BeiGene bags blockbuster deal with Anti-PD-1 Antibody Tislelizumab

BeiGene’s outlicensing deal with Novartis underscores how Chinese pharma companies are yards ahead of Indian pharma companies now.

Novartis, the Swiss Big Pharma company, has agreed to pay BeiGene  $650 million upfront and up to $1.55 billion in potential regulatory and sales milestone payments plus royalties on product sales. This is in exchange for rights to co-develop and commercialize tislelizumab in North America, Japan, EU, and six other European countries

Tislelizumab is an immuno-oncology drug candidate being developed by BeiGene Ltd. (patent US8735553B1).

Tislelizumab (BGB-A317) is a humanized IgG4 monoclonal antibody targeting the PD-1 immune checkpoint [3]. It contains an alternative hinge region compared to other IgG4 anti-PD-1 antibodies, and subsequently does not induce the crosslinking between PD-1 and FcγRI that is observed for existing agents and which is believed to negatively impact on anti-PD-1 antibody-mediated anti-cancer activity. This modified profile is predicted to enhance tislelizumab’s clinical efficacy. Like other anti-PD-1 antibodies tislelizumab acts to prevent the binding of the ligands PD-L1 and PD-L2 to PD-1.

It is already approved and marketed by BeiGene in China in two indications, classical Hodgkin’s lymphoma (cHL) following at least two prior therapies and locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression. In addition, three supplemental new drug applications for tislelizumab have been accepted by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) and are under review. These indications are first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy, first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, and previously treated unresectable hepatocellular carcinoma.

BeiGene describes itself as a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer. It started as a research and development company in Beijing in 2010, focusing on developing best-in-class oncology drugs Over the last ten years, it has developed into a fully integrated global biotechnology company, with significant commercial, manufacturing, and research and development capabilities.

The Company has built substantial commercial capabilities in China and the United States and is currently marketing both internally developed drugs and in-licensed drugs. In the United States, the Company markets BRUKINSA (zanubrutinib) for adult patients with mantle cell lymphoma (“MCL”) who have received at least one prior therapy. In China, the Company markets BRUKINSA in two indications: for adult patients with chronic lymphocytic leukemia (“CLL”) /small lymphocytic lymphoma (“SLL”) who have received at least one prior therapy, and for adult patients with MCL who have received at least one prior therapy.

The Company has filed additional new or supplementary new drug applications for regulatory approvals in China or elsewhere for its internally developed products and is planning to launch these additional products or indications in 2020 and beyond. The Company’s commercial portfolio also includes the following drugs in-licensed from third parties: REVLIMID, VIDAZA and ABRAXANE, which the Company has been marketing in China since 2017 under a license from Celgene Logistics Sàrl, a Bristol Myers Squibb company (“BMS”); and XGEVA (denosumab), from Amgen Inc. (“Amgen”), which the Company began commercializing in July 2020. The Company plans on launching additional in-licensed products once approved in China, including KYPROLIS (carfilzomib) and BLINCYTO (blinatumomab) from Amgen, and SYLVANT (siltuximab) and QARZIBA  (dinutuximab beta) from EUSA Pharma (“EUSA”).

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