[금일 제약업계 주요기사] SK Bioscience transfers NovaVax COVID-19 vaccine technology… Daewoong Pharmaceutical’s “Quotation of temporary injunction to stop the import ban of’Nabota’ in the US court”

【Youth Daily】 The main issue in the pharmaceutical industry on the 16th is the news that SK Bioscience has signed a technology transfer contract with NovaVax for the COVID-19 vaccine.

Daewoong Pharmaceutical said that it was cited for an emergency temporary injunction related to the suspension of the import ban order filed with the US Federal Circuit Court of Appeals, and Neo-Imuntek administered its’NT-I7′ and BMS’ immune checkpoint inhibitor’Optivo’ in combination In the U.S., phase 2 clinical trials began.

Geoyoung signed a 3PL logistics contract with BigThink Therapeutics for’Nerlynx’, a prolonged therapy for early breast cancer patients with human epithelial growth factor receptor type 2 (HER2) positive, and Huzel entered the global big market. Ahead of this, the academic content and pipeline will be strengthened.

Daewoong Pharmaceutical recorded sales of KRW 1.55 trillion last year, generating sales of KRW 1 trillion, and Seegene applied a saliva test method to the Corona 19 diagnostic kit to show similar accuracy to the existing PCR test method nasopharyngeal smear when diagnosing Corona 19. Said that it appeared.

Boryeong Pharmaceutical is conspiring with the winners of the ’20th Boryeong Cancer Academic Award’, and it was confirmed that 117 people were confirmed in the country as of 0 o’clock on the 16th, which occurred at the Sooncheonhyang University Seoul Hospital in Yongsan-gu, Seoul.

In addition, the government will start vaccinating Corona 19 at nursing hospitals and nursing facilities from the end of this month.

◆ SK Bioscience, NovaVax Corona 19 Vaccine Technology Transfer Agreement

It is said that the Corona 19 vaccine that SK secures, produces and sells, will be supplied to Korea. Korea is expected to be able to stably secure the Corona 19 vaccine in Korea without relying on imports of finished products with large global supply and demand volatility.

SK Bioscience has signed a license-in contract with Novavax, a US biotechnology company, to independently produce and supply the Corona 19 vaccine’NVX-CoV2373′, which has been approved for use in the U.S. and EU. Each vaccine supply contract was signed.

Under this contract, SK Biosciences has the right to produce, license, and sell exclusively in Korea by transferring the technology of’NVX-CoV2373′, a synthetic antigen-based COVID-19 vaccine developed by NovaVax. In addition, according to the supply contract with the Korean Disease Administration, 20 million people, a total of 40 million doses (one dose is one dose), were supplied to Korea.

SK Bioscience signed a CDMO (consignment development and production) contract with NovaVax in August last year, and has completed the manufacturing and process technology transfer of’NVX-CoV2373′, and is proceeding with commercial production for global supply. It is expected that the domestic supply through production will begin immediately.

◆ Daewoong Pharmaceutical “Cites a temporary injunction to suspend the import ban of’Nabota’ in the US Appeals Court”

It was cited that Daewoong Pharmaceutical’s emergency motion to interim stay was cited in relation to the suspension of the import ban order filed with the US Court of Appeals for the Federal Circuit (CAFC).

This was quickly quoted three days after applying for provisional injunction on the 12th. Accordingly, sales of the botulinum toxin drug Nabota (U.S. export name bulletin), which the U.S. International Trade Commission (ITC) ordered to ban imports for 21 months last December, can be resumed without a gap.

The bond conditions are the same as before, and like the ITC deposit, the payee will be determined by the appeal court or the final decision of the Supreme Court.

◆ Neo-Imüntech “First dose of US phase 2 clinical patient with NT-I7 and Opdivo”

Neo-Imüntech is in the US with its’NT-I7′ (efineptakin alfa) and the global pharmaceutical company’s BMS’ immune checkpoint inhibitor’Opdivo’ in the US. The first medication was recently administered.

The company started recruiting clinical patients after acquiring the clinical trial plan (IND) approval from the US Food and Drug Administration (FDA) for target carcinomas such as metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.

This clinical trial will evaluate the safety and anticancer efficacy through a comparison between the group of patients receiving the combination of’NT-I7′, which induces T cell amplification, and the group of patients receiving’Opdivo’ alone, the PD-1 blocking antibody’Optivo’.

◆ Geoyoung and Big Think, signed a 3PL logistics contract for breast cancer treatment’Neratinib’

Geoyoung signed a 3PL logistics contract with BigThink Therapeutics for’Nerlynx’, a prolonged therapy treatment for early breast cancer patients with human epidermal growth factor receptor type 2 (HER2) positive.

Big Think was established in 2016 as a domestic subsidiary of KPS, a KOSDAQ listed company. Neratinib, which the company has secured exclusive rights for commercialization in Korea, is an oral HER2 targeted anticancer drug, and is the latest anticancer drug recommended as a treatment for early and metastatic breast cancer through the National Cancer Network (NCCN) guidelines last year.

It was approved by the U.S. Food and Drug Administration (FDA) in 2017 and the European Medicines Agency (EMA) in 2018, and helps the prevention and treatment of oral mucositis caused by chemotherapy such as radiation and chemotherapy from Professional Dietetics International (PDI), an Italian amino acid pharmaceutical company. Also secured Asian copyright for the oral liquid formulation’Mucosamine’.

◆ Huzel’s “old doctor” headquarter Hyung-jin Moon recruited… “Enhancing academic content”

Ahead of Huzel’s entry into the global big market, strengthen academic content and pipeline.

For the first time in Korea’s rival industry, the existing medical division was promoted to the medical headquarters, and as the first head, Moon Hyeong-jin, who was known as a medical esthetic expert at home and abroad, was appointed.

According to Huzel, head of Hyung-jin Moon, who was appointed as the head of the medical headquarters on the 1st, graduated from Yonsei University College of Medicine, and has been a specialist with doctor’s licenses in three countries: Korea, China, and Vietnam. He has been a key opinion leader (KOL) of Huzel for the past several years and is considered to have contributed greatly to the growth of the company.

◆ Daewoong Pharmaceutical’s sales of 1.55 trillion won last year… 5.2% compared to the previous year↓

Daewoong Pharmaceutical recorded sales of 1.55 trillion won (consolidated) in 2020. Although it fell 5.2% year-on-year, it succeeded in winning sales of the KRW 1 trillion range.

On an individual basis, it recorded sales of KRW 944.8 billion, operating profit of KRW 12.6 billion, and net profit of KRW 4.7 billion.

Despite extraordinary factors such as ITC litigation costs and sales gaps caused by Albis sales bans, Nabota sales showed a significant increase, and ETC and OTC maintained a solid sales volume, the company explained.

◆ Seegene applies saliva testing to diagnostic kits… “More than 96% match rate”

It was found that the saliva test method was applied to Seegen’s Corona 19 diagnostic kit to show similar accuracy to the existing PCR test method nasopharyngeal smear (a method of collecting a sample by pushing a cotton swab into the nose) when diagnosing Corona 19.

In particular, as a result of saliva testing using Seegen’s Corona 19 diagnostic kit, the results were consistent with the nasopharyngeal smear test results under the conditions of extraction free, multiple diagnosis (corona 19 virus including mutation, Flu A/B. Reached 97%.

Kangwon National University’s medical department professor Seo In-beom’s research team (Korea Clinical Research Center) collected nasopharyngeal smears and saliva samples from all patients for 90 patients (46 positive, 44 negative) admitted to the hospital due to suspected COVID-19. Collect and perform PCR test.

Specimens are collected without any activity for 30 minutes after waking up with food intake restricted for effective collection of coronavirus in saliva.

For PCR testing, Seegene’s COVID-19 diagnostic kit’Allplex SARS-CoV-2 Assay’ and various respiratory viruses such as COVID-19 and flu,’Allplex SARS-CoV-2/FluA/FluB/RSV Assay’ are used.

As a result, it was found that the agreement between the nasopharyngeal smear and the saliva test result was more than 98.8% for both types of diagnostic kits.

◆ “The only academic award in the field of oncology in Korea”… Boryeong Pharmaceutical’Boryeong Cancer Academic Award’ Competition

Boryeong Pharmaceuticals invites the winners of the ’20th Boryeong Cancer Academic Award’.

The competition period is until March 31st, and has been engaged in research in the field of oncology for more than 5 years, and has been engaged in research in the field of oncology for more than 5 years, and for the last 3 years (January 1, 2018 to December 31, 2020) You can submit the paper published in the journal.

Those within 3 years of receiving other academic awards for similar achievements are excluded from the jury.

One winner will be selected after the judges commissioned by the Korea Cancer Research Foundation and won a plaque, medal, and research grant of 30 million won.

◆ Soonchunhyang University Hospital corona cumulative 117 people… Special inspection on wearing a hospital mask

It was confirmed that there were 117 confirmed cases of the COVID-19 group infection at Soonchunhyang University Seoul Hospital in Yongsan-gu, Seoul as of 00:00 on the 16th. Of these, 108 were confirmed in Seoul and the remaining 9 were confirmed in other cities and provinces.

At Soonchunhyang University Seoul Hospital, two inpatients were first confirmed on the 12th, 88 by the 14th and 27 additionally on the 15th. On the 15th, there were 11 patients, 3 workers, 1 carer, 12 people including guardians and acquaintances.

As a result of examining a total of 2,312 people, including those who were contacted by the facility officials, there were 115 positive and 2,156 negatives, except for the first two, and the rest did not show the test results.

◆ By next month, 760,000 people excluding the elderly have been vaccinated against Corona 19

The government started vaccinating Corona 19 at nursing hospitals and nursing facilities from the end of this month.

AstraZeneca (AZ) vaccine, which is the first to be released in Korea, and vaccination is given priority from under 65 years old. In the case of the elderly over 65 years old, the vaccination is withheld for about a month until additional clinical trial data are available, considering that the vaccination effect is still controversial.

Accordingly, in the first quarter of this year, a total of 760,000 people, including those under the age of 65 in nursing hospitals and nursing facilities and workers, health care workers at high-risk medical institutions, and workers responding to Corona 19 will receive vaccinations.

【Youth Daily = Reporter Ahn Sang-jun】