In recent years
With the number of domestic new drugs on the market repeatedly hitting new highs
Independent domestic drugs Continuous enhancement of innovation capability
China has ranked among the top
the second echelon of global pharmaceutical innovation
In 2021, Shanghai will receive 8 Class 1 domestic innovative drugs< /p>
A record high
Today, Shanghai Xiaoke will take you to Chi-Med Pharmaceuticals
to learn about the “first and only” independent innovative drug in China
China’s First Selective MET Inhibitor——Savortinib
In June 2021, as part of the “Science and Technology Innovation Action Plan” Biomedical Technology Support Project of Shanghai Science and Technology Commission. Sivotinib (trade name: Vorexa®) was conditionally approved by the National Medical Products Administration for the treatment of mesenchymal epithelial transition factor (“MET”) extracellular epithelial transition factor (“MET”) patients whose disease has progressed after systemic therapy or who cannot receive chemotherapy Non-small cell lung cancer patients with exon 14 skipping mutations.
This is the first independently developed new drug approved in my country for lung cancer patients with MET gene mutation.
The approval of savatinib in my country is based on the results of a phase II clinical study conducted by Shanghai Jiao Tong University. Led by Professor Lu Shun of the Affiliated Chest Hospital, it is carried out in 32 hospitals across the country. The findings were first presented at the 2019 American Association for Cancer Research Annual Meeting (AACR) and published in The Lancet Respiratory Medicine in June 2021.
Clinical study results showed that efficacy-evaluable patients with MET exon 14 skipping showed an objective response rate of 49.2% after receiving sevolitinib. Progression-free survival was 6.8 months, and the longest survival time was more than 4 years. Previously, the overall survival with traditional chemotherapy was only 8.1 months.
As the first and currently the only innovative and highly selective MET inhibitor approved for MET exon 14 skipping mutation indications in China, the launch of savatinib fills the gap of MET inhibitors in China Such patients in China provide a new targeted therapy option.
Twenty years of accumulation, doing the right thing in the right era
The “Double Ten” law is “10 years, 1 billion US dollars”, which is a classic example of global investment in new drug research and development generalize.
New drug research and development is like a “big gamble”, facing many uncertain factors such as long cycle, high cost and high risk. From a small molecular formula to a marketed drug that benefits patients, and even to maximize drug availability, new drug development will go through many stages such as compound screening, pharmacological research, process development, clinical research, and commercialization. Therefore, the success of an innovative drug is inseparable from the persistence of many aspects.
Insist on independent research and development
Founded in 2002, Chi-Med Pharmaceuticals is the first batch of innovative pharmaceutical companies to enter Zhangjiang. At the beginning of its establishment, it firmly took the road of independent research and development, focusing on the research and development of innovative drugs with global independent intellectual property rights for anti-tumor and immune diseases.
Currently, 12 self-discovered drug candidates are undergoing clinical research around the world, of which 4 of 3 class 1 new drugs are under clinical research. One indication has been approved in my country.
In addition to civotinib, in September 2018, fruquintinib was approved for marketing in my country for the treatment of metastatic colorectal cancer. This is the first innovative anti-tumor drug completed in my country from discovery, development to approval without additional conditions.
In December 2020, surufatinib was approved for marketing in my country for the treatment of non-pancreatic neuroendocrine tumors. In June 2021, surufatinib was approved for the second indication for the treatment of pancreatic neuroendocrine tumors, becoming the first innovative targeted drug covering neuroendocrine tumors of all origins.
Insist on catching up with the sea and insist on globalization
In 2021, the number of products in my country’s R&D pipelines will contribute 13.9% to the world, compared with only 4% in 2016. All of Chi-Med’s drugs are designed with higher efficacy and lower off-target toxicity as important goals, creating new drugs with better safety and pharmacokinetic characteristics for patients, and providing patients around the world with better drugs. Effective and safer innovative treatments.
Currently, 13 innovative anti-cancer drugs in clinical stage are undergoing clinical research around the world. Surufatinib has been granted “orphan drug” and two “fast track” qualifications by the US FDA.
In July 2021, the US New Drug Application for surufatinib was accepted by the US FDA, and the European Marketing Authorization Application was also accepted and confirmed by the European Medicines Agency (EMA).
Fruquintinib has also been granted Fast Track status by the US FDA, and its international registrational clinical study FRESCO-2 is being conducted in more than 150 clinical centers in 14 countries around the world.
Insist on accessibility
In 2021, the contract of Aiyoute® (fruquintinib capsules) was successfully renewed, and Suteda® (surufatinib capsules) was included in the new version of the country List of Medicare Drugs.
Su Weiguo, Chief Scientific Officer of Chi-Med Pharmaceuticals, said: “The significance of Chinese pharmaceutical innovation is not only to make several new drugs, but also It is to look at our ability to cultivate strategic scientific and technological innovation from the perspective of national security and people’s livelihood protection”; “Any commercial company needs a certain amount of profit to support subsequent research investment in order to achieve sustainable development.”
“We don’t want to see patients not taking our medicines for financial reasons, and I want our innovations to benefit as many patients as possible.”
Insist on local manufacturing
Under the guidance of the top-level design of Shanghai’s biopharmaceutical industry, “R&D in Zhangjiang, Made in Shanghai”, in 2020, Chi-Med will invest in global innovative drugs The production base has officially started construction and is planned to be officially put into use in 2025 to meet the new global production demand. Its annual planned production capacity can reach 250 million tablets and 550 million capsules. Build it into a first-class, global-oriented manufacturing center and clinical sample preparation center in China, and promote the on-site industrialization of innovative drug research and development results in Shanghai. At that time, China’s “smart-made” innovative drugs will “go overseas” from here.
Over the years, the “14th Five-Year Plan” of Shanghai Science and Technology Innovation Center, the legislation of Shanghai Pudong biomedical industry, the National Drug Administration A series of effective drug administration and support policies, such as the bureau’s review and approval system and the MAH system, have been introduced one after another, and the atmosphere of medical innovation in Shanghai has become increasingly strong. Under the guidance of the country’s vigorous development of biomedical macro strategy, Chinese biopharmaceutical companies are committed to establishing a science-oriented global innovative biopharmaceutical company, providing “Chinese solutions” for global patients, and leading the next wave on the global stage A wave of innovation.
Chi-Med Medicine
Chi-Med Medicine is one of the first innovative pharmaceutical R&D companies in China focusing on the global market. There are 13 innovative anti-cancer drugs in clinical stage currently under clinical research around the world, 12 of which are independently developed by the company. Its first three innovative medicines have been approved for marketing in China – Aiyoute® (fruquintinib capsules), Suteda® (surufatinib capsules) and Veresa® (savatinib tablets).
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Source: Chi-Med Pharmaceutical