Bayer's $1.5 Billion Investment in Diabetes Drug Fails, Collaboration with Hua Medicine Terminated

Bayer partnered with Hua Medicine in 2020 to commercialize its hypoglycemic drug doglietine in China, aiming to mitigate the risk of gathering its core hypoglycemic drug bitangpin. However, after Doglietine was approved for listing in 2022, the down payment and milestone fees paid by Bayer to Hua Medicine totaled 1.5 billion yuan. Despite this, Doglietin's sales totaled less than 200 million yuan in 2022 and 2023, and 102 million yuan in the first half of 2024, making it difficult for Bayer to recover costs and even facing losses. On November 22, Hua Medicine announced the termination of cooperation, 1.5 billion yuan was not refunded, and Bayer suffered setbacks in the Doglietin project.

Hua Medicine predicted in 2018 that doglietine could significantly reduce Hb1Ac and had the potential to become the strongest hypoglycemic drug. Although the phase 3 clinical data were not available, Bayer hoped that doglietine could make up for the market gap of bitospine, but the final data showed that doglietine monotherapy could only reduce HbA1c by 1.07%, similar to DDP4 and SGLT-2 monotherapy, and the standard treatment rate was only 45.5%. DAWN showed that doglietine combined with metformin had a limited effect, with a hemoglobin compliance rate of 44.4% at 24 weeks, while smaglutide combined with metformin could reduce HbA1c by 1.8%, and the compliance rate of the high-dose group was as high as 82%. Overall, the efficacy of doglietine was awkward, neither above nor below.

In the competition with other hypoglycemic agents, doglietine has potential shortcomings, especially the lack of control group validation for long-term benefits. Although the short-term effect is significant, the long-term effect and duration of efficacy remain uncertain and the reasons are not clear. At 52 weeks, doglietine consistently reduced HbA1c, but control data were lacking. The Phase 3 trial did not include a control group for the entire 52 weeks, resulting in an incomplete long-term safety assessment. In addition, doglietine did not have a significant advantage in terms of safety, and the incidence of hypoglycemia was comparable to traditional drugs. In terms of overall benefit, doglietine does not provide cardiovascular protection and may even increase the associated risk. In terms of price, doglietine is more expensive, with a daily cost of 10.78 yuan and an annual fee of 3935 yuan, 46% higher than the most expensive oral hypoglycemic drug in the medical insurance catalog. As a result, Doglietine's performance in the market is not ideal, and its only selling point may be an original new drug as the first completely new mechanism in the diabetes field in a decade. However, feelings can not be translated into high income, which also reflects the domestic pharmaceutical market's attention to the clinical value of drugs. Domestic pharmaceutical companies should remember that the purpose of innovative drug research and development is to meet clinical unmet needs, rather than simply pursuing profits.