Matica Biotechnology, CHA Biotech’s U.S. offshoot, said Thursday that it aims to achieve annual sales of 1 trillion won ($762 million) in 2030, emerging as one of the big-five cell and gene therapy CDMOs worldwide."The cell and gene therapy (CGT)’s contract development, and manufacturing organizatio
The Ministry of Food and Drug Safety (MFDS) said Wednesday that it has begun the preliminary review of the non-clinical and clinical trials results of Moderna’s Spikevax-2 mRNA Covid-19 vaccine submitted by Moderna Korea.Moderna’s Spikevax-2 is a multi-vaccine containing mRNA that expresses the anti
Ildong Pharmaceutical’s shares plunged to the lower limits on Thursday, as the Japanese regulator delayed giving emergency use approval (EUA) for Xocova, an oral Covid-19 treatment co-developed by Ildong and its Japanese partner, Shionogi Pharmaceutical.As of noon, Ildong’s shares stood at 37,400 wo
HLB's targeted anticancer drug, rivoceranib, has proven excellent efficacy, with 85 percent of patients showing cancer disappearance and more than 30 percent reduction in adenocarcinoma treatment for local progressive esophageal squamous cell cancer (ESCC).Following the recent successful clinical re
The ongoing strength of the U.S. dollar will likely result in mixed fortunes for Korean biopharmaceutical and biotech companies in the second quarter, according to industry analysts on Wednesday.According to the Korea International Trade Association, the Korean currency ended Wednesday’s trading at
In 2021, Korean biotech firm Bixink Therapeutics introduced Nerlynx Tab. (neratinib), a HER2 inhibiting breast cancer treatment developed by Puma Biotechnology and approved by the FDA in July 2017. The arrival of the drug drew much attention from the medical community.In Korea, Nerlynx obtained appr
Daewoong Pharmaceutical said it has completed preparations for speeding up its entry into the contract development and manufacturing organization (CDMO) business.The company said Wednesday that it received approval for an advanced regenerative medicine cell processing facility from the Ministry of F
Takeda’s oral drug Exkivity (mobocertinib) won the regulatory nod to treat non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (Ex20ins) mutation in Korea.The approval will prompt its competition against Janssen’s Rybrevant (amivantamab), an injection th
Chong Kun Dang Pharmaceutical said it would tap the 350 billion won ($267.4 million) local gastritis market with its new natural product-based treatment.On Monday, the drugmaker won regulatory approval for G-Tec (ingredient: cinnamon bark dried extract) to treat acute and chronic gastritis.Chong Kun
Samsung Biologics said Tuesday that it signed a contract with the Incheon Free Economic Zone (IFEZ) to purchase industrial facility land in the high-tech industrial cluster of Songdo International City’s 11th block.Samsung Biologics plans to become the "world's No. 1 CDMO company" by building four p
As the Omicron subvariants wreak havoc globally, Moderna’s top medical officer stressed the need to receive booster shots now instead of waiting for a revised vaccine that works better against Omicron mutations.Last week, Moderna released a study result, which showed that mRNA-1273.214, its revised
Daewoong Pharmaceutical said that the U.S. Food and Drug Administration had granted fast-track designation to its idiopathic pulmonary fibrosis (IPF) therapy, DWN12088.IPF is a lung disease in which the lungs gradually harden and lose their function due to excessive fibrous tissue. It is a rare and
Celltrion received approval from the Polish Pharmaceutical and Medical Equipment Registration Office (URPL) on Monday for the phase 3 clinical trial (IND) of its Actemra biosimilar, "CT-P47," which treats rheumatoid arthritis treatment.Celltrion won the investigational new drug (IND) approval two mo
Hanmi Pharm released the second-quarter earnings report on Monday, earlier than expected, to refute an analyst report’s prediction of the drugmaker’s operating profit.In a regulatory filing on Monday, Hanmi announced that it recorded 316.5 billion won ($240.3 million) in sales, 29.6 billion won oper
CanariaBioM, a parent company of CanariaBio, signed a contract on Friday to take over Sejong Medical by acquiring a 100 percent share of the latter’s equity jointly with foreign financial investors.Through this acquisition, CanariaBioM will secure Sejong Medical’s medical device business and new dru
Technology transfers concerning new drug candidates made by Korean biopharmaceutical companies this year fell from a year ago.The license-out deals of Korean biopharmaceutical companies grew from 10.14 trillion won ($7.7 billion) in 2020 to 11.44 trillion won last year. The number of contracts also
The Ministry of Food and Drug Safety has suspended importing three Viatris Korea’s eye drop products for one through Aug. 14.The suspension of import business was due to the company’s failure to report the changes in the manufacturing client after the merger of the Upjohn division of Pfizer and Myla
The American Society of Clinical Oncology recently (ASCO) issued a “rapid recommendation” to use Kimmtrak (ingredient: tebentafusp) to treat uveal melanoma.Kimmtrak won FDA approval early this year as the first uveal melanoma treatment.With the latest ASCO’s recommendation, Kimmtrak became the stand
HLB Therapeutics said Monday that it would simultaneously start clinical trials for neuroparalytic keratitis treatment in the U.S. and Europe, signing related contracts with a global contract research organization (CRO).Eye disease drugs usually require two repetitive clinical outcomes. However, HLB
New Korean pharmaceutical companies are racing to develop botulinum toxin (BTX) to sell them in the U.S. and Europe instead of the saturated Korean market, industry officials said. Such companies include BioPlus, CKD Bio, Jetema, EuBiologics, and ATGC.On Thursday, BioPlus announced a 2.3 billion won