Apatinib mesylate manufacturers

About apatinib mesylate

Apatinib mesylate manufacturers are led by Jiangsu Hengrui Pharmaceuticals, which sells it in China as Aitan, while Elevar Therapeutics, part of South Korea's HLB Group, holds rights outside China under the name rivoceranib. Apatinib is an oral tyrosine kinase inhibitor that blocks VEGFR-2 and tumour blood vessel growth. It is approved in China for gastric cancer and liver cancer, including first-line use with the PD-1 antibody camrelizumab. Pharmaceutical companies can source apatinib tablets and API through out-licensing, supply or technology transfer.

Apatinib mesylate key facts

Apatinib mesylate manufacturers and licensing history

Apatinib was the first tyrosine kinase inhibitor approved for gastric cancer in China, in October 2014. Jiangsu Hengrui Pharmaceuticals markets it as Aitan. China later approved it for second-line liver cancer in 2020, and with camrelizumab, Hengrui's PD-1 antibody, for first-line unresectable liver cancer in January 2023.

Outside China, Elevar Therapeutics, a majority-owned subsidiary of HLB, holds the rights and uses the name rivoceranib. In October 2023, Elevar also licensed camrelizumab from Hengrui for liver cancer worldwide, excluding Greater China and Korea.

The US application for the combination has received three complete response letters. The first, in May 2024, cited manufacturing issues at a camrelizumab site. The second, in March 2025, requested more information. The third, on 10 July 2026, cited deficiencies at a rivoceranib manufacturing site. None was related to clinical efficacy or safety. Elevar and Hengrui resubmitted on 9 October 2026.

Buyers should confirm the rights position in each territory, GMP status and the API salt form before choosing a partner.

Apatinib mesylate dosage forms and dossier types

Apatinib mesylate is approved in China as film-coated tablets. Outside China, development is led by Elevar under the name rivoceranib.

Apatinib mesylate regulatory and patent status

China approved apatinib in October 2014 for gastric cancer, in 2020 for second-line liver cancer, and in January 2023 with camrelizumab for first-line liver cancer. In the US, the combination for first-line liver cancer has received three complete response letters, most recently on 10 July 2026, all based on manufacturing or information issues. It was resubmitted on 9 October 2026. The combination is already included in 2025 BCLC and ESMO liver cancer guidance. Check patent status and territorial rights before any development.

Apatinib mesylate mechanism of action and therapeutic use

Apatinib selectively blocks VEGFR-2, which cuts off the blood supply that tumours need to grow. In China, it is used alone for advanced gastric cancer and second-line liver cancer. With camrelizumab, it is used as first-line treatment for unresectable liver cancer, where the CARES-310 trial showed longer overall survival than sorafenib.

Apatinib mesylate licensing and sourcing

Apatinib suppliers and licensing partners typically offer regional out-licensing, API supply or technology transfer. Buyers usually compare GMP status, territorial rights, regulatory status and patent position. Current offers and supplier contacts are listed among the apatinib mesylate manufacturers on Pipelinepharma.

Frequently asked questions about apatinib mesylate

Who are the main apatinib mesylate manufacturers? Jiangsu Hengrui Pharmaceuticals makes apatinib in China as Aitan. Elevar Therapeutics, part of HLB, holds rights outside China under the name rivoceranib.

What is the difference between apatinib and rivoceranib? They are the same drug. Apatinib is the name used in China, and rivoceranib is the INN used by Elevar outside China.

Is apatinib approved in the US? Not yet. The FDA issued a third complete response letter in July 2026, based on manufacturing issues, and the application was resubmitted on 9 October 2026.

What is apatinib used for? In China, apatinib is used for advanced gastric cancer and liver cancer, including first-line use with camrelizumab for unresectable liver cancer.

Is apatinib available for licensing? China rights are held by Hengrui, and rights outside China by Elevar. Licensing for other territories should be discussed with Elevar.