February 10, 2022, under the stars to watch the live broadcast. Xinda's FDA meeting touched the hearts of millions of medicine people.
The pioneer Cinda Biological failed to apply for the listing of PD-1 to FDA this time, but this meeting set an important example for the majority of domestic innovative drug enterprises and became a milestone event in the internationalization of domestic innovative drugs. Xinda Biology has won widespread praise in the industry.
Cinda Bio through friendly negotiations with Eli Lilly Pharmaceutical, the overseas rights and interests of Sindillizumab. This withdrawal will not affect the strategic cooperation between Cinda and Eli Lilly. In the Chinese market, Eli Lilly continues to maintain a high level of cooperation with Cinda Bio.
Sindillizumab was jointly developed and commercialized by Cinda Bio and Eli Lilly in China, and became the first PD-1 inhibitor to be included in the Chinese medical insurance catalog in 2019. In August 2020, the two sides expanded their global strategic partnership for Sindillizumab, with Lilly obtaining exclusive licensing rights for the drug outside China and planning to market it in the United States and other regions. Cinda Bio-will receive an initial payment of $200 million and development and sales milestones of $825 million, in addition to a double-digit percentage of net sales.
Cinda is not the first time that domestic drug companies have withdrawn PD-1's overseas interests.
In June 2019, Beigene recovered the global interest of PD1 from Suntec. Then in January 2021, Beekje and Novartis entered into an overseas licensing partnership for the PD-1. Baekje licensed PD-1 for the second time, with a down payment of $650 million, the largest down payment for a domestic drug licensing cooperation project to date.
Cinda Bio also said that this business decision is very beneficial to the comprehensive layout of the company's tumor pipeline. The overseas rights and interests of PD-1 will give the company more initiative and flexibility in the comprehensive layout of the IO (Immuno-oncology) pipeline in the future. For example, to explore the internationalization potential of PD-1 combined with LAG3, TIGIT and other targets.
The withdrawal was a logical and expected outcome for both parties, following the FDA application approval meeting in February. This step-by-step agreement is the end of the dust. Nor is it bad news for Cinda. In the tumor pipeline, PD-1 as the base drug can be used in combination.
Sindillizumab made the crucial leap from biotech to biopharma. In the domestic market, it has developed a commercial iron army, with the Q3 product revenue of 2022 exceeding 1.1 billion yuan, becoming one of the leading innovative pharmaceutical enterprises in China.
The potential of weight reduction drug IBI362 makes Cinda sit next. The second leap of Cinda biology is guaranteed.
Deppon Pharmaceutical believes that the weight loss market is a 40 billion weight gold track, GLP1 class drugs are growing at a high speed. More than half of China's population is overweight or obese, posing a serious burden on families and society.
The launch of a new generation of weight reduction drugs with good effects and high safety will usher in a revolution on the supply side and stimulate a potential large market. Among the dual-target agonists, Cinda Biological is in a leading position, and the therapeutic effect of IBI362(GLP-1/GCGR) on diabetes and obesity is potentially the best of its kind.
On October 17, Cinda Biological announced the publication in the Lancet of the high-dose cohort of a multi-dose-escalation Phase 1b clinical study of the GLP-1R/GCGR bisagonist Mazdutide (IBI362) in overweight or obese Chinese subjects. The results showed significant weight loss in the IBI362 group (administered subcutaneously once a week) compared to the placebo group. After 16 weeks of administration, subjects in the 10mg cohort who received IBI362 had a mean weight loss of 9.5% from baseline. After 12 weeks of administration, subjects treated with IBI362 in the 9 mg cohort had a mean weight loss of 11.7% from baseline. At the same time, those treated with IBI362 showed greater reductions in BMI and waist circumference than those in the placebo group. Compared with similar products such as SMeclutide and Tirzepatide, the weight change rate of IBI362 at 12 weeks was -11.7%, and the weight loss efficiency of IBI362 was higher than the previous level of smeclutide and Tirzepatide, which is expected to become one of the fastest weight loss GLP-1R drugs.
As a potential super heavyweight, Cinda has opened three phase III clinical trials of IBI362 in China.
The weight-loss Phase III clinical study (GLORI-1) was led by Ji Linong, former Vice president of the International Diabetes Federation (IDF), former chairman of the Diabetes Society of the Chinese Medical Association and professor of Peking University People's Hospital. The study included 600 patients.
The Phase III clinical study of oral medicine combined Therapy for Type 2 diabetes (EDdreamS-2) was jointly led by Professor Yang Wenying, former chairman of Asian Diabetes Society and honorary Chairman of Diabetes Society of Chinese Medical Association, China-Japan Friendship Hospital, and Professor Guo Lixin, president-elect chairman of Chinese Diabetes Society, Beijing Hospital, 720 cases;
The Phase III clinical study of first-line treatment of type 2 diabetes (Dreams-1) was jointly led by Professor Zhu Dalong from Nanjing Gulou Hospital, Chairman of the Chinese Diabetes Society, and Professor Zhao Jiajun from Shandong Provincial Hospital, chairman of the Chinese Endocrine Society. The total number of patients was 300;
Glory and Dreams, bearing the mission and belief of Cinda people, swallow mountains and rivers. On the tuyway, Cinda Biological aims at the 40 billion supermarkets in China and rolls up its sleeves to work harder.
