Journalist

Park Bo-ram
  • Lotte Biologics Signs CDMO Deal With U.S. Cancer Biotech for Antibody Drug Substance
    Lotte Biologics Signs CDMO Deal With U.S. Cancer Biotech for Antibody Drug Substance Lotte Biologics said Wednesday it has signed a contract manufacturing and development (CDMO) agreement with a U.S.-based biotech company specializing in cancer to produce antibody drug substance and develop related processes. Under the deal, Lotte Biologics will produce antibody samples needed for global late-stage clinical trials and optimize large-scale processes, supported by its Syracuse Bio Campus in New York. The company said the project is designed with follow-on clinical work and commercialization in mind, beyond producing clinical samples. It plans to support the candidate’s clinical and commercialization readiness using its large-scale facilities and manufacturing capabilities. Lotte Biologics said it is using the Syracuse campus as a base to expand collaboration with customers and will link it with its Songdo Bio Campus, scheduled for completion this year, to strengthen customized CDMO services built on integrated quality operations and to enhance supply chain management capabilities. A Lotte Biologics official said the order “has laid the groundwork for large-scale contracts” with cancer-focused biotech companies and added the company will work to ensure it leads to commercialization and additional orders.* This article has been translated by AI. 2026-04-01 11:42:00
  • Dongkook, Yuhan and Celltrion Post Global Marketing, Donation Updates
    Dongkook, Yuhan and Celltrion Post Global Marketing, Donation Updates Dongkook Pharmaceutical’s Centellian24 joins major global beauty expo Dongkook Pharmaceutical said its dermacosmetic brand Centellian24 participated in Cosmoprof Bologna 2026, billed as the world’s largest beauty trade show, held March 26-29 in Bologna, Italy. Now in its 57th year, the event is a venue for sharing market trends and business opportunities. Organizers drew about 3,100 companies from more than 150 countries and more than 250,000 industry participants, the company said. Centellian24 attended for a second straight year and ran a standalone booth to expand contact with global buyers. The booth featured hands-on demonstrations of key products including Madeca Cream Time Reverse; Expert Madeca Cream Active Renew PDRN; 360 Shot PDRN Active Serum; 360 Shot PDRN Lifting Eye Cream; 360 Shot PDRN Glowing Eye Patch; and the Madeca Prime Max beauty device. Yuhan holds blood drive across sites to support supply and cancer patients Yuhan said it ran a “blood donation campaign to save lives” across its operations, including its Daebang-dong headquarters as well as research facilities and plants, to help ease blood shortages and support cancer patients. The campaign was held over three days — March 16, 17 and 20 — the company said. Yuhan has run the program since 2008 and holds it regularly twice a year, in the first and second halves. A total of 71 employees participated this time, bringing cumulative participation to about 2,500, it said. Employees also donated blood donation certificates, which are to be used through the Korea Childhood Leukemia Foundation to support pediatric cancer patients who need transfusions. Celltrion holds Brazil launch event for autoimmune drug Omliclo Celltrion said it held a launch event in Brazil — the largest pharmaceutical market in Latin America — for Omliclo, an autoimmune disease treatment whose active ingredient is omalizumab. About 80 people attended, including Brazilian specialists in allergy, respiratory medicine and dermatology, as well as representatives from insurers, the company said. Presentations covered Omliclo’s clinical data, global prescribing experience and its value in real-world care settings. Attendees showed strong interest in prescribing experience and expressed expectations for broader use, Celltrion said. Celltrion’s Brazil unit has continued local marketing since launching Omliclo there in November. It recently won a bid from the Santa Catarina state government, securing an early supply channel, the company said. With Omliclo launched as a “first mover” in Brazil, Celltrion said it expects additional bid wins to continue. Jaseng delivers rice donation in Busan and launches local volunteer group Jaseng Medical Foundation said it delivered 480 bags of 10-kilogram white rice to the Busan Community Chest on March 30 to support food needs among vulnerable residents. The Busan city government will assist with administrative support for recipients, while the Busan Community Chest will select households in need, the foundation said. Each selected household will receive 10 kilograms of rice, to be distributed through food banks and food markets across Busan’s 16 districts and counties. A launch ceremony for the Busan Jaseng Volunteer Group was also held after the donation event. The group, formed with 21 members, is a private volunteer organization made up of local residents and aims to build sustained ties with the community, the foundation said. Busan Jaseng Korean Medicine Hospital will support its operations and activities.* This article has been translated by AI. 2026-03-31 17:29:12
  • GC Pharma Earns MSCI ESG Rating Upgrade to AA for Third Straight Year
    GC Pharma Earns MSCI ESG Rating Upgrade to AA for Third Straight Year GC Pharma said Monday it received an "AA" rating in the latest environmental, social and governance assessment released by Morgan Stanley Capital International, or MSCI. MSCI has evaluated key ESG issues for about 8,500 listed companies worldwide each year since 1999, assigning ratings on a seven-step scale from AAA to CCC. In this year’s review, GC Pharma was rated above industry peers in environmental impact management, corporate ethics, and product quality and safety management, lifting its score by one notch from the previous assessment. The company’s rating has risen for three consecutive years, from B in 2023 to A in 2024 and AA this year. The company said the upgrade reflected steps including building an environmental risk management system and cutting air pollutant emissions, strengthening anti-corruption training for employees, establishing a response system to stabilize pharmaceutical supplies, and adopting a responsible marketing policy. Kim Seong-yeol, head of GC Pharma’s management administration office, said the AA rating "shows our ESG capabilities have been recognized externally," adding that the company will "continue building a sustainable management system that meets global standards."* This article has been translated by AI. 2026-03-30 18:24:26
  • Drugmakers Expand Portfolios Through Co-Promotion Deals
    Drugmakers Expand Portfolios Through Co-Promotion Deals Co-promotion deals between multinational drugmakers with branded medicines and South Korean companies with local sales networks are continuing, as partners combine strengths to speed market penetration and lift revenue. Industry officials said March 27 that co-promotion has long been used in South Korea’s pharmaceutical sector. Multinationals gain access to the domestic market, while local firms broaden their presence in specific therapeutic areas by selling established products. Huons said it entered the vaccine business after signing a domestic distribution and co-promotion agreement on March 25 with global drugmaker Sanofi for injectable vaccines. Starting next month, Huons will handle distribution and marketing for five vaccines, including the influenza vaccine Vaxigrip. The company plans to leverage its injectable-drug sales force and cold-chain capabilities, drawing on refrigerated distribution experience built through products such as the vitamin C injection Merit C and the immune-boosting adjunct injection Hudaxin. It recently set up a dedicated Vaccine Business Division to run the effort. Bukwang Pharmaceutical is also expanding, teaming with Servier to strengthen its cardiovascular portfolio. Under a strategic co-sales agreement covering seven products, including treatments for hypertension and angina, Servier will cover general hospitals and other facilities with 300 beds or more. The two companies will jointly cover medical institutions with 100 to 299 beds, while Bukwang will lead sales and marketing for facilities with fewer than 100 beds. Bukwang, which has focused on gastroenterology and endocrinology, has been widening its prescription-drug lineup, including by acquiring Korea Union Pharmaceutical earlier this year for its chronic-disease products. The Servier partnership is seen as part of that push into cardiovascular care. Hanmi Pharmaceutical has sought to deepen share in areas where it already has a strong sales base. Earlier this year, it signed a co-promotion deal with Ferring Pharmaceuticals Korea for the nocturia and enuresis treatments Minirin and Nocdurna. It also agreed with Handok Teva to distribute and sell Ajovy, a preventive migraine treatment, expanding into the neurology field. Co-promotion is valued for enabling faster sales growth and more efficient market access. But if sales fall short or profitability weakens, contract terms may be adjusted, leaving local companies with the task of turning near-term gains into stronger in-house competitiveness. Jung Yoon-taek, head of the Pharmaceutical Industry Strategy Research Institute, said the industry has long relied on collaboration built on specialization and efficiency. “By combining each company’s areas of expertise, co-promotion can raise both sales and profits at the same time,” he said. “That makes its importance likely to grow.”* This article has been translated by AI. 2026-03-27 17:24:00
  • Korea Drug Regulator Eases Biosimilar Phase 3 Rules; Kolon Names New CEO
    Korea Drug Regulator Eases Biosimilar Phase 3 Rules; Kolon Names New CEO MFDS releases guidance to ease biosimilar Phase 3 trial requirements, offers pre-review South Korea’s Ministry of Food and Drug Safety said March 27 that its National Institute of Food and Drug Safety Evaluation has released guidance outlining what to consider when deciding whether a biosimilar needs a Phase 3 comparative efficacy trial. The agency also said it will run a pre-review process to support faster biosimilar development. The guidance covers the theoretical basis for easing Phase 3 requirements, quality and clinical factors to weigh, and the procedures and documents needed to discuss a waiver. The ministry said it also plans to revise approval regulations to apply the eased requirements. It includes criteria under which a Phase 3 trial may not be required when sufficient similarity and safety to an already approved original drug are demonstrated based on quality data and Phase 1 results. The ministry said it will set up a pre-review system so biosimilar developers can consult on whether Phase 3 requirements can be eased for products under development. Kolon Life Science appoints Lee Han-kook as CEO Kolon Life Science said March 27 that it appointed Vice President Lee Han-kook as CEO at a shareholders meeting and board meeting held March 26. Born in 1973, Lee is a pharmaceutical and biotech industry professional with experience across the full process of developing and commercializing new drugs, generics and active pharmaceutical ingredients, from R&D and manufacturing to regulatory approvals and business development at home and abroad. He worked at Daewoong Pharmaceutical on synthetic research, overseas regulatory approvals, overseas business and building overseas research hubs, and later served as an executive in regulatory affairs at a biotech company in San Diego. He then moved to Kunwha Pharmaceutical, where he led the medical and R&D divisions and served as CEO. Lee said, “Based on Kolon Life Science’s strong bio and chemical capabilities, I will build renewed trust in the global biotech market and deliver visible results.” Gachon University Gil Medical Center holds free public lecture for Heart Failure Day Gachon University Gil Medical Center said March 27 that it held a “heart failure public lecture” on March 25 to mark the Korean Society of Heart Failure’s Heart Failure Day. Hosted by the hospital’s Heart Failure and Pulmonary Hypertension Center, the event aimed to explain heart failure, treatment, rehabilitation and overall management in an accessible way. Heart failure is a condition in which the heart’s function declines and it cannot supply enough blood. The hospital said patient numbers have steadily increased with population aging. Because early symptoms can be mistaken for simple fatigue or shortness of breath, early diagnosis and ongoing management are important. The lecture was chaired by cardiology professor Shin Ik-kyun and thoracic and cardiovascular surgery professor Park Cheol-hyeon, with specialists presenting by field. A question-and-answer session followed. Jaseng Medical Foundation donates 30 million won for children’s spine health program The Jaseng Medical Foundation said March 27 that it donated 30 million won on March 26 to the child welfare organization ChildFund Korea to support a children’s spine health initiative. The donation ceremony was held in a meeting room at ChildFund Korea’s office in Seoul’s Jung District, with officials from both organizations attending. The foundation said the funds will be used through September for about 600 children at 25 community child centers in the Seoul metropolitan area, including tailored stretching programs, instructor support, and providing InBody body composition tests and portable height-measuring devices. This year’s program is scheduled to run from July through September for 10 sessions, once a week. The foundation said it has worked with various organizations on the project since 2011. It began with eight institutions but has expanded to 25, more than tripling in scale, to support children’s spine health. In 2017, it received an excellence award for a program at the Seoul Social Contribution Awards.* This article has been translated by AI. 2026-03-27 17:09:00
  • ADC Drug Development Shifts to Platforms as Linker Technology Becomes Key Edge
    ADC Drug Development Shifts to Platforms as Linker Technology Becomes Key Edge Antibody-drug conjugate (ADC) development is increasingly shifting from individual drug candidates to platform-based approaches, as companies seek technologies that can be scaled across multiple programs in cancer drug development, where costs and timelines are heavy. According to global market research firm Grand View Research, the ADC market is projected to grow from about $12 billion in 2024 to about $32 billion in 2033. As the market expands, companies that control core technology platforms are gaining value. With tumor-killing efficacy reaching a certain level, precise design to reduce toxicity and improve stability in the body has emerged as a key differentiator. Pfizer moved to secure an ADC platform by acquiring Seagen, an ADC leader, for about $43 billion in 2023. The goal was to obtain an integrated technology system that includes linkers, payloads and manufacturing know-how, rather than a single candidate. Pfizer expects more than $10 billion in revenue from the business by 2030. A platform strategy can also reduce development risk. An industry official said that even if clinical results for a specific candidate fall short, a platform makes it possible to switch to other targets, creating a structural advantage. South Korean drugmakers are also pursuing platform access. Chong Kun Dang Pharmaceutical followed joint ADC discovery research with Netherlands-based Synaffix by securing nonexclusive rights to related platform technology in 2023 for about $132 million. While other companies can also use the platform under a nonexclusive deal, the move is seen as a way to speed development by adopting a validated technology. Synaffix is known for linker technology that precisely attaches payloads at specific sites, and it has signed multiple technology-transfer agreements with global drugmakers including Janssen and Amgen. Chong Kun Dang's candidate CKD-703 targets the hepatocyte growth factor receptor (c-Met) and has received U.S. Food and Drug Administration approval to begin a Phase 1 clinical trial. Dong-A ST acquired ADC specialist Aptis to secure its third-generation linker platform, AbClick. The company aims to accelerate ADC development by combining its antibody research capabilities with Aptis' linker technology. Previously, attaching drugs effectively often required genetically modifying antibodies. AbClick is designed to selectively connect drugs at specific sites without antibody modification. DA-3501, an ADC candidate targeting gastric and pancreatic cancers that applies the platform, is scheduled to enter Phase 1 trials in the first half of this year. Samjin Pharm has also built in-house platforms for ADC development, including OncoStab and OncoFlame, and plans to improve research efficiency through open innovation with Novelty Nobility and APT Bio, companies specializing in antibody drug development. Its gastric and breast cancer treatment candidate SJA21 and immuno-oncology ADC candidate SJA71 are in preclinical stages. As technology advances, competition is also shifting. Han Yong-hee, a researcher at Growth Research, wrote in an ADC industry report that biotech companies with platforms can secure stable cash flow through technology transfers and royalties, while global drugmakers can speed development and diversify portfolios by licensing platforms. He said the ADC market is evolving from competition over new drugs to competition over platforms.* This article has been translated by AI. 2026-03-27 09:57:03
  • Dongkook Pharm Moves to Develop Generic of Chong Kun Dang Diabetes Drug Duvie
    Dongkook Pharm Moves to Develop Generic of Chong Kun Dang Diabetes Drug Duvie Dongkook Pharmaceutical has begun developing a generic version of Chong Kun Dang Pharmaceutical’s diabetes drug Duvie (lobeglitazone). According to the Ministry of Food and Drug Safety on the 27th, Dongkook Pharmaceutical on March 13 received approval to conduct a bioequivalence study for “DKF-457.” Duvie, developed by Chong Kun Dang, is described as South Korea’s first thiazolidinedione (TZD) class diabetes treatment, with annual prescriptions totaling about 20 billion won. TZD drugs once led the diabetes market in the 2000s, but their use declined after cardiovascular side-effect concerns emerged over GlaxoSmithKline’s Avandia (rosiglitazone). Dipeptidyl peptidase-4 (DPP-4) inhibitors later took the lead, and the market is now dominated by DPP-4 inhibitors and sodium-glucose cotransporter-2 (SGLT-2) inhibitors. While TZDs represent a smaller segment today, they continue to be prescribed for certain patients, including those with high insulin resistance or fatty liver disease. Interest has recently returned to combining TZDs with SGLT-2 inhibitors, and the move into TZD generics is being viewed as part of a strategy to broaden options for combination prescribing. Dongkook Pharmaceutical has been seeking to expand its share of the diabetes market in prescription drugs since 2023. It said it has 15 diabetes-related products, including Tenelican, Daplejin, Sitakan and the insulin injection Glazia, along with treatments for chronic conditions that often accompany diabetes, such as hypertension and high cholesterol. A company official said, “At the research stage, the flagship pipeline is DKF-447, a diabetes treatment that has completed product approval, and we plan to continue expanding the diabetes pipeline.” Competition in the Duvie generic market has already begun. Shin Poong Pharmaceutical started development first last year, setting up a race for generics. The substance patent is set to expire March 21 next year. A pharmaceutical industry official said competition is already overheated in markets centered on blockbuster products, adding that companies are expected to keep focusing strategies on areas where they can secure clear market share.* This article has been translated by AI. 2026-03-27 09:45:21
  • SK Chemicals, J2H Biotech sign MOU on drug development; Dongkook launches skincare brand
    SK Chemicals, J2H Biotech sign MOU on drug development; Dongkook launches skincare brand SK Chemicals, J2H Biotech sign MOU to expand joint new-drug development SK Chemicals said March 26 it signed a memorandum of understanding with J2H Biotech to strengthen cooperation on joint development of new drugs. The agreement is aimed at exploring collaboration on J2H pipelines for metabolic dysfunction-associated steatohepatitis, or MASH, and idiopathic pulmonary fibrosis, or IPF. J2H will share results from ongoing research with SK Chemicals, and the two companies plan to discuss development strategy and specific cooperation options. Founded in 2014, J2H is a biotech company developing drug candidates focused on metabolic diseases and cancer. Its MASH candidate, J2H-1702, has completed a Phase 2a trial and confirmed treatment effects, and the company is preparing to enter a global Phase 2b trial to further verify efficacy in a broader patient group. Its IPF candidate is in preclinical research. SK Chemicals said it will review the candidates’ development potential and commercial viability based on available data and then define whether to proceed with joint development and the scope of cooperation. Dongkook Pharmaceutical launches “LUONCELL” derma-science cosmetics brand Dongkook Pharmaceutical said March 26 it launched LUONCELL, a functional cosmetics brand whose name combines “LUX,” “ON” and “CELL.” The company said the products apply two proprietary complexes: “Happy Cell Complex” and “TECA Bioheal Complex.” Happy Cell Complex combines alpine skullcap, GABA and Spanish licorice root extract, which the company said helps protect irritated skin and support recovery of skin condition. TECA Bioheal Complex combines six bio ingredients, including TECA extracted from centella asiatica and PDRN, the company said. Among five LUONCELL products, the “High Lift Gel Mask,” a silicone gel mask, is billed as the first in South Korea to feature 1,300 vacuum suction plates. The company said the patented plates create vacuum tunnels to help active ingredients absorb more effectively and can also help reduce swelling. Osstem Implant says Ukrainian health delegation visited Seoul headquarters Osstem Implant said March 26 that Ukrainian government health officials, representatives of local medical equipment companies and international development and relief organizations visited its Twin Tower headquarters in Seoul’s Gangseo district on March 20. The delegation, led by Yevhen Honchar, deputy minister of health of Ukraine, toured key facilities including Osstem Implant’s central research institute and product showroom, the company said. Ukraine is pursuing its “Health Strategy 2030,” aimed at building a system that guarantees all citizens access to needed medical services, according to the company. The delegation also held cooperation talks earlier that day at a Korea-Ukraine business roundtable hosted by the Korea Health Industry Development Institute. Osstem Implant said it sees potential cooperation in areas including dental prosthetics and facial trauma reconstruction to help restore quality of life for war veterans, as well as in establishing dental implant policy. GC Biopharma’s varicella vaccine wins marketing approval in Guatemala GC Biopharma said March 26 that its varicella vaccine, Varicella Joo, received marketing approval from Guatemala’s Ministry of Public Health and Social Assistance. The company said it is the first time the vaccine has been approved in a Latin American country. It plans to accelerate expansion into individual countries in the region while continuing supply through the Pan American Health Organization, or PAHO. Varicella Joo is a live vaccine using GC Biopharma’s in-house MAV/06 strain. The company said it is the world’s first varicella vaccine made without any antibiotics in the manufacturing process, eliminating the risk of adverse reactions from residual antibiotics such as kanamycin, neomycin and erythromycin and maximizing product safety. In long-term follow-up clinical results, the neutralizing antibody rate after vaccination was 99% to 100%, and antibody persistence was shown to be comparable to leading global products, the company said. The company also said that after being listed in a World Health Organization position paper, the vaccine has received international evaluation comparable to global vaccines based on the Oka strain, and cross-prescribing has become possible. It said it plans to broaden the vaccine’s use in global markets. Kwangdong Pharmaceutical holds annual shareholders meeting Kwangdong Pharmaceutical said March 26 it held its 53rd annual shareholders meeting at Kwangdong Gwacheon Tower in Gwacheon, south of Seoul. Results disclosed at the meeting showed the company posted consolidated revenue of 1.6595 trillion won last year, maintaining a growth trend. On a separate basis, revenue totaled 1.0110 trillion won, marking the first time the company entered the “1 trillion won club” on a standalone basis. Separate operating profit was about 30.6 billion won, a slight improvement in profitability. Shareholders approved all agenda items as proposed, including approval of the 53rd financial statements and consolidated financial statements, partial amendments to the articles of incorporation, appointment of inside director Park Sang-young, appointment of outside director Lee Jae-won as an audit committee member, and approval of the cap on directors’ compensation. The company said the articles amendments codified an independent director system and advanced plans to establish new committees as part of ESG management to strengthen transparent governance.* This article has been translated by AI. 2026-03-26 18:06:00
  • Celltrion Expansion, HLB Tissue Bank License, Aribio Alzheimer’s Trial Update and More
    Celltrion Expansion, HLB Tissue Bank License, Aribio Alzheimer’s Trial Update and More Celltrion to expand new drug-substance production in Songdo, investing 1.2 trillion won Celltrion said March 24 it will secure additional manufacturing capacity, including a major expansion at its headquarters campus in Songdo, Incheon, with investment exceeding 1 trillion won. The company said the plan is intended to meet rising global demand for biopharmaceuticals and strengthen manufacturing competitiveness. The investment will be carried out in phases from this year through 2030 and includes infrastructure expansion across the Songdo campus, a U.S. production base and domestic sites. At Songdo, Celltrion will invest 1.2265 trillion won to expand Plants 4 and 5 simultaneously, bringing total capacity to 180,000 liters. The new facilities will apply automation and smart-factory technology, the company said, enabling production ranging from small-batch, multi-product runs to large-scale manufacturing. It said the system is expected to support faster production of future biosimilars and new drugs. Celltrion also finalized the scale of an expansion at its Branchburg, New Jersey, facility to strengthen competitiveness in the U.S. market. It plans to increase capacity there from 66,000 liters to 75,000 liters, securing total drug-substance production capacity of 141,000 liters. The Branchburg site is expected to play a key role in local supply for the Celltrion Group and in expanding its contract manufacturing (CMO) business, the company said. Celltrion is also moving to strengthen drug-product production. A new drug-product facility being expanded at Songdo is nearing completion within the year and, once operational, will be able to produce 6.5 million liquid vials annually. Combined with the maximum output of the Plant 2 drug-product line, Songdo would have total capacity of 10.5 million vials, the company said. A new drug-product plant planned for an industrial complex in Yesan, South Chungcheong province, has secured its site and is scheduled to begin design work within the year. Celltrion said that once the Yesan plant is completed and Celltrion Pharm’s planned expansion of prefilled syringe (PFS) production is finished, the group would be able to internalize about 90% of its global drug-product needs. The company said it expects significant manufacturing cost savings compared with overseas drug-product CMO production. HLB Life Science wins tissue bank license, expanding human tissue graft business HLB Life Science said March 24 it has obtained a tissue bank license and will move ahead with expanding its human tissue graft business. The approval provides a foundation to handle human tissues including bone, cartilage, fascia and skin, the company said. The product HLB Life Science will distribute, “Freedom Inject Refill,” is an injectable acellular dermal allograft derived from human tissue. Using acellular dermis as its raw material, it is used to treat damaged tissue such as ligaments, tendons and muscles and to support surgical procedures, the company said. The company said the material is produced by removing cells and fat components from skin-derived tissue while preserving extracellular matrix components needed for tissue regeneration, including collagen. It is expected to be used broadly for reconstruction, regeneration and recovery of damaged soft tissue and joints. Initial supply targets include orthopedic surgery, neurosurgery, obstetrics and gynecology, and urology clinics nationwide, with distribution to be expanded gradually, the company said. Aribio says ADPD 2026 presentation supports reliability of global Phase 3 data for AR1001 Aribio said March 24 that Sharon Sha, a Stanford University professor and the global principal investigator, presented an update on the global Phase 3 program for its oral Alzheimer’s disease treatment candidate AR1001 at ADPD 2026 in Copenhagen. POLARIS-AD is a large global Phase 3 trial evaluating the efficacy and safety of AR1001 (30 mg, once daily) in patients with early Alzheimer’s disease. A total of 1,535 patients are enrolled across 13 countries in North America, Europe and Asia, making it the largest trial among oral treatments currently in development, the company said. In the presentation, Sha said, “The baseline demographic characteristics and cognitive and functional indicators in POLARIS-AD are similar to those in existing global registration trials, and no unexpected safety signals have been observed to date.” Sha also highlighted what Aribio described as AR1001’s mechanistic differentiation. “AR1001 has very high blood-brain barrier (BBB) permeability, and its selectivity for PDE5 is superior to PDE6 and PDE11, resulting in fewer side effects than drugs in the same class,” she said. Aribio said this could be a competitive advantage in a market where long-term use is required. Aribio said it plans to release top-line data from the global Phase 3 trial in the third quarter and is aiming to submit a new drug application to the U.S. Food and Drug Administration in the second half of the year. Hugel’s Wellage runs mobile pop-up events to deepen consumer engagement Hugel said March 24 that its clinical cosmetics brand Wellage expanded offline consumer outreach through hands-on events. In collaboration with Beauty+, Wellage held a three-day “moving pop-up” from March 19 to 21 at university campuses and around Seongsu-dong. The company said the event was designed to strengthen brand experience among its core targets, including college students and the MZ generation, and drew about 2,800 visitors over three days. Wellage ran trial programs for its flagship “Real Hyaluronic Blue 100 Ampoule” and its new “Real Hyaluronic Soothing Cream,” and held a participatory product-draw event to gather consumer feedback, the company said. Daewoong Pharmaceutical signs supply deal with TR for digital spirometry device “The Spiro Kit” Daewoong Pharmaceutical said March 24 it signed a supply agreement with TR for a digital spirometry device, “The Spiro Kit,” and will strengthen sales to clinics, hospitals and health screening centers nationwide. Under the agreement, TR will handle development and manufacturing, while Daewoong Pharmaceutical will oversee distribution, sales and marketing through its nationwide network, the company said. Daewoong described the deal as a strategic partnership combining a medical device developer’s technology with a pharmaceutical company’s sales infrastructure. TR is expected to secure stable sales channels and marketing capabilities, while Daewoong Pharmaceutical adds a digital medical device to its business portfolio, it said. The companies said the partnership is aimed at meeting rising demand for pulmonary function tests as South Korea’s national health screening system is revised. With pulmonary function testing (PFT) formally added to general health screenings starting this year, people ages 56 and 66 will have an opportunity to detect major respiratory diseases such as chronic obstructive pulmonary disease (COPD) earlier through screenings, the company said.* This article has been translated by AI. 2026-03-24 17:06:28
  • Celltrion to Invest 1.2265 Trillion Won to Expand Songdo Drug-Substance Plants
    Celltrion to Invest 1.2265 Trillion Won to Expand Songdo Drug-Substance Plants Celltrion said Tuesday it will move to secure new production capacity, including a major expansion at its headquarters campus in Songdo, Incheon, with investment topping 1 trillion won. The company said the plan is aimed at meeting rising global demand for biopharmaceuticals and strengthening manufacturing competitiveness. The expansion will be carried out in phases from this year through 2030 and will cover infrastructure at its Songdo campus, U.S. production base and other domestic sites. At the Songdo campus, Celltrion will invest 1.2265 trillion won to expand Plants 4 and 5 at the same time, bringing total capacity to 180,000 liters. The new facilities will apply automation and smart-factory technology, the company said, enabling production ranging from small batches of multiple products to large-scale manufacturing. Celltrion said this should also speed preparations to produce future biosimilars and new drugs. To bolster competitiveness in the U.S. market, Celltrion said it has finalized the scale of an expansion at its Branchburg, New Jersey, facility. It plans to increase capacity there from 66,000 liters to 75,000 liters, securing total drug-substance (DS) capacity of 141,000 liters. The Branchburg site is expected to play an important role in local supply for the Celltrion Group and in expanding its contract manufacturing (CMO) business, the company said. Celltrion is also pushing to strengthen drug-product (DP) manufacturing. A new DP facility being expanded at the Songdo campus is nearing completion within the year and, once operating, will be able to produce 6.5 million liquid vials annually. Combined with the maximum output of the DP line at Plant 2, total DP capacity in Songdo would reach 10.5 million vials, the company said. A new DP plant planned for an industrial complex in Yesan, South Chungcheong province, has already had its site finalized, with design work scheduled to begin within the year. Celltrion said that once the Yesan DP plant is completed and a planned expansion of Celltrion Pharm’s prefilled syringe (PFS) production facilities is finished, the group would be able to internalize about 90% of its global DP needs. The company said it expects significant manufacturing cost savings compared with overseas DP CMO production. Celltrion said it is closely reviewing safety management systems for all ongoing construction projects. All expansion projects across the group, including Plants 4 and 5, will proceed with safety as the top priority, it said. A Celltrion official said the investment decision was made to respond to surging global demand for biopharmaceuticals while strengthening cost competitiveness and supply stability. “We will build manufacturing infrastructure that covers the CMO business as well, centered on the growth engines of new drugs and biosimilars,” the official said.* This article has been translated by AI. 2026-03-24 10:12:00