Boehringer cleared to manufacture Beigene's cancer drug for Chinese market - - pharmaphorum

Boehringer Ingelheim is to manufacture the first biologic drug approved in China using a new regulatory system, designed to strengthen the country’s domestic pharma infrastructure.

The German pharma successfully applied the Marketing Authorization Holder (MAH) system under China’s revised drug laws, allowing it to manufacture a biologic drug for partner BeiGene under multinational arrangements.

Chinese pharma BeiGene has developed tislelizumab, a PD-1 immune checkpoint inhibitor that is under development for a range of solid tumours.

In a statement Boehringer also noted that this is the first innovative biologic drug commissioned under the new model in China.

John Oyler, chairman and CEO of BeiGene, said the collaboration between BeiGene and Boehringer Ingelheim Biopharmaceuticals China demonstrates that the country’s MAH trial project can be successfully applied in order to advance the life sciences industry in China.

“This is an important milestone, not only to ensure the supply of medicines for patients in China, but also for the rapidly emerging Chinese biopharmaceutical research and development landscape,” he said.

In 2014, the Chinese government began reforming regulation to enable third parties to manufacture biopharmaceutical products for marketing authorisation holders.

Tislelizumab became the pilot project in 2015 and is now the first biologic approved under the new regulatory setup.

It is in pivotal phase 3 and phase 2 trials, including a pivotal trial in relapsed/refractory Hodgkin’s lymphoma.

It is also being tested in non-small cell lung cancer, hepatocellular carcinoma, and oesophageal squamous cell carcinoma, as well as two global phase 2 trials in patients with previously treated hepatocellular carcinoma or with R/R mature T- and NK-cell lymphomas, and an additional pivotal phase 2 trial in China in urothelial cancer.

Tislelizumab is also in development in combination with chemotherapy in first-line gastric cancer and first-line oesophageal cancer, and in China in first-line non-small cell lung cancer.

It is also being developed in combination with Beigene’s tyrosine kinase inhibitor, Brukinsa (zanubrutinib), which is a challenger to AbbVie/Johnson & Johnson’s blood cancer drug Imbruvica and has already been approved in the US for mantle cell lymphoma.

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