of the candidate to treat metastatic triple-negative breast cancer.  
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