Hanmi launches companywide task force to commercialize obesity drug efpeglenatide this year
"The development of Efe reflects Hanmi’s spirit of not being discouraged by failure and turning it into a bigger opportunity."
Lim Ju-hyeon, vice chair of Hanmi Group, made the remarks April 13 at Hanmi C&C Square in Seoul as the company launched a cross-company consultative body, dubbed the “Efe Project–Seosa,” aimed at commercializing the obesity drug candidate efpeglenatide, known as Efe, within the year.
The event included Lim and Hwang Sang-yeon, Hanmi Pharmaceutical’s new CEO and the company’s first chief executive hired from outside since its founding, along with key executives from new product development, marketing and R&D, the company said.
The group plans to hold formal meetings monthly to align execution strategies across development, clinical work, marketing, production and distribution.
Lim said Efe’s Phase 3 cardiovascular outcomes trial showed results indicating a reduced risk of major adverse cardiovascular events. She said the drug has strong protective effects for cardiovascular and kidney disease compared with other drugs in the same class currently on the market.
Hwang said the company must now shift to detailed commercial preparation. “It feels like a torchbearer has just entered the main Olympic stadium,” he said, adding that Hanmi should create results “beyond sales.” He said he is confident the drug can be developed into a “premium, Korea-style obesity treatment” and pledged to grow Efe into a new engine of innovation-led growth.
Daewoong Pharmaceutical wins Indonesian approval for GERD drug Fexuclu
Daewoong Pharmaceutical said its self-developed gastroesophageal reflux disease treatment Fexuclu has received marketing authorization in Indonesia, as the company expands its push into Southeast Asia. The drug has now been approved in 16 countries, including South Korea, Indonesia, China, Mexico and India, and has been launched in six countries, the company said.
Daewoong said April 17 that Fexuclu 40 mg, whose active ingredient is fexuprazan, was approved in Indonesia for the treatment of erosive GERD.
The company also said it applied to South Korea’s Ministry of Food and Drug Safety on April 10 for an investigational new drug plan for a multinational Phase 3 trial jointly conducted in South Korea and Indonesia, seeking to expand the drug’s indication to treat gastric ulcers.
Indonesia, with a population of 280 million, is the world’s fourth-most populous country and Southeast Asia’s largest economy, the company noted.
A company official said a China launch is also approaching and that the Indonesian approval is expected to accelerate Fexuclu’s global expansion.
Daewoong CEO Park Sung-soo said the approval in Indonesia, a key market in Southeast Asia, would be an important turning point for the company’s global push.
GC Biopharma USA to present IVIG quality and safety data at U.S. conference
GC Green Cross said its U.S. subsidiary, GC Biopharma USA, will present research evaluating the quality and safety of intravenous immunoglobulin products at an international conference in Denver, Colorado, running April 18-22 local time.
The company said the study compared protein size and particle forms in commercially available IVIG products to assess the degree of aggregation. IVIG is widely used to treat immune disorders, and as use has increased, the importance of quality and safety has grown, it said.
Protein aggregation can affect drug safety and adverse reactions during administration, making control of aggregation during manufacturing a key quality factor, the company said.
The study compared five products, including GC Green Cross’ ALYGLO. The analysis found ALYGLO had lower levels of excessively aggregated proteins (multimers) and damaged protein fragments than competing products, while maintaining relatively higher levels of monomers and dimers, which are considered normal functional structures, the company said.
A GC Green Cross official said the company will continue working to provide safer, more reliable treatment options for patients.
Lunit to supply integrated breast cancer AI diagnostics to Lexington Clinic in the U.S.
Medical AI company Lunit said it has supplied an integrated breast cancer AI diagnostic solution to Lexington Clinic in the United States, as it accelerates expansion in the Americas and aims to broaden its presence in the global breast screening market.
Lunit said April 17 that Lexington Clinic adopted its mammography AI image analysis software, Lunit INSIGHT MMG, and its 3D mammography AI solution, Lunit INSIGHT DBT, to build an AI-based breast cancer diagnostic system.
The clinic also introduced solutions from Lunit International, formerly Volpara, covering image quality optimization, breast density assessment and patient follow-up management. That will allow the full breast cancer diagnostic workflow to be operated on Lunit’s platform, the company said.
Lunit said the deal means that about a year after integrating Lunit and Lunit International products, it has supplied the combined solution to more than 330 medical institutions across the Americas, supporting about 1 million mammography screenings annually.
CEO Seo Beom-seok said supplying an end-to-end integrated solution to a large U.S. medical group and expanding to more than 330 sites reflects the combination of Lunit’s AI technology and Lunit International’s market capabilities. He said the company will continue to expand its influence beyond the Americas into the global breast cancer screening market.
* This article has been translated by AI.
Copyright ⓒ Aju Press All rights reserved.