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- 2026-04-12 10:11:26
- Company
- Bio Clusters gather to compete at BIO Korea 2022
- by Kim, Jin-Gu May 13, 2022 05:46am
- Major Bio Clusters of local governments have gathered in one place. Major Bio Clusters of local governments including Osong, Incheon, Hongneung, Gimhae, Wonju, and Daejeon municipalities as well as the event’s co-host Chungcheongbuk-do are in heated competition to promote their cluster in the ‘BIO KOREA 2022’ event that is being held from May 11th to the 13th at Coex Seoul to promote their region. At the event, the clusters are working hard to attract companies and investments by distributing handouts to participants and introducing the features of each bio cluster to corporate officials. ◆ Chungcheongbuk-do Bio Valley = Chungcheongbuk is promoting 5 Bio Valleys in its province. The five Valleys are ‘Osong Bio Valley,’ which has the Osong High-Tech Medical Complex, the ‘Chungju Bio Valley,’ which is scheduled to be completed by 2027, ‘Jecheon Oriental Medicine Bio Valley,’ ‘Okcheon Medical Device Valley’, and ‘Goesan Organic Bio Valley.’ The Chungcheongbuk-do province had released a blueprint to attract 1,600 bio-companies in its 5 Bio Valleys by 2030. The region has attracted 422 companies up to now. Through the recruited companies, the region aims to increase production from the current ₩ 1.8 trillion to ₩7 trillion and human resource training from 3,050 to 50,000. In particular, the province has been introducing corporate support incentives in detail at the exhibition hall. Up to 24% of facility investment made by the companies will be supported by the province. Also, a ₩500,000 subsidy for employment and education & training will be provided per month for all individuals for one year, and ₩2 million per month for one year if the company hires researchers. The province also emphasized its tax reduction benefits. In the case of the national tax, the corporate tax on capital gains is deferred for 5 years, then can be paid out in installments in the following 3 years. Corporate tax is reduced by 100% for 7 years and 50% for 3 years thereafter. Chungbuk will be also reducing the local acquisition tax and property tax by 75% each for 5 years. ◆ Osong High-Tech Medical Complex = The Osong Medical Innovation Foundation prepared a separate exhibition hall from Chungbuk to promote its Bio Cluster. Osong emphasized that it can provide full-cycle support for new drug R&D. By full cycle, the complex provides support from basic research to the derivation of candidate materials, clinical trials, permission, and production through its New Drug Development Support Center, Non-Clinical Support Center, Advanced Medical Device Development Support Center, Laboratory Animal Center, Biopharmaceutical Manufacturing Center (GMP), and Korea Bio Human Resources Development Center. Also, officials added that further support will be provided through the Advanced Clinical Trial Center which is scheduled to open this year, and the Innovation Startup Technology Commercialization Center, which is scheduled to open in 2024. In addition, the complex is close to the Osong Health Technology Administration Town where the ▲Ministry of Food and Drug Safety, ▲ National Institute of Food and Drug Safety Evaluation, ▲Korea Disease Control and Prevention Agency ▲National Institute of Health reside and have great accessibility to national and public research institutes such as the ▲National Biobank of Korea, ▲ National Center for Stem Cell and Regenerative Medicine Research, ▲ National Center for Medical Information and Knowledge, and the ▲Korean Vaccine Research and Development Center for Public Vaccines. In addition, the complex also actively promoted its Osong Bio Industrial Complex and Osong Cosmetics Industrial Complex which are scheduled to be sold in 2023, and the Osong 3rd Life Science Complex which is scheduled to be sold in 2025. ◆Incheon Technopark = Incheon Technopark, where Celltrion·Samsung Biologics reside, also introduced its various business support services. The supports provided by the Incheon Technopark include support for bio equipment use support, bio-health care product development, bioproduct effectiveness evaluation, biopharmaceutical raw material commercialization, etc. The support for bio equipment includes the use of 80 or more equipment including HPLC, GC-FID, MALDI-TOF, etc. at an inexpensive price at the joint laboratory. Companies that move into the Bio Cluster will receive a 20% discount on equipment usage. As efficacy assessment support, the Bio Cluster will support ₩18 million for non-clinical and clinical drug trials to 3 companies selected among those that have moved into the Incheon Bio Cluster. As startup support, the Incheon Technopark introduced the establishment of a K-Bio Health regional center, the Incheon Startup Park support project, the creation and operation of the Incheon start-up fund, and support for the Bio Cluster establishment. ◆Seoul Biohub= The city of Seoul also promoted its Seoul Biohub, located in Hongneung-dong, Seoul. Seoul Biohub first made a kick-off in 2017 with the opening of the Industrial Support Building. In 2019, the city added a research laboratory building, and an open region building, and in 2020, the Seoul Bio-Innovation Community Center and Industry-University Cooperation Center were opened. Last year, the BT-IT Convergence Center was opened to expand the bio-startup ecosystem. The Seoul Biohub is concentrating on attracting bio startups. The companies will be able to move into the biohub in 2 years and are provided opportunities to pursue joint challenges with global bio companies such as Johnson&Johnson, Novartis, and MSD. In particular, the companies may receive policy support for new technology demonstration and tax reduction as the region was designated as a special Innotown in 2020. ◆ Gimhae Biomedical Industry Promotion Agency = The Gyeongnam Gimhae city plans to establish a biomedical industry complex that specializes in the manufacture of medical devices by 2025 around the Biomedical Center it established in 2008. In addition, the city aims to bring in technologies such as AI-based image reading, bio-functional materials, and 3D bioprinting. Companies that move into the complex will receive various development support including those for patents, certification, and design development as well as marketing support such as for participation in domestic and foreign exhibitions. The city plans to discover R&D projects jointly with local medical institutions such as the Inje Paik Hospital and Pusan National University Yangsan Hospital, and provide clinical trial support.
- Policy
- MOHW holds a launching meeting of the pharmaceutical team
- by Kim, Jung-Ju May 13, 2022 05:46am
- The MOHW (Minister Kwon Deok-cheol) announced at 3 p.m. on the 12th that it will hold a launching meeting of the mid- to long-term strategic planning team for the pharmaceutical industry to establish the "third comprehensive plan for fostering and supporting the pharmaceutical industry." The government shall prepare a five-year comprehensive plan to promote the creation of a foundation for the development of the pharmaceutical industry and strengthening international competitiveness. The comprehensive plan to be established this time is the third plan since the implementation of the system in 2012, and will present a mid- to long-term vision of the pharmaceutical and bio industry promotion policy for the next five years from 2023 to 2027. The MOHW formed a strategic planning team including industry and academic experts (Lee Hyung-hoon, director of health and industry policy at the MOHW, and Lee Byung-gun, chairman of the Korea Sponsor Board of the International Vaccine Research Institute). The strategic planning team will be appointed as a sub-division of each industry (4) and strategy (4) to discuss the basic direction (vision, goal, strategy) of the comprehensive plan and comprehensively review the detailed implementation tasks discussed in each department. At the launching meeting, the results of the second comprehensive plan (2018-2022) were shared, and the strategic planning team and the division's operation plan were discussed. The main achievements of the second comprehensive plan were the expansion of R&D investments by the government and the private sector to promote new drug development, including the Ministry of Health, Science and Technology, Information and Communication, and Trade. To establish the third comprehensive plan, the strategic planning team will hold a meeting at least once a month, and it plans to first operate the industry division in May to June to find tasks for each field, and then prepare detailed action plans in each strategy division. The government plans to operate a strategic planning team (including the division) by the end of this year and announce the third comprehensive plan around December this year after deliberation by the Pharmaceutical Industry Promotion and Support Committee (Chairman, Minister of Health and Welfare). Lee Hyung-hoon, director of the Health and Industry Policy Bureau, said, "The year 2022 when the third comprehensive plan is established is an appropriate time to create a bio-health innovation ecosystem beyond the turning point of COVID-19 and to discuss mid- to long-term directions for Korea to become a pharmaceutical and bio powerhouse." He said, "As this comprehensive plan has been open to various opinions from academia and industry since the beginning of its establishment, industries and research circles will actively participate to express their outlook and opinions, and the planning team will prepare policy tasks and deliberate by the committee."
- Policy
- Vaccine consultative body launched
- by Kim, Jung-Ju May 13, 2022 05:45am
- Representative vaccine companies in Korea will launch a "Vaccine consultative body" to establish vaccine sovereignty and enhance international competitiveness, and actively cooperate with the aim of strengthening R&D capabilities in the industry and promoting vaccine commercialization. The MOHW (Minister Kwon Deok-cheol) and the Vaccine Practicalization Technology Development Project Group (Director Sung Baek-rin, professor of Yonsei University Medical School) held the launch ceremony of the Vaccine Practicalization Council at COEX at 3 p.m. today (12th). This reflects the need to secure vaccine sovereignty triggered by COVID-19, and companies have agreed to achieve self-sufficiency of essential vaccination vaccines as well as responding to the global pandemic (pandemic) of future infectious diseases. The consultative body will participate in 14 representative vaccine companies participating in research and development projects supported by the vaccine commercialization technology development project group, and support the overall operation as an executive agency. Participating companies are GC Pharma, LG Chem, SK Bioscience, EyeGene, Boryung Biopharma,HK inno.N, EuBiologics, InThera, Genexine, GeneMatrix, Geneone, Cha Vaccine Research Institute, QuadMedicine, and Quratis. The council is divided into two vaccine divisions: self-sufficiency of essential vaccinations, future response, and unresolved, and plans to seek alternatives and promote vaccine commercialization through follow-up research and discovery of new research needs. At the launch ceremony, the participating companies adopted a joint cooperation declaration to the effect of "cooperation to protect public health, establish vaccine sovereignty, and enhance international competitiveness as Korea's representative vaccine companies." Companies declared that they would strengthen their R&D capabilities, promote the commercialization of domestic vaccines, and actively cooperate with the government to come up with countermeasures in the event of an infectious disease-related national health crisis. Sung Baek-rin, head of the Vaccine Practicalization Technology Development Project, said in his opening speech, "The Vaccine Practicalization Technology Development Project is a large project involving domestic industry, academia, research, and disease experts, and it will be an opportunity to develop their research capabilities and draw collective intelligence." Park Geum-ryul, a leading medical support officer at the MOHW, said in a congratulatory speech, "We strongly sympathize with the purpose of the launch of the consultative body, and we hope that active exchanges and discussions will take place as it is launched with the full support and participation of representative companies in the future."
- Company
- Lumakras is a new opportunity for lung cancer patients
- by May 13, 2022 05:45am
- "Lumakras is the first-in-class and best-in-class for patients with KRAS G12C mutated non-small cell lung cancer who failed existing treatment. The reliability of drugs has also increased over the past two years with long-term data, and it is expected that they may be used in combination with other drugs such as immuno-cancer drugs in the future." Kim Hye-ryeon, a professor of oncology at Yonsei Cancer Hospital, expressed the meaning of the launch of the new cancer drug Lumakras. Lumakras is the first and only KRAS targeted anticancer drug that was approved by the MFDS in February. It targets non-small cell lung cancer KRAS G12C mutations. KRAS gene mutation is common in non-small cell lung cancer. In Asia, EGFR mutations are the second most common. Although the KRAS tumor gene was already discovered 40 years ago, it remained a homework that could not be solved for a long time due to molecular biological characteristics and drug toxicity. Amgen succeeded in commercializing it with FDA approval three and a half years after first discovering the Lumaras candidate material in November 2017. Lumakras binds to a P2 pocket near KRAS G12C Switch II to immobilize the mutant protein in an inactive state. By selectively blocking tumor-causing signals, only cancer cell growth can be prevented without affecting the KRAS normal gene. Professor Kim said in a meeting with Dailypharm, "The prognosis of patients for KRAS mutated non-small cell lung cancer has not been good because there is no targeted treatment. KRAS mutated non-small cell lung cancer is closely related to smoking, and nine out of 10 people have previously smoked or are currently smoking, so the high tumor heterogeneity is also considered a cause of poor prognosis, he said. "The launch of Lumakras is significant in that it has met the medical demand for lung cancer treatment." Since KRAS mutations generally do not overlap with other gene mutations with targeted treatments such as EGFR and ALK, chemotherapy was the only drug that patients could use. Fortunately, immuno-cancer drugs that can be used by patients without EGFR and ALK mutations have recently emerged, but the regret remains that there are no targeted treatments. This is because drugs that have a definite response and guarantee effectiveness are rare as targeted treatments that target specific gene mutations. Professor Kim said, "It is a retrospective study, but there are reports that the survival rate of patients has increased after targeted treatment in lung cancer treatment. Given the experience of prescribing other gene mutations, I think it is basic to use the treatment first." Amgen recently released long-term Lumakras data for two years, increasing reliability. This is the result of follow-up observation of 174 patients who participated in the Phase 1/2 CodeBreaK100 study, which was the basis for permission, for two years. It is the longest-running follow-up observation among targeted treatments for non-small cell lung cancer of KRAS G12C mutation. In this study, Lumakras confirmed long-term efficacy and safety. The ORR including CR and PR in the Lumakras administration group was 40.7%, and the reaction duration mDOR was 12.3 months. In addition, DCR 83.7%, mPFS 6.3 months, and OS 12.5 months were found. At the time of two years of treatment, 32.5% of all patients were alive. For two years of treatment, there were no reports of new adverse reactions that had not existed before. Regarding the two-year long-term data, Professor Kim said, "From the perspective of medical staff, 'long-term data' means really reliable," adding, "There are treatments that usually show good results in the first half of the phase, but Lumakras showed better response rates in the two-year long-term follow-up." In particular, considering that they are patients who have failed existing treatments, I think they are clinically valuable." The release of Lumakras has also changed the diagnosis of lung cancer. Professor Kim said, "When diagnosed with non-small cell lung cancer adenocarcinoma, this hospital based on five tests, including PD-L1, an indicator of immuno-cancer drugs, along with representative lung cancer genetic mutations such as EGFR, ALK, BRAF, and ROS1. With the emergence of treatments targeting minority mutations, including KRAS targeted treatments, we will now conduct additional NGS (next-generation gene sequencing) tests that can check other gene mutations together if all four previous gene mutations are confirmed negative, she explained. Professor Kim highly predicted the possibility of expanding Lumakras in the future. This is because immuno-cancer drugs and good synergy are expected. She said, "There have been no cases in which targeted treatments and immuno-cancer drugs have been approved for other gene mutations such as EGFR and ALK. This is because the treatment effect was not significant and the drug toxicity was strong. However, the KRAS mutation showed good results in the target + immunotherapy in the in vivo test. It is speculated that the high association with smoking may be affected, he said. "The response rate is also high when treating immuno-cancer drugs, so clinical trials related to targeted + immuno-combination therapy are actively being conducted."
- Company
- LG Chem’s partner enters Phase I trial on its immunotherapy
- by Kim, Jin-Gu May 13, 2022 05:45am
- On the 12th, Cue Biopharma, LG Chem’s partner in developing a cancer immunotherapy, announced it had won FDA approval to initiate Phase 1 clinical trials for ‘CUE-102 .’ LG Chem has exclusive rights to develop and market the candidate in 11 Asian countries including Korea, China, and Japan. With the trial approval, Cue Biopharma will assess CUE-102’s safety, tolerability pharmacokinetics, pharmacodynamics, and preliminary efficacy in treating Wilms' Tumor 1 (WT1)-positive recurrent/metastatic cancers, with an initial focus on gastric, pancreatic, ovarian and colon cancers. CUE-102 is a cancer immunotherapy that selectively engages and modulates targeted T cells that recognize and remove WT-1-positive tumors. Unlike existing T cell treatments that require the patients' T cells to be extracted, modified outside the body (ex vivo), and reinfused, CUE-102 is delivered directly into the patient's body (in vivo), In the preclinical trial, the candidate was found to proliferate and activates T cells that selectively respond to WT-1 positive tumors. CUE-102’s development is expected to accelerate further as the Phase I trial was approved as a dose-escalation trial to begin dosing at 1 mg/kg was supported by the interim safety and tolerability data from a Phase I trial for CUE-101, the first biologic from the CUE-100 series. In the trial for CUE-101, the starting dose was 0.06 mg/kg and required approximately 9 months to dose escalate from 0.06 mg/kg to 1 mg/kg. Based on the Phase I trial data of its partner, LG Chem will be designing the Phase II trial and directly participating in its development in the Asian region. With the trial entry of CUE-102, LG Chem’s anticancer candidate pipeline has increased to 4. In addition to Que Biopharma’s CUE-101·CUE-102, LG Chem also owns Korean Genome&Company’s solid cancer treatment ‘GEN-001' by the and Belgium and Frech PDC*line Pharma’s NSCLC treatment ‘PDC Lung.’ GEN-001 is now in Phase I trials in the US, and PDC lung is in Phase I trials in Europe.
- Company
- K-Cab & Fexuclu are quickly targeting the global market
- by Chon, Seung-Hyun May 12, 2022 06:07am
- New drug products developed by domestic pharmaceutical companies with their own technologies are accelerating their targeting in the global market. However, some point out that it is difficult to predict commercial success because there are many variables such as the situation of the local market even if they have reserved to enter the overseas market. ◆K-Cab Expands to 34 Export Contracting Countries...Maximum contract size of ↑1 trillion won According to the industry on the 11th, HK inno.N signed a contract with Indian pharmaceutical company Dr. Reddy's Laboratories to export new K-Cab for gastroesophageal reflux disease. Seven countries have signed export contracts, including India, South Africa, Russia, Kazakhstan, Uzbekistan, Ukraine and Belarus. With this contract, the number of countries where K-Cab has entered the market in the form of technology exports or finished product exports has increased to 34. HK inno.N signed a technology export contract with Chinese pharmaceutical company Luoxin for K-Cab in 2015. It is a condition to receive $18.5 million in technical fees for each stage according to down payment, clinical development, permission, and commercialization. The company estimated that if royalties from sales occur after local commercialization, the contract will rise to $95.29 million. In February 2019, HK inno.N signed an export contract for K-Cab with Mexican pharmaceutical company Laboratorios Carnot to 17 Latin American countries. It is worth $84 million over 10 years, including the amount of supply of products. Export contracts have become more active since K-Cab was released in Korea. In September 2019, contracts were signed to supply finished drugs to Indonesia, Thailand, and the Philippines, and in 2020, export contracts were signed to Mongolia and Singapore. Last year, it signed export contracts for Vietnam, Malaysia, the U.S., and Canada. The largest export contract of K-Cab is technology exports signed with U.S. company Braintree Laboratories Inc. in February, with a contract size of up to $540 million. The company explained that K-Cab's export contract will exceed KRW 1 trillion. ◆Fexuclu, export contract to 15 countries, maximum Contract Size 1.2 Trillion Among the new drugs developed in Korea, Daewoong Pharmaceutical's Fexuclu is showing the most active entry into the overseas market. Fexuclue is a potassium competitive gastric acid secretion inhibitor (P-CAB)-based gastroesophageal reflux disease treatment drug, which is the same as K-cap. It received domestic permission at the end of last year and is expected to be released in the second half of this year. Through six export contracts, Daewoong Pharmaceutical has booked Fexuclu exports to 15 countries including North America, Latin America, China and the Middle East. Daewoong Pharmaceutical began to enter Latin America in 2020 by handing over the local permission and sales rights of Fexuclu to Mexican pharmaceutical company and Brazilian pharmaceutical company EMS, respectively. In March last year, it signed an export supply contract worth about 384.5 billion won with Shanghai Haini of China. In June last year, it handed over Fexuclu's right to develop, license, and sell in the U.S. and Canada. Under the contract, Daewoong Pharmaceutical secured a 5% stake in Neurogastrx as an upfront fee and was guaranteed up to $430 million in the name of a step-by-step technology fee (milestone) for development, licensing and commercialization stages. Daewoong Pharmaceutical was promised to enter 10 countries in Latin America and the Middle East through two export contracts last year. Daewoong has secured up to 1.2 trillion won through Fexuclu's export contract. ◆ There are many cancellations and returns after the export contract Variables such as changes in the local market environment The industry expects K-Cab and Fexuclu to achieve commercial results in overseas markets. Domestic new drug products have tapped overseas markets in various ways, but have yet to produce successful cases. This is because even if an export contract is signed, the export contract does not guarantee commercial performance due to the nature of taking a considerable amount of time to sell through local licensing procedures. Overseas drug expansion is largely divided into technology transfer and exports of finished drugs. Technology transfer is a structure in which partner companies are in charge of commercializing products that have not yet been developed. Technology transfer is often terminated or rights returned depending on the partner company's intention to develop or the marketability of drugs. The contract for the supply of finished drugs is a structure in which exporters sell products that have succeeded in commercialization abroad. Although it is evaluated that the success rate of contract implementation is relatively high compared to technology transfer, there may be a number of cases that are terminated depending on local circumstances. The export contract between K-Cab and Fexuclu has a large proportion of completed drug supply contracts. It is a structure in which profits are generated only when sales are made through overseas local licensing procedures. In the case of K-Cab, it received Chinese permission last month and is expected to make full-fledged overseas sales are expected. Fexuclu is in the process of licensing items in the Philippines, Indonesia, and Thailand. Another variable is that the down payment already secured is not large. Although HK inno.N did not disclose the amount of down payment secured by K-Cab's export contract, it is known to be insignificant compared to the total size of the contract. There are two down payments secured through the Fexuclu export contract disclosed by Daewoong Pharmaceutical. In March last year, 6.8 billion won in advance received from Shanghai Haini was the largest. Daewoong Pharmaceutical's 5% stake from Neurogastrx was valued at 4 billion won as of the end of last year. An industry official said, "Even if finished drugs are already well-selling in Korea, various unexpected variables such as changes in the market environment will inevitably occur in overseas markets," adding, "Even if there is no problem with the product, it is highly likely that they will not achieve the export target set in the first place."
- Policy
- Will Ho-Young Chung be able to enter Cabinet?
- by Lee, Jeong-Hwan May 12, 2022 06:07am
- With the inauguration of the new administration on the 10th, whether the Health and Welfare Minister nominee Ho-Young Chung will be able to enter President Yoon’s Cabinet is now at a crossroads. Industry experts expect that the nominee will be appointed today (12th) after the Minister of Economy and Finance Choo Kyung-ho starts his role as Deputy Prime Minister. If President Suk-Yeol Yoon does not remove the nominee from the list of appointments, then Chung is expected to ascend to the ministerial position regardless of the NA’s personnel hearing report. However, there remains a possibility that he will be excluded from the list of appointments due to continued opinion on Chung’s inappropriacy within the People Power Party, the Democratic Party’s voluntary resignation request and they plan to press charges. The industry expects the appointment results to come out on the 12th because Prime Minister Bu-kyum Kim’s term ended at midnight on the 11th, after which Deputy Prime Minister Choo is given the authority to recommend appointments. Minister nominees are appointed upon the recommendation of appointment by the Prime Minister, therefore, the term of the Deputy Prime Minister Choo needs to first start sequentially appointing the Cabinet members that the opposition party criticized to be incompetent. President Yoon needs Chung’s appointment to meet the quorum of 15 Ministers required to hold the first cabinet meeting and deal with the supplementary budget bill for COVID-19. Therefore, the president is expected to fill out the quorum with the 7 Ministers that he appointed beforehand, additional appointments made immediately before the Cabinet meeting, and Ministers from the previous administration. Pushing Chung’s appointment ahead will intensify the conflict between the ruling and opposition party, as the personnel hearing report for Chung was not accepted due to the collective exit of Democratic Party members during the personnel hearing. The Democratic Party of Korea plans to file a complaint against Chung on allegations of his two children's transfer to Kyungpook Medical University and his son's military service exemption decision. The Democratic Party of Korea has been urging the president to drop Chung’s appointment, referring to Chung as an ‘evader and breaker of laws.’ An official from the NA Health and Welfare Committee who is a member of the Democratic Party of Korea, said, “Chung should be the first candidate to be dropped. If the president pushes ahead with the appointment despite the disruption shown at the hearing without adopting the personnel hearing report, the government will not be able to avoid conflict with the National Assembly for a while. I understand that there is strong opposition to appointing nominee Chung even within the People Power Party. Even if he enters the Cabinet, it is questionable whether he will be able to properly serve as the Minister of Health and Welfare.”
- Company
- 17 are immuno-cancer drugs out of 111 KDDF support projects
- by Kim, Jin-Gu May 12, 2022 06:06am
- Kim Soon-nam, head of the R&D division of the National New Drug Development Project, is presenting at 2022 BIO KoreaOf the 111 KDDF support tasks selected by the government last year, 17 are confirmed to be immuno-cancer drugs. Kim Soon-nam, head of KDDF R&D, who is leading the project, predicted, "In the future, R&D tasks related to immuno-cancer drugs will increase further." Kim Soon-nam, head of the headquarters, attended a session under the theme of "Trends in the Development of Immuno-cancer Drugs" at "2022 BIO Korea" held at COEX in Seoul on the 11th and introduced it as such. According to him, the government will invest a total of 2 trillion won for 10 years from 2021 to 2030 to develop KDDF. The goal of the project is to support a total of 1,234 projects over a decade and produce four new drugs approved by the FDA or EMA and one new global blockbuster drug before the project is over. In 2021, the first year, a total of 111 tasks were selected for support. Among the supporting tasks, anticancer drugs are the most important. Nearly half of the 52 (47%) projects were selected for support. It is followed by metabolic diseases (15), immune diseases (11), and central nervous system diseases (9). Government contributions were also focused on developing anticancer drugs. Of the total 127 billion won supported last year, 60.3 billion won was invested in research and development projects for anticancer drugs. Director Kim explained that there have been many recent research projects related to immuno-cancer drugs among anticancer drugs. She said, "32% (17) of the 52 anticancer drug tasks were immuno-cancer drugs," and predicted, "We expect more research on immuno-cancer drugs in the future." "Even within immuno-cancer drugs, the field of research is being subdivided in various directions," he said. "There will be more research on combination therapy, targeting, and biomarker studies." "KDDF is providing support from the stage of finding candidate materials to phase 2 clinical trials. In the end, the goal is to approve the sale of new drugs by global licensing agencies," she stressed.
- Policy
- Evusheld will be included in Govnt's supplementary budget
- by Lee, Jeong-Hwan May 12, 2022 06:06am
- The government is setting out to secure a supplementary budget for the introduction of ‘Evusheld (tixagevimab, cilgavimab),’ an antibody combination treatment used to prevent COVID-19 infection in the immunocompromised that see a low effect from vaccinations. With the National Assembly also agreeing on the need to introduce Evusheld, its introduction will gain momentum as soon as the supplementary budget submitted by the government passes the National Assembly. The government plans to hold a Cabinet Meeting on the afternoon of the 12th to pass the supplementary budget. In the proposed supplementary budget, attention is focused on the budget managed by the Korea Disease Control and Prevention Agency which includes the proposal to introduce Evusheld, an antibody treatment for the immunocompromised. Evusheld is administered to people who show inadequate response to COVID-19 vaccines such as cancer patients and dialysis patients to increase their prevention against COVID-19 infections. The drug was approved in December last year by the US FDA, and in the UK by NHRA in March this year. France, Australia, and Singapore also signed advance purchase agreements for Evusheld as preventive therapy for COVID-19. On the other hand, The Korean government had received criticism for being late in its response because Korea only announced that it will review the introduction of the drug and did not specify when. Accordingly, the government plans to include about ₩40 billion to purchase 20,000 courses of preventive antibody treatments needed for the prevention of infection and serious COVID-19 in the supplementary budget for the immunocompromised. Severe immunocompromised patients, such as organ transplant patients receiving immunosuppressive treatment and blood cancer patients, are eligible for support. If approved, Evusheld’s distribution is not expected to be difficult as Samsung Biologics is currently manufacturing the whole amount. Samsung Biologics has been supplying Evusheld to the global market under the long-term strategic manufacturing partnership signed with AstraZeneca in September 2020. The companies further expanded the size of the contract in December last year to strengthen the strategic partnership
- Company
- GLPharmtech has obtained approval IMD for Janumet XR
- by Nho, Byung Chul May 12, 2022 06:06am
- (CEO Wang Hoon-sik) announced on the 11th that it has obtained an item approval from the Ministry of Food and Drug Safety for a new salt-improving drug of Janumet XR (Sitagliptin Phosphate+ Metformin Hydrochloride. GLPharmtech items licensed this time adopted Sitagliptin, a modified salt drug for Chong Kun Dang Sitaformin XR/Hanmi Pharmaceutical Sitamefor XR, which was designated as generic for exclusivity in 2016. GLPharmtech will be able to compete simultaneously, away from the influence of generic for exclusivity secured by Chong Kun Dang/Hanmi Pharmaceutical until June 1, 2024. It plans to produce this product through technology transfer to Shinil, and will also be sold in Ildong, Dong-Wha, and Futecs. "Our subsidiary GL Pharma launched another DPP-4 inhibitor, GL Vildagliptin, in March," said Park Jae-kyung, director of GL Pharmtech's development division, the director said that we will continue to release additional products of DPP-4 inhibitors and SGLT-2 inhibitors, which are leading diabetes treatments, to expand our presence in the diabetes treatment market.
