A batch of innovative drugs emerged from Pudong, and institutional innovation solved the "one pill" dilemma

Release time:Apr 16, 2024 21:58 PM

For a long time, drug instructions in China have been developed based on "foreign evidence" because there are few "new Chinese drugs". However, the national innovative anti-tumor drug Fuquitinib, which is accelerating its preparation for overseas marketing, is "going the other way" by using Chinese innovation to benefit patients worldwide.

Furoquantinib, brought by innovative pharmaceutical companies in Pudong and Huang Pharmaceutical, has attracted attention. In addition to being the first domestically produced original anti-cancer drug and expected to successfully go overseas, it is also a pilot project for the first batch of innovative drug marketing license holder system in Shanghai.

In July 2016, Pudong took the lead in launching the reform of the drug marketing license holder system nationwide. Furoquantinib was included in the first batch of pilot projects under the MAH system of the Shanghai Food and Drug Administration. This innovative pilot drug has been overcoming obstacles in the Shanghai Pilot Free Trade Zone, born in Pudong and benefiting patients nationwide, and is now moving towards the global stage. More and more innovative drugs in Pudong are accelerating their listing under the support of the MAH system. This reform in the field of new drugs has greatly promoted technological innovation and quality system improvement in China's pharmaceutical industry, enhanced the R&D motivation of enterprises and the innovation enthusiasm of R&D personnel.

Accelerate the launch of "global new" pharmaceutical products

Before 2010, China had not yet established a complete innovative pharmaceutical industry, and there was almost no independently developed innovative drugs; More than a decade later, innovative drugs have developed into the most active force in China's pharmaceutical industry, and have begun to compete with multinational pharmaceutical companies. But in order to stand out in the fiercely competitive market environment, Chinese pharmaceutical companies must have innovative drugs that can be called for and sold well.

Before the introduction of the MAH system, innovative pharmaceutical companies had a "high threshold": there was a "bundling system" between marketing and production licenses. Due to this, after obtaining a new drug certificate, new drug research and development institutions could only transfer relevant drug technology to pharmaceutical production enterprises at a certain price.

Last September, Hualing Pharmaceutical Technology Co., Ltd. officially obtained approval from the National Medical Products Administration for the listing of its Class 1 new drug, Huatangning. This "global new" innovative drug has gone from original research to mass production, and Hualing Pharmaceutical has been using it for over a decade. During this process, the implementation of the MAH system pilot directly accelerated the speed of this new drug's launch. Hualing Pharmaceutical, which is conducting the Phase II clinical trial of a new diabetes drug, is one of the first batch of pilot enterprises, realizing the "seamless connection" from Phase II to Phase III clinical trials.

A batch of innovative drugs emerged from Pudong, and institutional innovation solved the "one pill" dilemma

"Thanks to this, we have saved two years and invested hundreds of millions of yuan in production lines, accelerating the pace of new drug launch." Chen Li, Chairman of Hualing Pharmaceutical Technology Co., Ltd., said that the drugs used in Phase III clinical trials do not need to be produced by Hualing Pharmaceutical's factory building. As holders of drug launch permits, they have entrusted drug production to Shanghai Hequan Pharmaceutical Co., Ltd. and Shanghai Desenor Biopharmaceutical Co., Ltd. Nowadays, Huatangning has synchronized prescription sales in multiple pharmacies across the country.

Biopharmaceuticals are not only an important emerging industry, but also a fundamental industry for safeguarding the health of the people. In recent years, innovative pharmaceutical companies in Pudong have seen an acceleration in the listing of new drugs, many of which have adopted the MAH system pilot.

"China's Innovative Prescription" benefits patients worldwide

"In 2016, Furoquantinib became the first pilot product in Shanghai to obtain innovative drug licenses under the MAH system, allowing it to be successfully launched and sold three years ahead of schedule." Su Weiguo, CEO and Chief Scientific Officer of Hehuang Pharmaceutical, said, "Against the backdrop of China's accession to the ICH and with precise guidance from relevant policies, we look forward to Furoquantinib being approved for sale in the United States this year, becoming the second small molecule anti-tumor innovative drug in China and the first successful" overseas "small molecule anti-tumor drug in Shanghai, allowing the" Chinese Innovative Prescription "to benefit patients worldwide and showcasing the" Chinese Plan "on the world stage."

This year, the company completed a license agreement with Takeda Pharmaceuticals for the development and commercialization of furoquantinib outside of China, with a down payment of $400 million, a total of $1.13 billion, setting a new record for Chinese small molecule new drug "going global" licensing transactions. At present, furoquinotinib has completed its application for new drug marketing in the United States and Europe, has been given priority review by the FDA, and will complete its marketing application to Japan within this year.

Thanks to the support of domestic policies, Hehuang Pharmaceutical has always adhered to the strategy of independent research and development and global synchronous development. Rooted in Pudong, it has built an independently owned, fully functional, and supportive Chinese original drug research and development platform that starts from early drug discovery. It has formed a product pipeline with multiple targets and comprehensive coverage of high-risk tumors. At the beginning of the development of all candidate drugs, it has been promoted according to the highest international standards, making it have the potential for global registration and laying the groundwork for "going abroad".

At the same time, the global innovative drug production base of Hehuang Pharmaceuticals, which has been comprehensively laid out and constructed in Pudong, is about to be completed within this year. After it is officially put into operation, it will realize the commercialization of innovative achievements in Shanghai. "For over 20 years, Hehuang Pharmaceutical has established a collaborative system for research and development, commercialization, and industrialization based in Shanghai. As a regional headquarters and global research and development center of multinational corporations, Hehuang Pharmaceutical will accelerate its development strategy of 'Zhangjiang R&D, Shanghai manufacturing, Chinese original, and going global' in this hot land of Zhangjiang, allowing more original new drugs to go global." said Cui Yigui, Senior Vice President of Hehuang Pharmaceutical.

Improve the "per mu output" of the innovative pharmaceutical industry

The CDMO industry is an important part of assisting new drug developers in achieving the most efficient way from concept to product, from process development to large-scale production. In 2019, the MAH system was officially incorporated into the Drug Administration Law, initiating nationwide promotion. Along with this, companies such as CDMO have also ushered in a golden period of development.

As one of the regions with the most concentrated domestic biopharmaceutical enterprises, the most complete industrial chain, and the most R&D pipelines, Pudong's CDMO industry is showing strong strength. Pudong multinational pharmaceutical company Bollinger Ingelheim actively participates in the MAH system reform pilot project. At the end of 2019, Boehringer Ingelheim Biopharmaceutical Co., Ltd. successfully approved the launch of an innovative tumor antibody drug produced and manufactured through a contract production model, becoming the first innovative biopharmaceutical in China to obtain market approval through a contract production model.

At present, Boehringer Ingelheim's biopharmaceutical commercial production base in Pudong has successfully completed the second phase expansion, and its currently operating production building can quickly expand two 2200 liter production lines based on business needs.

With the increasingly clear division of labor in the domestic drug research and development industry chain, local pharmaceutical companies have strengthened their innovation awareness, and the industrialization of innovative drugs and medical technologies is driving the rapid growth of the CDMO industry. Since the beginning of this year, multiple heavyweight CDMO platforms have landed in Pudong.

In May this year, the Kailaiying Biological Science and Technology Center, covering an area of nearly 2000 square meters, set sail in Zhangjiang Science City. "Drug developers can provide a blueprint for drug design, and we can assist them in completing the preliminary exploration of molecular preparation and technology for preclinical drugs, followed by gradually scaling up production in pilot trials." Gao Kai, Vice President of Kailiying Pharmaceutical Group and Chief Technology Officer of Kailiying Biotechnology, said, "We will provide services to different innovative drug customers in the most efficient operating mode, and seize time for their early launch and commercialization."

The reporter learned that currently Pudong has gathered more than 30 enterprises specializing in CDMO, and under the agglomeration effect, it continues to drive high-quality development of pharmaceutical innovation.

The MAH system is a system that is in line with the world, which suppresses low-level redundant construction of pharmaceutical enterprises from the source, enhances the enthusiasm for new drug research and development, and promotes the prosperity of commissioned production. The path of breaking through the difficulties of "One Granule Medicine" demonstrates the fruitful sense of achievement brought to enterprises by the reform results of "bold trial and bold breakthrough" in the free trade zone. It has also shortened the start-up time and accelerated the approval speed of "One Granule" innovative drugs, greatly stimulated the potential of drug research and development in Shanghai, pulled the entire industry chain, and improved the "per mu output" of the innovative drug industry, allowing patients nationwide and even globally to use good drugs as soon as possible.

Text: Yang Zhenying

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