Journalist

Park Boram
  • Global Biosimilar Rules Ease, but Market Seen Consolidating Around Established Leaders
    Global Biosimilar Rules Ease, but Market Seen Consolidating Around Established Leaders Easing regulations for biosimilars is lowering barriers to entry, but competition is expected to tighten around established leaders rather than shift to newcomers, industry watchers say. As of April 8, major regulators including the U.S. Food and Drug Administration and the European Medicines Agency are revising standards to simplify biosimilar approvals, according to industry officials. The aim is to reduce the burden of large Phase 3 trials used to prove equivalence to original drugs and to rely more on analytical data such as pharmacokinetics (PK). Industry estimates put the impact at about a 25% cut in overall clinical costs and a development timeline shortened by one to two years. South Korea is moving in the same direction. The Ministry of Food and Drug Safety has already shortened review times for new biologics and biosimilars to 295 days from 406 days and plans to reduce them further to 240 days. Even so, lower regulatory hurdles are not expected to change who leads the market. Developing a biosimilar remains a high-difficulty business that can require up to $300 million per product and take more than five years. Regulatory easing may encourage more companies to try entering, but few have the production facilities, quality control systems and global approval experience needed at the same time. As entry becomes easier, the advantages of incumbent players may stand out more, the industry says. Jung Yi-su, an analyst at IBK Investment & Securities, said Celltrion and Samsung Bioepis are likely to be key beneficiaries in South Korea. He said Celltrion is moving quickly to revise Phase 3 trial plans in line with the regulatory changes, making it more likely to reflect the benefits of streamlined trials sooner. External conditions are also favorable for Celltrion, the report said. A policy for "2027 Medicare Advantage" issued by the U.S. Centers for Medicare & Medicaid Services includes higher insurer burdens and higher patient out-of-pocket costs. That could increase preference for biosimilars over high-priced drugs. If costs tied to intravenous (IV) administration are reflected, demand could also rise for subcutaneous (SC) formulations that patients can self-administer. Celltrion's "Zymfentra" was cited as a direct beneficiary. Celltrion plans to expand its biosimilar portfolio to 41 products by 2038 from 11 now. Key pipeline candidates include autoimmune disease treatments "CT-P53" and "CT-P55" and cancer treatment "CT-P51," all in Phase 3 trials. Samsung Bioepis is viewed as ahead in developing its Keytruda biosimilar, "SB27." It completed global clinical patient enrollment earlier than competitors, raising its chances of securing an early position, the report said. U.S. biosimilar market analysis cited in the report says first movers can generate, on average, 27% higher sales than later entrants. Keytruda patents are set to expire in the United States in 2028 and in Europe in 2031. Because clinician trust is critical, products that enter first may be able to expand share based on prescribing experience, the report said. Samsung Bioepis has already expanded its global footprint, commercializing 11 biosimilars in more than 40 countries, including the psoriasis treatment "Pyzchiva" and the paroxysmal nocturnal hemoglobinuria treatment "Epyscli." It is developing biosimilars for seven additional blockbuster drugs nearing patent expiry and plans to expand to 20 products by 2030. Industry officials said the regulatory shift could reshape the competitive landscape, not just expand the market. "As the clinical burden falls, more companies will try to enter the biosimilar market, but the market itself will be reorganized around existing leaders with experience and infrastructure," one industry official said. 2026-04-08 19:03:43
  • Samsung Bioepis Expands AI Training; Seoul St. Mary’s Rolls Out Smart Nursing Tools
    Samsung Bioepis Expands AI Training; Seoul St. Mary’s Rolls Out Smart Nursing Tools Samsung Bioepis moves to boost employees’ AI skills Samsung Bioepis said April 8 it has launched artificial intelligence training for all employees to strengthen global competitiveness in the AI era. The company said the program is aimed at maximizing workplace efficiency and marks its first companywide AI training effort. Samsung Bioepis built a dedicated training space, the “AI Academy,” at its headquarters in Songdo, Incheon, to allow employees to study year-round. Through July, employees will complete at least seven hours of AI theory and hands-on training at the in-house facility, including use of the latest generative AI, job-specific AI model design and work automation initiatives. The company said it also plans to form a task force led by its AI unit to develop customized “AI agents” for each division and team. Medytox names actor Lee Min-jung as ambassador for fat-reduction probiotic LactiPLAN Medytox said April 8 it has selected actor Lee Min-jung as the official ambassador for LactiPLAN, a probiotic marketed for reducing body fat. The company said it chose Lee because her energetic and trustworthy image aligns with LactiPLAN’s brand identity, which emphasizes a scientifically designed approach to healthy dieting. Medytox said it will release TV and outdoor ads featuring Lee in stages. It also plans a digital campaign across its official YouTube, Instagram and Facebook channels built around the message, “A healthy diet starts with a plan.” Seoul St. Mary’s Hospital expands smart nursing services with AI and mobile tools The Catholic University of Korea’s Seoul St. Mary’s Hospital said April 8 it has declared 2026 “the first year of nursing innovation led by AI” and will apply a range of smart nursing services in clinical settings. The hospital said the project focuses on accelerating digital transformation in nursing to improve efficiency, record accuracy and the patient experience. Its nursing department has operated an AI-based voice electronic nursing record system, known as Voice ENR, across all wards since February. The hospital said it built the infrastructure in phases over about 11 months while running on-site tests. With testing completed, the hospital said it has finalized a package that includes dedicated devices with Voice ENR and pin microphones designed for voice recognition that block surrounding noise. It said one device is issued to each ward nurse, enabling immediate recording and review at the bedside. The hospital also said it has set up an operating model that uses devices and tablet PCs depending on the task. For work that requires frequent movement — such as medication administration, transfusions and tests — nurses use the more portable Voice ENR device. For tasks that require visual checks and detailed input — such as admission counseling and rounds — they use tablet PCs. Seoul St. Mary’s Hospital said it will continue linking additional systems so the approach can serve as a core tool for nursing work. Jaseng Hospital reports study on Yukgongdan’s protective effects on hippocampal nerve cells A research team led by Kim Hyun-sung at the Spine and Joint Research Institute of Jaseng Hospital of Korean Medicine has identified Yukgongdan’s protective effects on hippocampal nerve cells and its mechanism of action, the hospital said April 8. The findings were published in the SCI(E)-indexed international journal Biology (IF=3.5). The hospital said scientific research explaining how Yukgongdan acts on hippocampal nerve cells has been limited. The team isolated nerve cells from rats and used high-resolution imaging to track changes after administering Yukgongdan, identifying its effects and mechanism. The study found Yukgongdan increased survival of damaged hippocampal nerve cells and reduced cell death. The protective effect was stable under both short-term (three-day) immature culture conditions and long-term (15-day) mature culture conditions, the hospital said. It also reported that Yukgongdan suppressed tau protein modification, cited as a key cause of dementia, and reduced accumulation of amyloid-beta protein, which can cause toxicity between cells. The hospital said ERK levels, associated with excessive stress responses that can accelerate brain damage, decreased after Yukgongdan intake, while expression of the Nrf2 protein, which plays a key role in antioxidant defense, recovered. CHA Fertility Center reports pregnancies using CAPA-IVM with immature eggs CHA University’s CHA Fertility Center said April 8 it has confirmed successive pregnancy successes at Jamsil CHA Hospital and Ilsan CHA Hospital using CAPA-IVM, a hormone-injection-free approach, for patients who have difficulty creating embryos through standard in vitro fertilization. CAPA-IVM is a form of in vitro maturation treatment using immature eggs. At Jamsil CHA Hospital, the center applied CAPA-IVM to a 32-year-old patient identified as A who had difficulty conceiving naturally due to polycystic ovary syndrome. After improving the uterine environment through a hysteroscopic procedure, the patient underwent frozen embryo transfer (T-ET) in January 2025, became pregnant and delivered a healthy baby boy in September that year. At Ilsan CHA Hospital, the center said it confirmed its first pregnancy success after using CAPA-IVM for a patient who did not respond to hormone treatment and had difficulty obtaining mature eggs. The hospital said the results are significant because pregnancy outcomes were confirmed through CAPA-IVM in patient groups where existing infertility treatment had been difficult, including patients with PCOS and those who could not secure mature eggs despite repeated hormone stimulation treatments.* This article has been translated by AI. 2026-04-08 17:45:16
  • ABL Bio Says Compass’ Bile Duct Cancer Drug Wins FDA Orphan Drug Designation
    ABL Bio Says Compass’ Bile Duct Cancer Drug Wins FDA Orphan Drug Designation ABL Bio said Tuesday that tovecimig, a bile duct cancer treatment being developed by its global partner Compass Therapeutics, has been granted orphan drug designation by the U.S. Food and Drug Administration. The designation is intended to encourage development of treatments for diseases affecting fewer than 200,000 patients. In the United States, it can provide benefits including a period of market exclusivity, typically seven years, as well as tax credits, reduced FDA review fees and grants to support clinical trials. Tovecimig is a bispecific antibody developed by ABL Bio and licensed to U.S.-based Compass. It is designed to block both DLL4 and VEGF-A signaling pathways, which the company said play key roles in angiogenesis and tumor blood vessel formation. The company said inhibiting both pathways has shown strong anticancer effects by suppressing tumor cell growth. Compass is running a Phase 2/3 trial in second-line bile duct cancer patients combining the drug with paclitaxel. It plans to release key results this month, including overall survival and progression-free survival.* This article has been translated by AI. 2026-04-08 11:06:19
  • Korean Biotech CDMOs Expand From Manufacturing to Integrated Services
    Korean Biotech CDMOs Expand From Manufacturing to Integrated Services Korean biotech companies are tightening their grip on the contract development and manufacturing (CDMO) market, reinforcing South Korea’s standing as an Asian bio hub. As global drugmakers expand outsourcing, Korean firms are moving beyond basic production into higher-value work that includes process development and regulatory support. BioPlan, a biopharmaceutical market research firm, said on the 7th that Samsung Biologics’ Songdo Bio Campus in Incheon was selected as the world’s largest single facility by production capacity. It held the No. 1 spot again after a 2022 survey, a result seen as validating the company’s “super-gap” strategy. Celltrion also gained ground. Operating Plants 1, 2 and 3 in Incheon, Celltrion ranked seventh in the survey, joining the global top 10. China’s CL Biologics’ Shenzhen facility ranked second, and a Genentech facility in the United States acquired by Switzerland’s Lonza in 2024 ranked third. In revenue, Korean companies are also closing in on global leaders. Jefferies said Samsung Biologics ranked fourth in global CDMO sales in 2024, posting $3.27 billion (about 4.9458 trillion won), behind Lonza, Thermo Fisher and Catalent. The report cited surging demand as CDMOs shift from small-molecule drugs toward more complex products such as cell and gene therapies. The shift is reflected in business models. Samsung Biologics is expanding modalities such as antibody-drug conjugates, while extending into contract research through “Samsung Organoid,” building an integrated service system that spans research and development. It has also strengthened its production base. After securing 17 of the world’s top 20 pharmaceutical companies as clients, it completed the acquisition of a biopharmaceutical manufacturing facility in Rockville, Maryland, on March 31 local time. With a 60,000-liter drug substance plant capable of supporting clinical through commercial production, its total capacity expanded to 845,000 liters. Celltrion is also upgrading its structure on the back of growing orders. After signing a contract manufacturing (CMO) deal worth about 678.7 billion won with Eli Lilly early this year, it added further contracts, pushing its cumulative CMO order backlog past 1 trillion won within the first quarter. The company is also shifting weight toward higher-value services. It is pursuing a CMO strategy aimed at boosting clients’ competitiveness through formulation changes, seeking differentiation with its own subcutaneous (SC) formulation conversion technology. A key example is its “formulation-change CMO” business, applying know-how built through products such as Remsima SC and Herzuma SC to external clients. Celltrion is accelerating its overseas footprint as well. It recently completed the relocation of a biopharmaceutical production facility in Branchburg, New Jersey, and set its expansion scale at 75,000 liters. That would raise its drug substance capacity from 316,000 liters to 571,000 liters. The company aims to secure CMO revenue through local production while broadening into CDMO and cutting costs to expand supply to the U.S. market. Lotte Biologics said it signed a CDMO contract on the 1st with a U.S. oncology-focused biotech company to produce antibody drug substance and develop processes. It plans to produce late-stage clinical samples and optimize processes at its Syracuse, New York, campus, while linking with its Songdo campus to strengthen integrated CDMO capabilities. As companies broaden their scope, the basis of competition is changing. A production-only model is showing limits, and integrated capabilities that include clinical support and regulatory approvals are emerging as a key factor. Jung Yoon-taek, head of the Korea Pharmaceutical Industry Strategy Research Institute, said, “The market is being reshaped from CMO to CDMO and to CRDMO,” referring to contract research, development and manufacturing organizations. “Competition is shifting toward companies that can provide customized, integrated services,” he said. The trend is also feeding into expanded investment by global drugmakers in South Korea. Roche signed a memorandum of understanding with the Ministry of Health and Welfare last month on strengthening global competitiveness in the biohealth industry and agreed to pursue $500 million (about 750 billion won) in investment over five years. Eli Lilly also announced a plan this year to invest a total of $500 million over five years. Even as South Korea emerges as a new hub, companies still face the task of proving both capacity and technology. Lee Seung-gyu, vice chairman of the Korea Bio Association, said the CDMO market requires not only scale but also quality control, skilled operating staff and the ability to respond to regulatory approvals to win sustained orders. “The key is building global competitiveness that matches market demand,” he said.* This article has been translated by AI. 2026-04-07 18:33:00
  • Samchundang Pharm CEO says results will address doubts after $100 million U.S. deal
    Samchundang Pharm CEO says results will address doubts after $100 million U.S. deal "We will prove it through management and results." Jeon In-seok, CEO of Samchundang Pharm, said at a news briefing Monday at the company’s Seoul headquarters that he would restore trust by delivering business results amid controversy over a recent technology export agreement. The company disclosed March 30 that it had signed a $100 million (about 1.5 trillion won) technology export deal with a U.S. partner for an oral diabetes and obesity treatment. Market doubts spread over the profit-sharing structure and contract terms, and the controversy intensified after Jeon’s plan to sell a 2.5 trillion won stake in a block deal became public. Samchundang Pharm said it scrapped the block deal plan Monday morning and pushed back against suspicions. Jeon said, "We decided to eliminate the block deal itself, which became the basis for the rumors," adding, "I judged that protecting the company’s value and shareholder trust comes before my personal tax issues." Attention has shifted to whether the company’s technology and business case can be verified. At the briefing, the company focused on its platform technology, S-PASS, which it says converts injectable drugs into oral formulations. Samchundang Pharm said the technology delivers efficacy equivalent to the original product while avoiding existing formulation patents. Jeon said, "Malicious rumors about S-PASS are not true," adding that materials submitted to the U.S. Food and Drug Administration include the drug mechanism, stability data and the applied technology. "You cannot proceed through regulatory procedures with false technology or data," he said. The company said it uses an S-PASS-based substance (SNAC Free) to avoid formulation patents without existing excipients and to improve cost competitiveness. It said the biopolymer used instead of SNAC costs about one-tenth as much, and that it has secured competitiveness at what it called a global low of about $20 per gram.The company said it is developing oral semaglutide (Rybelsus and Wegovy oral generics) based on the technology and has signed an exclusive supply agreement with its U.S. partner. Addressing the structure under which it receives 90% of sales revenue, Jeon said it is possible because Samchundang Pharm develops and produces products with its own technology and supplies them to global markets. He described it not as a technology transfer deal but as a revenue-sharing supply agreement in which the partner sells the product and pays sales proceeds over 10 to 15 years. On milestones, he said the core of the contract is not one-time milestone payments but revenue generated from long-term product supply. Responding to criticism of its R&D capabilities, Jeon said the company has used a "strategically distributed innovation" structure from the start, with each team focused only on its project to minimize information leaks. Jeon apologized, saying communication with shareholders had been insufficient, and said the company would rebuild trust by proving global results in the second half of the year with numbers and outcomes. According to the Korea Exchange, Samchundang Pharm shares surged intraday to as high as 706,000 won but gave up gains to close down 4.63% at 618,000 won from the previous session. The stock has jumped 400% this year, overtaking EcoPro to rank No. 1 by market capitalization on the KOSDAQ and earning the nickname "imperial stock" for trading above 1 million won, but a recent sharp decline has jolted the market.* This article has been translated by AI. 2026-04-06 18:15:00
  • JW Pharmaceutical: Hemlibra Study Shows Lower Bleeding Risk in Children With Hemophilia A
    JW Pharmaceutical: Hemlibra Study Shows Lower Bleeding Risk in Children With Hemophilia A JW Pharmaceutical said on 6 that a study published in the international journal TH Open found children and adolescents with hemophilia A who received Hemlibra (emicizumab) maintained a low risk of bleeding even while taking part in a range of physical activities. Hemlibra is a novel drug designed to mimic the function of clotting factor VIII, which is lacking in people with hemophilia. The company said it is the only hemophilia A treatment that can be used in both patients who have developed antibodies that make standard factor VIII products ineffective and those who have not. It is given by subcutaneous injection, with preventive effects lasting up to once every four weeks. The study was conducted at 50 medical institutions in Japan over about 97 weeks. Researchers analyzed physical activity, bleeding, safety and changes in quality of life after patients switched to Hemlibra prophylaxis. Before Hemlibra, patients experienced an average of 1.5 to 2.0 bleeding episodes over the most recent 12 or 24 weeks. After switching treatment, the median annualized bleeding rate was 0.53. During the study, researchers recorded 172 physical activities: 44 high-risk, 70 moderate-risk and 42 low-risk. One traumatic bleed related to physical activity was reported, and no significant link was found between activity intensity and bleeding. Quality-of-life measures also improved. In caregiver surveys, 43.8% reported their child was more active, and 56.3% reported less anxiety about bleeding. On safety, no intracranial hemorrhage (ICH) or thromboembolism — concerns in infants and toddlers — were reported.* This article has been translated by AI. 2026-04-06 17:42:00
  • Samhchundang Pharm CEO Withdraws $1.9 Billion Share Block Sale Plan
    Samhchundang Pharm CEO Withdraws $1.9 Billion Share Block Sale Plan Samhchundang Pharm said Monday that CEO Jeon In-seok has withdrawn a 250 billion won ($1.9 billion) plan to sell shares in a block deal that was disclosed March 24. The company said the sale, originally intended to raise funds to pay taxes, had been misunderstood in the market and was weighing on the company’s value. Jeon said he decided to pull the deal amid growing distrust and concerns it could damage shareholder value. The planned sale was meant to cover taxes including gift tax, but some in the market raised suspicions that the size of a U.S. supply contract had been exaggerated. “There were no falsehoods in the contract details,” Jeon said, adding that he could not “leave the situation as it is” when negative allegations could harm shareholders. He said protecting the company’s underlying value took priority over meeting his personal financial obligations. Samhchundang Pharm said it will hold an afternoon news briefing to explain the withdrawal, allegations related to S-PASS and details of the U.S. contract. The company is said to be considering alternatives such as stock-backed loans instead of selling shares to pay the taxes. It said the approach is aimed at stabilizing the share price and reinforcing its commitment to responsible management. Samhchundang Pharm said it will proceed with its business plans without disruption, with key milestones ahead including additional global supply contracts in the second half of this year and clinical trials for oral insulin.* This article has been translated by AI. 2026-04-06 09:42:52
  • Oral Obesity Drug Race Intensifies as Efficacy and Convenience Shape Choices
    Oral Obesity Drug Race Intensifies as Efficacy and Convenience Shape Choices Novo Nordisk’s move into oral obesity drugs is now being matched by Eli Lilly, widening competition in a market long dominated by injections. As pills gain ground, analysts expect patients and prescribers to weigh results against ease of use more sharply. Industry officials said the U.S. Food and Drug Administration on April 1 approved Lilly’s oral glucagon-like peptide-1, or GLP-1, obesity drug Foundayo (active ingredient: orforglipron). The agency’s decision came 50 days after the application, an unusually fast timeline that industry watchers said underscores regulators’ priority on obesity treatments. Novo Nordisk entered first with an oral version marketed as “Wegovy pill.” Novo’s product requires dosing on an empty stomach and limits on water intake around the time of use, while Lilly says Foundayo can be taken without restrictions on food or timing. Lilly is promoting it as a GLP-1 tablet that can be taken at any time. Pricing is set at a similar level. Lilly priced Foundayo roughly in line with oral Wegovy: $25 a month for insured patients and $149 for those without insurance. That is far below the monthly cost of existing injectable drugs, which can run into the millions of won in Korea. Weekly injections remain the standard in obesity care, but oral drugs could spread quickly in early-stage treatment because they are easier to take, the industry said. The result, officials said, is likely a clearer split in choices based on effectiveness, convenience and lifestyle. On weight loss, injections still lead. Lilly’s injectable Zepbound showed average weight loss of 15 to 21 kilograms over 72 weeks, and about one-third of patients on the highest dose lost at least 26 kilograms. Lilly’s clinical data showed participants taking the highest dose of Foundayo lost an average of 12 kilograms over the same period. Because it is taken daily, results may vary, but the pill could broaden access among patients who are reluctant to use injections, the company and industry officials said. An industry official called the shift a turning point as obesity drugs move from “specialty therapies” toward “mass-market consumer products,” adding that oral drugs are clearly gaining momentum but choices will differ by effectiveness, convenience and lifestyle. Over time, the market is likely to split into two tracks, the official said. Lilly plans to begin shipping Foundayo on April 6 through its LillyDirect platform, aiming to secure early demand via U.S. retail pharmacies and telehealth providers. The company has submitted Foundayo approval applications in more than 40 countries, starting with the United States. Some countries that have been cautious about reimbursing obesity drugs because of high prices may revisit coverage as relatively cheaper oral options emerge, industry officials said. Another official said the market is expanding alongside growth in chronic-disease management, and that insurance and reimbursement talks are likely to accelerate. 2026-04-05 16:03:00
  • Korea Bio, Health Exports Top $4.16B in Q1 Despite War-Driven Uncertainty
    Korea Bio, Health Exports Top $4.16B in Q1 Despite War-Driven Uncertainty South Korea’s bio and health exports topped 6 trillion won in the first quarter, extending growth despite external uncertainty including war in the Middle East. The Korea Biopharmaceutical Association said Sunday that exports from January through March totaled $4.16 billion (about 6.3 trillion won). March exports rose 6.3% from a year earlier to $1.5 billion (about 2.3 trillion won). February increased 7.1% to $1.31 billion (about 2 trillion won), and January climbed 18.3% to $1.35 billion (about 2.035 trillion won). The association said biosimilars drove the gains, citing expanding demand in major markets including the United States and the European Union. It said exports have risen for five straight months. In the United States, about 90% (106) of biopharmaceuticals scheduled to lose patent protection from 2025 to 2034 have no biosimilar candidates in development, the association said, adding that Europe faces a similar situation. South Korean companies are expanding their presence on the back of those opportunities. Korea was named the country with the most U.S. Food and Drug Administration biosimilar approvals for two consecutive years in 2024 and 2025, the association said. Biosimilar exports rose 50% to $1.47 billion (about 2.2 trillion won) in 2022 from $980 million (about 1.4 trillion won) in 2021. The association forecast bio and health exports will rise 9% this year to $30.4 billion (about 46 trillion won), topping last year’s record $27.87 billion (about 42 trillion won).* This article has been translated by AI. 2026-04-05 11:15:00
  • Policy Split Deepens Divide Between Korea’s Pharma and Biotech Sectors
    Policy Split Deepens Divide Between Korea’s Pharma and Biotech Sectors Korea’s pharmaceutical and biotech industry is showing a sharper divide as government policy moves in opposite directions. While authorities are rolling out support measures to foster biotech, they have also decided to cut prices for generic drugs, leaving drugmakers bracing for tighter margins.  Industry officials said April 2 that Samsung Biologics and Celltrion, the country’s two biggest biotech companies, are each targeting more than 5 trillion won in sales this year.  Both companies have strengthened their positions in global contract development and manufacturing (CDMO) and biosimilars. Samsung Biologics posted 4.557 trillion won in revenue and 2.0692 trillion won in operating profit last year, setting a domestic industry record, and set a 2026 revenue target of 5.32 trillion won.  Celltrion reported 4.1625 trillion won in revenue and 1.1685 trillion won in operating profit last year, and its 2026 sales outlook also tops 5 trillion won. At a recent shareholders meeting, Celltrion Chairman Seo Jung-jin, who returned as chair for the first time in 11 years, presented sales guidance of 5.3 trillion won and pledged step-by-step operating profit of 300 billion won in the first quarter, 400 billion won in the second, 500 billion won in the third and 600 billion won in the fourth.  SK Biopharmaceuticals also posted its best-ever results, with revenue rising 29% from a year earlier to 706.7 billion won. Securities firms expect the company to reach 1 trillion won in annual sales in 2027.  Government backing is also seen as a tailwind for biotech growth. Authorities have said they will pursue licensing reforms aimed at enabling the world’s fastest product launch timeline of 240 days. Earlier this year, the approval period for new biotech drugs and biosimilars was cut to 295 days from 406 days, with a plan to reduce it further to 240 days. A Ministry of Food and Drug Safety official said the agency is expanding its review staff by about 200 to speed biosimilar approvals and will provide active support.  Late last year, the ministry enacted a special law to build a regulatory support framework for the CDMO industry. With a new registration system for export manufacturing of biopharmaceuticals — previously not covered under pharmaceutical regulations — the government plans to support measures including facility standards for export-focused plants, formalizing standards for good manufacturing practice certification and raw-material certification, and simplifying import customs procedures for active pharmaceutical ingredients.  In pharmaceuticals, HK inno.N exceeded 1 trillion won in revenue last year, expanding the number of companies in the “1 trillion won club” to 10. But companies centered on generics are widely seen as entering a fight for survival as price cuts take effect. The government lowered the generic pricing formula to 45% of the original drug price, a move expected to reduce sales and constrain research and development spending. The impact is expected to be significant for both top-tier and smaller drugmakers.  Changes are already being felt in the field. Analysts said companies that have relied on contract sales organizations (CSOs) are likely to face broad shifts in sales strategies. As firms move to cut fixed costs such as labor and marketing, more are expected to drop low-profit, low-priced generics and focus on higher-margin products.  “Developing new drugs is difficult to deliver results in the short term, and it requires large-scale investment,” an industry official said. “Because options to recover costs are limited if it fails, companies have no choice but to start by adjusting expenses they can cut immediately.” As a result, more firms are moving toward conservative management, including scaling back facility investment and revising hiring plans, while also preparing to seek certification as innovative pharmaceutical companies.  A task force for reforming the drug pricing system for industrial development criticized the price cuts, saying, “With the business environment worsening due to rising global instability, drug price cuts carried out now could make it difficult for domestic pharmaceutical companies to survive.” It urged the government to adopt flexible policies that “comprehensively consider public health, insurance finances and industrial competitiveness” so the industry ecosystem is not damaged. * This article has been translated by AI. 2026-04-02 18:15:00