2023-12-12 04:30:11
◆Genexine, re-certified as an ‘innovative pharmaceutical company’
Genexine announced on the 12th that it had succeeded in extending its certification as a ‘2023 Innovative Pharmaceutical Company’ hosted by the Ministry of Health and Welfare. Genexine was first certified as an innovative pharmaceutical company in 2014 and was re-certified in 2017 and 2020. Through this certification extension, we will maintain our status as an innovative pharmaceutical company for the fourth consecutive time until November 27, 2026. Innovative pharmaceutical companies are selected by the Ministry of Health and Welfare as companies judged to have excellent capabilities for new drug research and development (R&D) and overseas expansion in accordance with the ‘Special Act on the Promotion and Support of the Pharmaceutical Industry’, and the selected companies receive preferential participation in government R&D projects and receive tax benefits. You can receive a variety of support, including support, preferential treatment in determining drug prices, and relaxation of regulations on the location of research facilities. In addition, as Genexine’s certification as an innovative pharmaceutical company has been extended, it can be exempted from designation as a management item for failing to meet the sales standard by meeting the special requirements for sales as an excellent company in research and development. Through this, the company plans to focus more on research and development and securing new growth engines.
◆Jeil Pharmaceutical conducts comprehensive disaster response training
(Photo = Jeil Pharmaceutical)
Jeil Pharmaceutical announced on the 12th that it conducted comprehensive disaster response training at its Baekam factory in Yongin. The disaster response training was conducted as a mock training to respond to a hazardous chemical leak or fire accident within the company’s pharmaceutical manufacturing and quality management (GMP) facility. In particular, this training was conducted jointly with the cooperation of the Baekam 119 Safety Center, and training was also provided to respond quickly and safely to unexpected situations assuming real situations. In the comprehensive disaster response training, ▲ how to spread the situation within the factory and take action in case of an emergency ▲ how to operate the situation room and respond ▲ rapid preparedness training for executives and staff. In addition, with the cooperation of the Baekam 119 Safety Center, the Jeil Pharmaceutical Self-Defense Fire Department conducted training on ▲ how to use a portable fire extinguisher on a trial basis ▲ sprinkler training by opening an outdoor fire hydrant ▲ how to extinguish a fire in an emergency.
◆Pharos iBio announces phase 1 results of leukemia treatment
(From the left) Seongsoo Yoon, professor of hematology and oncology at Seoul National University Hospital, and Hyejeong Han, CEO of Paros iBio’s American corporation (Photo = Paros iBio)
Paros iBio announced on the 12th that it participated in the American Society of Hematology (ASH) and disclosed the results of the phase 1a/b clinical trial of ‘PHI-101’, an acute myeloid leukemia treatment (AML). The American Society of Hematology was held in San Diego, USA from the 9th to the 12th (local time). Phase 1 clinical trials of PHI-101 are being conducted on patients with acute myeloid leukemia who have relapsed or refracted following using other treatments. As a result of the test, all doses were well tolerated and no dose-limiting toxicities (DLTs) occurred. Phase 1b is being conducted with 160mg monotherapy, which is the recommended extended dose (RDE), and 60% of patients who can be evaluated to date have achieved a comprehensive complete response. (Composite Complete Response) was shown. Comprehensive complete response includes complete response (CR), CR with incomplete hematological recovery (CRi), and morphological leukemia-free state (MLFS). The company plans to complete phase 1 clinical trials of PHI-101 in the first half of next year and begin phase 2 trials in the U.S., Australia, and Korea in the second half of the year. Afterwards, the goal is to complete the phase 2 clinical trial of PHI-101 around 2025 and apply for conditional product approval through the ‘development-stage orphan drug system’ for early commercialization.
◆Handok donates 10 million won worth of ultraviolet experiment supplies to Konkuk University
Handok Production Plant (Photo = Handok)
Handok announced on the 12th that it had donated 10 million won worth of glass experiment supplies to Konkuk University’s Glocal Campus. A total of 1,032 donated glass experiment items were used, and although there were no problems with use, their use was discontinued in accordance with Handok’s strict internal quality standards. Handok donated the materials for the initial experiment in order to provide an opportunity to recycle resources and contribute to the educational field. Konkuk University Glocal Campus plans to use the donated glass experiment items in biomedical, cosmetics, and medical school laboratories and also as souvenirs for high school students who visit the university to cultivate talent. Last August, Handok also donated regarding 850 glassware experiment items worth 11 million won to Korea Biomeister High School, Cheongju University, and Konkuk University. In the future, Handok plans to expand its donation schools and consider donating not only initial experiment supplies but also experimental equipment.
◆NeoImmuneTech signs strategic partnership with Australia’s Immugene
NeoImmuneTech announced on the 12th that it signed a strategic research cooperation agreement with Imugene, an Australian immunotherapy drug developer. Under this contract, NeoImmuneTech will provide NT-I7 to Imugene, and Imugene will conduct research on using it in combination with their CAR-T, ‘azer-cel’. Imugene is a company developing various clinical-stage immunotherapies that activate the immune system of cancer patients, including azer-cel, a CAR-T treatment candidate, an oncolytic virus treatment (CF33), and an immunotherapy B-cell vaccine candidate. It has multiple pipelines. Recently, ‘VAXINIA’, one of CF33, was selected for expedited review by the U.S. Food and Drug Administration (FDA). azer-cel, the target of co-administration, is an allogeneic CD19 CAR-T, and is being strategically developed for rapid market launch with extensive clinical data, and has so far proven excellent safety in indications such as lymphoma and blood cancer. NeoImmuneTech explains that it did so.
◆HK Innoen “K-Cap continues to produce differentiated clinical results”
K-Cap product line (Photo = HK Innoen)
HK InnoN announced on the 12th that it disclosed the results of two differentiated clinical trials related to ‘K-Cap’, a new drug for gastroesophageal reflux disease, at the Korean Society of Clinical Pharmacology, American Society of Nephrology (ASN 2023), and Asian Society of Transplantation (ATW 2023). The contents disclosed by HK Innoen are ▲comparison of the pharmacokinetic characteristics of 50 mg of K-Cap orally disintegrating tablets when administered via nasogastric tube or orally ▲a study on the drug interaction between K-Cap tablets and immunosuppressants in kidney transplant recipients. The clinical results of K-Cap orally disintegrating tablets administered via nasogastric tube, led by Professor Kim Jong-ryul of the Department of Clinical Pharmacology at Inje University Busan Paik Hospital, confirmed pharmacokinetic equivalence compared to oral administration and also proved safety and tolerability. K-Cap orally disintegrating tablets dissolve quickly in a syringe with water, so they can be injected into the stomach through a nasogastric tube, dramatically improving the administration process compared to existing drugs. The results of this study on orally disintegrating tablets are expected to serve as a basis for suggesting a new alternative to administer K-Cap orally disintegrating tablets through a nasogastric tube to patients who are unable to take oral medication, such as hospitalized or intensive care unit patients using nasogastric tubes and patients with reduced consciousness. It is expected. Professor Jo Jang-hee’s team at the Department of Nephrology at Kyungpook National University Hospital divided patients who received kidney transplants into a group taking K-Cap tablets, a potassium-competitive gastric acid secretion blocker (P-CAB) class, or a group taking proton pump inhibitor (PPI) class drugs, and administered immunosuppressants in combination. Blood immunosuppressant concentration levels were compared over 12 weeks. As a result of the study, K-Cap tablets did not affect the trough drug concentration of immunosuppressants in the blood. She also confirmed that there was no immune transplant rejection in any of the patients who took K-Cap tablets, and that kidney function was also maintained. The company expects that the results of this study will provide evidence for patients who have received organ transplants to safely take K-Cap as a gastric protectant.
◆Kang Won-ho, CEO of United Pharmaceutical, received the Pharmaceutical Society’s ‘Pharmaceutical Technology Award’
(From left) Koo Bon-cheol, director of Colorcon Korea, Kang Won-ho, CEO of United Pharmaceuticals, and Won Kwon-yeon, president of the Pharmaceutical Society of Korea.
United Pharmaceutical Korea announced on the 12th that CEO Kang Won-ho received the Pharmaceutical Technology Award in recognition of his contribution to the development of pharmaceutical sciences at the ‘2023 Korean Pharmaceutical Society International Academic Conference’ event. The 2023 Korean Pharmaceutical Society International Academic Conference was held at the main building of The-K Hotel Seoul on the 30th of last month. CEO Kang contributed to the development of United Pharmaceutical’s various new improved drugs, and among them, he received an award in recognition of the excellent formulation technology of ‘Art McCombie Gel Soft Capsule’, which was released in 2021 and grew into a blockbuster. Meanwhile, United Pharmaceutical has been actively developing new improved drugs since the 2000s, developing 17 new improved drugs and improved new formulations, including ‘Cylostane CR Tablets’, ‘Gastin CR Tablets’, and ‘Art McCombiegel Soft Capsule’. We have pioneered and developed new markets. The company plans to continue to contribute to the development of the Korean pharmaceutical industry through continued investment in research and development.
◆Eutilex CAR-T treatment ‘307’ concludes KDDF support agreement
Eutilex announced on the 12th that ‘307’, a CAR-T treatment for patients with advanced hepatocellular carcinoma, was selected as the ‘3rd new support target project in 2023’ hosted by the Korea New Drug Development Foundation (KDDF) and will receive research and development funding for two years. revealed. 307, which was selected for the project, targets the GPC3 cancer antigen that is specifically overexpressed in hepatocellular carcinoma without affecting normal liver cells. In addition, it is a 4th generation CAR-T treatment that improves CAR-T function and tumor microenvironment through IL-18 production. Last February, 307 became the first domestic listed company to receive Phase 1 Clinical Trial (IND) approval as a CAR-T treatment for solid cancer. Young-gyun Jang, PM (Pipeline Manager), said, “Hepatocellular cancer is a disease with low responsiveness to standard treatments and a very high medical need for which there are no suitable alternative medicines.” He added, “With this national project selection, we will also receive support for research and development costs, so we will develop the 4th generation CAR-T treatment 307. “We plan to focus more on clinical trials,” he said.
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