Zydus Lifesciences marks China entry with approval for antidepressant drug

Indian pharma firms start get an opening in China; Glenmark got approval for nasal spray earlier

Zydus Lifesciences has secured its first-ever Chinese market approval for its antidepressant, Venlafaxine Extended-Release (ER) capsules (75 mg and 150 mg), marking its debut in the country and furthering the Indian company’s global expansion.

 

Venlafaxine ER capsules are prescribed for major depressive, generalised anxiety, social anxiety, and panic disorders. The medication helps restore the balance of serotonin and norepinephrine in the brain, addressing a critical need in mental health care by improving mood and reducing anxiety.

 

The capsules will be manufactured at Zydus’s facility in Moraiya, near Ahmedabad.

 

The Venlafaxine market in China was valued at Chinese Yuan 294 million (around $45.2 million) in 2020 and is projected to reach CNY 473.63 million ($66.52 million) by 2025, growing at a compound annual growth rate of 8.8 percent and driven by rising depression rates, increased urbanisation, and post-pandemic recovery of health care services.

 

 

Zydus plans to use strategic partnerships and local collaborations to “accelerate commercialisation” in China, ensuring the product reaches patients efficiently. The approval by China’s National Medical Products Administration (NMPA) aligns with Zydus’ strategy to expand its footprint in regulated international markets.

 

The company had earlier said that it has completed clinical trials for Desidustat, a novel oral drug for the treatment of anaemia in patients with chronic kidney disease, in China and is preparing for a commercial launch with a Chinese partner. It hopes to receive approvals for Desidustat in China in the next 12 months.

 

Zydus said it aims to strengthen its presence in China, expand access to innovative medicines, and reinforce its position as a globally competitive pharmaceutical company.

 

Glenmark Specialty S.A., a subsidiary of Glenmark Pharmaceuticals, said on Monday it has received approval from NMPA for RYALTRIS Compound Nasal Spray (GSP 301 NS), expanding its specialty respiratory portfolio in one of the world’s largest health care markets. Already approved in the United States, European Union, the United Kingdom, Australia, South Korea, and Russia, the product will be commercialised in China by Grand Pharmaceuticals. The Chinese allergic rhinitis market is projected to grow from $460 million in 2024 to over $650 million by 2034.