JRP Bio receives phase 2a IND approval for SH003 with docetaxel in NSCLC
Moving to efficacy after three monotherapy and combination phase 1 trials
JRP Bio (Jaein R&P Co., Ltd.) announced that the Ministry of Food and Drug Safety (MFDS) has approved its investigational new drug (IND) application for a phase 2a trial of SH003 combined with docetaxel in non-small cell lung cancer.
SH003 received Korea's first MFDS IND for an oral botanical anticancer drug. JRP Bio has completed three phase 1 trials: monotherapy in solid tumors (2019), high-dose monotherapy (2022) and combination with docetaxel (2023).
This approval brings JRP Bio's MFDS IND approvals to four. While developing SH003 as a prescription drug for combination oncology therapy, the company is also pursuing approvals suited to other targets — an OTC drug, a functional ingredient and overseas registration (FDA NDI) — based on the accumulated safety data.
About JRP Bio
JRP Bio (Jaein R&P Co., Ltd.) standardizes Korean medicine formulas and natural products, builds the evidence behind them, and secures approval to turn them into products people actually use. JRP stands for “Journey from Research to People.” The company received Korea's first IND for an oral botanical anticancer candidate, SH003, and holds 14 granted Korean patents and 42 SCI(E) publications.
Media contact
- Email bs@jrpbio.com
- Phone +82-2-6925-5568