[제약 바이오 이모저모] SK Bioscience, in charge of distribution and management of corona vaccine

[이데일리 노희준 기자]This is the news that attracted attention in the pharmaceutical and bio industry for one week (January 18 to January 22).

△SK Bioscience, selected as the establishment and operator of the COVID-19 vaccine distribution management

SK Bioscience has been selected as a service company to establish a distribution management system for the vaccine vaccination against Corona 19. The Korea Centers for Disease Control and Prevention (KCDC) announced on the 22nd that SK Bioscience was selected as the agency to carry out the’Corona 19 vaccine distribution management system establishment and operation project’ and concluded the contract. It is as announced in the National Comprehensive Electronic Procurement System (Nara Market) of the Public Procurement Service on the 21st. SK Bioscience will be in charge of distribution and storage of AstraZeneca, Janssen, Pfizer vaccines, and Covax Facility vaccines. In addition, by establishing a customized cold chain management system for each vaccine, it plans to operate a system that can monitor temperature maintenance and delivery routes in real time during vaccine transportation. To this end, M2Cloud will participate as a partner and build an integrated control center based on the Internet of Things (IoT). Gtree B&T and Dongwon I-Farm participate as distribution partners.

△ Verification Advisory Group “Celltrion Corona Treatment, Conditionally Granted”

An advisory body of the Ministry of Food and Drug Safety, composed of external experts, proposed to grant conditional permission for the Corona 19 treatment “Rekironaju”. The’Corona 19 Treatment/Vaccine Safety and Effectiveness Verification Advisory Group’ consisting of 8 external experts in the clinical trial field and 4 inside the KFDA held an advisory group meeting on the results of clinical trials in Rekkirona on the 17th. The’verification advisory group’ judged that “the reduction in the time for improvement of Corona 19 symptoms by administering Rekirona is statistically significant and clinically meaningful.” In the phase 3 clinical trial of Rekirona, it was recommended that a sufficient number of patients be confirmed to significantly reduce mild-moderate to severe morbidity. As for the prescription of Rekirona, adult patients with early mild and moderate corona19 were presented. The Ministry of Food and Drug Safety decided to hold a meeting of the’Central Pharmacy Review Committee’, the second consultation procedure of the licensing authority, on the 27th and disclose the results on the same day. Meanwhile, the first verification advisory group meeting for AstraZeneca’s Corona 19 vaccine will be held on the 31st, and the results will be released on February 1.

△GC Green Cross approved the world’s first treatment for severe Hunter syndrome

GC is the first in the world to receive a license for the treatment of Hunter syndrome using ventricular administration. GC Green Cross announced on the 22nd that its partner,’Clinigen’, has obtained approval for the item of’Hunterase ICV’, an intraventricular administration-based Hunter syndrome treatment from the Ministry of Health, Labor and Welfare of Japan. Hunterase ICV is a treatment in which a device is inserted into the head and the drug is administered directly to the ventricle. The existing intravenous formulation of drugs could not pass through the cerebral vascular barrier (BBB) ​​and thus could not reach the brain parenchyma. The approval is meaningful in that it is possible to provide a new treatment method for patients with severe Hunter syndrome. Hunter syndrome is a rare congenital disease in which skeletal abnormalities and decreased intelligence are caused by a deficiency of a specific enzyme in the body called IDS.

△Yoohan Corporation’s’Lecra Midnight’ permission… The 31st Korean drug was born in 3 years

Yuhan Corporation’s lung cancer treatment’Recrajajeong’ (ingredient name lasertinib) was approved as the 31st new drug developed in Korea. It is the second new drug of Yuhan Corporation that was born in 16 years following the anti-ulcer drug’Revanex’, which was approved in September 2005. It is also a new domestic drug for the first time in 3 years since HK Innoen’s gastroesophageal reflux disease treatment drug’Kcap Tablet’ was approved as No. 30 in 2018. The Ministry of Food and Drug Safety announced on the 18th that it has given conditional permission for Recra Jajung on the 18th under the condition of conducting a phase 3 clinical trial. Rekrazyme is used in patients with advanced lung cancer with mutations in certain genes who have previously been treated for lung cancer. It is a target anticancer drug that inhibits the proliferation and growth of lung cancer cells by interfering with the signal transmission involved in lung cancer cell growth.

△ABL Bio’s technology export anticancer drug, purchased by LP Science

Part of the rights of the anticancer drug (ABL001), which was transferred to Trigger Therapeutics by ABL Bio, a company specializing in double antibodies, has been transferred to Elpiscience, a Chinese immunotherapy company. Lpscience is a bio company that has become a hot topic as it succeeds in attracting investment from prominent companies such as Tencent, Lily Asia Ventures, and Hillhouse Capital Group. On the 22nd, ABLbio announced that “Trigger Therapeutics has transferred the exclusive development and sales rights of ABL001 in China, Hong Kong, Macau and Taiwan to LP Science on the 21st.” The total contract size of this contract is $117 million, including a down payment of $7 million. Current technical fees (royalties) are separate. AVL Bio and Trigger Therapeutics will share the revenue at the rate agreed upon by both companies.

△ Celltrion “Possibility of leaking documents such as Rekkirona due to European EMA hacking”

Celltrion said on the company’s website on the 22nd that “the EMA computer system was attacked by cyber attack, and it was notified from EMA that it was confirmed that some of the documents we submitted to EMA had illegal access to some of the documents related to Rekkirona, Hezuma, and Truxima.” Announced. Celltrion is negotiating with EMA to apply for product licenses in Rekirona. Therefore, some documents related to the state of Rekkirona have been submitted to EMA. Celltrion said, “There is a possibility that some of the documents submitted to EMA by this incident may have been leaked to the outside, but the documents do not contain any personal information of patients.” “Celltrion’s own IT system is also continuously monitoring and We confirmed that there was no leakage or damage.”

△ NG Chem Life Science completes recruitment of patients for phase 2 clinical trials for corona treatment

On the 18th, it announced that it has completed recruitment of patients for phase 2 clinical trials in Korea for the COVID-19 treatment under development. Earlier, in May of last year, NG Chem Life Science received approval for a phase 2 clinical trial for the second time in Korea as a therapeutic candidate EC-18 (Mocedipimod). EC-18 is a candidate drug that simultaneously exerts antiviral action to inhibit viral proliferation in corona19 virus infection and anti-inflammatory action to prevent hyperimmune reaction known as cytokine storm. The company announced that it plans to complete the analysis of the domestic phase 2 clinical trial within the first quarter and apply for conditional approval as a treatment for Corona 19.

△ Jinwon Life Sciences applied for FDA Phase 1 for Corona 19 vaccine

Genewon Life Sciences announced on the 19th that it has applied for a phase 1 clinical trial to the US Food and Drug Administration (FDA) for the COVID-19 vaccine’GLS-5310′. Jinwon Life Sciences said, “To prevent Corona 19, we plan to use GLS-5310 in combination with intradermal vaccination and intranasal spray administration to evaluate the efficacy and then use it to select optimal vaccination conditions for later clinical studies.” GLS-5310 is undergoing phase 1·2a clinical trials in Korea. Also announced on the 18th that it has confirmed the effect of reducing the Corona 19 virus in the nose area of ​​weasels and preventing infection in the animal model of weasel infection in relation to GLS-1200, a nasal spray treatment for preventing Corona 19 infection under development.

△ The Ministry of Food and Drug Safety approves Phase 1 and 2 of the Ubiologics COVID-19 vaccine

The Ministry of Food and Drug Safety announced on the 21st that it has approved the phase 1 and 2 clinical trial plans of’Yukobac-19′, a candidate for COVID-19 vaccine. The company evaluates the safety and immunogenicity of Yukobac-19 in healthy adults. After the first phase proceeds, proceed to the second phase. Yukobaek-19 is a’recombinant vaccine’ that uses gene recombination technology to produce the surface antigen protein of the Corona 19 virus. The vaccine’s surface antigen protein stimulates immune cells to form neutralizing antibodies to induce an immune response, and when the Corona 19 virus invades, the antibody removes it. Currently, 7 vaccines and 15 treatments are currently under development with approval for a clinical trial plan related to Corona 19 in Korea.

△ The Ministry of Food and Drug Safety canceled the license for Medytox Botulinum Toxin Inotox

The license for the product of Innotox, a liquid Botox product, has been revoked. The Ministry of Food and Drug Safety announced on the 18th that it will cancel the permission on the 26th as Innotox violates the’Pharmaceutical Affairs Act’ (Article 76, Paragraph 1, 2-3) after obtaining permission for product and modification by fraudulent or other fraudulent methods. . Medytox filed a lawsuit for cancellation of disposition and suspension of execution on the 19th. The first administrative government of the Daejeon District Court decided to temporarily suspend the effect of the cancellation of Innotox until the 11th of next month.

△ Hanmi Pharm, FDA approval for two new drug candidates for rare diseases

Hanmi Pharm is planning a phase 2 clinical trial by the U.S. Food and Drug Administration (FDA) for the rare disease congenital hyperinsulinemia treatment candidate’Glucagon Analog’ (HM15136) and Short Bowel Syndrome treatment candidate’GLP-2 Analog’ (HM15912). It was announced on the 21st that it had been approved. Congenital hyperinsulinemia is a rare disease that causes severe and persistent hypoglycemia in newborns and children. Short bowel syndrome is a rare disease that causes malabsorption and malnutrition because more than 50% of the entire small intestine is lost through congenital or postnatal surgical resection.

△ Hanmi Pharm launches Corona 19 Rapid Antigen Diagnosis Kit early next month

Hanmi Pharmaceutical announced on the 18th that it plans to launch a Corona 19 Rapid Antigen Diagnosis Kit in Korea early next month. This device is an antigen diagnostic test device approved for emergency use by the World Health Organization (WHO). The product features a sensitivity of 90% and a specificity of 96%, so that infection can be tested within 30 minutes. The Rapid Antigen Diagnosis Kit is a product that uses an antigen-antibody binding reaction in which a sample collected from the nasal cavity (inside the nose) is dropped into the kit, and the viral antigen binds to the antibody contained in the kit, resulting in a test result.

△ Hee-mok Won, president of the Pharmaceutical Bio Association, extended until February 2023

Won Hee-mok, president of the Korea Pharmaceutical Bio Association, has been extended for two years until February 2023. The board of directors of the association held the first meeting in 2021 on the 19th and unanimously decided to extend the term of office for the current President Hee-mok Won. After taking office as the 21st president in February 2017, Chairman Won was reappointed in February 2019. This reappointment is in accordance with the Articles of Incorporation that only the reappointed president can be extended one time by a special resolution of the chairman and the directors if necessary.