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- 2026-05-09 18:49:57
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- NTS will provide tax support for bio companies
- by Kang, Shin-Kook Jul 19, 2022 05:15am
- NTS CommissionerBiopharmaceutical companies are set to receive tax support from the National Tax Service. The National Tax Service (Commissioner Chang-ki Kim) held a roundtable meeting at the Incheon Free Economic Zone located in Songdo, Incheon to listen to the difficulties experienced by those in the field with leaders of small-to-mid-sized enterprises that are residing in the Songdo Bio Cluster. The roundtable meeting was prepared to listen to the tax-related difficulties experienced by SMEs in high-tech industries that represent Incheon as a region and devise tax support measures for their resolution. At the meeting, Commissioner Chang-ki Kim said, “We have been providing liquidity support by extending the payment deadline and providing early refunds for SMEs that are suffering from high prices, high interest rates, and high oil prices. We also have a tax support promotion task force in place based around tax offices nationwide to continuously monitor the damages in each region and provide customized tax support measures that fit their needs.” Commissioner Kim emphasized, “We are working to foster an environment that encourages corporate growth, by expanding exempting regular tax audits for SMEs in their early stages or those that created jobs to support economic revitalization, etc.” Commissioner Kim also added, “This year, we will simplify the document requirements to enable easier use of the prior review system for tax deduction provided to research and human resource development expenses while providing consulting on tax deduction and reductions that SMEs have difficulty with, as well as the family business succession system. Commissioner Kim added, “This year, we will simplify the document requirements to enable easier use of the prior review system for the tax deduction of research and human resource development expenses while providing consulting on tax deduction and reductions that SMEs have difficulty with as well as the family business succession system." The SME leaders that attended the meeting proposed ▲improving the tax credit system for integrated investments ▲reducint the tax audit burden ▲ expanding tax reduction for consigned R&D in the bioindustry ▲expanding tax deductions for companies that increase employment, etc. To such requests, Commissioner Kim said, “We will actively discuss the suggestions that were made with relevant departments so that the voices of the field can be reflected in the tax administration process.” Meanwhile, the Songdo Bio Cluster is located in Zones 4,5 (Bio cluster, high tech industry cluster) where companies and institutions in the bio-industry including universities, research institutions, hospitals, foreign companies, etc. are located. By 2030, about 700 companies and research institutes are expected to move in to the cluster. Major residents include Samsung Biologics, Celltrion, DM Bio, and Janssen Vaccine.
- Company
- Will social distancing resume?
- by Kim, Jin-Gu Jul 19, 2022 05:15am
- As the spread of the coronavirus is intensifying again, concerns in the pharmaceutical bio industry are also growing. Front-line companies seem to be paying keen attention to whether to resume social distancing measures, while asking executives and employees to strengthen personal quarantine rules ahead of the full-fledged summer vacation season. ◆ Please strengthen personal quarantine rules. & refrain from face-to-face meetings According to the Korea Centers for Disease Control and Prevention on the 13th, as of midnight on the 11th, there were 37,360 new confirmed patients in Korea. It is the first time in more than two months that the number of new confirmed patients in Korea has exceeded 30,000 since May 17 (36,31). The quarantine authorities believe that COVID-19 will be prevalent again. The government has announced the announcement of new quarantine measures in preparation for the re-pandemic in summer. The pharmaceutical bio industry is paying keen attention to the government's announcement of quarantine measures. Social distancing measures are not expected to be implemented immediately, but various scenarios are under consideration because the possibility cannot be completely excluded depending on the spread. Most companies do not have separate internal guidelines. However, the government plans to comprehensively review the government's announcement and the spread of COVID-19 and take measures such as refraining from face-to-face meetings and recommending distributed vacations. An official from a local pharmaceutical company said, "We did not take any special measures internally. We reiterated compliance with personal quarantine rules to employees." If we resume distancing measures, guidelines such as refraining from face-to-face meetings will be issued to executives and employees accordingly," he said. An official from a multinational pharmaceutical company said, "If at least one confirmed patient is found in the company due to the recent re-proliferation of COVID-19, new guidelines are expected to be prepared, such as expanding telecommuting internally. ◆ Increasing tension in factories and research institute In particular, factories and research institutes seem nervous about the re-proliferation of COVID-19. This is because, like when COVID-19 was rampant in the past, if a COVID-19 confirmed patient occurs, all of the departments are likely to go into self-quarantine for a certain period of time. An official from a domestic pharmaceutical company said, "Unlike the early stages of the COVID-19 crisis, the entire factory will not be shut down, but if all of the departments are self-isolated, it will inevitably disrupt the operation of the line." The official said, "We are paying attention to the possibility of a sharp increase in the number of COVID-19 confirmed cases in Korea during the summer vacation scheduled for early August," adding, "We have already had a special request for factory or research institute employees regarding summer vacation. If the situation becomes serious, measures such as distributed vacation may be recommended, he explained. Pharmaceutical factories are also mindful of the possibility that supply and demand difficulties for cold medicines and antipyretics will expand again. An official from a pharmaceutical company, who operated an emergency operation system at the time of supply and demand shortage earlier this year, said, "We have secured enough inventory in preparation for the possibility of supply and demand again." ◆Marketing and sales representatives, concerned about resuming distancing A marketing officer at a domestic pharmaceutical company said, "Distancing measures are not expected to be implemented immediately, but if the situation becomes serious, there is a possibility that it will resume. It's only recently that offline events have been possible. If distance measures are resumed, marketing activities will inevitably be disrupted." "We're already full of offline marketing events for the next two or three months. Confusion is expected to be severe over whether to push ahead with the scheduled event," he added.
- Company
- GC WellBeing transfers raw materials technology to Japan
- by Jul 18, 2022 06:06am
- GC Wellbeing (CEO Kim Sang-hyun) announced on the 15th that it has signed a technology transfer contract with Japan's Healthy Navi for the functional raw material Green-Cera F. Healthy Navi is a company in charge of product development and distribution of functional and general food ingredients in Japan. Green-Cera F is a raw material recognized by the Ministry of Food and Drug Safety for its functionality that can help stomach health by protecting the gastric mucosa. Through non-clinical tests, it has been confirmed that this raw material can help stomach health, such as antioxidant, anti-inflammatory, protecting the gastric mucosa, and increasing the amount of gastric mucus. In addition, through human application tests, statistically significant improvement was shown in the gastrointestinal liver symptom scale item. Through this contract, GC Wellbeing provides Green-Cera F to Healthy Navi and receives royalties for raw material sales in Japan. Healthy Navi will secure Green-Cera F's exclusive supply rights to Japan and the right to develop and launch products using this raw material. The company plans to further accelerate the overseas expansion of excellent functional materials held under this contract and expand markets such as Asia, the U.S., and Europe outside Japan. An official from GC Wellbeing said, "This contract is the first case of technology transfer of its functional raw materials overseas." "We plan to actively promote overseas expansion of our company's functional materials in the future," he said. GC Wellbeing is researching and developing functional raw materials derived from various natural products, which can help joint and cartilage health.
- Company
- SK’s epilepsy drug makes over ₩400 billion in 3 years
- by Chon, Seung-Hyun Jul 15, 2022 05:57am
- SK Biopharmaceuticals’s new anti-epileptic drug ‘Xcopri’ has brought in a total of ₩400 billion in upfront payments and milestone payments over the past 3 years. This is the largest amount of cash secured by a new drug that was licensed out by Korean pharmaceutical companies. According to the Financial Supervisory Service on the 14th, SK Biopharmaceuticals signed a licensing deal with the Brazilian pharmaceutical company Eurofarma Laboratorios SA for its anti-epileptic drug Xcopri. Under the agreement, SK Biopharmaceuticals will receive an upfront payments of $15 million and up to $47 million in milestone payments which are paid when each phase of development, approval, etc. is completed. The company will also separately collect royalties proportional to net sales upon Xcopri’s commercialization. Under the licensing agreement, Eurofarma will sell cenobamate in 17 Latin American countries including Brazil and Mexico. Eurofarma, which owns expertise in the sales and marketing of central nervous system (CNS) disorder treatments owns a sales network throughout Latin America. Cenobamate is a new anti-epileptic developed solely by SK Biopharmaceuticals from its initial development to US FDA approval as a treatment for partial-onset seizures in adults. It simultaneously regulates 2 targets related to excitatory/inhibitory signaling that is known to cause epilepsy to reduce seizure frequency. SK Biopharmaceutical received approval for cenobamate under the brand name ‘Xcopri’ from the US FDA in November 2019 and has been directly selling the drug through its US subsidiary SK Life Science ever since. SK Biopharmaceutical has been entering overseas countries other than the US by licensing out cenobamate to its local partners. SK Biopharmaceutical entered into a licensing agreement last February with the Swiss pharmaceutical company Arvelle Therapeutics to transfer technology on cenobamate for up to $530 million. At the time, SK Biopharmaceutical received an upfront payment of $100 million with no obligation of return. In October 2020, the company entered into an exclusive licensing agreement with Ono Pharmaceutical for Ono to develop and commercialize Xcopri in Japan. Under the agreement, SK Biopharmaceutical received an upfront payment of ¥5 billion with no obligation of return, and will also be eligible to receive up to ¥48.1 billion based on the achievement of certain regulatory and commercial milestones, as well as double-digit royalties on net sales generated in Japan. In November last year, SK Biopharmaceutical licensed out 6 new central nervous systems (CNS) drugs including cenobamate to Ignis Therapeutics. Under the deal, SK Biopharmaceutical received an upfront payment of $20 million, a milestone payment of $15 million, and royalties on net sales in the future. Through the technology export, SK Biopharmaceutical acquired 150 million shares of Ignis (share amounts to 44.9% including common stock). And in December last year, SK Biopharmaceutical signed a licensing deal with Endo Group for the commercialization of its epilepsy drug cenobamate across Canada. Under the deal, SK Biopharmaceutical received an upfront payment of $20 million in USD. The company will also be able to receive up to $21 million in Canadian dollars based on the achievement of certain regulatory and commercial milestones in the future. Paladin Labs Inc., a Canada-based operating subsidiary of Endo, will be responsible for all commercial activities related to cenobamate in the region, including its release. Endo is a global healthcare company headquartered in Ireland. In addition to upfront payments, the company has also received milestone payments upon cenobamate’s approval abroad. SK Biopharmaceutical received $123.22 million from its European partner Angelini Pharma as milestone payments last year. Angelini Pharma (formerly Arvelle Therapeutics UK) has collected additional milestone payments after receiving marketing authorization from the European Commission in March last year. SK Biopharmaceutical’s cash inflow from upfront payments and further milestones from the technology transfer of cenobamate is $278.22 million and ¥5 billion. Based on the recent exchange rates, the company had secured about ₩400 billion through upfront and milestone payments through technology transfer with cenobamate. This is estimated to be the largest amount earned from the technology transfer of a single new drug developed in Korea. In 2015, Hanmi Pharmaceutical received the largest amount as an upfront payment, €240 million (approximately ₩260 billion, to transfer the license of its 3 new diabetes drugs to Sanofi. No additional milestone occurred and all rights were returned to Hanmi Pharmaceutical. Yuhan Corp’s new anticancer drug ‘Leclaza (lasertinib)’ received $150 million (approximately ₩190 billion) in upfront and milestone payments. Yuhan Corp has made a licensing deal with Janssen biotech in November 2018. At the time, the company received an upfront payment of $50 million with no obligation of return. Yuhan Corp received a milestone payment of $35 million from Janssen in April 2020 for lasertinib. At the time, Janssen had paid an additional milestone to Yuhan Corp when it started a clinical trial for combination therapy using amivantamab and lasertinib. Yuhan Corp had collected an additional $65 million in milestone payments when Janssen started recruiting subjects for the Phase III trial of its self-developed anticancer drug amivantamab and lasertinib combination.
- Company
- Keytruda adds neoadjuvant/adjuvant therapy indication
- by Jul 15, 2022 05:57am
- Keytruda MSD’s anti-PD-1 immunotherapy drug ‘Keytruda (pembrolizumab)’ received approval to extend its indication as neoadjuvant/adjuvant therapy in triple-negative breast cancer (TNBC). From the 13th, the Ministry of Food and Drug Safety has extended Keytruda’s indication▲ as neoadjuvant therapy in combination with chemotherapy (carboplatin+paclitaxel, followed by doxorubicin or epirubicin+cyclophosphamide), and ▲ as adjuvant monotherapy in patients with previously untreated Stage II or III TNBC. The company expects the recent approval to benefit more patients as a PD-L1 expression test is not required for the use of Keytruda as neoadjuvant/adjuvant therapy. Also, its convenience of administration has been improved with the allowance of its administration every three weeks and every six weeks. As a result, in addition to being approved as a treatment for locally advanced recurrent or metastatic TNBC in July, the drug has established its position as a treatment in early TNBC. The recent approval as neoadjuvant and adjuvant therapy was based on the Phase III KEYNOTE-522 trial conducted in 1,174 TNBC patients. In the trial, neoadjuvant administration of the Keytruda+chemotherapy combination reduced the risk of disease progression that precluded definitive surgery, local/distant recurrence, second primary cancer, or death from any cause by 37%, and significantly prolonged event-free survival (EFS). The 36-month EFS of the Keytruda group was 84.5%, significantly higher than the 76.8% in the control group. In the median follow-up period of 15.5 months, the pathological complete response (pCR) of Keytruda as neoadjuvant/adjuvant therapy was 64.8%, a statistically significant difference from the 51.2% of the chemotherapy monotherapy group. The safety profile of the Keytruda regimen was consistent with the profile of chemotherapy or Keytruda monotherapy that is used in high-risk early TNBC patients, and no new safety concerns were identified. Most of the immune-mediated adverse events (AEs) occurred in the neoadjuvant phase. The immune-mediated AEs as adjuvant monotherapy were low-grade and at a manageable level. Sungphil Kim, Business Unit Head of the Oncology Franchise of MSD Korea, said, “We are pleased to be able to introduce Keytruda as a new therapy option for TNBC in only one year since we received approval for the first breast cancer indication. Keytruda will offer new hope to high-risk TNBC patients who are in dire need of a new treatment option by reducing tumor size as adjuvant therapy and preventing recurrence and metastasis as neoadjuvant therapy in TNBC as a single, integrated regimen."
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- Daewoong expects sales of 4 new drugs to rise
- by Lee, Tak-Sun Jul 15, 2022 05:57am
- Daewoong Pharmaceutical expects sales to rise through its new drug introduced along with the new drug Fexuclue, a new drug for gastroesophageal reflux disease. This includes biosimilars such as Lexapro, Ogivri, and Alymsys, the No. 1 items in the antidepressant market. According to industries on the 14th, Daewoong Pharmaceutical is planning to continue its performance increase through its new drug introduced this year. Last year, Daewoong Pharmaceutical recorded its highest-ever performance with sales of 1.1530 trillion won and operating profit of 88.9 billion won. The driving force behind the rise in sales is P-CAB gastroesophageal reflux disease, which was released this month. Fexuclu is expecting sales of 100 billion won. Although it is not known to the media, it is analyzed that the pipeline of new drugs will also contribute to the rise in sales. Daewoong Pharmaceutical signed four drug sales contracts with other companies last year, all of which are expected to have high sales in a short period of time. Lundbeck signed a joint sales contract with Lexapro last December. Lexapro is the number one item in the antidepressant market. Based on last year's UBIST, it is a large product with an out-patient prescription of 22.2 billion won. Daewoong signed a contract with Ebixa Corporation for dementia treatment in 2019 and is expanding cooperation with Lundbeck by jointly selling Lexapro. It is also worth paying attention to the contract, an exclusive license in Korea, for Viatris and Herceptin biosimilar Ogivri in September last year. Ogivri was approved by Alvogen Korea in August 2020. However, since then, the license holder has been changed to Daewoong Pharmaceutical. It is also being released with a salary in November 2020. Ogivri is the third Herceptin biosimilar to compete with Celltrion Herzuma and Samsung Bioepis Sampenet. Competition for the three items is expected to intensify as Daewoong Pharmaceutical holds domestic copyrights. Alymsys, an Avastin biosimilar waiting to be reimbursed, is also a rising star. Alymsys is an item authorized by Alvogen Korea earlier this year. Prior to this, in October last year, Daewoong signed an exclusive distribution and sales contract with Alvogen for Alymsys in Korea. As a result, when the salary is released, Daewoo will be in charge of domestic sales. Currently, Avastin biosimilar has been released only in Korea by Samsung Bioepis. Given that the original Avastin has a market worth 120 billion won in Korea, high sales are expected if it settles down well as a biosimilar. The last contract signed last year was signed with LG Chem. Currently, LG Chem has a joint sales contract with DPP-4 diabetes treatments Zemiglo and Zemimet, and in addition, a license contract was added in November last year to develop Gemigliptin and Enavogliflozin complex. Enavogliflozin is an SGLT-2 diabetes drug developed by Daewoong. It is analyzed that it is an attempt to increase its grip on the diabetes market by developing a complex that combines Zemiglo.
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- EUSA Pharma is entering the Korean market
- by Jul 15, 2022 05:57am
- EUSA Pharma, a British pharmaceutical company specializing in rare diseases, announced its full-fledged entry into the Korean market. EUSA Pharma plans to directly supply the existing domestic approved Castlemans disease treatment, Sylvant (Siltuximab), while also accelerating the introduction of new rare disease treatments. EUSA Pharma held a press conference at The Plaza in Seoul on the 13th and announced its ambition to improve its recognition of Castlemans danger and enter the Korean market. EUSA Pharma is a pharmaceutical company specializing in rare diseases established in the UK in 2015. It was established as EW Healthcare Partners Funding, an investment company specializing in life science. As of June last year, global sales were recorded at 130 million euros. The number of employees around the world is about 250. In the first half of last year, the Asia-Pacific regional headquarters was established in Korea and the Korean subsidiary EUSA Pharma was launched in the second half of last year. Korea is the first region outside Europe and the U.S. where EUSA Pharma has entered. The Korean corporation consists of a total of seven executives and employees. Lee Yeon-jae, CEO of EUSA Pharma CEO Lee Yeon-jae (46) was appointed as the integrated general manager of the EUSA Pharma Asia-Pacific headquarters and the Korean subsidiary. CEO Lee has worked as CEO of UCB Pharmaceutical Korea and executive director of Sanofi-Aventis Korea's rare blood disease business division through Novartis Korea and Daewoong Pharmaceutical. The representative item of EUSA Pharma is Silvant, a Castlemans disease treatment that was approved in Korea in 2015 and is being applied to benefits. EUSA Pharma acquired Sylvant from Jansen in 2020 and has global copyright. In Korea, Samoh is the right to import and sell, and EUSA Pharma will be in charge of supplying and marketing Sylvant. Regarding the background of EUSA Pharma's entry into Korea, CEO Lee said, "The Asia-Pacific region, especially Korea, is considered an important market for the company as multiple Castlemans disease diagnosis and treatment are actively conducted." He explained, "Korea is not a country with a large number of patients compared to the population, but thanks to the medical staff's efforts to find and diagnose patients, it is considered the best country to diagnose and treat multiple Castleman disease after the United States and Italy." EUSA Pharma's first activity is to create an environment where patients can be diagnosed faster by raising awareness of multiple Castleman disease. Multiple Castlemans disease is a rare blood disease that causes organs such as lymph nodes, liver with lymphatic tissue, and spleen to enlarge due to excessive proliferation of lymphocytes. According to Jeon Young-woo, a professor of blood medicine at Yeouido St. Mary's Hospital, it takes about 27.5 months for patients to be diagnosed with multiple Castlemans disease. Due to the low awareness of the disease and low specific symptoms, it is often diagnosed only after the disease has progressed considerably. There are about 150 annual patients in Korea, but it is speculated that there will be more hidden patients who have not yet been diagnosed. If you do not receive proper treatment early, there is a high risk of developing lymphoma. 27% of patients are diagnosed with cancer within 2 to 5 years after diagnosis of multiple Castlemans disease. In the case of idiopathic multiple Castlemans disease, 35% of patients died within 5 years. Professor Jeon said, "Even within the medical staff, the recognition of multiple Castlemans disease is not very high, so diagnosis is very difficult unless it is tested for a purpose." After the lymph nodes become enlarged, it can be said that the disease has already progressed to seriousness," he explained. Professor Jeon said, "As long as early diagnosis is done well, various drugs such as Sylvant can be used to treat it. In particular, if Sylvant is used for more than six months, symptoms improve dramatically, and permits and benefits are applied as the first treatment in Korea. We can suspect Castlemans disease as an early test, and we should try to raise the awareness of medical staff and patients," he said. EUSA Pharma plans to make efforts to introduce the treatment Dinutuximab beta, which targets another rare disease, high-risk neuroblastoma, in Korea. CEO Lee said, "We are currently preparing screening data for Dinutuximab beta permission." Meanwhile, as Global EUSA Pharma was acquired by Recordati at the end of last year, changes are expected in its Korean subsidiary. CEO Lee said, "We are discussing organizational charts and development strategies for each country, and major commercial organizations have been reorganized." CEO Lee added, "There is a possibility that the name of the company will be changed, and it is expected to be finalized at the end of this year."
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- Multinational companies leaving the Korean market
- by Jul 15, 2022 05:57am
- New drugs from multinational pharmaceutical companies such as Otezla, Cotellic, and Erievedge, which were not properly introduced in the domestic market, left the Korean market one after another this year. It is believed that it has made significant sales overseas but has decided to withdraw due to lack of marketability in Korea. According to the MFDS on the 7th, Roche voluntarily dropped two types of anticancer drugs, Cotellic and Erievedge, in the first half of the year. The licenses for Cotellic and Erievedge were revoked as of June 23 and April 7. Erivedge is a skin cancer treatment approved by the MFDS in 2013. It is used to treat metastatic basal cell cancer that cannot be operated or radiated. It is the first target anticancer drug for skin cancer and a rare drug that raised global annual sales of 380 billion won. Although Erivedge was a non-reimbursed drug in Korea, it was selected as the government's "disaster medical expenses support project" in 2015 as a treatment for rare diseases and provided medical expenses. However, as severe skin abnormalities were reported and it was pointed out that the drug price was higher than its clinical usefulness, In 2017, the UK removed Erivedge from the list of anti-cancer drug support funds. Even in Korea, Erivedge has not been imported since 2019. Cotellic is a melanoma treatment approved in Korea in 2015. Although it was conditionally approved as a new drug for MEK inhibitors, it was pointed out in the 2017 parliamentary audit because it was not supplied to Korea after approval. It seems that he did not enter the domestic market after that. Since it has never been supplied, no application for salary has been made. Due to the cancellation of the Cotellic, Roche's immuno-cancer drug Tecentriq and combination therapy are not expected to be used in Korea. Roche obtained an indication of progressive melanoma treatment in the United States with Tecentriq+Cotellic+Zelboraf 3 drug therapy in 2020. Amgen's psoriasis drug Otezla has left the market. Otezla is the first PDE-4 inhibitor that Amgen acquired from Celgene. In the global market, they performed so well that they were ranked as blockbusters. Otezla's annual sales reached 2.9 trillion won last year. Korea also showed high expectations for Otezla, which obtained permission in 2017. However, Otezla was not even released in Korea. It is believed that negotiations were not smooth because Celgene, the first permit holder, was merged with BMS, and Amgen changed one after another in the process of acquiring Otezla. In addition, as the expiration date of Otezla's patent approaches, Amgen seems to have decided that it has lost marketability in Korea. Amgen dropped Otezla's permission on June 9.
- Company
- Tabrecta can be prescribed at hospitals
- by Eo, Yun-Ho Jul 14, 2022 05:54am
- According to related industries, Tabrecta of Novartis Korea passed the D.C. of medical institutions such as the National Cancer Center, Pusan National University Hospital, Samsung Seoul Hospital, and Sinchon Severance Hospital. Tabrecta, which is currently undergoing the insurance benefit registration process, was approved in Korea in November last year. MET mutations are rare types that account for about 3% to 4% of metastatic non-small cell lung cancer, and as there have been no treatments, interest in these new drugs is increasing. Tabrecta targets c-Met and was first approved in the United States as a non-small cell Lung Cancer treatment in May 2020. The drug was validated by a phase 2 GEOMETRY mono-1 study of 97 patients with METex14. As a result of the study, the overall response rate was 68% in patients who had never been treated and 41% in patients who had previously been treated. Among patients who took Tabrecta, patients who had not previously been treated (DoR was 12.6 months and those who had been treated were 9.7 months. Tabrecta is also stepping up research for future combination therapy. In particular, it is expected to solve the resistance problem of EGFR TKI in lung cancer. Tabrecta is conducting clinical trials in combination with AstraZeneca's third-generation EGFR TKI Tagrisso. Specifically, combination therapy of Tabrecta and Tagrisso is compared with platinum-based chemotherapy for EGFR mutated non-small cell lung cancer patients with T790M negative and amplified MET genes during treatment with first and second generations EGFR TKI or Tagrisso. Han Ji-yeon, a professor of hematology and oncology at the National Cancer Center, said, "The prognosis of patients with MET amplification is also very poor. At a time when it is very important for MET inhibitors to enter the market quickly, it is significant that drugs such as Tabrecta, which proved a clear effect only on MET Exxon 14 deficit mutations, were approved."
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- SK Bioscience, "SKY Covione booster prevents Omicron”
- by Chon, Seung-Hyun Jul 14, 2022 05:54am
- SK Bioscience announced on the 13th that its ‘SKYCovione’ has shown to have an effect in preventing the Omicron variant as a booster shot. SK BioscienceThe company identified such results from an extension study on Phase I/II trial on SKYCovione that was conducted on 81 healthy adults who received a booster dose of SKYCovione around 7 months after primary vaccination. Study results showed that the neutralizing antibody titres against the Omicron variant BA.1 were 25 times the titres right after the second dose, and 72 times the titres 7 months after the second dose (immediately before receiving a booster shot) SKYCovione is a locally developed COVID-19 prevention vaccine that was approved in Korea last month. SKYCovione induces antibody response by administering antigenic proteins made by genetic recombination technology The vaccine had previously demonstrated its immunogenicity and safety through a global clinical trial. In a global Phase III trial conducted on 4,037 adults over 18 years of age, 98% of the participants seroconverted (with neutralizing titres after immunization greater than fourfold the titres at baseline). Neutralizing antibody responses also increased by 33 times the titres before SKYCovione injection and were 3 times the titres elicited by the control vaccine. In addition to the Phase I/II extension trial, the company is conducting an extension trial on the recent Phase III trial it had conducted, as well as a booster shot trial for those who have been vaccinated with other approved vaccines in Korea to further explore SKYCovione’s response to the Omicron variant. Jaeyong Ahn, CEO of SK Bioscience, said, “In addition to the various trials in progress for SKYCovione, we will make our most effort to accelerate the development of polyvalent vaccines and universal vaccines based on our platform in preparation of the endemic.”
