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- 2025-12-25 04:43:00
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- 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.
- 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"
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- 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.
- Company
- Kakao is throwing the hat into the healthcare business
- by Kim, Jin-Gu May 10, 2022 06:14pm
- Large domestic companies are throwing their hat into the healthcare business. In the past year, leading conglomerates such as Lotte, Kakao, Doosan, Hyundai Heavy Industries & Construction, GS, CJ, and OCI have formalized their entry into the healthcare market. Analysts say that Samsung and SK have succeeded in the pharmaceutical bio business one after another, stimulating these companies. ◆Lotte Biologics' pre-debut notice at "BioUSA" According to the pharmaceutical industry on the 9th, Lotte Group announced that it will attend the "BioUSA" in the U.S. in June. Lotte Biologics, which recently completed its trademark application, is expected to make its debut through BioUSA. In March last year, it became the second-largest shareholder by acquiring part of the stake in Enzychem. In August last year, Lotte Group's ESG Management Innovation Office established a new growth team (biological team) and a new growth team (health care team). Lotte Biologics, which is about to be officially launched, is known to be in charge of the CMO business of biopharmaceuticals. Lee Won-jik, a former executive director of Samsung Biologics, is said to be leading the new growth team, which will be the mainstay of Lotte Biologics. ◆ GS, CJ, Doosan, Hyundai Heavy Industries, Kakao, OCI In addition to Lotte, GS, CJ, Doosan, Hyundai Heavy Industries, Kakao, and OCI have visualized their entry into the healthcare business in the past year. GS acquired Hugel in August last year. A multinational consortium led by GS Group, APHRODITE ACQUISITION HOLDINGS LLC, signed a stock transfer contract to purchase a 46.9% stake in Hugel. The acquisition amount amounts to 1.724 trillion won. ▲ GS acquired Hugel, OCI acquired Bukwang, and CJ acquired ChunLab, signaling full-fledged entry into the pharmaceutical bio business OCI acquired Bukwang Pharmaceutical in February this year. OCI became the largest shareholder as it secured an 11% stake in Chairman Kim Dong-yeon, founder of Bukwang Pharmaceutical. It is interpreted as a signal that it will enter the pharmaceutical bio business in earnest. At this year's general meeting of Bukwang Pharmaceutical's shareholders, Lee Woo-hyun, vice chairman of OCI, became co-CEO of Bukwang with the existing CEO Yoo Hee-won. CJ officially launched CJ Bioscience under CJ group in January this year. CJ Bioscience selected Microbiome as its core business. To this end, it acquired ChunLab, a microbiome company, in October last year. CEO Chun Jong-sik, who led ChunLab, will continue to represent CJ Bioscience. Kakao newly established 'Kakao Healthcare' in March. Healthcare CIC, which was previously operated as an in-house independent corporation, was separated into separate corporations. Prior to this, Hwang Hee, a professor at Seoul National University Bundang Hospital, who was recruited in December 2021, was appointed. Kakao Healthcare is expected to focus on digital healthcare businesses such as AI-based medical solution development and service industry, health care by life cycle, and smart medical care. Doosan added a medical device business to its business area through the revision of its articles of association at a shareholders' meeting held in March this year. Doosan is planning to target the biopharmaceutical container market. In December last year, it invested $100 million in SiO2, a U.S. drug storage container company. At the same time, it secured exclusive business rights in Asia and Oceania for all SiO2 products. It is planning to start manufacturing in South Korea in the future. Hyundai Heavy Industries Holdings, the holding company of Hyundai Heavy Industries Group, changed its name to HD Hyundai at a shareholders' meeting in March this year and announced plans to support four future industries, including healthcare. Hyundai Heavy Industries Holdings established 'AMC' last year and is also developing new drugs. In the pharmaceutical industry, it is interpreted that the success of Samsung and SK, which entered the field first, served as a stimulus to large companies' entry into the bio business. Samsung Biologics, SK Bioscience, and SK Biopharm, affiliates of the two groups, have become leading companies in the industry before and after the Corona crisis. Large domestic companies began the pharmaceutical bio business with enthusiasm in the past, but withdrew one after another in the mid-2010s. Lotte Pharmaceutical was launched in 2002 when it acquired a subsidiary of Ilyang Pharmaceutical's health functional food. However, in 2011, Lotte Pharmaceutical was merged into Lotte Confectionery and withdrew from the market. In 2014, CJ spun off CJ Healthcare as a separate subsidiary of the pharmaceutical division, driving the pharmaceutical bio business. However, it sold its 100% stake in CJ Healthcare to Kolmar Korea for 1.31 trillion won in 2018. Hanwha established the pharmaceutical business department in 2996 and launched Dream Pharma by absorbing and merging H-PHARM in 2004. Although it made a large-scale investment to develop a biosimilar of Enbrel, a TNF alpha inhibitor through Dream Pharma, it eventually sold Dream Pharma to Alvogen in 2014 as product development was delayed and related contracts were terminated. AmorePacific sold its subsidiary Pacific Pharmaceutical Co. to Handok in 2013 to focus on its beauty business.
- Company
- Koselugo reattempts insurance benefit in neurofibromatosis
- by Eo, Yun-Ho May 10, 2022 06:07am
- The neurofibromatosis treatment Koselugo is once again making an attempt to receive insurance benefits in an area that has no available treatment options, According to industry sources, AstraZeneca has applied for the insurance reimbursement of its new neurofibromatosis drug Koselugao (selumetinib) recently. Koselugo is indicated for ‘the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in pediatric patients with neurofibromatosis type 1 (NF1) aged 3 years and above.’ After the drug received a non-reimbursement decision by the Drug Reimbursement Evaluation Committee of the Health Insurance Review and Assessment Service in March, the company has been working to promptly prepare the supplementary data to restart listing discussions for the drug. As NF1 is a rare disease area with no available treatment option, whether Koselugao will be able to receive reimbursement approval this time remains to be seen. Until now, patients had to rely on symptomatic treatment for neurofibromatosis due to the lack of an appropriate treatment option. Neurofibromatosis is a rare disease, and 85% of the patients with neurofibromatosis have neurofibromatosis type 1 (NF1), which is caused by a mutation in the neurofibromin tumor suppressor gene located on chromosome 17. The incidence of NF1 is approximately 1 in 3,000. Its first symptom is café-au-lait spots 1 to 3 centimeters in diameter early in life. Since then, the patients experience Optic nerve gliomas (brain tumors) at age 6, and scoliosis around age 6-10. In adulthood, lisch nodules, or iris hamartomas, occur predominantly in patients with NF1. If possible, treatment includes surgical removal of affected sites or chemotherapy and radiation therapy. However, most recur even after surgery, and as the patient must undergo a major operation, its treatment puts an immense burden on both the medical staff and the patient. Recurrence is even more frequent among pediatric patients, which means the patients must live with painkillers and often suffer from speech and movement disorders even after receiving several operations. Meanwhile, Koselugo was jointly developed by AstraZeneca and MSD. The drug blocks the activation of MEK to inhibit the growth of cell lines. The Phase II SPRINT study that became the basis for Koselugo’s approval showed that Koselugo reduced tumor size by over 20% in 68% of the patients that received Koselugo and achieved its primary endpoint of ORR. Also, 82% of the patients that showed a partial response had sustained responses lasting at least 12 months. Contrary to non-treated patients, half of which experience disease progression 1.5 years after diagnosis, only 15% of patients using Koselugo showed disease progression at year 3.
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- Powder-type child antipyretic analgesics have been released
- by May 10, 2022 06:07am
- Johnson & Johnson Korea (CEO Baek Joon-hyuk) announced on the 9th that it has released the first powder-type children's antipyretic painkiller Children's Tylenol powder 160 mg in Korea. Children's Tylenol powder has various effects such as headache, neuralgia, muscle pain, sprain pain, menstrual pain, toothache, and joint pain, as well as fever and pain caused by a cold, so it can be widely used for fever and labor. The new product with the unique technology of Tylenol, an original Acetaminophen product, is a fever reducer of "powder formulation" that relieves the discomfort of liquid and syrup types and improves the convenience of taking pills for consumers who are unable to swallow them. As soon as the powder touches the tongue, it melts immediately in 23 seconds, so it can be taken without water, and it is easy to carry in the form of a stick pouch. It can be eaten quickly and comfortably with a small amount, so the packaging material can be used hygienically without touching the mouth. Children's Tylenol powder has both taste and effect with its special coating. The special coating of Ethyl cellulose in children's Tylenol powder prevents the bitter taste of Acetaminophen from the tongue. Wild berries and natural berries make it easy for children who had difficulty taking medicine without feeling repulsed. Parents who had to watch their children refuse the medicine for reasons such as taste, formulation, and dosage will be able to provide new options to save them the trouble of taking the medicine. The age of taking is children aged 7 to 12 years old (can be taken by elementary school students with a weight of more than 23kg), and the recommended dose is taken directly every 4-6 hours without water. It should not be taken more than 5 times a day (75 mg/kg). It is sold at pharmacies based on 12 bags per product, and if you need to divide it separately, it is recommended to fold the pouch and divide it into small quantities such as measuring cups or spoons provided at home. "Children's Tylenol Powder is the first powder-type new product in Korea that can meet needs for young children who have difficulty swallowing pills or children who are too big to eat syrup, in the form of 15mg powder per packet," said Kim Hanna, a group manager at Johnson & Johnson's self-care division. She said, "At this point when the risk of children's COVID-19 infection continues, child Tylenol powder is expected to function as a home remedy for more convenient management of fever pains for the whole family."
- Company
- Sales of generic for Galvus are not affected
- by Kim, Jin-Gu May 10, 2022 06:07am
- A reversal occurred once again in the patent dispute for the DPP-4 inhibitor-based diabetes treatment Galvus. The original signing Novartis won the remand hearing that took place after the Supreme Court's dismissal. The pharmaceutical industry believes that the decision will not have a significant impact on sales of generic for Galvus, which was released earlier this year. This is because the material patent in question expired during the dispute. According to the pharmaceutical industry on the 4th, the Korean Intellectual Property Tribunal overturned the previous ruling in a lawsuit to invalidate the extension of the duration of the material patent of Vildagliptin and decided to win Novartis. The Galvus patent dispute has been complicated by the reversal. Ahngook and Hanmi filed a trial in 2017, claiming that some of the extended duration of material patent of Galvus was invalid. In the first trial, Generic companies won. In 2019, the Patent Tribunal ruled that 187 days of the extended duration were invalid. Novartis won the second trial. In 2020, the Patent Court ruled that 55 of 187 days were invalid. The case went to the Supreme Court on Novartis' appeal. In October last year, the Supreme Court ruled against the company and sided with the company. It was a ruling that Novartis, which won the second trial, was not eligible to appeal. The case was dealt with in the first trial. In the end, the Patent Tribunal took Novartis' side. Even 55 days recognized by the patent court did not constitute invalidity. However, the pharmaceutical industry predicts that there will be no problem with the sale and prescription of generic for Galvus even with the Korean Intellectual Property Tribunal's decision. This is because the material patent expired during the dispute. The Galvus material patent expired on March 4. Hanmi Pharmaceutical, Ahngook Pharmaceutical, Angooknewpharm, Kyongbo, Korea United Pharmaceutical, Samjin, and Shin Poong then released the generic. Hanmi Pharmaceutical, which launched Vildagle as generic for Galvus in January this year, is also determined to continue marketing and sales of its products as usual. An official from Hanmi said, "The material patent of Vildagliptin has already expired on March 4, and there is no impact on the distribution, sale, and prescription of the previously released Vildagle. We plan to appeal to continue to focus the company's capabilities for the success of Vildagle."
- Company
- The diagnosis of rheumatoid arthritis has been activated
- by Eo, Yun-Ho May 09, 2022 06:04am
- The treatment environment for rheumatoid arthritis has improved significantly. As the diagnosis became accurate, it increased, and the application of the new drug developed greatly. Recently, the number of patients has been steadily increasing every year as the diagnosis of rheumatoid arthritis has been activated in Korea. The HIRA updates disease statistics last year at the end of April every year. Recently confirmed and found that the number of patients with rheumatoid arthritis in 2021 was about 131.68 million, an increase of more than 25% over five years compared to 104,354 in 2016. Rheumatoid arthritis is an autoimmune disease in which the immune system attacks joint tissue, causing inflammation and pain, causing joint damage, dysfunction, and painful swelling. Early treatment is known as a disease that can be managed by positively improving the patient's prognosis. In the past, diagnostic criteria were diagnosed as rheumatoid arthritis if more than four of the seven symptoms, such as morning stiffness or osteoarthritis of the hand. This criterion was useful as a method for diagnosing rheumatoid arthritis, which has already progressed a lot, but it was pointed out that it was not suitable for early diagnosis. However, in 2010, ACR and EULAR set a new standard for diagnosing rheumatoid arthritis if the number of joint invasion, the results of rheumatoid factors and anti-CCP antibody tests through blood tests, the increase in inflammation levels, and the duration of symptoms are scored. This was a turning point in quickly and accurately diagnosing rheumatoid arthritis. An official from the association said, "It is understood that rheumatoid arthritis is being diagnosed well compared to the past due to the recent continuous development of diagnostic methods and the increase in disease awareness. However, there are patients who do not know the disease well yet and do not receive proper treatment, or who need pain improvement even if they receive treatment," he said. In fact, since bony erosion occurs in about 60-70% of rheumatoid arthritis within two years of the outbreak, rapid diagnosis and drug treatment are important to prevent the progression of the disease. However, there are still patients with poor treatment prognosis, so more diverse treatment options are required. In an overseas meta-analysis study of about 80,000 patients with rheumatoid arthritis, the rate of achieving remission was found to be only about 20% despite biological two-year treatment. As time goes by, various drugs are introduced, creating a smooth treatment environment. The latest treatments, such as biological drugs and JAK inhibitors introduced since the 2000s, are showing effects on patients who lack treatment effects with existing treatments or have difficulty improving symptoms. Among them, the most recently introduced JAK inhibitors show significant results in clinical remission, pain, and improvement of body function. Although these drugs differ slightly, they show significant improvements compared to anti-TNF drugs in the rate of reaching various criteria. "With the recent introduction of accurate diagnostic standards and new drugs, the treatment environment for rheumatoid arthritis has been dramatically improved. As it is possible to achieve and improve pain through the introduction of continuous treatments such as JAK inhibitors, if you have symptoms of rheumatoid arthritis, please visit the rheumatoid internal medicine immediately for an accurate examination.
- Company
- “Will become a CRO specializing in cell·gene therapy”
- by Lee, Tak-Sun May 09, 2022 06:04am
- Director Eun-Kyung Sohn, HCO at Seoul CRO “I believe the cell·gene therapy market will expand the greatest among biopharmaceuticals. The number of new clinical trials entering the field increased over threefold from 2016, and the role of CROs that have strengths in conducting clinical trials for cell· gene-based therapies will further increase in the coming future.” Director Sohn explained her vision of growing the company into a cell·gene therapy specialized CRO in line with the industry trend. Director Eun-Kyung Sohn, HCO (Head of Clinical Operation·46) at Seoul CRO, joined the company in December last year. Sohn aims to find a breakthrough in the midst of the intensifying competition in the CRO market by developing Seoul CRO’s own area of expertise. In an interview held at Seoul CRO’s Gangnam office, Sohn relayed the company’s vision for growth into a cell·gene therapy specialized CRO. Director Sohn is a seasoned veteran that has over 20 years of experience accumulated in various prominent CROs in Korea, including Dream CIS and C&R Research. During her previous work at QVIS, Sohn was in charge of general project management for bioventure companies. Sohn said, “Bioventure companies are highly dependent on CRO companies due to their weak clinical infrastructure, and I was in charge of providing consulting, management, and training for our clients that contracted their research to the company.” Sohn’s career in the field fits will with Seoul CRO’s direction in attracting more cell·gene therapy venture companies for research. After joining Seoul CRO, Director Sohn has been in charge of the overall management of CRO-related clinical tasks that were by the pharmaceutical and bio company clients. Seoul CRO’s plan to become a cell·gene therapy specialized CRO reflects the company’s strategy to embrace the market situation while incorporating the company’s strengths. Sohn said, “With the number of CROs increasing recently, I believe each CRO should have a specialized area of expertise rather than cover all services. Seoul CRO aims to attract bioventures, especially those that develop cell·gene-based therapies.” Seoul CRO is part of the CHA Medical & Bio Group. The group has companies that specialize in the development of cell therapy products, including CHA Biotech. It also has hospitals that can actually conduct clinical trials for contracted cell therapy products. Seoul CRO plans to fully utilize its internal infrastructure and actively conduct clinical trials related to cell therapies. "The CHA Bundang Medical Center of the CHA Medical & Bio Group has a Global Stem Cell Clinical Trials Center that offers a one-stop service from incubation to administration for more effective cell therapy trials. We plan to utilize such strengths to attract and conduct more clinical trials.” The company is also preparing to establish a logistics system for cell·gene therapies. Sohn said, “Unlike general chemical drugs that can be transported at room temperature, logistics is a sensitive issue for cell therapies as these drugs are sensitive to temperature and have time constraints, requiring rapid transport before entering clinical trials." "This is why logistics is a sensitive and important issue from the client’s perspective, and why we are planning to set a separate department dedicated to cell and gene therapies with logistics companies." The company will also strengthen training in related areas. Seoul CRO will provide training to its employees for accurate understanding and application of relevant clinical laws and guidelines, and hold seminars in cooperation with affiliate hospitals for its external clients. Seoul CRO has accumulated a broad range of clinical experience in biopharmaceuticals, managing over 40 clinical cases including those for antibody treatments, protein drugs, vaccines, and cell therapies. The company has the most clinical experience in cell therapies, with experience accumulated from 16 cases. The company plans to further strengthen its existing strengths while specializing in cell and gene therapies. Seoul CRO also has strengths in medical devices and post-marketing clinical trials. “We plan to expand our scope to the global market in the mid-to-long term in the growing field of post-marketing clinical trials. Seoul CRO focuses on providing customer-oriented communication and service, and owns specialized vendors and the internal infrastructure to provide consulting and clinical trial-based services for the whole cycle from early stages of development to post-approval marketing strategies.” “It is important to have the expert personnel and infrastructure to conduct clinical research for cell and gene therapies. Bioventures will look for CROs that own such infrastructure and networks, which makes it ever more important for local CROs to be equipped with such competitivity." “After serving over 20 years in this field, I believe I acquired a good understanding of what is desired and needed by the clients. In essence, the mindset of taking responsibility into my own hands until the end is important. I plan to incorporate this into my work at Seoul CRO.”
