Ministry of Health and Welfare expands to 49 innovative pharmaceutical companies

Ministry of Health and Welfare Ministry of Health and Welfare

(Health Korea News / Lee Si-woo) Seven companies, including Donga ST, Amgen Korea, Onconic Therapeutics, Curocell, Hanall Biopharma, SK Bioscience, and SK Biopharm, have newly entered the innovative pharmaceutical company category. Five companies, including Alteogen, ABL Bio, Ildong Pharmaceutical, AstraZeneca Korea, and Janssen Korea, succeeded in extending certification.

The Ministry of Health and Welfare announced the results of the ‘2024 Innovative Pharmaceutical Company’ certification review on the 27th.

In accordance with the ‘Special Act on the Promotion and Support of the Pharmaceutical Industry’, the Ministry of Health and Welfare has been evaluating companies with a certain level of investment in research and development and excellent performance in new drug research and development since 2012 and certifying them as innovative pharmaceutical companies.

The proportion of investment in research and development is more than 7% for pharmaceutical sales of less than 100 billion won, more than 5% for more than 100 billion won, and more than 3% for companies that have obtained GMP (Good manufacturing practice) in the United States and Europe.

(Innovative pharmaceutical company certification requirements)
❶ (Ratio of research and development expenses to sales) pharmaceutical sales 1,000Less than 100 million won 7% more, medicine salesliquid 1,000More than 100 million won 5% more, USA·europe GMP The acquiring company is 3% more
❷ (rebate) Disposal of rebates in violation of Pharmaceutical Affairs Act 2More than once or total amount 500More than 10,000 won
(ethics) move·Audit is embezzlement, breach of trust, stock price manipulation, assault, Due to sexual crimes, etc. Sentenced to a fine or greater

New certifications for innovative pharmaceutical companies are made every two years, and certification extensions are made every three years. If certified, the certification status will be maintained for 3 years. Once selected as an innovative pharmaceutical company, various benefits are granted, such as additional points for participation in government-supported projects such as R&D, preferential drug prices, and tax and licensing support.

This innovative pharmaceutical company certification review was conducted simultaneously for new certification and certification extension review. There were 25 companies subject to the new certification review, and a total of 7 companies including Donga ST, Amgen Korea, Onconic Therapeutics, Curocell, Hanall Biopharma, SK Bioscience, and SK Biopharm passed the certification review.

The five companies subject to the certification extension review were Alteogen, ABL Bio, Ildong Pharmaceutical, AstraZeneca Korea, and Janssen Korea, which were first certified in 2018, and all of them passed the certification review. As a result, a total of 49 companies were revised and notified as innovative pharmaceutical companies.

(Results of new certification and certification extension screening for innovative pharmaceutical companies in 2024)

New Certification(alphabetical order)	DongaST, Amgen Korea, Onconic Therapeutics, Curocell, Hanall BiopharmaSKbioscienceSkbio farm
Certification extension(alphabetical order)	Alteogen, ABL BIO, Ildong Pharmaceutical, AstraZeneca Korea, Janssen Korea

Jeong Eun-young, Director of Health Industry Policy Bureau at the Ministry of Health and Welfare, said, “Innovative pharmaceutical companies have played an important role in driving the development of the domestic pharmaceutical industry by investing more in research and development than general pharmaceutical companies,” and added, “Innovative pharmaceutical companies continue to expand investment in research and development.” “We will prepare support measures and promote reasonable system improvement to encourage the creation of innovative outcomes.”

(Certification status of 49 innovative pharmaceutical companies (as of December 28, 2024))

division	Company name
General pharmaceutical company(33)	SKbioscience, SKbio farm, green cross, Donggu Bio Pharmaceutical, Dongkuk Pharmaceutical, DongaST, Dongwha Pharmaceutical, Daewoong Pharmaceutical, Daewon Pharmaceutical, Conversation restrictions, Medytox, Boryeong, Bukwang Pharmaceutical, Samyang Holdings, Celltrion, Shinpoong Pharmaceutical, ST Pharm, HK Innoen, Onconic Therapeutics, Yuhan Corporation, Isu Abxis, Ildong Pharmaceutical, Taejun Pharmaceutical, Pharmicell, Korea BMI, Korea Pharmbio, Handok, Hallym Pharmaceutical, Hanmi Pharmaceutical, Hanall Biopharma, Hyundai PharmaceuticalsLGchemistrySKchemicals
bio venture company(12)	Bridge Biotherapeutics, BC World Pharmaceutical, Alteogen, Olix, ABL BIO, Genexine, GI Innovation, corestem, Curocell, Qurient, Tego Science, Helixsmith
Foreign pharmaceutical company(4)	Amgen Korea, AstraZeneca Korea, Janssen Korea, Korea Otsuka
2024Newly certified and extended certification companies in bold letters

(Innovative pharmaceutical company support system)

Support matters	Highlights
R&D preferential treatment	Government of innovative pharmaceutical companies R&D Additional points awarded for participation ㅇ Innovative pharmaceutical companies cooperate with the government in developing new drugs R&D When applying for an assignment, Additional points given in selection evaluation * National new drug development project(2% addition), Pan-ministerial regenerative medicine technology development project(2point addition) etc.
tax support	Corporate tax deduction for research and human resources development expenses * Special Tax Restriction Act10pharmacy1port Tax credit for facility investment costs for improving pharmaceutical quality control * Special Tax Restriction Act24article
Preferential drug prices	Preferential insurance prices for newly listed generic drugs and improved new drug combinations * Innovative pharmaceutical companies 68%(general company 59.5%)up to 5added per year Preferential insurance pricing for biosimilars * The price of the first listed item 70% → 80%up to 5years 10%p addition Actual drug price reduction rate 30% or 50%* reduction * the year R&D investment amount 500More than 100 million won or sales 3,000More than 100 million won R&D Investment ratio 10% Medicines from Lee Sang-in’s innovative pharmaceutical company amount used–Drug price index refund system(3+3year)
deregulation	Relaxation of location regulations and exemption from charges when constructing research facilities(Pharmaceutical Industry Act Regulations) * development levy, Traffic generation charge, Alternative forest resource creation cost, Exemption from replacement grassland development fee
License support	Designated as a priority review target for pharmaceuticals * Pharmaceutical Affairs Act35condolences4 my2antithesis2neck
business support	Additional points are given to innovative pharmaceutical companies for participating in global expansion projects. blanket Support project for innovative pharmaceutical companies to enter strategic overseas markets and improve global competitiveness* When applying, Additional points in selection evaluation(5dot) grant * Project to strengthen global expansion throughout the pharmaceutical industryK-Support for blockbusters entering the US market business, Domestic vaccine‧Raw materials‧Equipment performance testing support project
policy fund loan	pharmaceutical·Preferential interest rates applied to each loan product for bio companies(Export-Import Bank) blanket Export Promotion Fund Loan: Pharmaceuticals for export Domestic and overseas clinical trials 2For more than one project Long-term, low-interest clinical funding support for Korea blanket Export growth loan: Small and medium-sized with export performance․Export funds for mid-sized companies Comprehensive support within the scope of past export performance(6months ~ 3year) blanket Import loan: Stability of people’s lives, including raw pharmaceutical products, Import funding support for goods that contribute to increasing employment and promoting exports blanket Overseas business-related loans: Investment or business loan for overseas business such as establishment and acquisition of overseas corporations(Export-Import Bank)
KOSDAQ Special management requirements for listed companies	Exemption from sales requirements for companies with excellent technology, etc.(Financial Services Commission) blanket Sales for innovative pharmaceutical companies among bio companies that entered under technology and growth special provisions 30Exemption from 100 million won requirement

Source: www.hkn24.com

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