BeiGene was founded nearly ten years ago in China.
Today, the company a lot more than a cute-sounding name. It is a commercial-stage, publicly-traded biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer.
The Chinese biotech giant raised $2 billion in a registered direct offering in July. Beigene executives said net proceeds will primarily be used for general corporate purposes such as R&D for existing or new drugs in the pipeline. BeiGene’s stock offering is “the largest equity offering ever by a biotech company,” according to Bloomberg.
BeiGene made history in November of 2019 when its BTK inhibitor BRUKINSA became the first new cancer medicine discovered by a Chinese company to be approved by the U.S. FDA. The FDA’s approval of BRUKINSA was based on efficacy results from two single-arm clinical trials, with independent review committee (IRC)-assessed ORR per 2014 Lugano Classification as the primary endpoint. Across both trials, BRUKINSA achieved an ORR, which is the sum of complete responses and partial responses, of 84%.
BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK), discovered by BeiGene scientists, that is currently being evaluated globally in a broad pivotal clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies.
China’s pharmaceutical market is estimated to reach $161.8 billion by 2023, that’s 30% of the global market, just trailing the U.S., according to a December statement by Xudong Fu, senior vice-president of global pharmaceutical giant Bristol-Myers Squibb.
Recent Business Highlights and Upcoming Milestones
- Launched tislelizumab in China in March 2020 for patients with classical Hodgkin’s lymphoma (cHL) who have received at least two prior therapies;
- Received approval from the China National Medical Products Administration (NMPA) for tislelizumab as a treatment for patients with previously treated locally advanced or metastatic urothelial carcinoma;
- Generated $52.06 million in product revenue in the three months ended March 31, 2020;
- The NMPA suspended the importation, sales and use of ABRAXANE® (nanoparticle albumin-bound paclitaxel) in China supplied to BeiGene by Celgene Corporation, a Bristol Myers Squibb (BMS) company. As a result, Celgene initiated a voluntary recall of ABRAXANE in mainland China; and
- Received commercial insurance reimbursement for tislelizumab as a treatment for relapsed/refractory classical Hodgkin’s lymphoma in Zhuhai, China.
- Transition activities for the three Amgen commercial oncology medicines, XGEVA® (denosumab), KYPROLIS® (carfilzomib), and BLINCYTO® (blinatumomab) in China are on track. BeiGene is preparing to commence promotional activities for XGEVA in patients with giant cell tumor of bone in the third quarter of 2020. Regulatory activities for KYPROLIS and BLINCYTO are in progress, with new drug applications (NDAs) to the NMPA submitted in the fourth quarter 2019. Additionally, a supplemental NDA for XGEVA for an expanded indication in skeletal-related events in China was accepted by the NMPA; and
- BeiGene is working with Amgen to advance the clinical-stage oncology assets in the collaboration pursuant to the global development plan.
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