[금일 제약업계 주요기사]The first corona19 vaccine in Korea?… SK Bioscience, Covid-19 vaccine distribution

【Youth Daily】 A major issue in the pharmaceutical industry on the 22nd is the news that Hanmi Pharmaceutical has been ranked No. 1 in the domestic outpatient prescription market for three consecutive years.

The Korea Centers for Disease Control and Prevention selected SK Bioscience as an agency to carry out the’Corona 19 vaccine distribution management system establishment and operation project’ in Korea. It was confirmed that there was illegal access to related documents.

JW Choongwae Pharm said that the salary standard of the hemophilia subcutaneous injection, a hemophilia A preventive drug, will be expanded, and Huron obtained a software license from the US Food and Drug Administration (FDA) to quantify the protein’beta amyloid’ known to cause dementia. did.

Part of the rights of’ABL001′, which was transferred to Trigger Therapeutics by AVLBio, a company specializing in double antibodies, was transferred to Lpscience, a Chinese immunotherapy company, while Paros IBio developed and tested NGS-based co-diagnosis technology with Engenbio. A business agreement was signed for utilization.

Genexine and Yonsei University started to develop tuberculosis DNA vaccine candidate’GX-170′ in earnest through industry-academia cooperation, and Korea University Medical Center for Medical Sciences Cooperation promoted clinical research with LSK Global PS, a domestic clinical trial agency (CRO). A business agreement was signed to cooperate in fostering the clinical trial industry.

In addition, as the vaccine is expected to be vaccinated in Korea from the beginning of next month as early as next month, attention is focused on what will be the’Korea’s No. 1’vaccine.

◆ Hanmi Pharmaceutical “Last year’s prescription amount of 6665 billion won… No. 1 outpatient prescription for 3 consecutive years”

Hanmi Pharm ranked first in the domestic outpatient prescription market for three consecutive years.

In 2020, Hanmi Pharm achieved a total of 6665 billion won in outpatient prescription sales (UBIST) thanks to the even growth of major self-developed improved/combined new drugs such as Rosujet, Amosartan Family, Esomezol, and Gugu Tams, ranking No. 1 in the domestic pharmaceutical industry. Seat.

As a result, Hanmi Pharm maintained the leading position for three consecutive years until last year since it ranked first in domestic outpatient prescriptions in 2018. In particular, the company explained that it is significant in that it is an achievement made in a situation where economic activity was contracted in the whole society due to Corona 19 last year.

The company analyzed that the achievement of being the No. 1 outpatient prescription for the third consecutive year stems from the power of excellent and differentiated self-developed products created based on global pharmaceutical formulation technology.

◆ Domestic Corona 19 vaccine distribution, SK Bioscience is in charge

It is said that SK Bioscience has been selected as the agency to carry out the domestic’Corona 19 vaccine distribution management system establishment and operation project’.

The Korea Centers for Disease Control and Prevention announced the progress of building a storage and distribution system to safely transport the Corona 19 vaccine to the inoculation institution.

Since the storage and distribution conditions for Corona 19 vaccines differ by manufacturer and vaccination locations for each vaccine vary, the Agency’s plan is to establish a thorough distribution and storage system for tight management until vaccination after the vaccine arrives in Korea.

SK Bioscience was selected as the agency to carry out the’Corona 19 vaccine distribution management system establishment and operation project’ and the contract was concluded.

SK Bioscience will be in charge of distribution and storage of AstraZeneca, Janssen, Pfizer vaccines, and Cobax Facility vaccines.

◆ Celltrion “Possibility of leaking’Reckironaju’ documents due to EMA hacking”

Due to a recent cyber attack on the European Medicines Agency (EMA), it has been confirmed that there was illegal access to documents related to Celltrion’s Corona 19 antibody treatment drug’Recyronazu’ (CT-P59).

Celltrion announced that it was notified of this from EMA through the company website.

Celltrion is currently negotiating with EMA for an application for permission for items in Rekirona. For this reason, some documents related to the state of Rekirona have been submitted to EMA.

However, Celltrion emphasized that medicine and patient personal information were not leaked.

◆ JW Choongwae Pharmaceutical Expands Salary Standards for Hemophilia A Preventive Treatment for Hemophilia

JW Choongwae Pharmaceutical’s hemophilia-prophylactic treatment for hemophilia A (hemibrapi sub-injection) (Emisizumab) is expected to increase its salary standards.

In May of last year, if you are 12 years of age or older and weigh 40kg or more, if you have a history of antibody titer of 5BU/mL or more, you have been given a bypass factor drug for more than 6 times in the last 24 weeks, If it fails, it is the first to be listed on the basis of’recognition of pay for up to 24 weeks’.

The new revised bill, which will be applied from February 1, is subject to changes in detailed standards by reflecting domestic and international clinical research literature, opinions of related conferences, and overseas insurance standards.

The salary standard for those administered over the age of 1 and under 12 has been newly established, and the 24-week administration period and the standard for weight over 40kg have been deleted.

As a result, the company expects to reduce the economic burden of patients who need long-term administration and improve access to treatment for pediatric patients who have difficulty in intravenous injection.

◆ Huron “AI dementia analysis software acquired US FDA medical device approval”

Huron, a medical artificial intelligence (AI) company, obtained a software license from the US Food and Drug Administration (FDA) to quantify the protein’beta amyloid’ known to cause dementia.

This product was approved as a second-class medical device by the Korean Ministry of Food and Drug Safety in July last year, and the FDA approved it for use as a medical device.

The company explained that it can be used for early diagnosis of dementia and the development of new drugs by automatically quantifying the degree of accumulation of beta amyloid in the brain from positron tomography (PET) scan images.

◆ Technology transfer among some rights of trigger’ABL001′

Part of the rights of’ABL001′, which was transferred to Trigger Therapeutics by ABL Bio, a company specializing in double antibodies, was transferred to Lpscience, a Chinese immunotherapy company.

ABL001 is the first candidate to enter domestic clinical trials as a double antibody. By targeting double VEGF and DLL4, ABL001 has a mechanism of action to kill cancer by inhibiting the formation of angiogenesis in cancer tissues. Currently, clinical phase 1b combined administration is in progress in Korea.

Trigger transferred the exclusive development and sales rights for cancer tumors in China, Hong Kong, Macau and Taiwan to LP Science on the 21st. LPscience has successfully attracted investments from renowned companies such as Tencent, Lily Asia Ventures, and Hillhouse Capital Group.

The total contract size of this contract is $117 million, including a down payment of $7 million, and ordinary technology fees (royalties) are not included. It is said that AVL Bio and Trigger will share the profits at the rate agreed upon by both companies.

◆ Paros iBio and Engenbio signed a joint R&D agreement

Paros iBio signed a business agreement (MOU) with Engenbio for the development of NGS-based companion diagnostic technology and clinical use.

This MOU is part of a strategy for the development of’PHI-101′, a next-generation innovative new drug, FLT3 targeting anticancer drug of Paros iBio.

Using Engenbio’s NGS (Next Generation Sequencing)-based precision diagnostic products and analysis software, the FLT3 mutation type of patients registered in clinical trials will be identified, and will be used for selection of patients subject to a wider range of clinical trials in the future.

For this reason, a contract to provide detailed diagnostic testing and analysis services was also signed for initial clinical research.

◆ Genexine begins to develop’Tuberculosis DNA vaccine’ through industry-academia cooperation

Genexine, through industry-academic cooperation with Yonsei University, is expected to start developing the tuberculosis DNA vaccine candidate’GX-170′.

Genexine derives tuberculosis vaccine candidates and completes a patent application through industry-academic cooperation with Professor Sang-rae Cho’s team at Yonsei University College of Medicine, the highest authority in tuberculosis research.

The company expects the tuberculosis prevention vaccine to enter clinical trials more quickly based on the underlying technology and know-how accumulated through the development process of the corona 19 prevention vaccine’GX-19N’ over the past year.

◆ Korea University Medical Center, LSK Global PS, agreement to foster clinical trial industry

Korea University’s Medical Center for University-Industry Cooperation concluded a business agreement with LSK Global PS, a domestic clinical trial consignment agency (CRO), to cooperate with activating clinical research and fostering the clinical trial industry.

The Korea University Medical Center for Medical Center and LSK Global PS plans to jointly promote clinical trials and related projects for overseas expansion of domestic pharmaceuticals and medical devices.

◆’AstraZeneca vs Pfizer’… The first corona 19 vaccine introduced in Korea?

It is expected that the vaccine will be vaccinated in Korea from the beginning of next month as early as next month, and attention is focused on what will be the’Korea No. 1’vaccine.

The vaccine that the government initially predicted to be introduced the fastest is AstraZeneca. This is because AstraZeneca is the only Corona 19 vaccine that is being reviewed by applying for an item permission from the Food and Drug Administration. AstraZeneca vaccine will be approved in February.

However, in terms of overseas vaccinations, Pfizer vaccines are leading the way. Pfizer vaccine is being vaccinated in the United States, Israel, United Kingdom, Saudi Arabia, and Canada. Pfizer’s products are being actively reviewed for vaccines that will be delivered to Korea in early February through the international project’Covax Facility’.

【Youth Daily = Reporter Ahn Sang-jun】