China's biological similar drug concentration "explosion" within two years 7 approved is moving towards international development

Transfer from On September 3rd, Xinda Bio announced that its Adamo monobial-like drug (Su Lixin) had been approved for use in the treatment of rheumatoid arthritis, strong vertebrate and psoriasis.
September 4th, Dongju Pharmaceuticals announced that its application for the listing of a new drug for the beval-beaded anti-injection biosynthic drug had been accepted by china's State Drug Administration the day before.
time to go back, Fu Hong hanxuan announced at the end of July this year that the European Commission has approved the listing of its HLX02 anti-biosynthic drug.
fuhong Hanxuan press release pointed out that this is the first "Chinese nationality" mono-anti-bio-like drugs to enter the European market, achieved a breakthrough of zero.
There is also remarkable news that in August this year, Baiji Shenzhou and Baotai Bio signed a licensing agreement for the latter's research and development of Beva Zhu monobial-like drugs (BAT1706), which also means that Baiji Shenzhou's product portfolio will be expanded into bio-similar drugs.
according to incomplete statistics, at least seven biosypoloric drugs developed by China Biopharmaceutical Research and Development Corporation have been approved for sale in China, beginning to benefit patients.
"explosion" of these major advances and breakthroughs, let us see that China's biopharmaceutical industry in the field of bio-similar drug research and development and production is booming, is moving towards a rapid development stage.
China has been approved for the market of 7 biosypolisic drugs (incomplete statistics) China biosynthete drug research and development into the "harvest period" biosynthic drugs, refers to the quality, safety and effectiveness of the approved reference drugs similar to therapeutic biological products.
, the launch of biosypolytes is seen as helping to increase accessibility and lower prices for biopharmaceers and to better meet public demand for biotherapy products.
, however, due to the high barriers to the development and production of biological drugs, china has not yet approved the domestic biological drugs market before 2019.
February 2015, China's drug regulatory authorities formulated and issued the Technical Guidelines for the Development and Evaluation of Biosynthic Drugs (Trial).
this provides a direction for research and development enterprises, some Chinese pharmaceutical research and development enterprises quickly layout bio-similar drug development.
until February 2019, China's first biosynthic drug, the lytoxidan biosynamic drug developed by Fuhong Hanxuan, was approved, making the field a success in breaking the ice.
since then, we've seen a number of biosypolions approved for the market, and more biosynthic drugs have filed applications for listing.
In addition to the above at least 7 approved products, according to the CDE official website information, has been submitted to the market application and accepted bio-similar drug species are: from Fuhong Hanxuan, Zhengda Tianqing and Junshi biological 3 Adamo single anti-biological Similar drugs: 5 Beva Zhu single biosimilars from Hengrui Pharmaceuticals, Green Leaf Pharmaceuticals, Haizheng Pharmaceuticals/Beda Pharmaceuticals, Baiotai Bio and Dongju Pharmaceuticals, etc., and Lytoxi single anti-biosimilars from Cynda Biosimilars, etc.
According to china's State Drug Administration earlier public data show that China has become the largest number of biosynthic drugs in the study of the country, there have been more than 200 biosypolytic drugs clinical applications approved.
these products are mostly concentrated in lytoxi monoanti, terpene bead monoanti, beval bead monoanti, Adamo single resistance and other world-best-selling drugs.
Taking into account the requirements of the State Drug Administration of China to "support the imitation of biosimilar drugs and pharmaceutical combination products of clinical value", the registration and declaration of biosimilars has the opportunity to be included in the priority review and approval process, which will speed up the pace of product review.
a number of biosypolions that have been approved for listing and have submitted applications for listing mean that companies' years of investment in biosynthics and the hard work of scientists in research and development are ushering in a harvest period.
addition, many biosypolytes are being developed clinically, some of which are in the late stages of clinical development.
, such as the quercetoju single biosimilar drug GB221, is currently undergoing Phase 3 clinical studies in metastasis breast cancer; 1011 in China is in the clinical phase 3 and clinical phase 1 respectively, Shenzhou cells of the Beval pearl single anti-biosynthetic drug SCT510 and Adamo single anti-biosynthetic drug SCT630, have now entered phase 3 clinical research.
Biosynthic drug adaptation extraterrence is a major trend from the current approved market of biosynthic drugs, most varieties in the first approval, obtained a number of adaptations, some varieties have now been approved in China of the original products of all adaptations.
For example, the qutoju single anti-biosynamic drug (Hanquyou), developed and produced by Fuhong Hanyu, was approved for sale in China in mid-August, and indications include: HER2-positive early breast cancer; HER2-positive metastatic breast cancer; and HER2-positive metastatic stomach cancer.
same time, The Lytoxidan anti-biosynthic drug Hanlikang, from Fuhong Hanjun, received five adaptations, including four types of non-Hodgkin's lymphoma and chronic lymphocytic leukemia (CLL).
Also, Qilu Pharmaceuticals and Cinda Bio, respectively, have been approved for the Beval pearl single anti-biosimilar drugs, both in the first approval of the original varieties approved in China two adaptive disorders - advanced non-small cell lung cancer and metastatic colorectal cancer.
In addition, three approved Adamu monobial analog drugs from Cynda Bio, Haizheng Pharmaceuticals and Baiotai Biosynthics received three adaptations at their first approval, including rheumatoid arthritis, strong spina bifida and psoriasis.
, Baiotai's Adamo single resistance has won two other adaptations.
can be seen that bio-similar drug adaptation extraterrence is a major trend.
Mid-August, the Drug Review Center (CDE) of the State Drug Administration of China publicly solicited the opinions of the Technical Guidelines for the Evaluation of Biosic Drug Similarity and The Technical Guidelines for Adaptation Extratronation, which is expected to provide more technical guidance for adaptation extraterrion in the development of biosypolytic drugs in China.
According to the opinion draft, the adaptation extraterrestress refers to: within the scope of the reference drug approved to adapt, biosynthic drugs by direct clinical reference to the experimental approval of the adaptive disease, through the relevant data and information to scientifically prove and obtain other non-directly studied adaptive disorders.
trend of over-the-allergy extraterrence means that, under scientific and technical guidelines, more biosypolytic drugs are expected to be developed to benefit patients more quickly.
's international development accelerated to benefit more patients in July this year, Fuhong Hanxuan and its partner Accord Healthcare jointly announced that the European Commission has approved fuhong Hanxuan developed qutozhu single biosynamic similar drug (HLX02, EU trade name: Zercepac) listed in the European Union to treat HER2-positive early breast cancer, HER2-positive metastatic breast cancer, HER2-positive metastatic gastric cancer.
fuhong Hanxuan press release pointed out that this is the first "Chinese nationality" mono-anti-bio-like drugs to enter the European market, achieved a breakthrough of zero.
is an iconic event for the development of biosynthic drugs in China.
is one of the first regions in the world to develop guidelines for biospotonic drugs.
as early as 2004, the EMA issued the Biosynthics Guidelines (Draft), which are extremely strict in their scientific and regulatory compliance requirements for bioanalytical analysis.
as the first Chinese mono-anti-biosynthic drug to land in Europe, can be said to be an important milestone.
, we are seeing more and more biosypic drug developers internationalizing for the benefit of patients around the world.
, for example, the company reached an agreement with Cipla Limited in January 2019 to exclusively commercialize its beval-beaded monobial-like drug BAT1706 in some emerging markets, according to public information.
addition, Baatea Bio plans to file a relevant listing license application in the U.S. and the European Union in the fourth quarter of 2020 in response to the aforementioned cooperation with Baiji Shenzhou.
with the commercialization of biosynthic drugs in China, more and more products will enter the market, which is a great good for patient access.
we wish that the development of these biosynthetic drugs will be in place to provide more treatment options for Chinese patients.
References: China's State Drug Administration Drug Review Center. Retrieved Sep 7,2020, from the official websites and public press releases of the companies follow the WeChat Public Number of Pharmaceutical Mingkangde