“Science and Technology Innovation Board Daily”, December 26 (Reporter Zheng Bingxun, intern reporter Zhang Zhen) It has been around for a long time. The GLP-1 track is starting a gold rush. However, with the rapid expansion of players, competition on the GLP-1 circuit continues to intensify.

At a time when the “internal volume” is getting more intense, more players are choosing to leave. Recently, vTv Therapeutics announced that it has received a notice from Huadong Pharmaceutical, which wants to end its authorized cooperation on TTP273, a small-molecule GLP-1 receptor agonist. In response, Huadong Pharmaceutical confirmed the news to the “Science and Technology Innovation Board Daily” reporter.

▌Why did you choose to terminate the cooperation

According to public information, TTP273 is an oral non-peptide small molecule GLP-1 receptor agonist discovered by VTV Therapeutics using its small molecule drug development platform “TTP Translational Technology”.

In December 2017, Huadong Pharmaceutical “Heavy Fund” introduced TTP273. According to the agreement, Huadong Pharmaceutical should pay the total license fee of US vTV companies of 33 million US dollars in stages, and should pay sales milestone payments at four points based on actual product sales (annual net sales of more than 100 million US dollars to 750 million US dollars), with a cumulative maximum of no more than 50 million US dollars.

Huadong Pharmaceutical told the reporter that up to now the company has paid VTV Therapeutics a total of 10 million US dollars as agreed in the contract, including the down payment.

After introducing TTP273, Huadong Pharmaceutical rapidly advanced its clinical trials to treat diabetes. Currently, it has completed phase IIb clinical studies in the US; it has also completed phase II clinical trials in China.

However, it seems that commercialization of TTP273 has not progressed smoothly. Its original research company, VTV Therapeutics, also did not advance for many years after completing the phase II trial. The termination of cooperation with Huadong Pharmaceutical this time has basically determined that the drug is not perfect in terms of efficacy or safety.

More importantly, at a time when the GLP-1 weight loss market is being ignited, TTP273 has not been approved for any weight loss related indications.

Huadong Pharmaceutical told the “Science and Technology Innovation Board Daily” reporter: “The company's R&D team has independently developed the innovative oral small molecule GLP-1 receptor agonist HDM1002. After comprehensive evaluation and comparison within the company, we plan to continue to promote the self-developed HDM1002 project and stop further development of TTP273.”

According to reports, clinical trial applications for HDM1002 to treat adult type 2 diabetes have been approved by the NMPA and the US FDA; clinical trial applications for adult overweight/obese patients have also been approved by the NMPA.

▌What are the subsequent effects?

At a time when the number of players is rapidly expanding and competition on the GLP-1 circuit continues to intensify, differentiated play is gradually becoming the choice of many biotech companies.

Currently, oral administration and multiple targets are recognized as the two main directions of GLP-1 drug development. Multi-target GLP-1 drugs are developed to pursue better efficacy, while oral drugs have better compliance and are more in line with consumer medical trends.

However, due to the extensive layout, the termination of TTP273 project cooperation does not seem to have caused much damage to Huadong Pharmaceutical, which “bucked the trend”.

Among Huadong Pharmaceutical's multi-target GLP-1 drug currently being developed, Simeglutide injection diabetes indications have now completed the enrollment of phase III clinical subjects; HDM1005, a dual-target agonist, has submitted an IND application; the long-acting three-target agonist DR10624 is conducting phase I single-dose escalation (SAD) studies in China, while simultaneously conducting phase I SAD and multiple-dose escalation (MAD) trials in New Zealand.

In terms of oral GLP-1, Huadong Pharmaceutical chose HDM1002 to replace the vacancies left after the TTP273 project cooperation ended. It is worth mentioning that both drugs are small molecule GLP-1 oral preparations.

In response, some industry insiders pointed out that the difficulty in developing small molecule GLP-1 oral formulations is that the side effects are too great. In the future, the “Science and Technology Innovation Board Daily” will continue to pay attention to whether East China Pharmaceutical-related projects are progressing smoothly.