| |NOVEMBER 20248HUIDAGENE'S FIRST CRISPR RNA-EDITING THERAPY FOR NAMD CLEARED BY US FDAVenus Remedies announced that its robotic pre-filled syringe facility at the Baddi unit has been granted approval for good manufacturing practices (GMP) by the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia. Venus Remedies announced in a statement that their pre-filled syringe (PFS) facility has received its inaugural Pharmaceutical Inspection Co-operation Scheme (PIC/S) accreditation."Securing the PIC/S GMP accreditation from Malaysia's NPRA is a significant milestone and a testament to our commitment to quality and technological innovation in pharmaceutical manufacturing," Saransh Chaudhary, President, Global Critical Care, Venus Remedies and CEO, Venus Medicine Research Centre, said.Chaudhary further noted that "the major technological upgrades and investments we've made in our PFS facility over recent years have culminated in this recognition, reinforcing our team's dedication and excellence."The high compliance standards and world-class quality control measures at Venus Remedies' Baddi facility were highlighted by the approval process completed within six months of a rigorous audit in April 2024.Aditi Chaudhary, president of International Business at Venus Remedies, said, "the PIC/S GMP accreditation is a testament to the dedication and expertise of our teams across the globe. With this achievement, we are well-positioned to extend our international footprint and bring high-quality, life-saving medicines to more markets, thus ensuring better access to healthcare for all." POHuidaGene Therapeutics (HuidaGene), a worldwide biotech company focused on genome medicines in clinical trials, revealed that the US FDA has approved its HG202 investigational new drug (IND) application for neovascular age-related macular degeneration (nAMD). HG202 is the initial clinical-stage CRISPR/Cas13 RNA-editing therapy and the sole clinical-stage therapy for nAMD that targets RNA."This open IND for HG202 by the US FDA ­ the first regulator to have cleared CRISPR/Cas13 for clinical development ­ represents an important milestone for HuidaGene and the entire CRISPR gene-editing field of RNA editing," said Alvin Luk, Ph.D., M.B.A., C.C.R.A., co-founder and chief executive officer of HuidaGene. "We chose to go to the FDA because HG202 demonstrated good results in the in-vitro, in-vivo preclinical studies and first-in-human `SIGHT-I' trial. In September 2023, we dosed the world's first novel CRISPR/Cas13 RNA-editing therapy in humans, and we recently presented preliminary data at the ARVO, ASGCT, EURETINA, and ESGCT this year. The rigor of our clinical data in China using a non-receptor binding pathway approach through Cas13 RNA editor to partially knock down the mRNA expression of VEGFA brings the potential to AMD patients."This phase 1 trial, called BRIGHT, aims to assess the safety and tolerability of CRISPR/Cas13-RNA therapy targeting VEGF-A mRNA in patients with nAMD, a condition impacting around 190 million individuals over 60 globally. The main focus of the clinical study is to assess the safety and tolerance of HG202 at various doses following a single dose administration. Additional outcomes measured include alterations in best-corrected visual acuity (BCVA), central retinal thickness (CRT), and the necessity for anti-VEGF rescue injections. POTOP STORIESVENUS REMEDIES GAINS PIC/S GMP APPROVAL FOR ROBOTIC SYRINGE FACILITY
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