GX-H9, a long-acting recombinant human growth hormone codeveloped by Handok and Genexine, has won the European Medicines Agency (EMA) designation as an orphan drug for growth hormone deficiency.Handok and Genexine apply antibody-fusion technology (hyFc) to develop GX-H9, a next-generation growth hor
Medicinal products developed with homegrown technology have entered the ranks of blockbuster drugs with annual prescriptions of more than 100 billion won ($86.7 million), industry watchers said Friday.For instance, LG Chem's Zemiglo, Boryung Pharmaceutical's Kanarb, Hanmi Pharmaceutical's Amosartan,
Hanall Biopharma has submitted an investigational new drug (IND) for the second phase 3 clinical trial (VELOS-3) of its dry eye treatment, HL036 ophthalmic solution (ingredient: Tanfanercept), to the U.S. Food and Drug Administration.In the U.S., if the initial IND plan maintains its validity, the f
The labor unions of global pharmaceutical companies’ Korean offshoots, which experienced job insecurity due to their headquarters’ unilateral spinoff decisions, are now busy creating a union culture encompassing desk workers and field reps.Most of them resorted to strikes in the past, but many are t
Handok signed an agreement to exclusively market Jazz Pharmaceuticals’ acute myeloid leukemia (AML) treatment, Vyxeos, in Korea on Tuesday.Jazz Pharmaceuticals, an Ireland-based global biopharmaceutical company, has portfolio models of neural and cancer medical products already in the sale or under
Hanmi Pharmaceutical said it would develop antibody-drug conjugates (ADC) using bispecific antibody platform Pentambody with Beijing Hanmi Pharm (Beijing Hanmi) and LegoChem Biosciences.Under the contract agreed on Thursday, Hanmi Pharmaceutical and LegoChem Biosciences would discover next-generatio
Theragen Bio has identified new predictors of diabetes risks through joint research with Professor Jeong Dong-hyeok of the Department of Family Medicine at Yongin Severance Hospital.Blood levels of C-reactive protein (CRP) and albumin may be new predictors of diabetes risk, the company said.The join
inno.N said Thursday that it would enter the Kosdaq stock market early next month to jump to a global bio-health company.The company plans to raise 505.9-596.9 billion won ($440-$519 million) through the initial public offering of 10,117,000 shares at the expected price of 50,000-59,000 won, It will
Ono Pharma Korea and BMS Korea said Opdivo (ingredient: nivolumab) has improved gastric cancer patients' overall survival (OS) to provide a turning point in the treatment paradigm of cancer immunotherapy.Professor Rha Sun-young of the Medical Oncology Department at Yonsei Cancer Center introduced th
A consortium led by GL Rapha to produce Sputnik V, Russia's Covid-19 vaccine, is nearing its composition.Following ISU Abxis and Hankook Korus Pharm, Jetema has received technology transfer to finish preparations for manufacture as a member of the consortium.As GL Rapha has announced that it could s
Yuyu Pharma said Thursday that it has signed a deal with Novartis Korea to exclusively supply the latter's five prescription drugs for athlete's foot, dyslipidemia, and epilepsy in Korea.Under the accord, Yuyu Pharma would supply Lamisil (ingredient: terbinafine hydrochloride) for athlete's foot, Le
Dong-A ST and its Japanese partner Meiji Seika Pharma signed a global license-out agreement with Intas Pharmaceuticals for DMB-3115, a biosimilar of the inflammatory disease treatment Stelara, the Korean company said Wednesday.Under the contract, Dong-A ST and Meiji Seika Pharma will research and de
The Ministry of Food and Drug Safety has suspended the sales of GSK's Tivicay 50mg Tab., a human immunodeficiency virus-1 (HIV-1) treatment, for 15 days for failing to submit documents in applying for drug reexamination.According to industry sources, the ministry issued the 15-day sales suspension o
The domestic biopharmaceutical companies are speeding up research to develop a drug to cure cerebral infarction, for which there is only one treatment worldwide currently.The intravenous injection of recombinant tissue plasminogen activator (tPA), developed by Boehringer Ingelheim, is the only drug
A generational shift seems to have begun in earnest in the pneumococcal conjugate vaccine market, as MSD’s 15-valent vaccine Vaxneuvance won approval from the U.S. Food and Drug Administration recently, following Pfizer’s Prevnar 20.MSD’s Vaxneuvance is likely to go one step ahead in the pediatric p
GC Pharma said Tuesday that it has signed an agreement with its U.S. partner Speragen to co-develop treatment for Succinic Semialdehyde Dehydrogenase Deficiency (SSADHD), a rare intractable disease.SSADHD is caused by enzyme deficiency caused by defective genes that show a recessive pattern of inher
Santen Korea said Tuesday that it has confirmed the efficacy of Taflotan in lowering intraocular pressure and inhibiting the progression of glaucoma for a long time, by comparing it with other prostaglandin analogs (PGA).“The study, dubbed LOTUS, was the first multicenter retrospective cohort resear
As Covid-19 prolongs, experts emphasize the importance of oral therapeutics because the novel coronavirus is increasingly likely to become an endemic that occurs periodically rather than a one-off pandemic.“We should begin to prepare to live with the coronavirus,” said Rep. Shin Hyun-young of the ru
Celltrion said that the Indonesian drug regulator granted emergency use authorization (EUA) for its Covid-19 antibody treatment, Regkirona, last Saturday.The Indonesian food and drug safety agency, known by the acronym of BPOM, announced that it would approve the use of Regkirona on high-risk adult
Medipost said Monday that it had terminated the establishment of a joint venture, Shandong Orlife Pharmaceutical, in China as its local partner did not fulfill the contract as agreed.Medipost signed an agreement to establish a joint firm with a Chinese biotech company to market Cartistem, its stem c