2022 Inventory | 416 domestic improved new drugs were accepted, including Qilu, Chia Tai Tianqing, Yueyang...

In recent years, with the strengthening of domestic drug R&D innovation awareness, a large number of resources have poured into the field of innovative drugs. While domestic Class 1 new drugs are rapidly forming a "roll" trend, part of the research work is invested in the field of improved new drugs, in order to develop a blue ocean. As a result, the number of Class 2 improved new drug acceptance numbers has also grown rapidly.

So, what is the application status of domestic improved new drugs in 2022? How's it going? What can it tell us? This article will do the analysis.

01

Registration application of domestic chemical drugs Class 2 improved new drugs in the past three years

Through the data query of PharmaIntelligence (as of 2022-12-28), the application trend of Class 2 chemical drugs in the past three years (2020-2022) has gradually stabilized in the state of overall growth (see Figure 1 for relevant data).

In terms of acceptance numbers, the number of Class 2 chemical drugs undertaken in 2020 was 327; In 2021, the growth rate reached 31% compared to the previous year; However, there were a total of 416 acceptance numbers in 2022, similar to the number in 2021, and the trend tends to be stable;

In terms of IND, the number of Class 2 chemical drugs undertaken in 2020 was 222; In 2021, compared to the previous year, the growth rate reached 44%; However, there were a total of 269 acceptance numbers in 2022, which was a significant decline compared with 2021;

In terms of NDA, the number of undertakings in the past three years was 52, 40 and 52, respectively, which was relatively stable.

02

Distribution of Class 2 improved new drug applications in 2022

As a Class 2 improved new drug, according to the registration application, it can be refined into Class 2.1, 2.2, 2.3 and 2.4; Among them, the category with more attention and greater difficulty is category 2.1, that is, "APIs and preparations containing known active ingredients prepared by splitting or synthesis, or esters of known active ingredients, or salts of known active ingredients, or changes the acid, base or metal elements of the active ingredients of known salts, or forms other non-covalent derivatives, and has obvious clinical advantages". Category 2.2 focuses on "new dosage forms, new prescription processes, and new routes of administration containing known active ingredients", Category 2.3 focuses on "new compound preparations containing known active ingredients", and Class 2.4 focuses on "preparations containing new indications of known active ingredients"; At the same time, it is also necessary to focus on "having obvious clinical advantages".

Based on the above registration classification requirements, and looking at the registration application data of Class 2 new drugs in 2022, it can be found that the number of acceptance numbers for Class 2.1 is 9, which is the lowest number of categories among the four subcategories; The combined quantity of 2.2 and 2.4 accounts for 86% of the total number of new drugs declared for the entire class 2, and the specific technology points to new dosage forms and new indications.

Here we will focus on the 2.1 varieties registered and declared in 2022. The application types are new drugs such as HR1801 for injection of Nanjing Hairong Pharmaceutical Technology Co., Ltd., MBT-1316 tablets of Beijing Junke Huayuan Pharmaceutical Technology Co., Ltd., and levalbutamol isoprium hydrochloride isoprium bromide inhalation solution of Jiangsu Hechen Pharmaceutical Co., Ltd., and the others are supplementary applications. See the table below.

03

Analysis of IND registration application for Class 2 chemical drugs in 2022

In 2022, the number of Class II chemical drug IND varieties totaled 269, including 183 new drugs and 86 imported varieties.

Among the drugs with the application type of "new drug", "antitumor drugs and immune function modulators" accounted for the highest proportion, 34.24%; This was followed by "sensory organs", "nervous system", "digestive tract and metabolism", and "respiratory system".

In terms of reporting enterprises, there are nearly 89 enterprises related to Class 2 new drug IND varieties, which are Qilu Pharmaceutical, Chia Tai Tianqing Pharmaceutical, Yueyang Pharmaceutical, Lizhu Group Lizhu Pharmaceutical Factory, Beijing Huahao Zhongtian Biomedicine, Jiangsu Hengrui, Shiyao Zhongqi, etc. in order of the number of acceptance numbers.

The application type was "imported", and "antitumor drugs and immunomodulatory drugs" also accounted for the highest proportion, 62.5%, followed by "digestive tract and metabolism", "musculoskeletal system", "cardiovascular system" and so on. Compared with the type of "new drug", there are still slight differences in the distribution of varieties, such as the distribution of cardiovascular system drugs and musculoskeletal system drugs.

In terms of reporting enterprises, there are nearly 32 declaring enterprises related to Class 2 imported IND varieties, in order of the number of acceptance numbers: Novartis Pharmaceutical, Eli Lilly, Albireo AB, Biogen, Johnson & Johnson, AbbVie, etc.

04

Analysis of NDA variety registration application for Class 2 chemical drugs in 2022

In terms of NDA, in 2022, the number of acceptance numbers undertaken by the Class 2 chemical drug CDE was nearly 52, and the ratio of new drugs:imports was nearly 2.7:1.

In terms of domestic new drugs, Jiangsu Hengrui has the largest number of NDA acceptance numbers, followed by Shanghai Hengrui, Lipin Pharmaceutical, Xiamen Encheng Pharmaceutical, Sichuan Pritech Pharmaceutical, Sichuan Kelun Pharmaceutical, Shandong Shengdi, Shandong Luye, etc.

In terms of varieties, there are specific arisartan amlodipine tablets, risperidone oral melting film, dalcillib isethionate tablets, etc., and the overall registration types are 2.2 and 2.4 as the main categories.

In terms of imported new drugs, the number of NDA acceptance numbers is AbbVie, Bayer Pharmaceutical, Eli Lilly Pharmaceutical, AstraZeneca, etc.

In terms of varieties, there are upatinib sustained-release tablets, dapagliflozin tablets, ibrutinib capsules, darrotamide tablets, fenerone tablets, and baricitinib tablets, and the registration types are all 2.4 categories.

05

Summary and phase outlook

The number of domestic Class 2 new drug registration applications is mainly Class 2.2 and Class 2.4, while Class 2.2 and Class 2.4 are highly correlated with the number of Class 1 new drugs, so the registration and application trend of Class 2 new drugs will be related to the number of Class 1 new drugs.

The number of 2.1 varieties is still small, and the deep digging and technical accumulation in this field still need to be strengthened.

Enterprises with a large number of Class 2 new drug acceptance numbers are still concentrated in some large pharmaceutical companies at home and abroad, and although some new biopharmaceutical companies are involved, the overall investment is not enough.

The trend of Class 2 improved new drugs has stabilized, and the phased development panorama has emerged, and there should be little change in the future.