(Yicai Global) July 25 -- The European medicines watchdog has issued a positive opinion on approving BeiGene’s cancer drug for licensing and launch in Europe, according to the Chinese biotech company.

The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended approval for Tislelizumab as a treatment for adult patients with esophageal squamous cell carcinoma, BeiGene said on July 23. BeiGene will await the final review opinion from the EMA, a source at the Beijing-based firm told Yicai Global.

Competition in China for programmed cell death protein 1 cancer drugs is fierce, with the market shares that companies can gain being very limited if they only eye the domestic market. 

Although Tislelizumab, an anti-PD-1 monoclonal antibody, is China's best seller among these homegrown treatments, its sales stood at just CNY2.9 billion (USD397.9 million) last year. US pharmaceutical giant Merck's Pembrolizumab, available globally, sold more than USD20 billion.

Chinese firms need to explore overseas markets in pursuit of larger market shares. But last year, some producers of PD-1 inhibitors faced a number of challenges when going global. 

The US Food and Drug Administration said in March 2022 that it is difficult to evaluate the efficacy and safety of a new drug for the US population using data from only one country and rejected Suzhou-based Innovent Biologics' Sintilimab from entering the US market.

At the same time, plans by Shanghai Junshi Biosciences and BeiGene to apply to debut their PD-1 inhibitors in the US market were also postponed as the FDA failed to finish the required on-site verification in China as scheduled because of the travel restrictions. 

Still, the launch of Chinese PD-1 inhibitors in overseas markets has made progress this year.

Junshi Biosciences's PD-1 monoclonal antibody Toripalimab completed the FDA's pre-license inspection of its production facility, the Shanghai-based firm said in May. Junshi's partner Coherus BioSciences was preparing to commercialize Toripalimab in the US, it added. 

Tislelizumab also completed the FDA's inspection of Current Good Manufacturing Practices, BeiGene said on July 18, noting that it hopes the upcoming reviews can be finished as soon as possible. 

Shares of BeiGene [SHA: 688235] fell 0.7 percent to close at CNY118.22 (USD16.52) in Shanghai today. Its Hong Kong-traded stock [HKG: 6160] came off 0.2 percent at HKD119.30 (USD15.27). 

Editors: Shi Yi, Martin Kadiev