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Innovent gears up for PD-1 inhibitor launch in China

Analysts say the approval marks a move away from developing ‘me-too’ drugs


Chinese biotech Innovent is in the final stages of preparing to launch its cancer immunotherapy Tyvyt in its home market.

Tyvyt (sintilimab) was jointly developed by Innovent and partner Eli Lilly in China and was approved by the National Medical Products Administration (NMPA) for relapsed or refractory classical Hodgkin's lymphoma (cHL) in December.

The green light has been trumpeted as a key milestone in the emergence of China in the field of immuno-oncology, along with the earlier approval of Shanghai Junshi Biosciences’ PD-1 inhibitor Tuoyi (toripalimab) for melanoma.

GlobalData says the two approvals show that China is moving away from its traditional focus on developing ‘me-too’ drugs aimed at the domestic market to independently develop brands that will compete with Western developers’ drugs.

The home-grown PD-1 inhibitors join Bristol-Myers Squibb and Merck & Co/MSD’s rival drugs on the Chinese market. BMS’ Opdivo (nivolumab) was cleared in China for previously-treated non-small cell lung cancer (NSCLC) in June 2018, while Merck’s Keytruda (pembrolizumab) got the nod from the NMPA for melanoma the following month.

Innovent hosted a forum this week to highlight the impending availability of Tyvyt as well as the launch of a Clinical Oncology Research Fund, jointly initiated by the Beijing Xisike Clinical Oncology Research Foundation, which aims to encourage doctors in China to conduct more translational research in oncology and to improve their skills in the diagnosis and treatment of patients.

“The approval of Tyvyt…enables Innovent's delivery on its social responsibility to offer innovative drugs affordable to patients in China,” said the Chinese biotech in a statement.

Innovent and Lilly are carrying out more than 20 clinical studies of sintilimab, including seven registration studies, that are testing the drug in other solid tumours and will be used to support approval in other markets, including the US and Europe.

Last month it started a phase 3 study of Tyvyt in in combination with capecitabine and oxaliplatin, as first-line treatment for patients with advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma.

“The government-supported Chinese biotech revolution will bring forth many Chinese drug developers to compete with well-established multinational drug companies,” says GlobalData.

“Simultaneously, the massive untouched market holds opportunities for foreign investors. By increasing competition, China’s rise will impact the global pharmaceutical industry and as a result, it could give rise to more innovation.”

Article by
Phil Taylor

22nd February 2019

From: Research



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