Hanmi Pharmaceutical will present the results of its Phase 2 clinical trial for a treatment of congenital hyperinsulinism at a European conference.
The company announced on September 4 that it will share findings on its treatment, 'Epegaglutide' (HM15136), for congenital hyperinsulinism (CHI) at the 64th European Society for Pediatric Endocrinology (ESPE 2026) conference, taking place from September 8 to 10 in Marseille, France.
Congenital hyperinsulinism is a rare condition characterized by excessive insulin secretion, leading to hypoglycemia. Currently, there are no FDA-approved treatments specifically for this condition.
Existing approved treatments for hypoglycemia due to hyperinsulinism have limited efficacy based on specific genotypes and are associated with side effects such as hirsutism, fluid retention, and heart failure.
As a result, many patients rely on unapproved medications or undergo pancreatic surgery despite the risks of side effects.
Hanmi Pharmaceutical is developing Epegaglutide as a weekly injectable treatment, the first of its kind aimed at overcoming the limitations of existing therapies.
According to the company, Epegaglutide demonstrated excellent safety and tolerability in patients with congenital hyperinsulinism during the Phase 2 trial presented at last year's ESPE. It also showed effectiveness in reducing both hypoglycemia and severe hypoglycemia incidents.
Earlier this year, the treatment received Breakthrough Therapy Designation (BTD) from the FDA. This designation provides various benefits to drugs that show significant clinical improvement potential over existing therapies for serious conditions based on preliminary clinical evidence.
Drugs designated as BTD receive intensive guidance and support from the FDA throughout the development process, including the option for a Rolling Review, which allows for partial submission of data during the approval process.
Additionally, Epegaglutide has been designated as an orphan drug (ODD) by the FDA, the European Medicines Agency (EMA), and the Korean Ministry of Food and Drug Safety (MFDS). In the U.S., it has also been classified as a treatment for pediatric rare diseases (RPD).
The EMA has also designated Epegaglutide as an orphan drug for the treatment of autoimmune insulin syndrome.
Lee Moon-hee, head of Hanmi Pharmaceutical's clinical team, stated, "In this presentation, we will discuss the demographic and clinical characteristics of patients who participated in the Phase 2 trial."
Meanwhile, Hanmi Pharmaceutical is also gaining attention in the obesity drug sector. Shinhan Investment Corp. has projected that the value of Hanmi's entire obesity treatment pipeline will be reassessed following the technology transfer of a candidate drug aimed at reducing muscle loss to the global pharmaceutical company Genentech (a subsidiary of Roche).
As a result, the firm maintained a buy rating on the stock and raised its target price from approximately 510,000 won to 650,000 won, an increase of 27.5%. This target price adjustment is primarily based on the technology transfer agreement for HM17321 signed on August 24. Hanmi Pharmaceutical transferred global rights, excluding Korea, for the muscle-preserving obesity treatment candidate HM17321 to Roche's subsidiary Genentech. The total contract value is $2.35 billion (approximately 3.2 trillion won), with an upfront payment of $190 million (approximately 2.7 trillion won).
The company announced on September 4 that it will share findings on its treatment, 'Epegaglutide' (HM15136), for congenital hyperinsulinism (CHI) at the 64th European Society for Pediatric Endocrinology (ESPE 2026) conference, taking place from September 8 to 10 in Marseille, France.
Congenital hyperinsulinism is a rare condition characterized by excessive insulin secretion, leading to hypoglycemia. Currently, there are no FDA-approved treatments specifically for this condition.
Existing approved treatments for hypoglycemia due to hyperinsulinism have limited efficacy based on specific genotypes and are associated with side effects such as hirsutism, fluid retention, and heart failure.
As a result, many patients rely on unapproved medications or undergo pancreatic surgery despite the risks of side effects.
Hanmi Pharmaceutical is developing Epegaglutide as a weekly injectable treatment, the first of its kind aimed at overcoming the limitations of existing therapies.
According to the company, Epegaglutide demonstrated excellent safety and tolerability in patients with congenital hyperinsulinism during the Phase 2 trial presented at last year's ESPE. It also showed effectiveness in reducing both hypoglycemia and severe hypoglycemia incidents.
Earlier this year, the treatment received Breakthrough Therapy Designation (BTD) from the FDA. This designation provides various benefits to drugs that show significant clinical improvement potential over existing therapies for serious conditions based on preliminary clinical evidence.
Drugs designated as BTD receive intensive guidance and support from the FDA throughout the development process, including the option for a Rolling Review, which allows for partial submission of data during the approval process.
Additionally, Epegaglutide has been designated as an orphan drug (ODD) by the FDA, the European Medicines Agency (EMA), and the Korean Ministry of Food and Drug Safety (MFDS). In the U.S., it has also been classified as a treatment for pediatric rare diseases (RPD).
The EMA has also designated Epegaglutide as an orphan drug for the treatment of autoimmune insulin syndrome.
Lee Moon-hee, head of Hanmi Pharmaceutical's clinical team, stated, "In this presentation, we will discuss the demographic and clinical characteristics of patients who participated in the Phase 2 trial."
Meanwhile, Hanmi Pharmaceutical is also gaining attention in the obesity drug sector. Shinhan Investment Corp. has projected that the value of Hanmi's entire obesity treatment pipeline will be reassessed following the technology transfer of a candidate drug aimed at reducing muscle loss to the global pharmaceutical company Genentech (a subsidiary of Roche).
As a result, the firm maintained a buy rating on the stock and raised its target price from approximately 510,000 won to 650,000 won, an increase of 27.5%. This target price adjustment is primarily based on the technology transfer agreement for HM17321 signed on August 24. Hanmi Pharmaceutical transferred global rights, excluding Korea, for the muscle-preserving obesity treatment candidate HM17321 to Roche's subsidiary Genentech. The total contract value is $2.35 billion (approximately 3.2 trillion won), with an upfront payment of $190 million (approximately 2.7 trillion won).
* This article has been translated by AI.
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