Hanmi Pharm has initiated the product approval course of with the Ministry of Meals and Drug Security (MFDS) for its weight problems remedy efpeglenatide. Commercialization is anticipated subsequent yr. Hanmi Pharm plans to implement an efpeglenatide growth technique to broaden its weight problems and metabolic area portfolio.
Hanmi Pharm introduced on Dec. 17 by way of a disclosure that it had utilized for MFDS product approval for Hanmi Efpeglenatide Auto-injector Injection (HM11260C; energetic ingredient efpeglenatide). The utilized doses are 2mg, 4mg, 6mg, 8mg, and 10mg. The indication targets grownup weight problems sufferers with out diabetes.
Hanmi Pharm is pursuing commercialization of efpeglenatide within the second half of subsequent yr, however there are forecasts that it could launch sooner than anticipated. That is because of efpeglenatide being designated as a topic for the MFDS International Progressive drug Quick Monitor (GIFT) expedited evaluation. In line with the MFDS, when designated for GIFT, the evaluation proceeds on a schedule that’s roughly 25% shorter in comparison with common evaluation durations.
Efpeglenatide demonstrated weight reduction efficacy by way of earlier Part 3 40-week topline outcomes. Within the medical trial performed on 448 Korean topics, the efpeglenatide remedy group confirmed a median weight discount charge of 9.75%.
Together with this approval software, Hanmi Pharm plans to totally activate its ‘Life Cycle Administration (LCM) technique’ to materialize efpeglenatide’s growth potential. The technique focuses on attacking the market as a complete weight problems and metabolic administration answer by increasing efpeglenatide’s worth by way of ▲diabetes indication growth ▲formulation improvement together with prefilled syringe (PFS) and multi-pen ▲Korea’s first Digital Therapeutics (DTx) improvement ▲custom-made well being practical meals and OTC (over-the-counter drug) packages.
Hanmi Pharm views weight problems as a fancy metabolic illness resulting in Sort 2 diabetes and cardiovascular ailments, and is creating efpeglenatide not restricted to weight problems remedy. At the moment, the corporate is pursuing indication growth as a diabetes remedy by way of Part 3 medical trials combining with SGLT-2 inhibitors and metformin, with improvement focusing on approval in 2028.
Hanmi Pharm can also be difficult to develop Digital Therapeutics (DTx) as the primary home pharmaceutical firm. Digital Therapeutics is a next-generation remedy mannequin that enhances therapeutic results by combining prescription drugs with digital medical gadgets. The plan is to maximise built-in remedy results by fusing efpeglenatide with digital medical gadgets for muscle power and train efficiency enchancment, weight reduction help, and life-style enchancment. The corporate goals to submit an IND (Investigational New Drug) software within the first quarter of subsequent yr.
Park Jae-hyun, CEO of Hanmi Pharm, emphasised, “Via the launch of efpeglenatide, we purpose to open new horizons within the weight problems and metabolic remedy area past easy weight reduction and current a remedy paradigm that considerably improves sufferers’ high quality of life.”
