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- 2026-05-15 20:38:08
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- 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.
- Company
- Will Luxturna be reimbursed by the end of this year?
- by Eo, Yun-Ho May 11, 2022 05:56am
- Attention is focusing on the procedure for registering insurance benefits for another one-shot gene therapy. According to related industries, discussions are underway to register the benefit of Novartis' Inherited Retinal Dystrophy (IRD) treatment Luxturna. As the application for benefits was submitted in September last year, it remains to be seen whether it will be possible to announce the HIRA's drug benefit evaluation committee within the first half of the year. Depending on the speed of the procedure, Luxturna can enter the benefit right within this year. Luxturna restores function by replacing the deficient and defective RPE65 gene, one of the causes of IRD, with a normal gene only once administered. In other words, fundamental treatment of diseases is possible. The drug was designated by the U.S. FDA for Breakthrough Therapy in 2014, Orphan Drug in 2016, and Priority Review in 2017, and was quickly approved in 2017. IRD is a rare and intractable disease that causes visual loss due to mutations in the genes responsible for the structure and function of cells in the retina. It includes more than 20 different ophthalmic diseases and has about 300 causative genes. IRD, which is caused by RPE65 gene mutation, causes abnormalities in the visual cycle in the retina, which converts visual information into neural signals and transmits it to the brain. The RPE65 gene mutation reduces the RPE65 protein, which is essential for visual circuits, and destroys retinal cells, gradually narrowing the field of view, and eventually reaching blindness. Kang Se-woong, chairman of the Korean Retina Society (Samsung Medical Center's ophthalmology professor), said, "Luxturna's single injection is expected to restore not only vision but also independent walking without the help of a guardian"
- Company
- Domestic COVID-19 vaccine developers at a crossroads
- by Kim, Jin-Gu May 11, 2022 05:55am
- HK Inno. N announced it will voluntarily discontinue the development of its COVID-19 vaccine due to the sudden change in the spread of COVID-19 in Korea. With the marketing approval of SK Bioscience’s COVID-19 vaccine imminent, the indecisiveness among the other vaccine developers in Korea is increasing According to industry sources on the 10th, HK Inno. N has decided to discontinue the development of its COVID-19 vaccine, ‘IN-B009’ in Korea. The company had been developing a recombinant vaccine, the same as SK Bioscience’s GBP510 or Novavax’s Nuvaxovid in terms of platforms. The company pointed to the rapid change in the Korean COVID-19 situation as a reason for discontinuing its trial. Unlike in July last year when HK Inno. N received approval for the Phase 1 trial of IN-B009, the company said the need for COVID-19 vaccines had reduced significantly. HK Inno. N said, “Most of the people in Korea have secured immunity to COVID-19, being infected or through multiple vaccinations. The COVID-19 situation has now changed rapidly. With the situation moving to the endemic phase, there is no clear purpose for us to enter a late-stage clinical trial." ◆Second company after Genexine to discontinue development… 7 companies remain The company became the second after Genexine to drop the development of its vaccine. Before HK Inno. N, Genexine had announced that it will voluntarily discontinue its Phase II and Phase III trials in March. At the time, Genexine also explained that it “determined that the business feasibility of GX-19N was low in the rapidly changing COVID-19 market in consideration of the global vaccine supply and demand.” With Genexine and HK Inno. N’s voluntary withdrawal, 7 domestic COVID-19 vaccine developers now remain in the market. The companies that remain are SK Bioscience, Eubiologics, Cellid, Geneone Life Science, Quratis, Eyegene, and ST Pharm. Among the companies, SK Bioscience’s GBP510 is soon to be commercialized. On the 29th of last month, the company applied for the marketing authorization of GBP510 under the name ‘SKY Covione.’ The drug is currently under review by the Ministry of Food and Drug Safety and is likely to receive an approval within the month. Eubiologics is continuing the development of its‘EuCorVac-19’ through a global Phase III trial. After receiving approval for its trial in three countries in Africa, Eubiologics also initiated a Phase III trial in the Philippines on the 7th of this month. As such, the company has entered Phase III trials by securing a comparator vaccine overseas. In Korea, the company also received approval for its Phase 3 trial protocol and is in search of comparator vaccines. ◆ Companies change trial plan due to low marketability…concerns deepen among developers Excluding the two, no other company has entered Phase III trials yet. The industry is paying attention to the possibility that more companies will stop developing COVID-19 vaccines. Cellid has started its Phase IIb trial for 'AdCLD-CoV19-1' in Korea. Cellid has prepared a two-track strategy to continue clinical trials for its vaccine for primary inoculation that was in development while developing another vaccine as a booster shot (additional inoculation). Geneone Life Science changed its strategy from developing a vaccine for primary inoculation to developing a booster vaccine. Last month, the company announced that it had completed the registration of subjects for the Phase IIa clinical trial of 'GLS-5310', which is being developed as a DNA vaccine. After confirming the safety and efficacy of clinical trials in a Phase IIa trial, the company plans to continue on studying its vaccine through Phase IIb and III trials as a booster vaccine. The changed COVID-19 situation is analyzed to have played a decisive role in the changes in the development strategy of the two companies. With the COVID-19 pandemic entering the endemic stage, the market competitiveness of vaccines has been greatly reduced. The other companies are having difficulty in the patient recruitment stage. Quratis and Eyegene received approval for their Phase I and Phase I/2a trial in July and August last year but are still recruiting patients. ST Pharm has received approval for the Phase I trial plan of its mRNA platform-based 'STP2104' in March this year and is starting to recruit patients.
- Policy
- “Dualized RWD collection for Kymriah is inefficient”
- by Lee, Tak-Sun May 11, 2022 05:55am
- With the registration of the ultra-expensive one-shot treatment Kymriah, the opinion was raised that a plan should be prepared to ensure the efficiency of the system by standardizing the dualized real clinical data (RWD) collection required by different institutions. That the separate collection of data by the Ministry of Food and Drug Safety and the Health Insurance Review and Assessment Service is a burden on the medical staff. Ji-Hye Byun, Assistant Research Fellow of the Evidence-based Research Division at HIRA claimed so in the 22nd issue of ‘HIRA’ that was recently published. Kymirah is the world’s first chimeric antigen receptor T-cell (CAR-T) therapy that was developed by Novartis Korea. The drug was approved as the first advanced biopharmaceutical under the ‘Advance Regenerative Bio Act’ in March of last year. The drug injects genetic information that can recognize specific antigens of cancer cells to the surface of an immune cell (T cell) collected from the patient and is indicated for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. Its listing had raised much attention, being a ‘one shot’ treatment that can bring an effect with a single administration and is an ultra-high-priced drug that costs 500 million won per shot. The government listed the drug for insurance benefit at 360 million won per shot in April and decided to cover the drug price with the National Health Insurance. However, the issue is that each organization requested RWD as a condition in the approval and listing process. The MFDS designated Kymirah as an advanced biopharmaceutical and ordered the company to conduct a 15-year long-term follow-up study on the drug. Also, the company needs to submit a post-management form to HIRA at the time of administration, 6 months after administration, and 12 months after administration. The global registry, EU’s EBMT will also be collecting treatment information on domestic patients, Byun said, “As a result, the HCPs will have to bear the burden of inputting and submitting RWD of similar content to three institutions - the MFDS, HIRA and EU EBMT- after patient treatment. We need to improve the domestic RWD collection system to become more efficient.” Byun explained that in Europe, the authorities are working to understand the differences in the RWD collection environment of each country and establish governance for RWD utilization among all patients. EU’s EBMT was also established as a single registry to serve the multi-purpose of post-marketing safety research, reimbursement management, and clinical research. Byun added that HIRA already owns the infrastructure to manage such information, and argued that it is necessary to use this infrastructure to separate the additional information necessary as RWD and devise a way to link it with the hospital's electronic medical record system.
- Policy
- Reblozyl was approved after 1 yr of designation of rare drug
- by Lee, Hye-Kyung May 11, 2022 05:55am
- Reblozyl 25mg, a treatment for patients with beta-Mediterranean anemia, was officially approved for items a year after designation as a rare drug. The MFDS approved Reblozyl applied by BSM Pharmaceutical Korea. Reblozyl is equipped with▲ the treatment of adult beta-Mediterranean anemia patients who need red blood cell transfusion as an indication, and ▲MDS-RS with minimum, low, and moderate risk of ring ferrous hematopoietic stem cell or low, moderate risk of ring ferrous hematopoietic and thrombocytopenia with increased myelogenesis/myeloproliferative tumor (MDS/NMP-T) Reblozyl was designated as a rare drug on April 1 last year. Beta-Mediterranean anemia, also called Cooley's anemia, is a blood disorder genetic disease that reduces the production of hemoglobin, an iron-containing protein of red blood cells, and delivers oxygen to cells in the body. Although iron treatment through red blood cell transfusion and chronic blood transfusion therapy for survival are used to treat patients, the risk of thrombosis increases to an abnormal level. Reblozyl obtained FDA marketing approval in 2019 based on clinical results of placebo administration of 112 out of 336 patients with beta-Mediterranean anemia. At the time of FDA approval, 21% of patients administered with Reblozyl had a 33% higher blood transfusion reduction rate than 4.5% of patients administered with placebo. Common side effects of Reblozyl include headache, bone pain, joint pain, fatigue, cough, abdominal pain, diarrhea, and dizziness, and high blood pressure may occur within the dose period. Thrombotic monitoring should also be accompanied when administered. It should be prohibited if a pregnant or breastfeeding woman takes Reblozyl because it can harm the fetus or newborn.
