Anlotinib manufacturers

About anlotinib

Anlotinib manufacturers are currently led by its originator in China, Chia Tai Tianqing Pharmaceutical, part of Sino Biopharmaceutical, which sells it as Focus V. Anlotinib is an oral multi-target tyrosine kinase inhibitor that blocks tumour blood vessel growth and tumour cell growth. It is approved in China for eight cancer indications, including lung cancer, sarcoma, thyroid cancer, endometrial cancer and kidney cancer. Pharmaceutical companies can prepare anlotinib capsule and API dossiers for launch after the Chinese compound patent expires in 2028.

Anlotinib key facts

Anlotinib manufacturers and licensing history

Anlotinib is marketed in China by Chia Tai Tianqing Pharmaceutical, a subsidiary of Sino Biopharmaceutical. China's NMPA approved it in May 2018 as the first drug for third-line treatment of advanced non-small cell lung cancer in China.

Approvals have since expanded to eight indications. These include soft tissue sarcoma in 2019, small cell lung cancer in 2019, and medullary and differentiated thyroid cancer in 2021 and 2022. Combinations with Sino Biopharm's PD-L1 antibody benmelstobart were approved for small cell lung cancer in May 2024, endometrial cancer in November 2024 and kidney cancer in May 2025.

All approved anlotinib products in China currently come from the originator, and the core compound patent expires in China in 2028. Generic developers are preparing API and capsule dossiers for that date. Buyers should confirm the API's salt and crystal form, GMP status and freedom to operate before choosing a dossier partner.

Anlotinib dosage forms and dossier types

Anlotinib is approved as 8, 10 and 12 mg capsules. Generic anlotinib manufacturers develop all three strengths, referencing Focus V.

Anlotinib regulatory and patent status

China's NMPA approved anlotinib in May 2018 and has since approved seven further indications, alone or with benmelstobart. Anlotinib is included in China's National Reimbursement Drug List. It is not approved in the US or EU, although it has received FDA orphan drug designations. The core Chinese compound patent expires in 2028, so check patent and data protection status before filing.

Anlotinib mechanism of action and therapeutic use

Anlotinib blocks several tyrosine kinases, including VEGFR, FGFR, PDGFR and c-Kit. This cuts off tumour blood vessel growth and slows tumour cell growth. It is taken once daily for 14 days, followed by 7 days off, in 21-day cycles. In China, it is used for lung cancer, soft tissue sarcoma, thyroid cancer, endometrial cancer and kidney cancer.

Anlotinib licensing and sourcing

Anlotinib suppliers and licensing partners typically offer dossier out-licensing, API supply or technology transfer, timed for patent expiry. Buyers usually compare GMP status, dossier readiness, patent position and territory availability. Current offers and supplier contacts are listed among the anlotinib manufacturers on Pipelinepharma.

Frequently asked questions about anlotinib

Who are the main anlotinib manufacturers? Chia Tai Tianqing Pharmaceutical, part of Sino Biopharmaceutical, makes anlotinib as Focus V. As of mid-2025, all approved anlotinib products in China come from the originator.

When does the anlotinib patent expire? The core compound patent for anlotinib expires in China in 2028. Generic developers are preparing dossiers for that date.

What is anlotinib approved for? In China, anlotinib is approved for non-small cell and small cell lung cancer, soft tissue sarcoma, medullary and differentiated thyroid cancer, and, with benmelstobart, endometrial and kidney cancer.

What forms and strengths of anlotinib are available? Anlotinib is available as 8, 10 and 12 mg capsules.

Is anlotinib approved in the US or EU? No. Anlotinib is approved only in China, although it has received FDA orphan drug designations.