Domestic anti-cancer new drugs approved for listing increased by 125% YoY, forcing MNC Hengrui, Baiji and other attacks.

Is the era of domestic innovation really coming? As of September 10, a total of 9 new domestic anti-tumor drugs have been approved for market in 2020, and 10 new MNC drugs have been approved.
the number of new drugs should see changes in growth, with domestic new drugs up 125% year-on-year and MNC down 9%.
, the proportion of new domestic drugs has been close to 50%.
2020, Kadcyla, the country's first ADC drug, was approved; small cell lung cancer made a breakthrough, with the approval of the first PD-L1 inhibitor attilijuta (T-drug); and the first domestically produced independent intellectual property right, the third-generation TKI's new drug, methadone, was approved... Yang Zhimin, Director of Clinical Department of CDE Pharmaceuticals, summarized the above in his interpretation of the 2020 China Anti-Tumor Innovation Drug Review Report.
" at the same time, we also have some bio-like drugs such as querceton mono-resistant in China and the European Union have been simultaneously declared and approved.
19 approved new drugs, and some start-ups are starting to emerge in different ways.
first category of new pharmaceutical companies represented by authorized transactions.
, for example, north Sea Kangcheng through the licensing of the transaction to introduce Malay acid nelatinini, to win a new drug in the field of breast cancer.
, which focuses on the development and commercialization of rare disease drugs and targeted tumor drugs, currently has 11 products in its pipeline, all of which are external partnership models, including a long-term enzyme replacement drug for mucosal polysaccharide storage type II. Hunterase was recently approved.
although North Sea Kangcheng currently relies heavily on the way of building pipeline assets, it is favored by industrial and institutional capital, including Pharmaceuticals Mingkang, Tiger Pharmaceuticals, Qiming Ventures and other investors.
the second category is from imitation combination to imitation combination, to innovative drug-based bigpharma, to independent research and development of varieties positive PK multinational pharmaceutical companies.
Pharmaceuticals is one of the most prominent cases this year.
the company's methyl sulfonate ametinib as the first approved domestic three-generation EGFR-TKI inhibitor, and the world's second third-generation EGFR-TKI inhibitor.
the first is AstraZeneta's Oghitini, which dropped a list of the top 10 drugs in China's 100-bed compound in the first half of this year, with sales up more than fivefold.
, according to people familiar with the matter, Amethini this product from the project to the approval, the time is about six years.
entered Clinical Phase 1 in May 2017 and was approved on March 18, 2020, reflecting, on the one hand, the strengthening of research and development capabilities of enterprises, on the other hand, reflecting the current innovative drugs are experiencing an increasingly good approval environment.
Hengrui with PD-1 product Karelli pearl single resistance in liver cancer, esophageal cancer 2 adaptation certificate expansion accounted for two seats.
currently Hengrui Pharmaceutical's Karelli Zhu single resistance has been approved 4 adaptation certificates, and K drug approved in China 5 adaptation certificates.
this year, some media quoted IQVIA data said that the sales of Karelli pearl single resistance has exceeded 2 billion yuan, has been anti-K drugs.
the third category is based on independent research and development as the representative of the local new drug companies.
Beji Shenzhou is the most typical example of this wave of innovation, in 2020 Baiji Shenzhou with Zebutini and Tyreli zhu single anti-urethra skin cancer adaptation certificate expansion, accounted for 2 pit positions, and Heng Rui Qiping.
from the action of Baiji Shenzhou this year, the company has entered the development of 2.0 era.
the end of August, there were six authorized transactions in Baiji Shenzhou, surpassing the total for the whole of 2019.
Take the most competitive PD-1 products, Baiji Shenzhou's Tyreli Zhu single resistance went on sale in March this year, four months sales of about 350 million yuan, if you can maintain this level, the end of the year can exceed 1 billion.
addition, Baiji Shenzhou currently has at least 5 commercial products in hand, within a year there are a number of self-research and cooperative products are expected to be approved.
fourth category is new drug companies that have been approved for biosynthic drugs.
Fuhong Hanxuan is a domestic biosynthic drug head pharmaceutical enterprises, the first domestic biosynthic drug Hanlikang from this company, this year the company also with the injection of trichomo-bead single anti-similar drugs into, its many biosypolithic drugs in the clinical.
June 17th, Xinta Bio's Beval pearl monoantigen-like drug was approved this year as the second bio-similar drug of the species, and three months later, the company's Adamo monoantigen was approved.
the company has also made a number of licensing partnerships this year, including dual resistance, ADC and other purposes.
is also worth noting that Thyda's PD-1 product, Xindelli Monody, entered health care through health care negotiations last year, with sales of nearly 1 billion yuan in the first half of this year, close to the full year of last year.
last category is MNC.
the sharp leap forward in local pharmaceutical companies, MNC this year's anti-tumor drugs showed a slight decline due to a variety of factors, such as the outbreak.
as of September 10 this year, MNC approved 10 new drug varieties in China, compared with 11 in the same period last year.
yang Zhimin's summary, some of the "first" products were brought by MNC.
the first ADC drug, Kadcyla, is Roche's new ace drug, which was approved by the FDA in 2013.
another ADC drug from Takeda's injectable virtoxides, which was approved by the FDA in 2011.
is also notable that the FDA has also approved two ADC drugs this year, which can be seen in the number of CDE reviews on the ADC has been in line with the FDA.
addition, Roche has brought the country's first PD-L1 inhibitor, Atiliju monoanti (Tai Sanqi), a product with Kadcyla as the company's new growth point.
the 10 approved new drugs, many are still FDA-listed varieties, such as ceretinib.
is getting closer to FDA approval time for new drugs in the clinical phase submitted by MNC this year.
, for example, plans to introduce Takhzyro, a product to prevent the onset of hereditary angioedema (HAE), in the second half of the year, which was approved in the United States in August 2018 and submitted three months later in China.
this product is the first single anti-drug for HAE, can target inhibit the long-term uncontrolled plasma peptide release enzyme in patients, so as to achieve the effect of preventing the onset of disease.
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