Ruimei Jipan orally disintegrating tablets have been launched in the pilot area of Boao Lecheng and the Greater Bay Area of Guangdong, Hong Kong, and Macao, and have now benefited hundreds of migraine patients. From the current timeline, the official launch of Ruimei Jipan in China is expected to be in the first half of 2024, and Pfizer has been working hard to accelerate the launch of this product, Chen Ye, the head of the migraine field business at Pfizer China, revealed the above information in an interview with a reporter from Pengpai News.
At the 6th China International Import Expo, Pfizer showcased two migraine products, among which Ruimei Jipan orally disintegrating tablet is currently the world's first and only calcitonin gene related peptide (CGRP) receptor antagonist with a rapidly dissolving orally disintegrating tablet type, which can be used for both acute treatment and preventive treatment of migraine. After the first exhibition in China International Import Expo last year, it was launched in Boao Lecheng, Hainan and the Greater Bay Area of Guangdong, Hong Kong, and Macao, Breaking the previous situation of non-specific migraine treatment and prevention drugs in China.
Another migraine drug, Zavzpret, is the first and only nasal spray type CGRP receptor antagonist in the world to treat acute migraine. Its nasal spray type design will help more patients avoid adverse reactions and first-pass metabolic effects caused by gastrointestinal absorption.
Migraine is a common neurological disease, with a global prevalence rate of approximately 14.4% and 9.3% in China. There are approximately 130 million patients in China, and one in 10 adults aged 18 to 65 has migraine. Li Yansheng, affiliated with Renji Hospital of Shanghai Jiao Tong University School of Medicine, introduced to media outlets including Pengpai News that the professional name of migraine is primary headache. In international classification, headache is divided into primary headache and secondary headache. The so-called primary headache is "if the cause cannot be found, it appears to be pain, if it starts, it will be good". For this reason, there is currently no specific examination method in clinical practice to confirm migraine, and clinical diagnosis mainly relies on symptoms.
Due to multiple factors such as the complex etiology of migraine, the treatment rate of Chinese migraine patients is only 52.9%, and the correct diagnosis rate is only 13.8%. Patients also have huge unmet needs in terms of treatment. Li Yansheng stated that in the past, when dealing with migraine, most patients chose non-steroidal anti-inflammatory drugs such as aspirin or traptan. Both have certain effects, but there are also shortcomings. For example, non-steroidal anti-inflammatory drugs are not suitable for patients with poor kidneys or digestive systems, and traptan drugs are not suitable for patients with cardiovascular and cerebrovascular diseases. Nowadays, CGRP receptor antagonists provide new options for patients.
In 2020, Rimazepam orally disintegrating tablets were approved in the United States, with two major indications for acute treatment and prevention. In China, the drug is the first to land in the pilot area of Boao Lecheng and the Greater Bay Area of Guangdong, Hong Kong, and Macao. Especially in the pilot area of Hainan, the Ruimei Jipan orally disintegrating tablet has entered the special drug insurance of Hainan. insured residents in Hainan can receive 100% reimbursement in the event of a confirmed migraine at the initial diagnosis.
Chen Ye pointed out to Pengpai News reporters that in the future, after the official launch of Ruimeizhipan orally disintegrating tablets, Pfizer will continue to promote rich and multi-level commercial insurance projects, as well as various innovative payment methods, to further reduce the payment burden on patients.
Regarding the Zavzpre nasal spray, Chen Ye revealed that it is expected to land in the pilot trial area of Boao, Hainan in early 2024. At present, Pfizer is also rapidly advancing its testing of nasal sprays, hoping to be officially approved between 2025 and 2026.
Globally, a total of 8 products targeting CGRP or its receptors have been approved for launch.
In China, there is still a blue ocean surrounding CGRP targets. In September of this year, Novartis announced that its application for the use of irinotezumab injection as a preventive treatment for adult migraine was officially approved by the National Drug Administration, becoming the first fully human monoclonal antibody drug targeting CGRP receptors in China.
Multinational pharmaceutical company Tiva also has an innovative migraine drug called Remanezumab targeting CGRP targets, which has been launched in the Guangdong Hong Kong Macao Greater Bay Area. During the CIIE, Huang Diren, the General Manager of Tiva Greater China, stated in an interview with Pengpai News that according to the regular registration schedule, Rimacizumab will probably receive approval from the National Drug Administration in 2026.
In terms of domestic enterprises, JS010 developed by Junshi Biotechnology is also a CGRP target. In March 2023, the new drug clinical trial application (IND) for this drug was approved. Pre clinical in vivo pharmacodynamics data show that JS010 has a significant inhibitory effect on vascular dilation. In addition, animals showed good tolerance to JS010, and no significant abnormalities were observed in all animals during the study period.
Regarding the development potential of future CGRP targets, Chen Ye told Pengpai News that CGRP targets not only exist in the brain, but also have many possibilities in other disease fields, We are also exploring other diseases in the field of neurology and other diseases in the general internal medicine, which are also our future development directions. However, science requires time, and we need clinical data to verify whether it can have other indications