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    Home > Biochemistry News > Biotechnology News > Clinical Implied Licensing Anniversary: More than 600 IND approved Top5 Popular Tumor Research and Development At a Glance

    Clinical Implied Licensing Anniversary: More than 600 IND approved Top5 Popular Tumor Research and Development At a Glance

    • Last Update: 2020-06-17
    • Source: Internet
    • Author: User
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    July 27, 2019 is an ordinary day for most peopleA year ago, On July 27th, it was a day of important change for companies developing new drugs in ChinaThat is, China's drug clinical trial review and approval system, from the previous approval system formally into a more efficient expiration default systemSpecifically, if the applicant does not receive a negative or challenge opinion from the Drug Review Center (CDE) of the State Drug Administration, the applicant may conduct a drug clinical trial in accordance with the submitted plan within 60 days from the date of acceptance and payment of the applicationThree months later, CDE announced the initial batch of clinical trials with implied licensing, with eight acceptance numbers from companies such as MSD, AbbVie, and Platinum Pharmaceuticals, meaning the clinical trials are under displayDecember 2018, the CDE website opened the clinical implied licensing related functions, in the "hot topic column" and "information disclosure" in the "clinical trial notice query / clinical trial implied license" moduleThe module will dynamically publish projects that can be conducted by default after expiration, as well as access to basic information on the varieties of clinical trials that have been obtainedJust over a year after the clinical trial's implied licensing column has announced 858 registration applications (as of 16:00 on July 26, 2019)Today, let's take a brief look at these projects82% of applications for new drugsthese 858 items can be further classified according to the acceptance numberBy dosage form, about 36% of the drugs are tablets, about 30% are injectables and about 16% are capsulesAccording to the application, there were 669 clinical applications, accounting for about 78%, 134 supplementary applications, accounting for about 15.6%, and only about 6.3% of applications for listingPharmaceutical Mission Map (Data Source: CDE Clinical Trials Implied License s)by type of drug, more than 65.2% are chemicals, compared with half less biological products than chemicals, accounting for 32.8%This means that the vast majority of these under-approved programs are chemical and biological products, and few Chinese medicines are licensed for clinical trials corresponds to existing national standards (i.e genericdrugs), with new drug applications accounting for the vast majority (703), of which 380 were domestic ally and 323 were imported This also partly reflects the fact that China's innovation forces are gradually being benchmarked with the international level more than 36% of anti-tumor products
    according to these proposed clinical trials of the indications, a total of 858 projects of the largest number of anti-tumor products (313), accounting for more than 36.5% Second, diabetes treatment candidates, accounting for 10.5% Because the indications published in this column are more detailed, this paper only analyzes anti-tumor projects Specifically, the top five cancers with the largest number of approvals in anti-tumor projects were: lung cancer, breast cancer, lymphoma, liver cancer and stomach cancer, with 85, 46, 42, 41 and 35, respectively approved clinical Top10 cancer (Pharmaceutical Watch, data source: CDE Clinical Trials Implied License section) this is also in line with the National Cancer Center released the latest issue of national cancer statistics Lung cancer ranks first in China in malignancy, and is also the highest number of cancerdeaths in China Estimates show that in 2015 there were about 787,000 new cases of lung cancer in China, with a incidence rate of 57.26 per 100,000, a death toll of about 631,000 and a mortality rate of 45.87 per 100,000 , Pharma Mission Hasshithas has previously reviewed lung cancer programs that were implicitly approved by clinical trials until June 17 A total of 70 clinical trials of new drugs for lung cancer indications were published in this section, covering 42 candidate drugs, including carr-ilycenics, epinetose, pabolizumab, bevalo-zumas, etc So far, 15 more clinical trials have been approved for lung cancer New candidates include SYHA1807 capsules from Shipharma Group, BEBT-109 capsules from Guangzhou Bibert Pharmaceuticals, TQB3804 tablets in Zhengda, etc Hengrui Pharmaceuticals, Novartis and Roche lead the Based on the statistics of clinical trial applicants, the companies that received the most non-implied licenses for clinical trials were Hengrui Pharmaceuticals, Novartis, Roche, Lilly, Mercado, Janssen Pharmaceuticals, Shipharma Group Zhongqi Pharmaceuticals, AstraZeneca, Zhengda Qing, Novo Nordisk According to the number of drugs, the top three enterprises are Hengrui Pharmaceuticals, Novartis and Roche, three enterprises have 18, 16, 11 products approved clinical approved clinical Top10 enterprises (pharmaceutical watch, data source: CDE clinical trial simplied license column) these products, there is no shortage of heavy anti-tumor products Roche's polatuzumab vedotin, a "first-in-class" anti-CD79b antibody conjugate drug (ADC) used to treat several types of NHL, was approved by the FDA in June to treat recurrent/refractive diffuse b lymphoma (DLBCL) SHR-1316 injection is a human-derived anti-PD-L1 monoclonal antibody developed by Hengrui Pharmaceuticals, which is mainly used in the treatment of malignant tumors In January 2017, the drug was notified in writing of clinical trials of the drug in the United States At the same time, the drug has been approved for a number of clinical trials in China Novartis is an extracellular signal-regulating kinase inhibitor (MEK inhibitor) that inhibits MEK1 and MEK2 activity and was approved by the FDA in 2013 for the treatment of braF V600E/K mutation non-removable or metastatic melanoma in adult patients In May 2018, the FDA approved the combination of qumetinib and Dalafini as an auxiliary therapy for patients with BRAF V600E/K mutant melanoma Notably, this combination therapy has been qualified by the FDA for breakthrough therapy recognition and prioritization review another of the company's products, Darafini, is a BRAF inhibitor The drug cannot be used in wild melanoma and the BRAF V600E mutation needs to be tested before use In 2013, the FDA approved it for the treatment of metastatic melanoma and melanoma patients who cannot undergo surgery This is the third FDA-approved drug to treat metastatic melanoma, following Verofini and Eply monosar approved clinical Top10 enterprise-specific products (pharmaceutical top-based watch, data source: CDE clinical trial implied licensing column) accelerate the reform of clinical trial management, adjust and optimize the review and approval procedures of drug clinical trials, is one of the key tasks of drug review and approval system reform in recent years There is no doubt that new drugs in China and abroad are being approved for clinical trials at a faster rate since the implementation of the clinical trial implied licensing system, which will accelerate the clinical development of candidate drugs and bring innovative drugs to patients more quickly References: notice on the opening of clinical implied licensing related functions on the Drug Review Center website Retrieved Nov 4, 2018, from
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