KDDF’s Support Reflected In Robust R&D, Licensing By Korean Firms
Executive Summary
Various government support schemes seem to have led to recent successful new drug development activities and licensing deals by South Korean pharma and biotech firms. The state-run Korea Drug Development Fund is seen as having played a key role in this effort, providing assistance to 153 R&D programs in the country so far to speed up development of novel and innovative global medicines.
The state-run Korea Drug Development Fund (KDDF) has so far provided or is giving ongoing support to 153 innovative drug development programs in the pharma/biotech industry, universities or research institutes, with a goal of advancing South Korea’s development and commercialization of new drugs for the global market.
The fund, which is supported by multiple government ministries including health and welfare, has also been aiding the licensing out of pipeline assets to South Korean or foreign entities, resulting in 40 such deals so far – 17 global and 23 domestic - worth an aggregate KRW7.36tn ($6.52bn). Of the total, 16 deals have been reached since the beginning of 2018, noted the ministry of health and welfare.
The KDDF’s support seems to have contributed to the recent robust amount of R&D activity and licensing out deals by South Korean companies, with the country witnessing a sharp increase in such agreements in the past few years and particularly in 2018. (Also see "Biotech Deals Stand Out In 2018 Korean Licensing Trends " - Scrip, 7 Jan, 2019.)
Some examples of fund-supported programs involved in major global licensing out agreements in the past few years include Hanmi Pharmaceutical Co. Ltd.’s diabetes alliance with Sanofi, Yuhan Corp.’s lung cancer deal with Janssen Biotech Inc., SK Biopharmaceuticals Co. Ltd.’s epilepsy agreement with Arvelle Therapeutics GmbH, HanAll BioPharma Co. Ltd.’s autoimmune disorder deal with Roivant Sciences GmbH and JW Pharmaceutical Corp.’s atopic dermatitis pact with Leo Pharma AS.
In particular, the health ministry highlighted SK’s novel epilepsy drug cenobamate, which is undergoing a US FDA approval review, as this is viewed as the first South Korea-developed drug that could become a global blockbuster with annual sales of more than KRW1tn.
Programs Selected For Support In 2018
Meanwhile, several new drug development programs were selected in 2018 for KDDF support, including:
1. GC LabCell’s assessment of anticancer efficacy and IND filing for a Phase I clinical trial for HER2 CAR-expressing NK cells targeting HER2-positive gastric cancer;
2. Y-Biologics’ project to explore the possibility of being the final candidate for the development of the anti-PD-L1/CD3 bispecific antibody ACE-05, constructed using the company’s proprietary T-cell-redirecting bispecific antibody platform ALiCE (Antibody-Like Cell Engager);
3. Yuhan’s clinical development of a third-generation EGFR TKI, YH25448 (lazertinib), for non-small cell lung cancer and global out-licensing;
4. Dongwha Pharm Co. Ltd.’s DW2008, which is a natural product that inhibits both allergic inflammation and bronchoconstriction, and is undergoing a Phase I clinical study (SAD & MAD) for obtaining information on safety and tolerability in healthy volunteers. The company additionally plans to test the toxicity and efficacy of DW2008 for global out-licensing, as well as for launch in South Korea;
5. Phase II clinical development of Qurient Co. Ltd.’s telacebec (Q203), a novel drug candidate against multidrug- and extremely drug-resistant tuberculosis. The study aims to secure safety, tolerability, and activity of through 14-day dosing in drug-sensitive patients, which enables proceeding to late Phase II studies in TB patients.
6. A Phase I study of OliX Pharmaceuticals Inc.’s OLX10010, a potential treatment for hypertrophic scars, using self-delivering RNAi technology for global market entrance, and IND approval for a Phase II study.
How KDDF Provides Support
Established in 2011, KDDF is a government-initiated drug development support program that now manages a total budget equivalent to around $1bn, backed by a collaborative effort between healthcare-related South Korean ministries. The fund will provide support for new drug projects from the discovery through to clinical stages, until 2020.
Its general aim is to select novel and innovative programs such as first-in-class, antibody, peptide, synthetic, RNAi, gene therapy, therapeutic vaccine and natural product based therapeutics that are in high demanded by global pharma firms and have the potential to become worldwide products. The fund doesn’t have any specific disease areas of focus.
“KDDF’s support has served as the primer for the pharma industry to leap forward to a flagship industry from a future growth engine, as well as created massive added economic value,” said the health ministry statement.
Through the second phase of the program, which is undergoing a preliminary feasibility study at present, the government will continue to expand its global level consulting support and R&D program management systems to industry, academia and research institutes, in line with its push for development of novel drugs and international out-licensing deals, it said.
To assist and support this, the KDDF has adopted an open innovation strategy to explore new opportunities and has also introduced and brokered good overseas drug candidates to South Korean companies. As an example, it has been convening a global connection and development tech fair each year to introduce promising overseas compounds to domestic pharma and biotech firms.
In an interview with Scrip in 2016, Sang Aun Joo, who was the CEO of KDDF at the time, said that the country has to bring in outstanding novel drug candidates from abroad so that Korean companies can further develop, commercialize or license out the drugs. (Also see "INTERVIEW: KDDF CEO On Building R&D Success, Pipelines" - Scrip, 24 Feb, 2016.)
The open innovation strategy aims to secure promising novel compounds from a variety of sources, including domestic or foreign bioventures, pharma companies and universities, through co-development or compound transfer agreements.
KDDF is also seeking joint R&D programs with multinationals, including Johnson & Johnson, in which the two sides will jointly select, invest and manage promising Korean R&D assets.
Aside from providing financial support to each program, KDDF also evaluates the value of drugs under development by using external experts, after discussions with the sponsor companies. Also using external expert institutions, the fund generates technology marketing materials related to the evaluation results, analyzes the drug’s strengths and weaknesses related to drug approval information, and aims to differentiate licensing competitiveness by creating "story lines" for raising value.
From the editors of PharmAsia News.