new drug Archives | Be Korea-savvy
SK C&C Turns to AI for New Drug Development

SK C&C Turns to AI for New Drug Development

SEOUL, Sept. 7 (Korea Bizwire) — SK C&C Co., an IT service unit of South Korean conglomerate SK Group, said Monday it had expanded the application area of its artificial intelligence (AI)-based target identification platform to include non-alcoholic fatty liver disease. The platform, originally intended for the development of new drugs for metabolic diseases, was [...]

Junshi Biosciences Announces Acceptance by NMPA of Supplemental New Drug Application for Toripalimab Plus Chemotherapy as First-Line Treatment for Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Junshi Biosciences Announces Acceptance by NMPA of Supplemental New Drug Application for Toripalimab Plus Chemotherapy as First-Line Treatment for Advanced or Metastatic Esophageal Squamous Cell Carcinoma

SHANGHAI, China, July 30 (Korea Bizwire) — Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that the National Medical Products Administration (NMPA) of China has accepted its supplemental New Drug Application (sNDA) for toripalimab in combination with platinum-containing chemotherapy as [...]

Junshi Biosciences Announces NMPA Acceptance of Investigational New Drug Application for JS014

Junshi Biosciences Announces NMPA Acceptance of Investigational New Drug Application for JS014

SHANGHAI, China, June 28 (Korea Bizwire) — Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that the National Medical Products Administration (NMPA) has accepted its Investigational New Drug (IND) application for JS014. In June 2019, Junshi Biosciences and Anwita Biosciences [...]

Samsung Biologics to Expand New Drug Development: CEO

Samsung Biologics to Expand New Drug Development: CEO

SONGDO, March 19 (Korea Bizwire) — South Korean pharmaceutical firm Samsung Biologics Co. will accelerate its new drug development to secure future growth engines, its chief said Friday. Samsung Biologics is a leading contract development and manufacturing organization (CDMO) specializing in the development and manufacturing of biopharmaceutical products for major pharmaceutical firms from both home [...]

Junshi Biosciences Announces Acceptance of a Supplemental NDA in China for Toripalimab in Advanced Nasopharyngeal Carcinoma

Junshi Biosciences Announces Acceptance of a Supplemental NDA in China for Toripalimab in Advanced Nasopharyngeal Carcinoma

SHANGHAI, China, April 30 (Korea Bizwire) — Junshi Biosciences (HKEX: 1877), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, today announced that the China National Medical Products Administration (NMPA) has accepted a supplemental New Drug Application (sNDA) for toripalimab as a treatment for patients with recurrent/metastatic nasopharyngeal carcinoma [...]

Celixir Announces US FDA Approval of the IND Application for Cell Therapy Heartcel

Celixir Announces US FDA Approval of the IND Application for Cell Therapy Heartcel

Stratford-upon-Avon, UK, Jun. 8 (Korea Bizwire) – Celixir, a privately owned company discovering and developing life-saving advanced therapies, announces that the US Food and Drug Administration (FDA) has approved its Investigational New Drug application (IND) for HeartcelTM, its immuno-modulatory progenitor (iMP) cell therapy for the treatment of adult heart failure. Celixir announced in January the approval [...]

Best in Class Erectile Dysfunction Drug – DRGT Announces Dose Escalation Study Results of Its Super-Tadalafil DRGT-99

Best in Class Erectile Dysfunction Drug – DRGT Announces Dose Escalation Study Results of Its Super-Tadalafil DRGT-99

MALTA, May 2 (Korea Bizwire) — DRGT, a specialty pharmaceutical company with a proprietary formulation technology, announced the results of its successful dose escalation PK study for DRGT-99, an innovative formulation of tadalafil.  Tadalafil (Cialis®) was originally developed by Lilly ICOS, LLC –a longer lasting alternative to Sildenafil Citrate (Viagra®) and is indicated for the [...]

RedHill Biopharma and IntelGenx Submit New Drug Application to FDA for RIZAPORT® for Migraines

RedHill Biopharma and IntelGenx Submit New Drug Application to FDA for RIZAPORT® for Migraines

TEL-AVIV, Israel and RALEIGH, N.C., Nov. 1 (Korea Bizwire) — RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, together with IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) (“IntelGenx”), a leading [...]