BeiGene became the first Chinese-origin pharma company to market a Programmed Cell Death Protein 1 (PD1) therapy for oncology indications in various global markets, beginning with the EU. With expanding international reach and continuing manufacturing support from Novartis, BeiGene is primed for a promising future in the global oncology landscape . This will pave the way for Chinese pharma companies to come to the forefront to position their novel therapies commercially in the global markets, says GlobalData, a leading data and analytics company.

Tislelizumab has 11 approved indications in China, including non-small cell lung cancer (NSCLC), small cell lung cancer, gastric cancer, esophageal squamous cell carcinoma (ESCC), hepatocellular carcinoma (HCC), and nasopharyngeal cancer.

Sasmitha Sahu, Pharma Analyst at GlobalData, comments: “Of late, Chinese pharma companies have made significant progress in the development of oncology therapies.  However, they have been completely relying on international partners starting from clinical development, regulatory, as well as product launch activities owing to their lack of respective capabilities in the international markets. This was seen in the numerous deals and agreements involving oncology therapy candidates developed by Chinese companies.”

According to GlobalData’s Pharma Intelligence Center, there are 17 marketed innovator PD1 therapies for various oncological indications. However, only seven PD1 therapies including two combination brands of pembrolizumab and nivolumab have been approved in the US or EU or both while the remaining therapies have been approved only in China.

The European Commission (EC) has recently approved Tevimbra as monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior platinum-based chemotherapy. Regulatory submissions for tislelizumab are also under review in the US, the UK, Australia, China, New Zealand, Brazil, Korea, Switzerland, Israel and Indonesia. The global clinical development program for tislelizumab includes more than 11,500 subjects enrolled to date in 30 countries and regions.

BeiGene has the experience of commercializing Brukinsa (zanubrutinib), its first indigenous oncology therapy, in various global markets including the US, EU and Australia. It has an operational European presence, including commercial and clinical teams, since May 2022.

Sahu adds: “BeiGene is in a comfortable position in terms of market entry considering many clinical trials and regulatory submissions were completed as part of its collaboration agreement with Novartis. However, it needs to leverage the commercialization experience gained through Brukinsa to position its PD1 inhibitor tislelizumab. Given that there are only a few blockbuster PD1 inhibitors available in the market, this will be an uphill task but not impossible, especially in indications where only few PD1 inhibitors are already approved.”

Novartis will continue to be the manufacturing partner for tislelizumab. BeiGene announced recently that its new manufacturing facilities in the US and China will be ready in 2024.

Sahu concludes: “Novartis’ ongoing collaboration as the manufacturing partner will reduce market adoption hurdles for tislelizumab. Moreover, strategic investments in biologics manufacturing facilities, both in China and abroad, to attain production self-sufficiency by 2024, reinforces the company’s preparations for global expansion.”