Journalist

Park Boram
  • GC Pharma, Dongkook, Kwangdong and ABL Bio report R&D, anti-counterfeit and sales updates
    GC Pharma, Dongkook, Kwangdong and ABL Bio report R&D, anti-counterfeit and sales updates GC Pharma shares lysosomal storage disease drug development updates at WORLD Symposium 2026 GC Pharma said Tuesday it presented updates on its lysosomal storage disease (LSD) drug programs at WORLD Symposium 2026, held Feb. 2-6 in San Diego. WORLD Symposium is an international forum where LSD specialists share the latest research and discuss improved treatments. GC Pharma presented a poster on preclinical results for GC1130A, a candidate treatment for Sanfilippo syndrome type A (MPSIIIA). The company is developing the drug for direct delivery into the brain’s ventricles (ICV) to improve efficacy. In preclinical animal studies, heparan sulfate levels in the brains of disease-model animals given GC1130A fell significantly, and researchers observed reduced brain inflammation and improved cognitive ability. GC1130A is in Phase 1 trials in the United States and South Korea and has received fast-track designation from the U.S. Food and Drug Administration. The company plans to complete Phase 1 this year and aims to commercialize the drug before 2030. GC Pharma also joined a global investigator meeting for HM15421/GC1134A, a Fabry disease treatment candidate, sharing safety indicators and preliminary pharmacokinetics and pharmacodynamics data from cohort 1 and discussing clinical strategy. With enrollment for cohort 1 complete, the company plans to begin registering cohort 2 participants in the second quarter. Dongkook Pharmaceutical asks Korean IP office for continued cooperation in anti-counterfeit efforts Dongkook Pharmaceutical said Tuesday it held a meeting Feb. 9 with the Korean Intellectual Property Office at its headquarters in Seoul to discuss preventing counterfeit distribution and protecting consumers for its dermacosmetics brand Centellian24. The two sides shared information on the spread of counterfeit goods, particularly through domestic online channels and overseas distribution, and discussed cooperation to crack down on counterfeits and block distribution. They agreed the issue has significant implications for consumer safety and brand trust and said continued cooperation is needed. Dongkook Pharmaceutical said counterfeit versions of key Centellian24 products, including Madeca Cream and Melacapture Ampoule, are being sold in packaging similar to genuine items. The company said counterfeit products can be difficult to verify for ingredients and may pose a high risk of serious side effects if applied to the skin. Kwangdong Pharmaceutical says Cheonghyeonghwan tops 160 billion won in cumulative sales Kwangdong Pharmaceutical said Tuesday that cumulative sales of Kwangdong Cheonghyeonghwan surpassed 160 billion won from its 2019 launch through 2025. The pill-form product uses agarwood and deer antler velvet as main ingredients. The company said cumulative sales volume reached about 27 million pills, based on 30 pills per box, and the repurchase rate was 99.8%. Kwangdong Pharmaceutical said it runs a quality-control system covering the full process from ingredient selection to manufacturing. It said it tests for about 540 types of harmful substances, including pesticide residues, and produces the product through a 45-step process at facilities certified under the Hazard Analysis and Critical Control Points standard, from raw-material intake to finished-product inspection. The company said it has introduced automation in the filling and packaging stage. ABL Bio publishes review paper on 4-1BB antibodies in international journal ABL Bio said Tuesday it published a review paper in the international journal mAbs on 4-1BB, a target drawing attention for next-generation cancer immunotherapy. The paper, titled “Expanding the horizon of cancer therapy with next-generation 4-1BB antibodies: a review of molecular and clinical strategies to maximize efficacy and ensure safety,” was released online Feb. 6. According to the paper, 4-1BB bispecific antibodies showed improved anticancer efficacy and a favorable safety profile compared with conventional monoclonal antibodies. It described an approach that limits T-cell activation through 4-1BB signaling to the tumor microenvironment where cancer cells are present, as a way to address limitations seen with earlier 4-1BB monoclonal antibodies urelumab and utomilumab. The paper said 4-1BB may also support longer-lasting anticancer effects and could play an important role in future combination therapies.* This article has been translated by AI. 2026-02-11 17:42:00
  • Hugel posts record 201.6 billion won operating profit on strong global sales
    Hugel posts record 201.6 billion won operating profit on strong global sales Hugel said Tuesday that its consolidated operating profit for last year rose 21.3% from a year earlier to 201.6 billion won. Revenue increased 14% to 425.1 billion won, and net profit edged up 0.6% to 144.0 billion won, based on preliminary results. The company said it was the best performance in its history. Hugel said results were driven by strong global sales of its botulinum toxin product Botulax and its hyaluronic acid fillers The Chaeum and Byryzn, along with rapid growth in its cosmetics brands Wellage and Byryzn BR. By product, toxin revenue rose 15% to 233.8 billion won, while filler sales increased 1.7% to 129.7 billion won. Cosmetics and other products climbed 45.9% to 61.6 billion won. Combined annual sales of toxin and fillers rose 10% to 363.5 billion won, including overseas sales up 22% to 268.5 billion won. The export share for the two products expanded to 74% in 2025 from 66% in 2024. Growth was strongest in North and South America, including the United States and Brazil. Combined toxin and filler sales in the region jumped 105% to 67.9 billion won, and fourth-quarter revenue surged 310% from a year earlier to 29.2 billion won. Carrie Strom, Hugel’s global CEO, said the company posted sales in the 400 billion won range for the first time, citing “solid global competitiveness.” She said Hugel plans this year to strengthen its mid- to long-term growth base in key markets including the United States, China, Europe and Brazil.* This article has been translated by AI. 2026-02-11 17:00:00
  • South Korea flags 178 false online ads for cosmetics, devices ahead of Lunar New Year
    South Korea flags 178 false online ads for cosmetics, devices ahead of Lunar New Year 178 false or exaggerated cosmetics ads flagged ahead of Lunar New Year South Korea’s Ministry of Food and Drug Safety said Tuesday it found 178 cases of false or exaggerated online advertising after inspecting ads for medical devices, cosmetics and quasi-drugs expected to see higher gift demand ahead of the Lunar New Year holiday. For medical devices, the ministry flagged 100 ads tied to illegal overseas purchasing-agency sales involving medical magnetic field generators, personal low-frequency stimulators and electric cupping devices. In cosmetics, inspections of online ads for functional products marketed for whitening and wrinkle improvement, as well as products claiming to ease muscle pain, found the most common violation was advertising as if the products had drug-like efficacy (25 cases, 71%). In checks of ads for gift-set items such as mouth fresheners, tooth whiteners and toothpaste, the ministry found 43 cases of false or exaggerated claims about efficacy or performance approved for quasi-drugs. The ministry said it asked the Korea Communications Standards Commission and online platforms including Naver, Coupang and 11st to block access to violating posts under relevant laws. It also requested on-site inspections by authorities for repeat offenders. Dongkook Pharmaceutical applies for MFDS approval of DKB-138 as individually recognized functional ingredient Dongkook Pharmaceutical said Tuesday it completed an application to the Ministry of Food and Drug Safety for individually recognized functional-ingredient status for DKB-138, a “hyunggae extract powder” it says may help improve muscle strength. With muscle weakness among middle-aged and older adults drawing attention, the company said it is developing functional ingredients aimed at improving strength. After completing the recognition process, it aims to launch a product in 2027. DKB-138 uses the flower stalk of hyunggae, a plant in the mint family. The company said a human study of 120 adults ages 50 to 70 confirmed both efficacy and safety. After taking 1 gram daily for 12 weeks, participants showed increases in grip strength and isokinetic thigh strength compared with a control group. Dongkook Pharmaceutical also cited joint research with a team led by Kim Young Suk at the Korea Institute of Oriental Medicine, saying the work identified mechanisms including inhibiting muscle-cell death and protease activity and protecting skeletal muscle from oxidative stress. The findings were published in the SCIE-indexed journal ABCH (impact factor 2.7), and the company said another paper is scheduled for publication in May in the English-language journal of the Korean Society of Food Science and Technology. Celltrion’s Remsima tops 1 trillion won in annual sales for second straight year Celltrion said Tuesday its autoimmune disease treatment Remsima (infliximab) posted global sales of about 1.0495 trillion won last year, topping 1 trillion won for a second consecutive year after 2024. The company attributed the results to steady prescribing worldwide and expansion of Europe’s infliximab market, which it said grew about 9% a year on average from 2019 to 2024. Celltrion said demand has risen since the COVID-19 pandemic for self-administered subcutaneous injections, boosting prescriptions of RemsimaSC. It said a “dual formulation” effect — switching from existing infliximab products to Remsima and then to RemsimaSC — also supported sales growth. As of the third quarter of last year, Remsima’s share in Europe’s five major markets was 62% in the U.K., 49% in Spain and 48% in Germany, the company said. It also reported high shares in other European countries including Ireland (75%) and Austria (64%). Celltrion said it plans to roll out a newly added liquid formulation of Remsima across Europe this year. The liquid version shortens preparation time and reduces storage and handling burdens compared with the existing lyophilized formulation. GCCL signs MOU with MICS on multinational clinical trial services GCCL said Tuesday it signed a memorandum of understanding on Monday with Europe-based clinical trial and diagnostic services company MICS to cooperate on global, multinational clinical trial services. The companies said the MOU sets up a cooperation framework spanning Europe, the United States and the Asia-Pacific region, aiming to improve operational stability by combining their regional trial-operations experience and customer communication capabilities. The agreement includes cooperation on cross-regional trial operations and sample analysis; support for project management and coordinated customer communication by region; joint marketing; joint customer development and market expansion; and linking test items and improving analysis efficiency to strengthen service competitiveness.* This article has been translated by AI. 2026-02-10 18:06:00
  • GC Biopharma Joins CEPI-Led Pandemic Vaccine Drill; Other Korea Pharma Updates
    GC Biopharma Joins CEPI-Led Pandemic Vaccine Drill; Other Korea Pharma Updates GC Biopharma joins CEPI-led tabletop drill to prepare for future pandemics GC Biopharma said Monday it took part in the Korea 100Day Mission Tabletop Exercise held Feb. 5-6 and organized by the Coalition for Epidemic Preparedness Innovations, the Korea Disease Control and Prevention Agency, the Ministry of Food and Drug Safety and the International Vaccine Institute. The scenario-based drill tested whether the full process — from vaccine development to approval, manufacturing and supply — could be completed within 100 days in a future pandemic. Organizers said the goal was to refine decision-making among the government, international organizations and vaccine makers to reduce the risk of delays during an actual outbreak. GC Biopharma participated as a manufacturer capable of handling the full production process for messenger RNA, or mRNA, medicines, using the exercise to review its vaccine development and manufacturing capacity based on its mRNA platform. The company said the drill also included discussions on flexible approaches to clinical and regulatory procedures during a pandemic, and it expects closer coordination with the government could enable faster responses. Kwangdong Pharmaceutical backs Ulsan children’s rights committee Kwangdong Pharmaceutical said Monday it held a launch ceremony for the Ulsan Metropolitan City Children’s Happiness Committee with the Korea Child Abuse Prevention Association to support children’s rights protection in the region. The company said the event included programs with children participating directly. The committee plans initiatives including child safety and anti-violence campaigns, promoting positive parenting, operating children’s rights education programs and expanding child participation in policymaking. It also plans to focus on strengthening local safety nets, including safety checks of school routes and play environments and building an early detection system for child abuse risks. Cha Bio F&C’s Evercell launches ‘Cell Youth Plumping Ampoule’ Cha Bio F&C said Monday its premium anti-aging cosmetics brand, Evercell, launched a new product, the Evercell Cell Youth Plumping Ampoule. The ampoule mist is a new addition to the Cell Youth line and features lactobacillus-derived exosomes and rose polydeoxyribonucleotide, or PDRN, as key ingredients. The company said it is designed to support anti-aging care and help create an immediate look of skin volume and radiance. Cha Bio F&C said its CHA-probiotics EV Complex™, an exosome delivery ingredient, and rose PDRN help improve skin condition and support regenerative care, while 20-layer hyaluronic acid helps deliver moisture for hydration. The product uses a dual-texture formula with separate gel and oil layers that are mixed by shaking just before use, the company said, adding that the feel can vary depending on how it is used. Alteogen reports progress on once-monthly obesity drug candidate Alteogen said Monday it disclosed development progress on a once-monthly obesity treatment based on its in-house ultra-long-acting platform. Built on the company’s protein engineering technology, the platform extends dosing to once a month, compared with its existing long-acting platform, NexP, which supports once-weekly dosing. With once-weekly obesity treatments established as the standard in the global market, the company said next-generation candidates are being developed to achieve greater weight loss and improve dosing convenience. Alteogen said a once-monthly obesity drug candidate it previously disclosed last year showed a long half-life and sustained drug concentration in animal pharmacokinetics tests. In the latest pharmacodynamics study, the company evaluated weight-loss effects and patterns of weight regain after stopping dosing in an obese rat model. It said the candidate showed weight loss comparable to the control group, retatrutide, and also showed a trend toward reduced rapid weight regain after treatment stopped.* This article has been translated by AI. 2026-02-09 18:06:00
  • Dong-A Socio Holdings 2025 Operating Profit Rises 19.1% to 97.8 Billion Won
    Dong-A Socio Holdings 2025 Operating Profit Rises 19.1% to 97.8 Billion Won Dong-A Socio Holdings said it posted solid results last year on broad-based growth across major subsidiaries. The company said Monday that its consolidated operating profit rose 19.1% from a year earlier to 97.8 billion won. Revenue increased 7.2% to 1.4298 trillion won. In the fourth quarter, revenue rose 14.7% to 371.9 billion won, while operating profit fell 26.4% to 16.0 billion won from the same period in 2024. Healthcare subsidiary Dong-A Pharmaceutical reported revenue of 726.3 billion won, up 7%, as all business segments grew. Operating profit rose 2% to 86.9 billion won. Over-the-counter drug sales climbed 26.4% to 223.9 billion won, and the Bacchus fatigue drink business rose 2.1% to 270.0 billion won. The consumer health business fell 5.7% to 196.1 billion won. Biopharmaceutical contract manufacturer STGen Bio posted revenue of 103.7 billion won, up 76.2%, driven by overseas commercialization of a Stelara biosimilar and expanded new orders. Operating profit jumped 323.4% to 7.1 billion won. Logistics unit Yongma Logistics reported revenue of 423.8 billion won, up 5.8%, and operating profit of 21.0 billion won, up 10.6%. Affiliate Dong-A ST, in which Dong-A Socio Holdings is the largest shareholder, said on a separate basis that operating profit fell 16.1% to 27.2 billion won last year, while revenue rose 16.3% to 745.1 billion won. Fourth-quarter revenue increased 22.6% to a quarterly record 200.4 billion won, but operating profit swung to a loss. Prescription drug revenue rose 19% to 527.8 billion won on higher sales of key products including growth hormone Grottropin and indigestion treatment Motilitone. Overseas business revenue increased 12.8% to 170.4 billion won, supported by biosimilar growth. In R&D, Dong-A ST said it completed a Phase 2a trial of DA-1241, a treatment candidate for metabolic dysfunction-associated steatohepatitis and Type 2 diabetes being developed through its U.S. affiliate Metavia. It said a Phase 1a trial of obesity candidate DA-1726 is ongoing. The company also said it will run a Phase 1 trial in the first half for antibody-drug conjugate candidates targeting gastric and pancreatic cancers after acquiring ADC specialist AbTis. It said Phase 1 trials in South Korea are also underway for a dementia treatment and an immuno-oncology drug. Another affiliate, CDMO company ST Pharm, reported operating profit of 55.1 billion won last year, up 98.9%, and revenue of 331.6 billion won, up 21.1%. In the fourth quarter, ST Pharm posted revenue of 129.0 billion won and operating profit of 26.4 billion won, up 11.4% and 15.9%, respectively, from the same period a year earlier. ST Pharm said results improved on growth in its oligonucleotide drug CDMO business. Annual oligonucleotide revenue rose 35% to 237.6 billion won, and its order backlog stood at 204.0 billion won at the end of last year. In January, it won a new single supply contract worth 83.0 billion won.* This article has been translated by AI. 2026-02-09 17:15:00
  • Bukwang Pharmaceutical tops 200 billion won in annual sales for first time; operating profit up 775%
    Bukwang Pharmaceutical tops 200 billion won in annual sales for first time; operating profit up 775% Bukwang Pharmaceutical said Monday that its consolidated operating profit for last year rose 775.2% from 2024 to 14.1 billion won.  Revenue increased 25.4% to 200.7 billion won, topping 200 billion won in annual sales for the first time since the company was founded.  On a conference call, the company said stronger sales of its diabetic neuropathy treatments Dexid and Thioctacid, along with the antipsychotic drug Latuda, drove the improvement. Sales of the Dexid- and Thioctacid-centered product group rose about 40% year over year, while its central nervous system strategy products, including Latuda, grew about 90%. R&D progress continued as well. Subsidiary Contera Pharma said CP-012, which it is developing as a treatment for morning akinesia in Parkinson’s patients, produced positive topline results in a Phase 1b trial. Bukwang Pharmaceutical said the sharp rise in consolidated operating profit was also due to an upfront payment tied to its contract with Lundbeck. Contera Pharma previously signed a research and development collaboration with the global drugmaker to jointly study ribonucleic acid (RNA)-based therapies for severe nervous system diseases. Separately, Bukwang Pharmaceutical was selected on Jan. 5 as the final bidder to acquire Korea Union Pharmaceutical. It is proceeding with the acquisition under the ongoing rehabilitation process, and expects the deal to close in early April after the Fair Trade Commission completes its merger review.* This article has been translated by AI. 2026-02-09 15:42:00
  • South Korea’s Fast-Track Rule Opens Door for AI Medical Devices, Raising Oversight Questions
    South Korea’s Fast-Track Rule Opens Door for AI Medical Devices, Raising Oversight Questions A new system allowing certain “immediate market entry” medical technologies to be used in clinics without a separate new health technology assessment is reshaping South Korea’s artificial intelligence medical device sector. The lower barrier is expected to expand the size and competitiveness of K-AI medical devices, but debate remains over safety verification and accountability. Industry officials said 113 of the 199 device items covered by the immediate-entry system are digital medical devices that include AI-based standalone software. Companies have welcomed what they call an opening of the AI medical device market, expecting faster commercialization to spur research and development and attract outside investment. Park Chang Min, president of the Korean Society of Medical Artificial Intelligence and a radiology professor at Seoul National University Hospital, said the move reflects urgency as competitors such as the United States and China move quickly. “It can improve access to innovative technology for patients and clinicians, and give breathing room to domestic medical AI companies facing financial strain,” he said. A medical device industry official said it was “clearly positive” that shortened procedures improve conditions for new entrants. Another industry official said companies may face higher expectations: “As the review period shrinks, the standards regulators demand will rise. The change is both an opportunity and pressure.” Clinicians and patient-safety advocates raised broader concerns. Jeon Jin Han, policy director at the Association of Doctors for Humanism, said AI has already been a major beneficiary of early-entry policies such as deferrals of new health technology assessments. “The key issue is that medical technologies that have not gone through the new health technology assessment are hard to view as sufficiently verified for safety and effectiveness,” he said, adding that approval by the Ministry of Food and Drug Safety does not itself mean clinical effectiveness has been proven. The system is intended to introduce and use strong medical technologies earlier. Critics warn that skipping the new health technology assessment — which can take up to 250 days — and allowing market entry based only on ministry approval could lead to adverse outcomes such as misdiagnosis. Some experts also called for separate standards for generative AI-based medical devices. In a report, the Korea Health Industry Development Institute said generative AI medical devices need new evaluation criteria that consider potential indications, and that a management system is essential to monitor adverse events in real time and update products continuously. The government said it is putting procedural safeguards in place. Seong Hong Mo, director of the medical device policy division at the Ministry of Food and Drug Safety, said AI medical devices already undergo strict review of safety and effectiveness at the approval stage, and that companies and medical institutions are required to report adverse events. Seong said a separate oversight system is also in place for AI model updates. Under the Digital Medical Products Act that took effect last year, he said, companies must seek approval again if key performance or intended use changes significantly. Experts said the policy’s success will depend on tighter post-market controls. Park said a clear mechanism must work to remove technologies from the market if they fail to prove effectiveness in clinical use or if misuse or side effects are confirmed. “Speed and safety are separate issues,” he said, adding that lower entry barriers must be paired with strong post-market monitoring and a clear exit structure.* This article has been translated by AI. 2026-02-08 18:33:00
  • SK Biopharm posts record profit on strong US sales of epilepsy drug
    SK Biopharm posts record profit on strong US sales of epilepsy drug SEOUL, February 06 (AJP) - SK Biopharmaceuticals said on Friday that its operating profit more than doubled last year to a record high, driven by strong U.S. sales of its epilepsy drug cenobamate. The drugmaker reported consolidated operating profit of 203.9 billion won for the year, up about 112 percent from a year earlier. Revenue rose 29.1 percent to 706.7 billion won, while net profit increased 11.6 percent to 253.3 billion won. Cenobamate, marketed in the United States under the brand name Xcopri, generated U.S. sales of 630.3 billion won for the year, up around 44 percent. The company said the drug was the main driver of the profit surge and also delivered about 27 billion won in annual royalty income. Monthly prescriptions for cenobamate in the United States reached about 47,000 in December. In the fourth quarter, total prescriptions rose 6.8 percent from the previous quarter and 29.2 percent from a year earlier. Fourth-quarter revenue increased 19.2 percent year-on-year to 194.4 billion won, while operating profit fell 34 percent to 46.3 billion won. The company attributed the quarterly decline in profit to year-end seasonality and inventory in transit, despite steady prescription growth. * This article, published by Aju Business Daily, was translated by AI and edited by AJP. 2026-02-06 14:17:44
  • SK Biopharmaceuticals posts record operating profit on strong U.S. cenobamate sales
    SK Biopharmaceuticals posts record operating profit on strong U.S. cenobamate sales SK Biopharmaceuticals said Thursday that its consolidated operating profit jumped about 112% last year to 203.9 billion won, the highest on record. Revenue rose 29.1% from a year earlier to 706.7 billion won. Net profit increased 11.6% to 253.3 billion won. Its main product, cenobamate (sold in the U.S. as Xcopri), posted annual U.S. sales of 630.3 billion won, up about 44% year over year. The company said the surge drove operating profit and generated about 27.0 billion won in annual royalty income. Monthly U.S. prescriptions for cenobamate reached 47,000 in December. Total fourth-quarter prescriptions rose 6.8% from the third quarter and 29.2% from a year earlier. SK Biopharmaceuticals’ fourth-quarter revenue increased 19.2% from a year earlier to 194.4 billion won, while operating profit fell 34% to 46.3 billion won. The company said prescriptions held up, but year-end seasonality and in-transit inventory kept results around the prior quarter’s level. SK Biopharmaceuticals said it is focusing on expanding prescriptions through its direct sales and marketing in the U.S. market. It also said it plans to use cash flow from cenobamate to broaden its research and development portfolio in central nervous system treatments, radiopharmaceutical therapeutics and targeted protein degradation.* This article has been translated by AI. 2026-02-06 11:09:00
  • Dongkook Drug Marks 87 Million Madeca Cream Sales; Hanmi Wins FDA Breakthrough Tag; Yuyu Invests in U.K. Pet Food Firm
    Dongkook Drug Marks 87 Million Madeca Cream Sales; Hanmi Wins FDA Breakthrough Tag; Yuyu Invests in U.K. Pet Food Firm Dongkook Drug to hold customer sale after Madeca Cream tops 87 million in cumulative sales Dongkook Drug said Wednesday it will run a “Madeca Cream Customer Appreciation Sale” through Feb. 28 to mark cumulative sales of 87 million units of its Centellian24 derma-cosmetic flagship product, Madeca Cream. The promotion will be offered on the company’s official online store, DK SHOP, under two themes: a Lunar New Year gift event and a “Find the right Madeca Cream for my skin” campaign. Through Feb. 18, the Lunar New Year gift event will offer discounts of up to 87% on best-selling products including Madeca Cream Tight Lifting, Expert Madeca Mela Capture Ampoule Max and Madeca Cream, and provide a 100,000-won coupon pack. DK SHOP will also give gifts based on purchase totals of 30,000 won, 50,000 won and 70,000 won or more, and run events including a first-purchase welcome deal and a lucky-bag New Year’s cash drawing. Through Feb. 28, the “Find the right Madeca Cream for my skin” promotion will sell a 9,900-won kit that lets customers try multiple versions at once, including Madeca Cream Time Reverse Zero, Madeca Cream Power Boosting Formula, Madeca Cream Hydra Calming and Madeca Cream Tight Lifting. New members will receive coupons worth up to 30,000 won, and DK SHOP will also hold a review event for the “NEW Aging Focus Cream.” Hanmi Pharmaceutical says FDA grants breakthrough therapy designation for congenital hyperinsulinism drug Hanmi Pharmaceutical said Wednesday that the U.S. Food and Drug Administration has granted breakthrough therapy designation to efpeglucagon, its treatment candidate for congenital hyperinsulinism. The designation is intended to speed development and review for drugs targeting serious or life-threatening conditions when early clinical evidence suggests a meaningful improvement over existing therapies. Breakthrough therapy drugs receive intensive guidance and support, and may qualify for rolling review, allowing portions of an application to be submitted and reviewed as they are completed. Congenital hyperinsulinism is a rare disease in which excessive insulin secretion causes hypoglycemia. Hanmi said no FDA-approved treatment has been approved specifically for the condition. Hanmi is developing efpeglucagon as a once-weekly formulation. The company said an interim analysis from a global Phase 2 trial last year showed favorable safety and tolerability and a marked reduction in both hypoglycemia and severe hypoglycemia. The global Phase 2 trial is ongoing, with results expected in the second half of this year. Yuyu Pharma makes strategic investment in U.K. freeze-dried pet food company James & Ella Yuyu Pharma said Wednesday it has made a strategic investment in James & Ella, a U.K. premium freeze-dried pet food company. The company described James & Ella as a leading player in the U.K. freeze-dried pet food category. It sells through major retail channels including Waitrose, Ocado and Amazon, and also operates a direct-to-consumer subscription channel. Yuyu said demand for freeze-dried nutrition products is rising in the pet market, driven by interest in premium ingredients suitable for human consumption, high digestibility and veterinary-based products. The investment is part of Yuyu’s global expansion strategy in the pet wellness market. Yuyu said it plans to build an animal-industry portfolio spanning veterinary biologics, sustainable food-system technologies, and pet nutrition and community models.* This article has been translated by AI. 2026-02-05 17:45:00