China’s innovative drugs to the sea gradually into a scale

2022-04-26 0 By

The JP Morgan Healthcare Conference held at the beginning of each year is a bellwether of the global healthcare industry.In recent years, the number of Chinese pharmaceutical companies attending the conference has increased significantly.More and more Chinese pharmaceutical companies understand and explore overseas markets by participating in global platforms.From the perspective of this annual conference, China’s innovative drug exploration has been internationalized for many years, and has made breakthroughs in recent years, gradually becoming a scale.In November 2019, based on the data of two key clinical studies, Zebutinib, a BTK inhibitor independently developed by Baijinzhou, was approved by the US Food and Drug Administration (FDA) for marketing in the United States, achieving a “zero breakthrough” in China’s original new drugs going to the sea.Baekje Is not alone in going to sea.Hengrui pharmaceutical, xinda biological and other large pharmaceutical enterprises as well as tianjingbiological, genxi biological and other new forces, have begun to layout overseas markets.Chuangqi Health Research Institute executive director CAI Jiangnan believes that Chinese pharmaceutical companies in recent years to accelerate the overseas market layout, on the one hand, because the strength of the enterprise significantly improved, on the other hand, there is also a lot of passive pressure.”China has accelerated the review and approval of innovative drugs. Hkex and GEM have also provided strong policy support to unprofitable biomedical enterprises, helping enterprises to finance. Driven by a series of policies, the development of innovative drugs in China has accelerated significantly.But at the same time, the enterprise also faces not small market pressure.The research and development cost of innovative drugs is getting higher and higher, and the trend of medical precision is becoming more and more obvious, which makes the restriction of single indication of products more and more subdivided. Coupled with the market pressure brought by collective procurement, it is inevitable that many pharmaceutical companies will look to the overseas market.”Cooperation with other enterprises, especially large multinational pharmaceutical enterprises, is a common way for Chinese pharmaceutical enterprises to go abroad.They either license clinical development and commercialization rights to other pharmaceutical companies or co-develop new drugs.Multinational pharmaceutical companies often choose cooperation partners based on many factors.First, the partner product is often required to have strong safety and efficacy data.Secondly, the product should have great commercial potential.Despite the often stringent standards of multinational drug companies, Chinese innovative drugs have achieved a number of high-profile global collaborations in recent years.In January 2021, Pegenzene entered into a cooperation and licensing agreement with Novartis for the development, production and commercialization of tirelizumab, a pD-1 antibody drug, in multiple countries, with a total transaction value of more than $2.2 billion.In August 2021, Rongchang Bio and SeattleGene entered into a partnership for the development and commercialization interests in some overseas markets of the new ADC drug, Vidicetuzumab, valued at us $2.6 billion.The increasing amount of cooperation shows the increasing value of these pharmaceutical companies in the global market.Still, getting out to sea isn’t easy.In the view of industry insiders, Chinese pharmaceutical companies need to be further strengthened in terms of intellectual property layout, overseas clinical execution, overseas commercialization layout ability and global business expansion.Localization capabilities, in particular, are critical in pharmaceutical markets with strong regulatory environments.Baekje Shenzhou, which is in the forefront of going to sea, has a deep understanding of this.So far, Baekje has established local commercialization teams in the United States, Europe and Asia Pacific.The company’s commercial products have covered Brazil, Israel, South Korea, Russia, Australia and other more than 40 countries and regions, become a strong support.Another major challenge for pharmaceutical companies going overseas is to establish independent internal clinical development capabilities, especially global phase III clinical trial capabilities.Typically, doing phase I trials overseas is relatively easy, and many companies can do it through a CRO (pharmaceutical r&d contract outsourcing service).However, when it comes to phase III clinical trials, it is necessary to communicate closely with the drug regulatory authorities in different countries. From the way of drug delivery and delivery to the design of clinical trial schemes, enterprises have high requirements.In addition, overseas market development is difficult, high investment, resource utilization efficiency of enterprises is not a small test.Genxi biological responsible person said that the company’s development gap can often be attributed to the original project decision and subsequent implementation.Based on this, genxi biological focus on platform innovation, pay attention to the layout of intellectual property rights from the source, more systematic research and development, and select mature targets, according to the immune characteristics of immune cell drugs, select and verify the best products of the same kind, into the global new drug clinical trials with high investment.Wang Lai, senior vice president and head of global research and development of Baiji Shenzhou, told reporters that since 2017, the preclinical research of Baiji Shenzhou has focused on first-in-class (the First new drug of its kind).Prior to that, We will also focus on targets that have clinical data or are already in the clinic, especially those that have proven of concept and have the potential to become best-in-class.In addition to enterprises’ independent exploration, China is speeding up its integration with the international system in terms of rules and regulations, which will give more impetus to enterprises going overseas.In 2017, China joined the ICH (International Technical Coordination Committee for Registration of Medicinal Products for Human Use), which significantly promoted domestic pharmaceutical companies to improve product quality according to international standards.Some pharmaceutical companies are also thinking more about going overseas.”Going to developed countries and regions is a testament to capability, but developing countries are more short of medicines, which is precisely the focus of innovative pharmaceutical companies to bring huge benefits to these countries and people.””Said Wu Xiaobin, global president and chief operating officer of Baiji Shenzhou.(Economic Daily Reporter Yuan Yong)