1,447 domestic drug development pipelines… 157.8% increase in 3 years

Pharmaceutical and Biopharmaceutical Association Announces New Drug Pipeline and License In/Out Results

(Seoul = Yonhap News) Reporter Jandi Kim = According to a survey result, there are close to 1,500 new drug pipelines in R&D by domestic pharmaceutical and bio companies.

The Korea Pharmaceutical and Biotechnology Association announced on the 5th that as a result of a new drug pipeline survey of 299 domestic pharmaceutical and bio companies, 193 companies had 1,477 drugs.

This is an increase of 157.8% compared to the 100 companies and 573 new drug pipelines confirmed in the survey conducted by the association in 2018.

◇ Synthetic drugs account for 40.6%… 37.3% of substances entered clinical trials

By type of new drug pipeline, the proportion of synthetic drugs was slightly higher than that of biopharmaceuticals.

Synthetic drugs accounted for the most with 599 (40.6%), followed by biologic drugs with 540 (36.6%) and other 338 drugs (22.9%). In 2018, there were 225 synthetic drugs, 260 biologic drugs, and 88 other new drugs such as natural products.

Pipeline by type of new drug

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By clinical stage, 403 cases (27.3%) of the lead and candidate substances were selected from the initial stage of the study. There were 397 cases (26.9%) in the non-clinical stage, which means cell tests or animal tests.

266 cases (18.0%) of phase 1 clinical trials starting human administration, 169 cases (11.4%) of phase 2 clinical trials, and 116 cases (7.9%) of phase 3 clinical trials were followed.

The pipelines that have entered each stage, such as candidate substances, non-clinical, and clinical phases 1, 2, and 3, have increased rapidly, more than double the number of the 2018 survey.

Among them, the growth rate of phase 3 clinical trials (274.2%), the last stage before commercialization, was found to be the steepest.

By disease, anticancer drugs were the most actively developed with 317 (21.5%). It was followed by metabolic diseases (173 cases, 11.7%), nervous system (146 cases, 9.9%), infectious diseases (112 cases, 7.6%), and digestive system (79 cases, 5.3%).

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◇ R&D ‘vigorous’ throughout the industry regardless of company size

Regardless of the size of companies such as pharmaceutical companies and bioventures, R&D in the industry as a whole was found to be active.

The number of pipelines of large corporations and medium-sized companies (55 companies) and small and medium-sized companies (138 companies), which were classified based on annual sales of 100 billion won, was 641 (43.4%) and 836 (56.6%), respectively, showing a significant difference. there was no

However, large companies and mid-sized companies accounted for the highest proportion of synthetic drugs (375 drugs, 58.5%) among the new synthetic drugs, bio drugs, and other new drug pipelines.

On the other hand, SMEs and venture companies showed contrast with the largest number of new biologic drugs (399, 47.7%).

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◇ Activate technology transfer… Accelerate open innovation

It was also found that open innovation (open innovation) is accelerating between pharmaceutical companies, bioventures, and foreign-funded companies as license in/out has been greatly activated.

The total number of technology transfers, including license in and out, increased from 36 in 2019 to 105 last year. In the first quarter of this year alone, there were 85 cases, accounting for 80% of the annual number of cases last year.

By substance, 58 cases (45.7%) were biologics, half of them were synthetic drugs (34 cases, 26.8%), and other new drugs (21 cases, 16.5%).

At the stage of technology transfer, excluding others (140 cases) that were not disclosed, non-clinical cases accounted for the most with 50 cases. It was followed by phase 1 clinical trials (18 cases), phase 2 clinical trials (10 cases), phase 3 clinical trials (6 cases), and approval (2 cases).

By disease, license transfers for anticancer drugs (57 cases, 25.2%) were the most active. Infectious diseases (22 cases, 9.7%), metabolic diseases (13 cases, 5.8%), eye diseases (11 cases, 4.9%), and digestive system (9 cases, 4.0%) were followed.

By company size, the number of license transfers by small and medium-sized enterprises (SMEs) was 250, more than three times that of large and medium-sized enterprises (81).

As a result of analyzing previous partners, large and medium-sized companies had a high proportion of out-licensing (17 cases) to foreign-funded companies.

The partners of SMEs and venture companies were evenly distributed, including domestic small and medium-sized ventures (64 cases), foreign-funded companies (50 cases), and large and medium-sized companies (35 cases).

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◇ Domestic industry changes to advanced R&D-oriented model

The association saw the results of this survey suggesting that the domestic pharmaceutical and bio industries are changing to focus on R&D.

The R&D expenditure of listed pharmaceutical and bio companies increased by an average of 4.7% annually from 1.798.2 trillion won in 2016 to 2.159.2 trillion won last year.

During this period, the ratio of R&D investment to sales also increased from 8.9% to 10.7%.

As of 2019, the ratio of R&D investment to sales in the manufacturing sector to which the pharmaceutical industry belongs was 2.45%, but the pharmaceutical industry reached 6.61%.

The ratio of R&D to sales in the domestic pharmaceutical and bio industry is low compared to the US (18.2%) and Japan (17.3%) as of 2019, but it is meaningful that it continues to expand, the association emphasized.

Chairman Won Hee-mok said, “The results of this survey show that domestic pharmaceutical and bio companies’ willingness to develop new drugs and bold investments are changing the industrial soil and constitution. We need full support from the government so that we can complete the project and create a new blockbuster drug,” he said.

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