![[위클리 제약·바이오] Ministry of Food and Drug Safety, Binex and non-preservation pharmaceutical drug sales suspension and collection, etc.](https://img.etoday.co.kr/pto_db/2021/03/600/20210312154611_1593018_1200_800.jpg "[위클리 제약·바이오] Ministry of Food and Drug Safety, Binex and non-preservation pharmaceutical drug sales suspension and collection, etc.")
Prestige Biologics announced on the 8th that it is promoting the construction of a vaccine production center with a total area of about 8,500m2 by utilizing 2000m2 of additional space among the site of the second plant. When the production center is built, it will have a global production scale of up to 100,000 liters, and will proactively respond to the production of vaccines not only for corona 19 vaccines but also for various viral infectious diseases occurring in the future.
The vaccine production center will be designed to maximize efficiency and can be applied to various production processes by utilizing Custom Engineering, a specialized service of Prestige Biologics. Construction begins this month and plans to complete construction and production system validation within this year.
Chong Kun Dang announced on the 8th that it has applied to the Ministry of Food and Drug Safety for conditional approval and phase 3 clinical approval of’Napabeltan’ (ingredient name Napamostat) as a treatment for COVID-19 for severely high-risk patients. It plans to secure the basis for overseas emergency use approval through a permit application and export it to a number of countries, including the UK, France, Japan, and Russia.
In the phase 2 clinical trial conducted in Russia, 104 patients in the severely high-risk group were randomly assigned to the Napabeltan-treated group and the standard treatment group and administered for 10 days, and the results of 36 high-risk groups with a National Early Warning Score (NEWS) of 7 or more were evaluated. It was analyzed and confirmed that the statistical significance index (p-value) reached 0.012, reaching the target of 0.05 or less.
The Ministry of Food and Drug Safety announced on the 8th that it will determine provisional manufacturing, sales suspension, and recall measures for six medicines by the pharmaceutical manufacturer Binex, and will initiate an investigation into the relevant factory in Busan. Subsequently, the sales suspension and collection were expanded to 32 items.
Binex submitted a recovery plan for the item that was manufactured differently from the licensed or reported matter to the Busan Regional Food and Drug Administration. The Ministry of Food and Drug Safety decided this action as a preventive measure and conducted an investigation to confirm the overall manufacturing and quality control of the plant.
Genome & Company announced on the 9th that it has signed a second joint research and development contract (CTCSA) with Merck and Pfizer, Germany, with the aim of developing microbiome immune anticancer drugs. This clinical trial (Study 201) is a trial to study the efficacy of combined administration of’GEN-001′ and’Babencio’ (ingredient name Avelumab) for gastric adenocarcinoma and gastroesophageal junction cancer, where existing immunotherapy drugs do not work well.
The entire clinical trial process is overseen by Genome & Company. Germany Merck and Pfizer plan to cooperate in general on clinical trials, including supplying clinical trial substances and providing advice on clinical trial operation.
Daewon Pharmaceutical announced on the 10th that S1AMP, a treatment for gastroesophageal reflux disease, exceeded the annual prescription amount of 20 billion won. According to U-BEST, a drug market research institute, S1MP tablet recorded a prescription amount of about 20.2 billion won last year, an increase of about 14.2% compared to the previous year.
S1AMP Tablet is a PPI (Proton Pump Inhibitor) formulation of esomeprazole, launched in 2014. It is effective against gastroesophageal reflux disease and has a stronger effect than other PPI agents due to its strong gastric acid secretion inhibitory effect.
Seegene held a board meeting on the 9th and decided on changes to the shareholder-friendly articles of incorporation, such as approval of financial statements and introduction of quarterly dividends, as well as the introduction of quarterly dividends, as the content of the agenda of the 21st general shareholders meeting. By introducing quarterly dividends, shareholders can receive dividends more than once within the year.
Apart from the agenda at the general shareholders’ meeting, the company decided to purchase treasury stock worth 30 billion won in consideration of the recent plunging stock price and undervalued corporate value. In addition, KOSPI relocation was also discussed at this board of directors.
▲ SK Bioscience employees are inspecting the Corona 19 vaccine produced at Andong L House.
SK Biosciences uses the development platform of the Corona 19 vaccine’GBP510′, which is currently in clinical trials, to secure a vaccine to prevent the mutant virus, and invests up to $14.2 million (approximately KRW 16 billion) in research and development costs to innovate against infectious diseases. It announced on the 11th that it will be supported by the Alliance (CEPI). In addition, up to $12.5 million (approximately 14.1 billion won) was additionally supported as a process development cost to expand the GBP510 process to commercial production scale.
CEPI’s support is aimed at addressing the threat of the COVID-19 mutant virus more broadly. SK Bioscience plans to build an all-round response system against the Corona 19 virus based on globally recognized technology.
Hanmi Pharmaceutical’s partner Spectrum announced on the 11th (local time) that the non-small cell lung cancer drug’Pogiotinib’ has been designated as Fast Track by the US Food and Drug Administration (FDA). Spectrum plans to submit an application for marketing authorization (NDA) for Pogiotinib to the FDA at the end of this year.
For drugs designated for Fast Track, the review period for marketing authorization applications is shortened from 10 months to 6 months through priority review.
Cha Biotech subsidiary Cha Vaccine Research Institute announced on the 12th that it has passed the technical evaluation necessary for listing on the KOSDAQ technology special case by obtaining A grade from the Korea Institute of Bioscience and Biotechnology and BBB grade from the Nice Evaluation Information. The company explained that the competitiveness of its own immunity enhancement technology and related patents, and the differentiation that it is developing innovative vaccines such as premium vaccines, therapeutic vaccines, and anticancer vaccines received positive evaluation.
The Cha Vaccine Research Institute plans to request a preliminary review as soon as possible by coordinating the schedule with Samsung Securities, the organizer. It plans to finish listing on the KOSDAQ within this year after quickly completing the preliminary examination process for listing.
UBiologics announced on the 12th that the Corona 19 vaccine’Yukobac-19′, which is being developed, has been selected as the lead agency for the ‘2020 3rd Corona 19 Vaccine Clinical Support Project’ of the National New Drug Development Project and receives government contributions. In addition to the company contribution of 3.2 billion won and the 9.4 billion won received from the Ministry of Health and Welfare (Korea Health Industry Promotion Agency, National New Drug Development Foundation), a total project cost of 12.6 billion won will be used to proceed with the Phase 1/2 clinical development of the Yukobaek-19 clinical trial.
Yukobaek-19 is currently undergoing phase 1 clinical trials, and will quickly enter phase 3 clinical trials after obtaining sufficient data on safety and immunogenicity through phase 1/2 clinical trials. Given the availability of vaccines, large-scale phase 3 trials are not feasible, so a clinical plan that applies the immune proxy (ICP) is being discussed with experts.
Through regular inspection, the Ministry of Food and Drug Safety confirmed that 4 drugs for sale manufactured by the non-preservative pharmaceutical company and 5 drugs consigned and manufactured by other companies were manufactured differently from the license requirements, and temporarily manufactures and sells the corresponding item as a precautionary measure. It was announced on the 12th that it would be suspended and recalled.
Non-Preservation Pharmaceutical (formerly Enist Bio Pharmaceutical) was acquired by Non-Preservation Healthcare in September last year, and was incorporated into the Non-Conservation Group. Recognizing the problem of manufacturing’J-Octin Tablet (thioctic acid)’ in the process of checking internal work after the acquisition. Voluntarily reported to the Ministry of Food and Drug Safety.
Dong-A ST announced on the 12th that it has signed a contract to delegate the voting rights of Neurobo with E&Investment, the largest shareholder of Neurobo Pharmaceuticals, a US pharmaceutical company. With this contract, it plans to secure management rights of its partner, Neurobo, with the voting right of about 13% of Neurobo’s stake and about 33% of the stake entrusted by E&Investment.
The company plans to use Neurobo as a forward base for global research and development (R&D) based on its geographical advantage in Boston, USA and easy financing as a NASDAQ-listed company by securing management rights. to be. Neurobo is a NASDAQ-listed company established for the purpose of developing neuroscience-based natural medicines.