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Review of clinical application of new drugs in the first half of the year: anti-tumor drugs are the

Time：2022-11-28 10:52:42 Source： Author：

According to incomplete statistics, in the first half of 2022 (as of June 30, 2022), there were 789 new drug clinical applications accepted by CDE (calculated according to the acceptance number, the same below), basically equal to the number of applications in the first half of 2021 (785). Among them, 407 have been approved clinically (implied permission).

Antineoplastic drugs are still the hottest

From the perspective of drug types, 464 new drugs applied for clinical use were mainly chemical drugs, accounting for about 59%; The number of therapeutic biological products was 283, accounting for 36%; The number of Chinese patent medicines is still small, but there are also 29; In addition, there are 13 biological products for prevention.

According to the registration classification, Category 1 new drugs accounted for the most (79%), reaching 627; 133 new drugs of category 2, accounting for about 17%; There are only 29 new drugs of category 3.

From the perspective of therapeutic field, anti-tumor and immunomodulators (major categories) are still far ahead, with a total of 363, accounting for 46%, of which anti-tumor drugs (sub categories) are the main (339); No other categories exceed 50; There are another 142 unpublished therapeutic areas.

In recent years, the incidence rate and mortality of cancer in China have continued to increase, and the cost of treatment is high, which has become a heavy economic burden for patients, families and the country. From the perspective of clinical demand and market, it is natural for antineoplastic drugs to become a research and development hotspot. The number of antineoplastic drugs has always been large, whether they are applied for clinical or listed.

In terms of homogeneous competition, in addition to clustering in the anti tumor drug track, there is also a phenomenon of target clustering. Statistics show that in the field of anti-tumor drugs, EGFR, PD-L1, PD-1, VEGFR, HER2, CD19, FGFR and other targets involve a large number of new drugs.

Diabetes related fields are popular

Among the new drugs applied for clinical use, 37 were ophthalmic drugs, accounting for the second largest proportion; Then there were 28 diabetes drugs.

Previous data showed that among the ophthalmic drugs under development, the first indication was retinal diseases, mainly diabetes retinopathy and AMD, accounting for nearly 50%; The second is glaucoma, accounting for about 20%; The third is dry eye, accounting for 15%.

From this perspective, in addition to the most popular anti-tumor drugs, drugs for diabetes and its related diseases have become the second major research and development hotspot among the new drugs declared for clinical use in the first half of 2022.

Although sugar control drugs with multiple mechanisms of action have been introduced, the blood sugar control of diabetes patients is still not ideal. In addition to the damage of related organs, there are still many clinical unmet needs in the field of diabetes. There is a large population of diabetes patients in China. In addition, the treatment rate, control rate and complication screening rate of diabetes continue to increase, followed by a considerable prospect of the drug market for diabetes.

Declaration preference of "top three" enterprises

From the perspective of the applicant, Hengrui Pharmaceutical is a well deserved benchmark enterprise of innovative drugs in China. In the first half of 2022 alone, Hengrui Pharmaceutical (including its holding subsidiaries) applied for 42 new drug clinics, far ahead of other enterprises. Among the 42 new drugs, in addition to 19 drugs in the treatment field that have not been announced, there are 10 anti-tumor drugs, 4 anti gout drugs and diabetes drugs, and 1 anti thrombotic drug, urinary system drug, endocrine therapy drug, ophthalmic drug, and pain killer.

Qilu Pharmaceutical ranked second, with 28 new drug clinical applications, including 13 new drugs of category 2, including atropine sulfate eye drops and oseltamivir phosphate oral membrane. With regard to oseltamivir, many dosage forms have been declared in China, the most of which is capsules, with more than 100 application acceptance numbers, as well as dry suspensions, granules, dry grain slurry, orally disintegrating tablets and sustained-release tablets. Qilu Pharmaceutical's orally soluble film is the first declaration in China. The improved dosage forms that meet the clinical needs and target the market segments may avoid centralized procurement, so the pharmaceutical enterprises are still enthusiastic about the approval of dosage form improvement.

The third place is Fosun Pharmaceuticals, which has applied for 16 new drug clinics. Among them, 8 were declared by Fuhong Hanlin and 7 by Shanghai Fosun Pharmaceutical, all of which were antineoplastic drugs. Among these drugs, except bevacizumab injection, which is Class 3.3, other drugs are Class 1 new drugs. The bevacizumab injection of Fuhong Hanlin has been approved for marketing in 2021. The clinical application of this application is joint application, that is, the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC) with Slulizumab combined with bevacizumab and HLX07 (innovative anti EGFR monoclonal antibody). This is the ninth combined immunotherapy study carried out by Fuhong Hanlin around Slulizumab. In April this year, the Phase II clinical application of the study was approved.

Other enterprises with more than 10 applications include Chia Tai Tianqing (14), Baekje Shenzhou (12), Langlai Technology (12), Junshi Bio (11), Kelun Pharmaceutical (10), Yaojie Ankang (10) and Qiyuan Bio (10).

Among the top ten enterprises, there are 6 listed companies and their subsidiaries. Among non listed companies, Yaojie Ankang has also completed round D financing. The "high investment and high risk" characteristics of new drug R&D make the financing demand of new drug R&D enterprises larger, while the "high return" of new drugs is the characteristic that capital likes. While capital intervention accelerates the promotion of enterprise innovation and R&D, it also attracts more innovation resources to gather in this field. In this process, the strong are always strong, and many biotech are growing rapidly.

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Review of clinical application of new drugs in the first half of the year: anti-tumor drugs are the