[김창수의 e뉴스 브리핑] Artenex “FDA demands supplementation of marketing permission for’Oraxol’”… Misapproval

[FETV=김창수 기자] Hanmi Pharmaceutical partner Atenex received a letter from the US FDA (Food and Drug Administration) requesting supplementation for the marketing approval of’Orasol’, an oral anticancer drug for metastatic breast cancer treatment, through its press release on the 1st (U.S. local time). Revealed. Yuhan Corporation was selected as No. 1 in the industry and No. 4 in All Stars for 18 consecutive years in the ‘2021 Korea’s Most Admired Company’ by the Korea Management Association. Samsung Bioepis started phase 1 clinical trial of SB17 (Stellara biosimilar, ingredient name Ustekinumab), its 10th biosimilar pipeline.

◆ Atenex “FDA demands supplementation of marketing permission for’Oraxol’”… Misapproval

Athenex, a partner of Hanmi Pharmaceuticals, reported that it received a complete response letter (CRL) from the US FDA (Food and Drug Administration) requesting a supplement to the marketing of’Orasol’, an oral anticancer drug for metastatic breast cancer treatment. It was revealed on the 1st (U.S. local time).

According to the Athenex press release, the FDA raised concerns about the sequelae of neutropenia compared to intravenous injections of Oxol, an oral anticancer drug.

In addition, the FDA expressed concern about the uncertainty of the results of the objective response rate (ORR), the primary evaluation variable evaluated by the blinded independent central review (BICR) at week 19. He advised that appropriate new clinical trials in patients need to be performed.

◆ Yuhan Corporation, ranked 1st in the pharmaceutical sector, the most respected company for 18 consecutive years

Yuhan Corporation was selected as No. 1 in the industry and No. 4 in All Stars for 18 consecutive years in 2021 Korea’s Most Admired Companies by the Korea Management Association.

In particular, Yuhan Corporation has not missed the first place in the pharmaceutical sector for 18 years since the award for the most respected company began.

Yuhan Corporation inherited the entrepreneurial spirit of the late founder, Dr. Ilhan Ilhan, and has been loved for a long time with the corporate image of ‘Wow Yuhan, a symbol of credit.’

In particular, it has grown and developed into a reliable company for a long time through the production of excellent medicines and household goods as a result of focusing on building trust between customers and companies while growing with society.

◆ Samsung Bioepis, Stellara biosimilar SB17 clinical trial started

Samsung Bioepis has started phase 1 clinical trial of SB17 (Stellara biosimilar, ingredient name Ustekinumab), its 10th biosimilar pipeline.

According to the content posted on the global clinical trial information website’Clinical Trials’ on February 26th, Samsung Bioepis has developed the pharmacokinetics and safety of SB17 for 201 healthy volunteers in France from February 2021. , Phase 1 clinical trials to confirm immunogenicity and the like were initiated.

Stellara is a treatment for autoimmune diseases such as psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis sold by Johnson & Johnson in the United States, with annual global sales of about 8.4 trillion won ($7.7 billion) in 2020.

◆ Korea Eundan Healthcare launches’Solar C Gumi Shine Muscat Flavor’

Korea Eundan Healthcare has launched’Solar C Gumi Shine Muscat Flavor’, which allows you to consume vitamin C in Gumi form.

‘Solar C Gumi Shine Muscat Flavor’ is a product that upgrades the existing green grape flavor according to the continued popularity of Shine Muscat.

This product also uses vitamin C ingredients from DSM, a global vitamin ingredient manufacturer, and the content of vitamin C is 500mg, equivalent to the equivalent of 9 lemons, which is 500% of the recommended daily vitamin C. The package is a zipper bag type, and it is easy to carry and store.

An official from Korea Eundan said, “Solar C Gumi is a product that has been loved by both adults and children for its moist yet soft texture and various flavors of fruit juices.” “This new product can also take vitamin C with the Shine Muscat flavor that many consumers prefer. I’m looking forward to being popular.”

◆ Hyundai Pharm signed an exclusive supply contract for oral pregnancy cessation drugs

Hyundai Pharm has signed a domestic copyright and exclusive supply contract for oral pregnancy cessation drugs with the British pharmaceutical company Line Pharma International. It also said that it is in close consultation with the Ministry of Food and Drug Safety to submit an application for approval as soon as possible.

This drug is a combination product of mifepristone and misoprostol, and has been recognized as a safe pregnancy stop drug as it has been designated as an essential drug by the World Health Organization (WHO).

An official of Hyundai Pharm said, “There are frequent cases of illegally purchasing and taking pregnancy stop drugs on the Internet. In this case, serious side effects may occur due to inaccurate information on dosage, method, and contraindications, and sequelae may remain. “This drug introduction was a choice considering the safety of women, and I hope that the drug can be safely taken through consultation with experts in the future.”