■ Celltrion announced on the 7th that its autoimmune disease treatment 'Steqeyma' (ingredient name ustekinumab) was listed in the formulary of one of the three major prescription benefit management companies (PBMs) in the United States on the 3rd (local time). Steqeyma has secured listings across all public and private insurance formularies operated by the PBM and has gained preferred drug status for priority prescriptions. It is known that the PBM oversees public and private insurance covering about 22% of the total U.S. insurance market. Steqeyma was launched in the U.S. market on the 12th of last month (local time) as a Low WAC version with an 85% discount from the original product's wholesale acquisition cost (WAC).
■ S.Biomedics announced that it presented the one-year follow-up results of its embryonic stem cell-derived Parkinson's disease cell therapy, TED-A9, at the 'AD/PD 2025 Conference,' the world's largest Alzheimer's and Parkinson's disease congress, held in Vienna, Austria, from the 1st to the 5th (local time). The clinical trial included 12 patients who had been diagnosed with Parkinson's for more than five years and showed side effects from antiparkinsonian drug therapy, conducted at Severance Hospital. The one-year follow-up results showed that in the 'MDS-UPDRS Part 3 (Off)' evaluation, a measure for objectively assessing motor function improvement in Parkinson's patients, the low-dose group improved by 21.8% on average (a decrease of 12.7 points) compared to before transplantation, and the high-dose group improved by 26.9% on average (a decrease of 15.5 points). In the 'MDS-UPDRS Total (Off)' evaluation as well, the low-dose and high-dose groups showed an average improvement of 26.4% (a decrease of 29 points) and 28.9% (a decrease of 34.7 points) compared to before transplantation, respectively, indicating comprehensive improvement. In another motor function assessment, the Hoehn & Yahr Scale, the low-dose group showed an average improvement of 27.8% compared to before transplantation, and the high-dose group showed an average improvement of 43.1%. Evaluations using the PD Diary showed that off time decreased by an average of about 3.6 hours in the low-dose group and by about 3 hours in the high-dose group.
■ Daewoong Pharmaceutical has launched its gastroesophageal reflux disease treatment Pexuclu in India. This is the first time a domestically produced P-CAB formulation has been launched in India. Pexuclu, a third-generation gastroesophageal reflux disease treatment, was launched by Daewoong Pharmaceutical in 2022. The company expects Pexuclu to quickly gain market share in the Indian anti-ulcer drug market by overcoming the slow effect onset and short half-life of existing PPIs (proton pump inhibitors), as well as the limitation of pre-meal dosing. Park Seong-su, CEO of Daewoong Pharmaceutical, expressed confidence that Pexuclu would establish itself as a breakthrough treatment option for gastroesophageal reflux disease patients in India, the fourth largest anti-ulcer drug market in the world. The company is also planning to expand to 100 countries by 2027 and reach its 'one product, one trillion won' vision by 2030.
■ JW Pharmaceutical announced on the 7th that Baek Soon-gu, president and CEO of Yonsei University Wonju Medical Center and sub-department, has been selected as the 33rd recipient of the JW Pharmaceutical Humanitarian Award. This award was jointly established by JW Pharmaceutical and the Korean Hospital Association to discover medical professionals who embody a spirit of compassion in society. Baek, who serves as both the president and CEO of Yonsei University Wonju Medical Center, contributed to increasing vaccine adoption rates by being the first medical staff member to get vaccinated at the hospital during the initial phase of COVID-19 vaccine administration, thereby easing concerns among medical staff and building trust. In 2019, he attracted the Sunflower Center to the region to protect and support victims of sexual violence, domestic violence, and child abuse. Moreover, he has continued to engage in activities to protect victims' rights, provide violence prevention education and awareness enhancement activities, and promote civic responsibility. In 2021, he contributed significantly to strengthening public healthcare by establishing the regional main center for rare diseases in Gangwon Province (currently the specialized institution for rare diseases in Gangwon Province). Along with the JW Pharmaceutical Humanitarian Award, the JW Pharmaceutical Service Award has been awarded to Ahn Hee-bae, director and hospital president of Dong-A University Medical Center, and Kang Jong-dae, Director at Jesus Hospital Maintenance Foundation.
■ Hanmi Pharmaceutical has discovered a new biomarker for the dual inhibitor 'HM97662' under development as a next-generation targeted anti-cancer innovative new drug, and unveiled it at an international conference. Hanmi Pharmaceutical said on the 7th that it presented research results on HM97662 at the '24th Bio IT World Conference & Expo 2025' held in Boston, USA from the 2nd to the 4th (local time). The proteins EZH1 and EZH2, referred to as 'gene regulator switches,' play a key role in controlling cancer cell growth and differentiation. It is anticipated that effectively inhibiting the function of the cancer-causing protein complex 'polycomb repressive complex 2 (PRC2)' by simultaneously targeting both proteins will yield a strong anti-cancer effect. HM97662 has shown a more powerful effect and the possibility of overcoming resistance compared to EZH2 single-target anticancer drugs by simultaneously inhibiting EZH2 and EZH1. The company is assessing the safety and tolerability of HM97662 as a monotherapy through a global phase 1 clinical trial involving patients with advanced or metastatic solid tumors in Korea and Australia.
■ SK Biopharm announced on the 7th that its U.S. subsidiary SK Lifescience presented study results proving the seizure reduction effect of the epilepsy treatment 'cenobamate' at the 77th Annual Meeting of the American Epilepsy Society held from the 5th to the 9th (local time) in San Diego, California, USA. The study analyzed the responsive neurostimulation (RNS) data of 37 adult patients aged 18 and over with focal seizures who had been taking cenobamate as an adjunct therapy at a minimum dose of 50mg daily for more than two weeks. As a result, during the treatment period, the frequency of epileptic discharges decreased by 84%, from 15.7 times per 28 days at the baseline (pre-dose standard) to 2.5 times at the final observation point on day 29. According to SK Lifescience, common side effects such as dizziness and drowsiness were reported, but could be improved by gradually increasing the cenobamate dose or reducing the dose of concomitant antiepileptic drugs.
■ Yuhan Corporation announced on the 7th that the clinical trial plan for the phase 1 and 2 tests of its immune anticancer drug YH32364 has been approved by the Ministry of Food and Drug Safety. YH32364 is a bispecific antibody targeting both epidermal growth factor receptor (EGFR) and '4-1BB'. It operates by inhibiting growth signals by binding to EGFR on the surface of cancer cells while simultaneously stimulating the 4-1BB signal to activate immune cells and maximize the anticancer effect. In preclinical studies, YH32364 showed a stronger anticancer effect compared to the competing drug cetuximab in tumors with EGFR expression and was found to maintain long-term anticancer effects through immune memory. It was also found to induce tumor-infiltrating immune cells and changes in the tumor microenvironment through 4-1BB activation in tumors expressing EGFR. The approved study is the first phase 1 and 2 clinical trial administering YH32364 to humans. The study will assess the safety, tolerability, pharmacokinetics, and antitumor activity of YH32364 in patients with locally advanced or metastatic solid tumors confirmed to overexpress EGFR.
■ Yuhan Corporation and partner Recens Medical announced on the 7th that they will support medical devices and consumables such as VedEase and Vexoheal, known for their effectiveness in treating burns, if the animal rescue organization 'WEACT' rescues pets and livestock affected by wildfires and transports them to animal medical centers. VedEase is an animal medical device that combines IceNeedlingTM and Vexoheal Exosome, delivering exosomes effectively to the skin using precision cooling technology, providing relief from skin inflammation and promoting skin tissue regeneration. Yuhan Corporation supports seven animal medical centers across regions and plans to provide additional support as the number of animals affected by wildfire burns increases.
■ Huons has launched a new product, 'Super NMN 15600,' containing 'Nicotinamide Mononucleotide' (NMN), fermented yeast powder known for its effects. NMN is a precursor that converts into nicotinamide adenine dinucleotide (NAD+), an essential coenzyme involved in cell energy production and physiological functions. Super NMN 15600 uses NMN derived from premium American yeast fermented powder with confirmed NMN content of over 50% purity. It contains 15,600mg of NMN in total per 120 tablets. It should be taken in two tablets and plenty of water at any convenient time of the day. The average NMN content obtainable from food is about 2mg per day, requiring consumption of 92.9kg of tomatoes, 57.8kg of cabbage, or 37.7kg of broccoli. It also includes 12 key supplementary ingredients such as organic fruit and vegetable powder, a mixed probiotic of 17 strains, and a vitamin E mixture.
■ Cha Bio F&C, a subsidiary of Cha Bio Group, announced on the 7th that it has signed a 'Joint Research and Cosmetic Application Agreement (MOU) for Stem Cell Activation Inductive Biomaterials' with Cosmecca Korea. The two companies will jointly design the entire process from exploring effective substances, evaluating efficacy, to advancing materials, in order to develop and commercialize high-functionality biomaterials such as stem cell activation inductive materials. The agreement period is for two years, and depending on initial research outcomes, the partnership scope may expand to mid-to-long-term research and development (R&D) and technology commercialization. Kim Seok-jin, CEO of Cha Bio F&C, stated, 'We aim to expand our raw material commercialization business, allowing the use of developed materials for in-house product development as well as by other corporations.'
■ HANDOK is conducting a pre-order event ahead of the launch of an upgraded version of its continuous glucose monitoring device, Barozen Fit. The Barozen Fit pre-order event is being held from the 7th to the 13th through HANDOK's official online mall Ilsang Health and Naver HANDOK Mall. By purchasing through pre-order, customers can buy the upgraded Barozen Fit product at a 10% discount, and 30 participants will be drawn to receive a Galaxy Watch7. A maximum of five units can be purchased per person, and products pre-ordered will be shipped in bulk after the official launch of the upgraded application version, roughly a week later.