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- 2025-12-25 12:25:16
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- A reimbursed optn in hormone-sensitive prostate cancer?
- by Eo, Yun-Ho Dec 29, 2021 05:58am
- Whether a treatment option may be added to the hormone-sensitive metastatic prostate cancer treatment environment that lacked options is gaining attention. According to industry officials, Astellas Korea applied for the extended insurance benefit of its anticancer drug ‘Xtandi (enzalutamide)’ in combination with androgen deprivation therapy (ADT). The agenda is expected to be deliberated at the National Health Insurance Service’s Cancer Disease Deliberation Committee meeting in January. The company applied for the indication to treat ‘metastatic hormone-sensitive prostate cancer (mHSCP),’ an area where a great unmet need remains. ADT+docetaxel, a standard therapy option for mHSPC treatment, may not be appropriate for older patients who have various underlying diseases. Also, the use of other treatment options is limited to high-risk mHSPC patients whose disease has progressed significantly. Therefore, the Xtandi+ADT combination is receiving attention for demonstrating its effect in low-risk mHSPC patients that had limited options. Due to the term ‘low-risk,’ low-risk mHSPC patients may seem to be at less risk, but it is a term defining advanced prostate cancer patients with accompanying distant metastasis. In the Phase III ARCHES study that was conducted on 1,150 mHSPC patients, the Xtandi+ADT combo significantly reduced the risk of radiographic progression-free survival (fPFS) by 61% compared to placebo+ADT, regardless of disease volume or degree of metastasis. Xtandi+ADT combo therapy is recommended in various international guidelines for the treatment of mHSPC including the US National Comprehensive Cancer Network (NCCN), European Association of Urology (EAU), American Urological Association (AUA) as well as in the domestic ‘2020 Korean Treatment Guideline for Metastatic Prostate Cancer’ published by Korean Society of Medical Oncology, Korean Cancer Study Group, the Korean Urological Oncology Society, and the Korean Society for Radiation Oncology. Cheol Kwak, Professor of Urology at Seoul National University Hospital, said, “The treatment objective for mHSPC is extending the life of metastatic prostate cancer patients and delaying progression to metastatic castrate-resistant prostate cancer (mCRPC) while maintaining the quality of life for the patients.” He added “Xtandi is a treatment that allows low-risk mHSCP patients with low-volume disease to better manage their disease, including those that are not suitable to use abiraterone or docetaxel due to their underlying disease or condition. We hope that discussions on its reimbursement promptly take place so that more patients can maintain quality of life at a relatively healthy state for a long time.”
- Company
- LegoChem transfers candidate technology to British company
- by Chon, Seung-Hyun Dec 29, 2021 05:57am
- LegoChem Biosciences announced on the 27th that it has signed a technology transfer contract with Iksuda for joint development of a new anti-cancer drug candidate LCB14. The contract is worth up to $1 billion (about 1.2 trillion won). With this contract, LegoChem Biosciences secured $50 million (about 60 billion won) in advance payments and short-term milestones. Milestones according to the development, permission, and commercialization stages are up to $950 million. Iksuda will have the right to develop and commercialize LCB14 globally except for China and Korea. LegoChem Biosciences will jointly conduct clinical trials in the United States with Iksuda in a way that pays part of the initial clinical cost. This contract also includes the conditions of receiving advance payments received by Iksuda and additional Revenue Sharing at a fixed rate for all milestones if third-party technology transfers are made during development. LCB14 is a new anticancer drug developed by LegoChem Biosciences using ADC original technology, and phase 1 clinical trials in China are underway. Iksuda is known to have the world's best ADC development capabilities, including Dr. Robert Lutz, who led the preclinical and early clinical trials of global blockbuster ADC drug Kadcylla. Iksuda CEO David Simpson said, "We will continue to develop valuable treatments by focusing on cancer species with limited treatments and establishing competitive pipelines using partners and self-developed toxin and ADC platforms." Cho Young-rak, vice president of LegoChem Biosciences, said, "We will do our best to strengthen our own clinical development capabilities and quickly develop subsequent ADC programs by actively accepting the highest level of development capabilities and know-how through this U.S. clinical joint progress."
- Company
- SK Bioscience will complete major facilities in Songdo
- by Chon, Seung-Hyun Dec 28, 2021 05:51am
- SK Bioscience, the third-largest pharmaceutical bio company in market capitalization, will build a new construction in Songdo, Incheon. It will invest 300 billion won by 2024 to build a new factory and laboratory. Along with Samsung Biologics, Celltrion, and Celltrion Healthcare, the first to fourth place in the pharmaceutical bio market will gather in Songdo side by side. ◆SK Bioscience will complete the facility in Songdo in 2024 and invested 300 billion won SK Bioscience announced on the 27th that it has signed a land sale contract with the Incheon Free Economic Zone Authority. The plan calls for the construction of a global R&PD (Research & Process Development) center on a 34,414㎡ site in Sr14 district 7, Songdo-dong, Incheon. Earlier in August, SK Bioscience signed a contract with the Incheon Free Economic Zone Authority to acquire 33 billion won worth of land and buildings. The newly created global R&PD center will house research institutes, factories, and offices for basic research and process development and production in the vaccine and bio sectors. SK Bioscience plans to invest about 300 billion won in business expenses with the aim of completing it in the fourth quarter of 2024. SK Bioscience plans to invest about 200 billion won by 2024 to expand manufacturing facilities for L-House, which has the latest vaccine production facilities such as cell culture, bacterial culture, gene recombination, and protein bonding, and build new platform facilities such as mRNA and next-generation viral vectors. When SK Bioscience moves to Songdo, all the first to fourth largest pharmaceutical bio companies in Korea will be located in Songdo. SK Bioscience, which was listed on the KOSPI market in March, has a market capitalization of 17.978 trillion won, ranking third after Samsung Biologics and Celltrion among pharmaceutical bio companies. Samsung Biologics, a bio-captain, was established based in Songdo in 2011. Samsung Biologics is currently operating three biopharmaceutical plants in Songdo. Samsung Biologics is building its fourth plant with the aim of operating it in 2023. The fourth plant is the largest ever with 256,000 liters of production. When the fourth plant is in operation, Samsung Biologics will secure a total of 618,000 liters of production facilities along with its third plant (3,000 liters of first plant, 152,000 liters of second plant, and 180,000 liters of third plant). Celltrion, which ranks second in the market capitalization of pharmaceutical bio companies, is the main player in growing Songdo, Incheon, as a mecca for biopharmaceuticals. Celltrion's market capitalization is 28.1412 trillion won. Founded in 2002, Celltrion operates two factories in Songdo. In 2005, the first factory of 100,000 liters was completed in Songdo, and in 2011, the second factory of 90,000 liters was joined. Celltrion is building a 60,000-liter plant with the aim of completing it in 2023. Celltrion is also planning to build a 20-liter plant. When the fourth plant is completed, a total of 450,000 liters of production facilities will be secured in Korea. Celltrion Healthcare, an affiliate of Celltrion, is also evaluated as a bio company representing Songdo. Celltrion Healthcare receives antibody biosimilar products from Celltrion and sells them to global retailers. Celltrion Healthcare is located with Celltrion in Songdo, Incheon. The market capitalization totaled 13.2084 trillion won. The market capitalization of four companies, Samsung Biologics, Celltrion, SK Bioscience, and Celltrion Healthcare, totaled 117.696 trillion won. These companies are by far one of the best among domestic pharmaceutical bio companies. Among the major pharmaceutical bio companies that handle medicines in the third quarter, only three companies recorded operating profits of more than 100 billion won, including Samsung Biologics, Celltrion, and SK Bioscience. The operating profit ratio of SK Bioscience and Celltrion to sales amounts to 45.5% and 40.9%. Samsung Biologics also recorded a high purity return of 37.1%. Along with Celltrion Healthcare, the average profit margin of the four Songdo bio companies exceeds 30%. Recently, SK Bioscience saw its operating profit rise 175.3% year-on-year to 100.4 billion won in the third quarter and sales rise 123.8% year-on-year to 220.8 billion won. The biggest factor in the surge in performance is the consignment production of the COVID-19 vaccine. SK Bioscience signed a consignment production (CMO) contract with global pharmaceutical company AstraZeneca in July last year to supply COVID-19 vaccines. It is a condition to produce the COVID-19 vaccine under development by AstraZeneca at L House in Andong, Gyeongsangbuk-do. In August last year, the MOHW and Novavax also signed a three-way contract to supply the COVID-19 vaccine NVX-CoV2373 and began production.
- Company
- ST Pharm has applied for phase 1 of the COVID-19 vaccine
- by Kim, Jin-Gu Dec 28, 2021 05:50am
- ST Pharm will join the ranks of COVID-19 vaccine development. It introduced mRNA vaccine platforms such as Pfizer and Moderna vaccines. ST Pharm announced on the 24th that it has applied for a phase 1 clinical trial plan for the mRNA-based COVID-19 prevention vaccine STP-2104 to the MFDS. Clinical trials were planned in stages of capacity increase, multisystem, and disclosure to evaluate the safety and immunogenicity of the COVID-19 vaccine STP-2104 for healthy adults aged 19 to 55. The clinical scale is at least 30, and the subjects will be divided into two groups, and STP2104 will be administered twice with doses of 25㎍ and 50㎍, respectively, to confirm safety and immunogenicity. According to ST Pharm, STP2104 contains mRNA designed based on modified nucleosides. 5-Capping Agent (SMARTCAP) technology developed by itself was used to improve the capping and transcription effects. In addition, lipid nanoparticles (LNPs) that have already been proven to be safe through global clinical trials are used as mRNA carriers. ST Pharm said, "If we confirm the safety and immunogenicity of STP2104 targeting delta mutations, we expect to be able to respond quickly by changing only the mRNA sequence to new corona mutations such as omicrons." ST Pharm said, "We plan to conduct follow-up clinical trials at home and abroad through the K-mRNA consortium in the future," adding, "We will then seek commercialization in Korea and ASEAN countries with conditional approval for use and sales." Currently, there are nine companies and institutions in Korea that have been approved for COVID-19 clinical trials. SK Bioscience, Genexine, Cellid, Geneone, EuBiologics, Curitas, HK inno.N, Eyegene, and International Vacuum Institute are challenging the development of vaccines. Among them, SK Bioscience is the only one to enter phase 3. By vaccine platform, there are three genetically recombinant vaccines (SK Bioscience, EuBiologics, HK inno.N), three DNA vaccines (Genexine, Geneone, International Vaccine Institute), one virus vector vaccine (Cellid), and two mRNA vaccines (Quaratis, Eyegene).
- Company
- Ildong's new DM GLP-1 analog has acquired a new patent
- by Dec 28, 2021 05:49am
- Ildong (CEO Yoon Woong-seop) announced on the 24th that it has obtained a patent for domestic substances for ID110521156, a new drug candidate for type 2 diabetes treatment under development. ID110521156 is a drug in the GLP-1 receptor agonist family that acts as a analog to the Glucagon-like peptide-1 (GLP-1) hormone that regulates blood sugar levels by inducing insulin secretion. GLP-1 hormones are produced and secreted in β cells of the pancreas and are known to be involved in the secretion and blood sugar control of insulin in the body, digestive organ exercise, and appetite suppression. ID110521156 has the same function as GLP-1 hormone and has a low molecular weight compound structure, so it is expected to be developed as an oral drug that is advantageous in terms of marketability and convenience of administration. Earlier, Ildong Pharmaceutical confirmed safety not only in excellent pharmacological activity but also in the effect on cardiovascular relations as a GLP-1 receptor agonist through ID110521156 study. Currently, the company is conducting nonclinical research to develop an oral type 2 diabetes treatment.
- Company
- The development of Kcav's Mucovac is in full swing
- by Dec 27, 2021 05:57am
- A spray-type COVID-19 vaccine sprayed on the nose, not on injections, is being developed by domestic company. Amid the trend of muscle injection, attention is focused on claims that mucosal immunity is more effective in defending the COVID-19 virus. Kcav (CEO Song Chang-seon) announced on the 27th that Mucovac, a COVID-19 mucosal vaccine candidate that is jointly researching with Konkuk University and Bionote, has succeeded in entering the second stage of the "Bio Medical Technology Support Project" supported by Ministry of Science and ICT and National Research Foundation of Korea. Accordingly, Kcav will receive 2 billion won in research funds for non-clinical trials and clinical sample production necessary for submitting the clinical trial plan (IND) of the COVID-19 mucosal vaccine Mucovac. Mucovac, which is being developed by Kcav, is a candidate substance for the COVID-19 mucosal vaccine derived by combining the ECSL immune enhancer, which signed a contract with Eubiologics in March, with a new antigen developed by Bionote. Mucovac confirmed that nasal administration using hACE2 TG Mice and Ferret animal Model enhances body fluidizing antibody and cellular immunity (IFN-r ELISPOT) to the COVID-19 virus. In addition, as a result of conducting attack vaccination tests using Wuhan and Delta, the Mucovac vaccine group showed a 100% survival rate. In particular, Kcav is planning to analyze Mucovac's ▲MoA-related analysis ▲ Evaluation of defense ability through attack inoculation after the sale of Omicron mutant and ▲ Boostershot application test (existing muscle vaccination + Mucovac inoculation). Since many pathogens, including COVID-19, invade through mucous membranes, mucosal vaccines can be said to serve as the first defense mission against pathogens invading from the outside. Since injection needles are not used, they can be administered safely and easily. It has been argued that vaccines using nasal cavity are more effective against COVID-19 than through veins and muscles. Currently, there are about 100 vaccines being developed worldwide, of which seven are vaccines using nasal cavity. This is why the Korean government desperately needs support for the success of commercialization of Mucovac while global efforts are underway to overcome the COVID-19 pandemic situation. An official from Kcav said, "The mucous membrane vaccine currently under development is a spray-type vaccine sprayed on the nose, not a conventional injection vaccine." He explained, "When applied with booster shots to existing vaccinations, it induces not only systemic immunity but also mucosal immunity." "We expect Mucovac to increase the ability to prevent infection through the respiratory tract of COVID-19 and respond to various mutant viruses," he said. "We have already confirmed our defense against delta mutant as well as Wuhan." Kcav has already confirmed its ability to defend against the SARS-Cov-2 virus of COVID-19 mucosal vaccine candidates using ECLS immunostrengthening agents by receiving research funding from the Global Health Technology Research Fund "RIGHTFUND," co-invested by the Bill & Melinda Gates Foundation, and eight domestic life science companies in 2020. Meanwhile, Kcav was established in 2014 by Professor Song Chang-sun of Veterinary Science College as the first subsidiary of Konkuk University's technology holding company. It has secured a variety of vaccine pipelines for animals and humans using core platforms such as Live attenuated vaccines and Newcastle Disease vector vaccines.
- Company
- To introduce a phase 3 clinical drug preferential policy
- by Nho, Byung Chul Dec 27, 2021 05:56am
- Attention is focusing on whether the industry, the National Assembly, and the MOHW will be able to derive a reasonable and efficient institutional direction in relation to the "policy for preferential treatment of new drugs in phase 3 clinical trials for Koreans." According to related industries on the 23rd, after the drug preferential regulations for innovative pharmaceutical companies were deleted during the 2018 Korea-US FTA negotiations, Article 17-2 of the Pharmaceutical Industry Promotion Act was introduced, but the legislation process seems urgent. Generic, which is released by innovative pharmaceutical companies, can get additional drug prices if it meets certain items of drug decision and adjustment standards, while there is no incentive for new drugs developed by all domestic and foreign pharmaceutical companies, that is, new drugs that have conducted clinical trials in Korea. As the global innovative drug preferential system was virtually stranded due to trade friction such as WTO and FTA three years ago, drug preferences such as 10% of the highest price of alternative drugs to encourage innovative pharmaceutical companies to develop new drugs and application of similar drugs (adjusted lowest price) in A7 countries have disappeared. With the outbreak of the COVID-19 Pandemic, public opinion on the formation of public opinion on the independence of vaccines and treatments and the government's justification for establishing pharmaceutical sovereignty is also gaining momentum. As Big Pharma such as Pfizer, Moderna, AstraZeneca, and MSD exclusively develop vaccines and treatments, other countries may suffer supply and demand difficulties at any time, as well as the fact that they are not the main clinical subjects. The "Phase 3 Clinical New Drug Treatment for Koreans" is a system that benefits 5-10% of alternative drugs when domestic and foreign pharmaceutical companies conduct clinical trials (300-1000 people) or higher in Korea when developing innovative drugs. In order to prevent international trade problems such as negotiations on the revision of the Korea-US FTA in 2018, there is an international obligation to introduce a drug price system within the scope of compliance with the agreement. The regulations in question in the FTA agreement at the time allow drug and medical device registration or procedures, rules, standards, and guidelines applied to establishing benefits for medicines and medical devices to apply for benefit based on evidence of safety. The phase 3 clinical drug preferential treatment for Koreans is a system that provides common benefits not only to domestic companies but also to foreign companies, so there is no concern about trade friction. In the case of new drugs that have proven that there is no difference in safety and effectiveness of drugs due to ethnic factors, they have the advantage of creating customized drug therapy, providing appropriate treatment, and securing clinical data while maintaining the maximum drug effect. The revision of the HIRA's drug adjustment standards can achieve the desired results, preventing waste of time and unnecessary costs due to the preparation of new bills such as legislation of the National Assembly and government. According to Article 7 (7) of the Drug Adjustment Standard, the cost of medical care benefits for drugs that omit drug price negotiations is 90% of the weighted average price of alternative drugs, but exceptionally 100% for new drugs, biopharmaceuticals, and rare diseases. An industry official said, "As a result of reviewing 122 drugs registered over the past six years, 4·13 domestic and foreign drugs will be applied to the preferential treatment of phase 3 clinical drugs in Korea." This can benefit in common from domestic and foreign pharmaceutical companies through various legal review, so there is no concern about trade friction due to the application of special cases, he said. In addition, he predicted, "Multinational pharmaceutical companies' drugs are unlikely to be subject to the revision as they are exempted from submitting Bridge study data due to anticancer drugs and rare drugs, and biological drugs will need to be given 100% of the average drug price."
- Company
- Reimb of SGLT-2i combos unclear... nears PMS expiry
- by Eo, Yun-Ho Dec 24, 2021 05:49am
- SGLT-2 inhibitors approved in Korea Anticipation has turned to tension. The companies that own SGLT-2 and DPP-2 combination therapies are facing hardships ahead of their post-marketing surveillance period expiry. At the diabetes expert meeting that was held by the Health Insurance Review and Assessment Service in September, the members concluded that the authorities should integrate and accept reimbursement of 2-drug and 3-drug combinations that use DPP-4 inhibitors with SGLT-2 inhibitors. The conclusion harbored industry hopes of being granted reimbursement listing for their non-reimbursed combinations. However, no progress has been made since in extending the insurance benefits to the combinations so far, putting pressure on the Post Marketing Surveillance (PMS) results. The PMS results of combination therapies such as Boehringer Ingelheim Korea’s ‘Esglito (empagliflozin/ linagliptin), AstraZeneca’s Qtern (dapagliflozin/saxagliptin)’ that is sold by Ildong Pharmaceutical, and MSD Korea’s ‘Steglujan (ertugliflozin/ sitagliptin) is due to the MFDS by 2023-2024. Only 1-2 years are left until the deadline. However, hundreds to thousands of patients need to enroll and register to conduct PMS, and due to the nature of the diabetes treatment market, it is difficult to recruit and attract prescriptions for non-reimbursed drugs. In other words, unless the drugs receive reimbursement, the companies will not be able to meet the number of patients required for PMS that was set by the Ministry of Food and Drug Safety. An official from a pharmaceutical company with an SGLT-2 inhibitor said, “In this pace, the license will inevitably be revoked. With the government policy supporting the active use of combinations, treatment accessibility is hindered if patients cannot be prescribed the drug due to non-reimbursement. I hope reimbursement is extended to SGLT-2 inhibitor combinations as soon as possible.” Meanwhile, at the expert meeting, the authorities decided that TZD class drugs that have cardiovascular risks should be reviewed ‘case by case.’ Therefore, the use of TZD combinations will continue to be restricted depending on individual ingredients.
- Company
- GI Innovation·A/Z, a study on immuno-cancer drugs combined
- by Nho, Byung Chul Dec 24, 2021 05:48am
- The appearance of GI Innovation clinical team members challenging large-scale global clinical trials. (Photo provided = GI Innovation)GI Innovation (CEO Hong Joon-ho) announced on the 17th that it has signed a clinical supply contract with AstraZeneca in the UK to develop a combination therapy with GI-101, an immuno-cancer drug, and Impinzi (Durvalumab). With this contract, GI Innovation will conduct clinical trials with AstraZeneca to evaluate the combination of immuno-cancer drugs GI-101, Impinzi, and chemotherapy. This clinical trial targets patients with small cell lung cancer, gastric/gastroesophageal junction cancer, biliary tract cancer and triple-negative breast cancer in the United States, Australia, and Korea. GI Innovation will be provided with Infinzi necessary for this clinical trial from AstraZeneca, and it will gain the driving force to conduct successful clinical trials by jointly designing clinical trial designs based on AstraZeneca's expertise in developing immuno-cancer drugs. The clinical trials of both companies aim to treat patients with combination therapy with GI-101, an immuno-cancer drug, in addition to the current standard treatment, chemotherapy, in metastatic and advanced cancers. Despite the use of immuno-cancer drugs in clinical settings, small cell lung cancer, gastric/gastroesophageal junction cancer, biliary tract cancer, and triple negative breast cancer did not show sufficient efficacy alone. To compensate for this problem, a combination of chemotherapy and immuno-cancer drugs has recently been attempted, and some carcinomas have shown encouraging therapeutic effects. A typical example is that a combination of chemotherapy and Imfinzi in small cell lung cancer has been approved as a primary treatment. GI Innovation is a strategy to maximize the treatment effect through the combination of GI-101, chemotherapy, and Imfinzi. The IL-2 site of GI-101 not only directly proliferates and activates apoptotic T cells and natural killer cells in the tumor microenvironment, but also effectively inhibits CTLA-4, an immune gateway expressed in immune cells through CD80. Through CD80-CD28 interaction, it is also possible to activate the immune response of cell killing T cells. Finally, it also has a mechanism to relieve immunosuppression by regulatory T cells that express CTLA-4, an immune gateway, in large quantities. Another immune gateway, PD-L1, can be expected to have excellent anticancer immunity when used in combination with Imfinzi, which activates immune cells. GI Innovation's clinical trial was designed as an adaptive and basket trial to confirm the anticancer activity of four solid cancers in one clinical trial and to register more patients in solid cancers that are effective depending on the results of interim analysis. The clinical trial will be conducted at about 20 medical institutions in Korea, the United States, and Australia. Yoon Nari, head of GI Innovation's clinical division, said, "GI-101 is a bispecific fusion protein that has a complex immune regulation function that proliferates and activates cell-killing T cells and natural killer cells only with monotherapy. The combination of GI-101, Imfinzi, and chemical anticancer drugs is designed to fully utilize the inherent mechanisms of the drug to recover the degraded immune response in cancer patients, respectively. Through this clinical trial, we will do our best to secure meaningful clinical differentiation data.
- Company
- MSD's Delstrigo can be prescribed in general hospitals
- by Eo, Yun-Ho Dec 23, 2021 05:42am
- Delstrigo, an HIV combination that succeeded in registering insurance benefits, is preparing to enter the market in earnest. According to related industries, the HIV combination Delstrigo ( Doravirine 100 mg, Lamivudine 300 mg and Tenofir Disoproxil Fumarate), which is taken once a day by MSD Korea, has now passed the DC of medical institutions such as Sinchon Severance Hospital. The drug was approved in Korea in January last year, submitted a benefit application at the beginning of this year, and was listed in January. Delstrigo's benefit indication is "the treatment of HIV-1 infection in adults who have no previous anti-retrovirus treatment experience." Among the ingredients, Doravirine 100mg was approved by the MFDS under the brand name Pipeltro as of November 22, 2019, and is required to be administered in combination with other anti-retroviral drugs. Both Pipeltro and Delstrigo received indications for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients who had no previous anti-retroviral treatment experience. Delstrigo was confirmed its validity through DRIVE-AHEAD clinical trials. In the clinical trial, Delstrigo proved non-equivalence compared to therapy of Efavirenz ·Emtricitabine·Tenofovir. The proportion of patients who reached viral inhibition (less than 40 copies/mL of HIV-1 RNA) at 48 weeks was 84% in Delstrigo treatment group and 80% in EFV/FTC/TDF treatment group. The rate of discontinuation of treatment due to adverse reactions was 3% and 6.6%, respectively, which was lower in the Delstrigo treatment group. Meanwhile, Gilead, GSK, MSD, Janssen, AbbVie, and BMS are currently competing in the HIV sector, of which Gilead and GSK account for about 90% of the market.
