[Special Stock] Alteogen Receives China Market Approval for Herceptin Biosimilar... Stable Royalties

Bio platform company Alteogen is showing strong performance.

As of 9:43 AM on the 12th, Alteogen is trading at 277,500 KRW, up 2.97% from the previous day.

Alteogen announced on the same day that it received a notification from China’s Chiru Pharmaceutical that the Herceptin biosimilar ALT-L2 obtained marketing authorization from the Center for Drug Evaluation (CDE) under the National Medical Products Administration of China.

ALT-L2 is one of Alteogen’s early pipelines. Although the Phase 1 clinical trial conducted independently in Canada in 2016 was successful, the company halted its own development due to intensified global market competition. After determining competitiveness in the Chinese market, Alteogen negotiated with Chiru Pharmaceutical and proceeded with a technology transfer in 2017. The Phase 3 clinical trial was completed in China in 2022, and the marketing authorization application was submitted in April last year, with approval obtained in July 2024.

An Alteogen representative said, "Two biosimilar products developed by Alteogen, Ailia and Herceptin, have each applied for and received marketing authorization, realizing the fruits of research and development." They added, "Once the first proprietary product, Tergase, is launched and subcutaneous formulation therapeutics using the Hybrozyme platform technology are commercialized, we expect to become a company generating substantial sales."