BeiGene, Ltd. American Depositary Shares - BGNE STOCK NEWS

BeiGene announced that the FDA has deferred action on the BLA for tislelizumab, a treatment for esophageal squamous cell carcinoma. The deferral is due to COVID-19 travel restrictions preventing required inspections in China. The FDA has not provided a new anticipated action date. Currently, the application remains under review, and BeiGene is collaborating with Novartis to facilitate inspections. Previously accepted in September 2021, the BLA demonstrated significant survival benefits in clinical trials.

BeiGene has appointed Chan Lee as General Counsel, effective July 18, 2022. Lee, who previously served at Sanofi, brings extensive legal expertise in the biopharma sector, overseeing compliance, intellectual property, and other legal matters. He succeeds Scott Samuels, who played a key role in establishing BeiGene's global legal team. CEO John V. Oyler highlights Lee's leadership skills as crucial for BeiGene's continued global expansion and business priorities. Lee will join the Executive Committee, reporting directly to Oyler.

Leap Therapeutics, in collaboration with BeiGene, announced the initiation of Part C of the DisTinGuish study, evaluating DKN-01 plus tislelizumab and chemotherapy in first-line gastric cancer patients. The study targets about 160 HER2-negative patients whose tumors express high DKK1 levels. Leap is also launching a second-line colorectal cancer trial with DKN-01 and bevacizumab, and supporting a trial in endometrial cancer with pembrolizumab. The company hosted an R&D Day to discuss these advancements and highlight strong preliminary results from previous trials.

BeiGene has announced a strategic collaboration with InnoRNA to research mRNA-LNP programs. This partnership grants BeiGene exclusive global rights to develop and commercialize the therapies resulting from this collaboration. Furthermore, BeiGene will obtain a non-exclusive license to InnoRNA's proprietary LNP Technology to bolster its internal mRNA drug discovery efforts. InnoRNA will receive upfront cash and potential milestone payments as well as tiered royalties based on the collaboration's success.

BeiGene announced positive results from the RATIONALE 306 trial, demonstrating that the PD-1 inhibitor tislelizumab combined with chemotherapy significantly improves overall survival (OS) for patients with advanced esophageal squamous cell carcinoma (ESCC). Patients receiving tislelizumab had a median OS of 17.2 months, compared to 10.6 months for those on chemotherapy alone, marking a 34% reduced risk of death. The trial's safety profile showed treatment-related adverse events similar across groups, with no new safety signals reported.

BeiGene (NASDAQ: BGNE) announced the acceptance of a supplemental biologics license application (sBLA) by the Center for Drug Evaluation (CDE) in China for tislelizumab, its anti-PD-1 inhibitor, to be used with chemotherapy as a first-line treatment for advanced gastric or gastroesophageal junction adenocarcinoma patients with PD-L1 expression. This is the 10th regulatory submission for tislelizumab in China. Tislelizumab is already under review by the FDA and EMA for other indications, highlighting its potential in the oncology landscape.

BeiGene has received regulatory approval for its BTK inhibitor BRUKINSA (zanubrutinib) in Kuwait, Bahrain, and Qatar for treating mantle cell lymphoma (MCL) in adult patients with prior therapies. This approval expands access to BRUKINSA, which has previously been authorized in multiple countries including the U.S. and China. The drug is known for its potent pharmacokinetic properties and aims to improve treatment outcomes in regions where MCL is prevalent.

BeiGene announced that the FDA has extended the PDUFA goal date for the BRUKINSA sNDA to January 20, 2023. This extension allows time to review new clinical data demonstrating BRUKINSA's superiority over ibrutinib in treating chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The data comes from the global ALPINE clinical trial, which showed improved overall response rates (ORR). BRUKINSA is already approved for multiple indications and aims to improve treatment outcomes for patients globally.

BeiGene has announced the approval of its anti-PD-1 antibody, tislelizumab, in combination with chemotherapy for treating recurrent or metastatic nasopharyngeal cancer (NPC) in China. This approval adds to the nine indications already granted for tislelizumab in the country. The decision is supported by positive results from the Phase 3 RATIONALE-309 trial, which showed statistically significant improvement in progression-free survival and a manageable safety profile. This marks a step forward in addressing the high medical need for NPC treatment in China.