BeiGene, Ltd. (BGNE - Free Report) announced that the National Medical Products Administration (NMPA) in China has approved its PD-1 inhibitor tislelizumab for the treatment of patients with classical Hodgkin’s lymphoma (cHL) who received at least two prior therapies. Following this nod, tislelizumab became BeiGene’s first drug to be approved in the country.
The recommended approved dose of tislelizumab is 200 mg, which is to be administered intravenously every three weeks, until disease progression or intolerable toxicity.
The approval in China was based on data from a single-arm, multi-center, pivotal phase II study called BGB-A317-203. The study evaluated tislelizumab in the given patient population with a minimum follow-up of 12 months and a median follow-up of 14 months. The objective response rate (ORR) was 76.9% and the complete response (CR) rate was 61.5% per the independent review committee.
BeiGene is currently working with Boehringer Ingelheim for the commercial launch of tislelizumab in China.
Shares of BeiGene have rallied 19.2% so far this year compared with the industry’s increase of 8.8%.
Tislelizumab is also being evaluated in several mid-late-stage studies for various oncology indications in the first-line or later-line settings. Currently, 15 registration-enabling studies are ongoing to evaluate tislelizumab for treating several cancer indications, such as lung, liver, esophageal and gastric cancers with more than 4,800 patients enrolled to date.
Meanwhile, a supplementary new drug application (sNDA) for tislelizumab is already accepted and granted a priority review by the Center for Drug Evaluation (CDE) at the NMPA. The sNDA is seeking approval of tislelizumab for addressing previously treated patients with locally advanced or metastatic urothelial carcinoma.
Notably, in November 2019, the FDA granted accelerated approval to Brukinsa (zanubrutinib) for the treatment of mantle cell lymphoma (MCL) in adult patients who received at least one prior therapy. Post this nod, Brukinsa became the first BeiGene-discovered product to receive a regulatory approval.
We remind investors that BeiGene markets and generates revenues from the sales of cancer drugs, namely Abraxane, Revlimid and Vidaza in China under a distribution license from Celgene, now part of Bristol-Myers Squibb (BMY - Free Report) .
Zacks Rank & Stocks to Consider
BeiGene currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Innoviva, Inc. (INVA - Free Report) and Guardant Health, Inc. (GH - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Innoviva’s earnings estimates have moved 18.7% north for 2019 and 25.2% for 2020 over the past 60 days.
Guardant Health’s loss per share estimates have narrowed 30.7% for 2019 and 8.5% for 2020 over the past 60 days. The stock has skyrocketed 109.6% so far this year.
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