Week In Review: Sinopharm Transfers $4.6 Billion In Assets, Including Two COVID-19 Vaccines

Trials and Approvals 

  • Shanghai Junshi Bio (HK: 1877) announced China's NMPA approved a third indication for the company's PD-1 drug (see story). Toripalimab is now approved as a second-line therapy for locally advanced or metastatic urothelial carcinoma in patients who failed platinum-based chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum chemotherapy. Previously, toripalimab was approved as a second-line treatment for metastatic melanoma and a third-line therapy for nasopharyngeal carcinoma. 
  • Innovent Biologics (HK: 01801) of Suzhou reported positive data from a Phase III trial of its anti-PD-1 drug, Tyvyt®, as a second line therapy for patients with non-small cell lung cancer (see story). Patients who received Tyvyt® experienced a statistically significant improvement in overall survival compared to those who received docetaxel. Currently, Innovent has three Tyvyt® NDAs under review in China. In addition, the company is conducting more than 20 clinical trials of Tyvyt® in a variety of cancer indications.  
  • Adlai Nortye, a Hangzhou-New Jersey biopharma, has dosed the first patient in a global Phase III trial of Buparlisib at the Shanghai Eastern Hospital Medical Center (see story). The trial will test Buparlisib, an oral pan-PI3K inhibitor, as a second-line therapy in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). Patients must have disease that progressed after a previous PD-1/PD-L1 treatment. Adlai Nortye said the trial is the first global multicenter Phase III trial of a PI3K inhibitor as an HNSCC therapy.  
  • Gracell Biotech, a Suzhou cell therapy company, reported positive results from a China Phase I trial of its allogeneic CAR-T candidate (see story). GC027 targets CD7. It was administered to adult patients with relapsed/refractory T-cell acute lymphoblastic leukemia (r/r T-ALL) who had previously been treated with a median of six therapies. A single infusion of GC027 at one of three dosing levels produced a complete remission in all six patients. In the future, Gracell plans to test GC027 in global markets for T-All and other cancers as well.  
  • LintonPharm, a Guangzhou biopharma, was approved to start a China Phase I/II clinical trial of catumaxomab to treat recurrent Non-Muscle-Invasive Bladder Cancer (NMIBC) (see story). The trial will enroll patients whose tumors have recurred due to Bacillus Calmette-Guerin (BCG) vaccine failure. In 2020, LintonPharm started a China Phase III trial of catumaxomab. an immunotherapy, in patients with advanced gastric cancer. LintonPharm develops innovative T cell engaging bispecific antibodies, aiming to turn malignant cancers into manageable or curable diseases.  
  • Suzhou Kintor Pharma (HK: 9939) was approved to start China clinical trials of a proposed treatment for acne and androgenetic alopecia (see story). GT20029, which degrades the androgen receptor protein via the E3 ubiquitin ligase pathway, is the first topical AR therapy to begin clinical tests, according to Kintor. In preclinical studies, the candidate was more effective than other small molecule AR inhibitors, while avoiding excessive drug accumulation and other side effects.  
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