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BeiGene (BGNE) Up on Label Expansion of Tislelizumab in China

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Shares of commercial-stage biotechnology company, BeiGene, Ltd. (BGNE - Free Report) , gained 8.33% after it announced that its anti-PD-1 antibody, tislelizumab, received approval from the China National Medical Products Administration (NMPA) for a third indication.

Tislelizumab is now indicated for use in combination with two chemotherapy regimens as a first-line treatment for patients with advanced squamous non-small cell lung cancer (NSCLC).

The approval of tislelizumab for the treatment of patients with advanced squamous NSCLC was supported by results from a phase III study of tislelizumab combined with either paclitaxel and carboplatin or nab-paclitaxel (Abraxane) and carboplatin compared to paclitaxel and carboplatin alone in patients with untreated stage IIIB or IV squamous NSCLC from mainland China (NCT03594747).

The trial met the primary endpoint of statistically significant improvement in progression-free survival (PFS), as assessed by an independent review committee (IRC), in the pre-planned interim analysis. No new safety signals were identified.

The sales of the drug should get a boost with the approval of this indication, given the high prevalence rates. Approximately 815,563 new cases of lung cancer were reported in China in 2020.

We remind investors that tislelizumab has also received conditional approval from the NMPA for the treatment of patients with classical Hodgkin’s lymphoma, who received at least two prior therapies, and those with locally advanced or metastatic urothelial carcinoma with PD-L1 high expression, whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. 

Moreover, two supplemental new drug applications for tislelizumab have been accepted by the Center for Drug Evaluation (CDE) of the NMPA and are under review for the first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy and those with previously treated unresectable hepatocellular carcinoma.

At present, the candidate is being evaluated in 15 potentially registration-enabling clinical studies in China and globally (including 13 phase III studies and two pivotal phase II studies).

Shares of BeiGene have rallied 100.2% in the past year compared with the industry’s growth of 10.7%.

The company currently markets two internally discovered oncology products — BTK inhibitor, Brukinsa (zanubrutinib), in the United States and China and anti-PD-1 antibody, tislelizumab, in China.

The commercial portfolio of BeiGene also includes certain drugs in-licensed from third parties, including Xgeva (denosumab) from Amgen (AMGN - Free Report) , which the former began commercializing in July 2020. Additionally, BeiGene markets, Revlimid and Vidaza in China under a distribution license from Celgene, now part of Bristol-Myers Squibb (BMY - Free Report) .

The company was in the news recently after Swiss pharma giant, Novartis (NVS - Free Report) , in-licensed tislelizumab, in major markets outside of China.

BeiGene currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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