The new drug R&D level further improves in China with the development of the pharmaceutical technology, technological innovation has become the key part in the pharmaceutical industry development, and the main line of transformation and upgrading of pharmaceutical industry gradually becomes clear in China. An expert said, "There have been the basic conditions for the transformation and upgrading of pharmaceutical industry in China." "China has become the largest new drug R&D country in Asia." The pharmaceutical market demand is rising in China at present, there is also support from policies, and the new drug R&D in China is showing the thriving situation. Next, let’s see some breakthroughs of the Chinese-produced new drugs.
World’s first long-acting anti-AIDS innovative drug for injection: Chinese-made!
Before this drug, there was none made by China among the 28 anti-AIDS new drugs on the market, however, a research team in Nanjing has developed this first anti-AIDS new drug with independent intellectual property in China after 16 years, which will be immediately put into production after receipt of the approval. It’s reported that this drug is developed by Lu Rongjian, an expert in the Thousand Talents Plan of China and Senior Vice President of Frontier Biotechnologies, and his research team, which breaks overseas long-term monopoly of anti-AIDS new drugs. As recalled by Lu Rongjian, this new drug had been developed for nearly 7 years in 2009, with a tortuous road travelled, however, Lu Rongjian and his team did not give up, stuck to over 150 trials, and overcome difficulties, to finally succeed.
R&D expenses of 8 Chinese-produced new drugs have all exceeded RMB 100 million
According to incomplete statistical data and information disclosed by relevant enterprises, there are roughly 8 new drugs with R&D expenses exceeding RMB 100 million in China, including the Pyrotinib Maleate Tablets and Retagliptin Phosphate Tablets of Hengrui Medicine, Compound Danshen Dripping Pills of Tasly, HLX01 (rituximab analog) and HLX02 (trastuzumab analog) of Henlius, hyzetimibe tablets of Hisun Pharmaceutical, anti-HER2-ADC (ARX788) of Zhejiang Medicine, and AT132 (anti-TNFα monoclonal antibody) of Livzon Pharmaceutical Group. Compared with advanced enterprises overseas, the new drug R&D in China still has a very long way to go as seen from the figures of R&D expenses, however, Chinese pharmaceutical enterprises have attached greater importance to R&D. Furthermore, enterprises that were willing to spend on new drug R&D and actively transformed towards innovative R&D in their early years have already made quite breakthroughs, and occupied important positions on the Chinese and even overseas markets.
Many new Chinese-produced drugs have received clinical trial approvals of FDA or CFDA
R&D of Chinese-produced new drugs continues to heat up, and there are more and more cases of Chinese enterprises receiving clinical trial approvals of FDA and CFDA. It’s reported that the Class I natural drug: innovative drug "KPCXM18 for injection" for acute ischemic stroke of KPC Pharmaceuticals has received the clinical approval of CFDA, meaning that the drug is approved to enter the clinical trial in China; it is also the first innovative drug registered according to Class I natural drug since CFDA’s issuance of the Technical Requirements for New Drug Research of Natural Drugs (2013). Ascentage Pharma’s APG-1387 has received the U.S. FDA’s approval for clinical trial. According to Ascentage Pharma, the drug, if successfully developed, would fill in drug gaps in IAP target field in China, and is expected to become one of drugs of its kind first marketed in the world, to provide new regime for clinical combination therapy and hopefully provide effective treatment for patients with refractory or drug resistant solid tumors.
Conclusion:
New drug R&D is money consuming. China has become the biggest new drug R&D country in Asia as Chinese pharmaceutical enterprises continue to increase drug R&D. According to relevant data statistics, there were 112 Chinese-produced Class 1.1 chemical drugs and 62 biological drugs applied for in 2017, totaling 174, the ...
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