SK bioscience held a completion ceremony on the 30th to celebrate the expansion of the pneumococcal vaccine production facility at its vaccine production plant, ‘L HOUSE,’ in Andong, North Gyeongsang Province. The company expanded the existing vaccine production building within L HOUSE, securing a new space of approximately 4,200 square meters (1,300 pyeong). The expanded facility will be used as a production base for the 21-valent pneumococcal vaccine (PCV21) candidate ‘GBP410,’ which is being co-developed with France’s Sanofi. The two companies view this expansion as a fruit of their strategic partnership and plan to further strengthen their collaboration system to successfully complete the global launch in the future.
Daewoong Pharmaceutical announced on the 30th that the bone regeneration-inducing protein ‘BMP-2’ has received approval as a raw material drug from the Ministry of Food and Drug Safety. BMP-2 is a protein that differentiates stem cells into bone cells at the site of bone defects and plays a key role in promoting new bone formation. Daewoong Pharmaceutical’s BMP-2 is produced using Escherichia coli, offering higher productivity and cost competitiveness compared to animal cell-derived proteins. This is the first time that BMP-2 single component has received raw material drug approval in Korea.
Dong-A ST announced on the 30th that it has signed a co-marketing agreement for the precocious puberty and prostate cancer treatment ‘Diperelin (generic name triptorelin)’ with Ipsen Korea. Diperelin is a GnRH (gonadotropin-releasing hormone) agonist developed by the global biopharmaceutical company Ipsen, used for treating central precocious puberty and prostate cancer. Under the agreement, the two companies will jointly conduct domestic promotional and marketing activities for Diperelin starting from the 1st of next month. Sales to general hospitals will be a joint effort, while outpatient sales will be solely handled by Dong-A ST.
Curocell announced on the 30th that it has applied for an Investigational New Drug (IND) for the CD19-targeted CAR-T therapy ‘Anbalcel (CRC01)’ for systemic lupus erythematosus (SLE). This clinical trial will begin at Catholic University of Korea Seoul St. Mary’s Hospital, with additional institutions participating. Notably, CAR-T clinical trials for severe SLE patients are currently being actively conducted in the U.S. and Europe, and in Korea, Seoul St. Mary’s Hospital was the first to administer Anbalcel to severe SLE patients through treatment-use approval last March. The patient recovered sufficiently to carry out daily activities without acute side effects, showing stable disease indicators even after discontinuing immunosuppressive therapy, indicating the potential success of Anbalcel as an autoimmune disease treatment.
Korea University Guro Hospital announced on the 30th that Newlive, a digital therapy equipment company founded by Professor Song Jae-jun of the Department of Otorhinolaryngology, has signed an export contract for the vagus nerve stimulation medical device ‘SoriCle’ with an annual scale of about $1 million (13.55 billion won) to Brazil. SoriCle is a non-invasive device designed to improve symptoms of tinnitus and insomnia, boasting advantages such as precise stimulation, ease of use, and exceptional portability compared to competing products. The recent contract, signed with a local distributor in Brazil, marks the first case of exporting a domestically developed vagus nerve stimulation medical device to Brazil. SoriCle has already obtained local medical device certification in Brazil, and formal distribution is set to commence through this contract.
Binex announced on the 30th that it has signed a biopharmaceutical manufacturing supply contract worth approximately 16.2 billion won with a global pharmaceutical company. The identity of the other party is confidential. This contract amount corresponds to about 12.5% of Binex’s sales last year. The contract period is until July 31 of next year. Binex stated that ‘the contract period and other conditions may change through mutual agreement as production progresses.’
Medytox announced on the 30th that its probiotic ‘MT961’ has been approved as an individual recognized functional ingredient by the Ministry of Food and Drug Safety. An individually recognized functional ingredient is a newly developed material whose functionality and safety have been proven through preclinical and human application trials. MT961 has been recognized as an individually recognized functional ingredient that can help reduce body fat.
Dongkook Pharmaceutical announced on the 30th that its dermatological cosmetic brand Centellian24’s representative product ‘Madeca Cream’ has reached its 10th anniversary. Madeca Cream, launched in 2015 along with Centellian24, contains the key ingredient ‘TECA’ (titrated extract of Centella Asiatica) and various active ingredients derived from Centella, enhancing skin elasticity, calming, and moisturizing effects. To date, eight products, including Madeca Cream and Centella Hydrating Formula, and Hydra 3X Formula have been launched. As of March, the cumulative sales of Madeca Cream have surpassed 73 million units. Centellian24 achieved a cumulative sales amount of 1 trillion won last year, thanks to the popularity of Madeca Cream.
JW Pharmaceutical C&C New Drug Research Institute announced on the 30th that its research on the development of a STAT6-targeting eosinophilic esophagitis treatment has been selected as a task for the 2025 1st National New Drug Development Project. The C&C New Drug Research Institute plans to use the funding for 16 months to optimize lead compounds that directly inhibit the STAT6 protein and advance toward preclinical development for oral low-molecular-weight therapeutics. Eosinophilic esophagitis is a chronic inflammatory disease caused by excessive Type 2 (Th2) immune response in the esophagus, and it is a rare disease with limited treatment options.
AptaBio announced on the 30th that its immune-oncology candidate ‘APX-343A’ has received orphan drug designation from the U.S. Food and Drug Administration (FDA). APX-343A is a next-generation immune-oncology candidate targeting cancer-associated fibroblasts (CAF), which plays a key role in the efficacy reduction and resistance development of immune checkpoint inhibitors (ICI). So far, there have been no commercially available cancer drugs that directly target CAF. With this orphan drug designation, APX-343A will receive benefits including seven years of market exclusivity, exemption from FDA review costs, and support for clinical trial subsidies.
i-SENS announced on the 30th that it has completed the establishment of a new automated production line for continuous glucose monitors (CGM) with an annual production capacity of 1.5 million units at its Songdo 2 facility and has launched the first shipment. With this, i-SENS will have established a total annual CGM production system of 2 million units, adding to the existing 500,000 units of capacity from its Songdo 1 factory. This automation line has been proactively established in response to the increasing demand for i-SENS’s CGM product ‘CareSens Air.’ The CareSens Air produced at Songdo 2 is expected to be supplied to a total of 35 countries.
Medical AI solution company Maihub announced on the 30th that it has successfully launched the ‘Lung Health Safety Bus Campaign’ in collaboration with AstraZeneca Korea and the Korean Tuberculosis Association, signing a tripartite memorandum of understanding (MOU) for the joint promotion of the campaign.
It aims to operate mobile screening buses linked with AI-based chest X-ray screening equipment nationwide, targeting the early detection of major lung diseases such as lung cancer and tuberculosis, as well as raising public health awareness.
The Jaseng Korean Medicine Hospital’s Spine and Joint Research Institute announced on the 30th that it has published research analyzing the therapeutic effects of the traditional herbal medicine ‘OKONG (dried centipede)’ in the international journal ‘Toxins.’ The research team, led by Director Lee Ye-seul, analyzed the pharmacological effects and mechanisms of action of OKONG, which has been used for a long time in the treatment of cramps, pain, and inflammation. The research findings confirmed that the herbal medicine OKONG showed excellent effects in pain relief, anti-inflammatory, antibacterial, and antioxidant properties. Notably, some components demonstrated effects equal to or greater than those of strong analgesics like morphine, with less concern for tolerance or toxicity.
Ybrain announced on the 30th that its prescription digital drug for depression, MindSTEAM, has been designated as a candidate for extending the grace period for new medical technologies by the National Evidence based Healthcare Collaborating Agency (NECA). This decision was made based on the revised ‘Rules on the Evaluation of New Medical Technologies,’ during the 5th New Medical Technology Evaluation Committee held on the 13th. According to the review results, Ybrain’s MindSTEAM meets the criteria for extending the grace period for approval application based on its clinical applicability, usefulness, evidence creation potential, and capabilities as a treatment for major depressive disorder using transcranial direct current stimulation. As a result, MindSTEAM can now be prescribed as an outpatient treatment for an additional two years.