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- 2025-12-18 22:55:43
- Opinion
- [Reporter’s View] Legislation needed for telemedicine drugs
- by Lee, Jeong-Hwan Sep 19, 2025 06:12am
- Discussions on institutionalizing telemedicine have progressed swiftly after the Ministry of Health and Welfare submitted its proposal at the National Assembly last month, The Lee Jae-myung administration confirmed telemedicine as a national agenda, and the Democratic Party of Korea pledged to pass a Medical Service Act amendment during this NA session. In this process, several bills for the legalization of telemedicine have been additionally introduced in the National Assembly. Notably, these bills include new regulatory provisions for non-reimbursed drugs that the government has banned from tele-prescription due to their high risk of side effects and the lack of health insurance prescription data. Narcotics, psychotropic medicines, hair loss treatments, acne drugs, and obesity medications that are prohibited from tele-prescription have long been pointed out as areas of concern in the institutionalization of telemedicine, since excessive prescribing could lead to widespread adverse drug events and misuse. Particularly, if non-reimbursed prescription drugs are not properly regulated, telemedicine could result in patients concentrating at certain medical institutions or pharmacies in order to obtain such prescriptions, raising concerns among doctors and pharmacists. Fortunately, a bill (proposed by Representative Sun-min Kim of the Rebuilding Korea Party) has been introduced that makes it mandatory to use and check the Drug Utilization Review (DUR) system during telemedicine, thereby blocking patients from receiving prescriptions via telemedicine for drugs that the government has banned. This enables the National Assembly to deliberate on legislating regulatory provisions for prohibited tele-prescription drugs during bill reviews. Currently, even if the Ministry of Health and Welfare designates certain drugs as prohibited for tele-prescription based on feedback from the medical community, there is no enforcement mechanism if doctors ignore this and prescribe them via telemedicine. However, according to Representative Kim Sun-min, once the DUR requirement is legislated, prescriptions for such banned drugs will be automatically blocked. At present, more than 800 items fall under the category of drugs prohibited for tele-prescription, including narcotics, drugs with misuse potential, obesity drugs, and emergency contraceptives. Since these drugs can trigger a range of adverse outcomes when prescribed via telemedicine—such as misuse, concentration at specific medical institutions or pharmacies, and overprescribing—the mandatory use of DUR provision must be incorporated into institutional discussions to ensure a safe telemedicine environment. Representative Kim’s bill also specifies prohibited actions for telemedicine intermediaries, such as platform companies. This is another necessary provision for the safe legalization of telemedicine. Among these, the clauses that prohibit platforms from receiving monetary or other rebates in return for directing patient prescriptions to specific medical institutions or pharmacies, and that require platforms to submit statistical data quarterly to the Minister of Health and Welfare for telemedicine monitoring, along with stipulations for administrative actions such as corrective orders, license revocation, and business suspension in case of violations, are expected to effectively curb platform misconduct or illegal practices from the outset. As of the 17th, a total of 6 bills on the institutionalization of telemedicine are pending in the National Assembly, with additional bills being prepared. Beyond regulatory measures that prohibit tele-prescription drugs and platform supervision, many hurdles remain to achieve a comprehensive telemedicine system. With the possibility of institutionalizing the amendment of the Medical Service Act for telemedicine likely within the year, it is this reporter’s hope that the National Assembly fully demonstrate its legislative efforts and capabilities in unifying the diverse positions and opinions of relevant stakeholders—including the MOHW, doctors, pharmacists, and platforms—with the public at its core.
- Company
- Will 'Bylvay' be listed in the second half the year?
- by Eo, Yun-Ho Sep 18, 2025 06:04am
- Attention has been drawn to whether Bylvay, the first drug in the Concurrent Approval-Evaluation-Negotiation Pilot Program, will be approved for the reimbursement listing. Ipsen Korea is currently in negotiations with the National Health Insurance Service (NHIS) over the drug price for Bylvay (odevixibat), a treatment for pruritus in patients aged 3 months and older with Progressive Familial Intrahepatic Cholestasis (PFIC). Bylvay recently passed the Health Insurance Review & Assessment Service's (HIRA) Drug Reimbursement Evaluation Committee (DREC) in July after a second review. It had previously been sent back for re-deliberation at the DREC in April. The government initiated the first phase of the Concurrent Approval-Evaluation-Negotiation Pilot Program in October of last year, selecting two drugs as its initial targets: 'Qarziba (dinutuximab),' a treatment for pediatric rare diseases, and Bylvay. The Concurrent Approval-Evaluation-Negotiation Pilot Program is a system designed to support swift insurance listing by conducting the Ministry of Food and Drug Safety (MFDS) approval, HIRA reimbursement evaluation, and NHIS drug price negotiation in parallel. However, questions were raised about the program's effectiveness in expediting drug listings when Bylvay initially failed to pass the first reimbursement hurdle. The review for Qarziba, the other drug in the first phase of the program, was also briefly halted at the DREC. Now that Bylvay has entered the final stage of negotiation, it remains to be seen if the Concurrent Approval-Evaluation-Negotiation Pilot Program can live up to its name by Bylvay's successful reimbursement listing. Meanwhile, the efficacy of Bylvay was proven in the Phase 3 ASSERT study, which was conducted on pediatric and adolescent patients up to 17 years of age. The study results showed that Bylvay met its primary endpoint by significantly reducing pruritus compared to the placebo. It also significantly improved the key secondary endpoints, including the mean serum bile acid concentrations at weeks 20 and 24 compared to placebo. These effects of Bylvay were sustained for up to 24 weeks of treatment.
- Company
- Rewriting the Medical Field with AI: KHF 2025
- by Hwang, byoung woo Sep 18, 2025 06:03am
- “Artificial intelligence (AI) technology is no longer just being applied to clinical settings; it is reshaping daily life.” Korea’s largest healthcare exhibition, the Korea-Hospital and Health Tech Fair (KHF2025), kicked off on the 17th at COEX in Seoul for three days. KHF2025 held its opening ceremony on the 17th and commenced its three-day schedule. Experts and stakeholders at the venue remarked that the medical field has now moved beyond simply adopting AI technology to actively exploring how best to utilize it. Now in its 12th year, the event highlighted the use of AI in hospitals and digital innovation across the sector. A wide range of players—from startups to public institutions—showcased their approaches to applying AI in healthcare, drawing significant attention. Right at the exhibition entrance, medical imaging company DK Medical Solution drew visitors’ attention with its equipment and technology that adopts medical AI. The company partnered with Google for the past 3 years, integrating Google Workspace collaboration tools and generative AI technologies into clinical workflows. DK Medical Solution showcased technology it developed in partnership with Google For example, AI agents can take care of hospital documentation and repetitive administrative tasks. A DK Medical Solution representative explained, “Previous AI adoption sometimes led to what we call ‘AI fatigue,’ placing burdens on medical staff. We found the solution through Google. In fact, hospitals that have implemented this system responded with comments like, ‘It’s much better than expected, beyond what we imagined.’” New AI technologies showcased by NIPA in the Digital Health Special Pavilion The National IT Industry Promotion Agency (NIPA), under the Ministry of Science and ICT, also participated in this exhibition, showcasing its digital health industry support strategies. NIPA has been overseeing medical AI projects for over a decade and responded swiftly to new developments—for instance, just three months after the emergence of ChatGPT last year, it began planning new projects in the healthcare field. The digital healthcare special hall organized by NIPA was structured around three themes: ▲Large-scale AI ▲DTx (digital therapeutics) ▲Public healthcare. Specifically, projects were unveiled for specialized counseling LLM services to manage chronic conditions in children and adolescents and to provide mental health care for depression and suicide prevention, as well as the development of digital therapeutics for conditions such as bruxism and irritable bowel syndrome. NIPA highlighted the companies and technologies it is supporting at its Digital Healthcare Special Pavilion. In particular, the AI-powered emergency medical network “Smart Ambulance” drew attention for its role in narrowing regional healthcare disparities. According to Myung-sook Yoon, a team leader at NIPA, the Smart Ambulance project was developed from 2019 to 2021 and is now in operation as an AI emergency system linking 119 ambulances with hospitals in real time in parts of Gangwon, Jeonnam, and Chungcheong (including Gwangyang and Yeosu) provinces. When a patient’s condition is recorded by voice in the ambulance, it is transcribed into text in real time and sent to the emergency room. The system also automatically displays bed availability at nearby hospitals using GPS, helping to reduce the so-called “ER ambulance carousel” problem. Yoon emphasized that the paradigm of medical AI is shifting. “In the past, domestic medical AI support was concentrated on diagnostic areas such as CDSS (Clinical Decision Support Systems) and medical imaging interpretation. Now, the focus is shifting toward pre-care (disease prevention) and post-care (prognosis management). For technology to take root in practice, it is crucial to enhance flexibility and usability at the level of the end user.” NIPA plans to continue supporting digital health policies through regulatory sandboxes and assisting regional hospitals in their digital transformation. AI is no longer novel - “We must consider what to use and how to use it” Industry stakeholders generally expressed positive expectations regarding the integration of medical AI, as observed through this event. At the same time, challenges remain. Hospital representatives visiting the booths remarked, “There are so many AI solutions that we don’t know which ones to actually use.” For this reason, experts at the fair predicted that the role of solutions would increasingly shift from merely developing AI suitable for clinical medicine to helping determine which AI systems to use. An industry official commented, “In clinical settings, the most common question is which AI solution to use among so many. Ultimately, finding the most optimized service will become critical. The consulting sector will also continue to expand, evolving into more customized services.” Many companies participating in KHF2025 prominently featured AI technology in their promotional activities. For instance, cost-related issues such as insurance reimbursement remain significant hurdles to adopting AI in healthcare. Experts were in consensus that institutional support is essential to ensure that the benefits of AI technology permeate every corner of the healthcare field. The experts particularly emphasized pan-ministerial cooperation. The Ministry of Health and Welfare should establish reimbursement policies grounded in safety and efficacy, while the Ministry of Science and ICT supports initial adoption through pilot projects and infrastructure development—a two-track approach. If regulators adopt a more flexible mindset and actively incorporate feedback from medical practitioners, the medical AI integration efforts highlighted at KHF2025 may well take root soon in more hospitals, pharmacies, and other care settings in Korea.
- Company
- Alteogen secures EU authorization for Eylea biosimilar
- by Cha, Jihyun Sep 18, 2025 06:03am
- [Bio platform company Alteogen (CEO Soon-jae Park) announced on the 17th that it has obtained marketing authorization from the European Commission (EC) for ‘Eyluxvi (project name ALT-L9),’ an Eylea biosimilar it had jointly developed with Alteogen Biologics. Eyluxvi is Alteogen’s second biosimilar product to receive approval, following its Herceptin biosimilar. The final authorization was granted about two months after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion in July. Eylea is a widely used treatment for ophthalmic diseases such as wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). In 2024, it generated blockbuster sales of USD 9.5 billion (approximately KRW 13 trillion). With the authorization, Eyluxvi can now be prescribed in Europe for approved indications, including wAMD, DME, macular edema secondary to retinal vein occlusion (BRVO/CRVO), and myopic choroidal neovascularization (myopic CNV). Alteogen CEO Soonjae Park said, “Eyluxvi is Alteogen's first biosimilar product, developed through our proprietary research to derive the substance, followed by global clinical development completed with our subsidiary Alteogen Biologics, and ultimately approved independently. Through this process, we not only advanced R&D but also gained valuable experience with European regulators and the approval process, thereby expanding Alteogen’s capabilities.”
- Policy
- MFDS, "Increase in fees will expedite biosimilar approval"
- by Lee, Tak-Sun Sep 18, 2025 06:02am
- The Ministry of Food and Drug Safety (MFDS) has announced that it will expedite biosimilar approvals in relation to a recent "increase in approval fees." The MFDS plans to establish a dedicated review team to provide approval and review services commensurate with the new fees. The MFDS issued an administrative announcement on September 12 regarding a partial amendment to the 'Regulations on Fees for Pharmaceutical Approvals, etc.', which primarily details the reorganization of approval fees for biosimilars (biological medicines). According to the amendment, the approval fee for biosimilars will increase to KRW 310 million, a significant jump from the previous KRW 8.031 million. Also, the MFDS announced that it will shorten the approval period from the current 406 days to 295 days. According to the amendment, the approval fee for biosimilars will increase to KRW 310 million, a significant jump from the previous KRW 8.031 million. An MFDS official stated on September 16 to a group of specialized journalists, "Similar to our innovative plan for new drug approvals, we will expand customized consultations through the operation of a dedicated review team." The MFDS plans to establish a dedicated review team (10-15 reviewers) from various fields to conduct biosimilar reviews in areas such as ▲safety and efficacy ▲quality management ▲Good Manufacturing Practice (GMP) ▲Good Clinical Practice (GCP). Specifically, the teams will be organized by product, centered around the Biopharmaceutical Policy Division's 'Bio Approval TF' within the Biopharmaceuticals and Herbal Medicines Bureau. An official from the Bio Approval TF said, "We have received positive feedback from the industry since implementing the innovative plan for new drug approvals in January," and added, "The dedicated teams will be structured similarly to the new drug innovation plan and are expected to provide swift and accurate approval reviews for biosimilar products." The MFDS also announced plans to prioritize GMP inspections for biosimilar products. The core of this initiative is to conduct GMP evaluations and on-site inspections within 90 days of submitting the approval application. The agency also plans to recruit highly qualified reviewers. Another MFDS official stated, "This matter has not yet been finalized, so I must be cautious in expressing an opinion," and added, "If the biosimilar approval fee increase is finalized, we plan to supplement our staff with highly qualified reviewers to enhance our approval and review capabilities, thereby improving patient access to treatment in Korea. We will do our utmost to respond to the growing demand for biosimilar products." The industry believes that if GMP inspections are completed within 90 days, the approval speed could increase even further. An industry official said, "The demand for biosimilar products has been increasing recently due to the rise in chronic diseases and the aging population," and added, "Because of this, pharmaceutical companies are seriously beginning the development and approval applications for biosimilar products. If the fee increase becomes a reality, the shortened approval timeline will likely accelerate product launches." According to the '2024 Drug Approval Report' released by the MFDS, biosimilar products (equivalent biological medicines) recorded a total of 18 items (10 APIs), an increase of 6 items from the previous year, marking the highest number of approvals since the first product approval in 2012. More than half of these (13 items, 7 APIs) were domestically developed in Korea, suggesting that the domestic biosimilar industry, led by Celltrion and Samsung Biologics, has gained global competitiveness.
- Policy
- Reimb listing a hurdle for Dutasteride + Tadalafil combos
- by Jung, Heung-Jun Sep 18, 2025 06:02am
- The dutasteride-tadalafil combination was approved in January for the treatment of benign prostatic hyperplasia (BPH), but has failed to clear the reimbursement hurdle, which is delaying the drug’s market launch. Four companies – Dongkook Pharmaceutical, Dong-A ST, DongKoo Bio&Pharma, and Shinpoong Pharm - are reportedly discussing a non-reimbursed launch, though some differences in opinion remain. According to industry sources on the 16th, the four companies are debating whether a non-reimbursed launch would have sufficient market potential or whether it would be better to attempt another reimbursement bid. If they proceed with a non-reimbursed launch, they must also decide on the appropriate timing. Dongkook Pharmaceutical (Uresco Tab), Dong-A ST (Dutana Tab), DongKoo Bio&Pharma (Uroguard Tab), and Shinpoong Pharm (Avocial Tab) drew attention in January for obtaining the world’s first approval of fixed-dose dutasteride-tadalafil combinations. Although the companies applied for reimbursement listing, concerns over potential misuse became an obstacle. In particular, the non-reimbursed component of tadalafil was said to have been the sticking point. An industry official commented, “If launched without reimbursement, we need to assess how much market potential it would really have. Some companies also favor making another reimbursement attempt, so consensus must be reached.” The companies are in a difficult position, as launching without reimbursement and then reapplying for listing is not an easy path. The dutasteride-tadalafil combination was first developed by Dongkook Pharmaceutical in 2012 and has come to fruition after 13 years of research. A Dongkook Pharmaceutical representative said, “No definite timeline has been set for a non-reimbursed launch yet, and discussions are still ongoing with the three partner companies.” The companies hold exclusive sales rights for 6 years following approval. The longer the launch is delayed, the shorter the effective exclusivity period becomes. According to IQVIA, the market for dutasteride has been steadily growing alongside the hair loss treatment market. Last year, sales of the original product Avodart reached KRW 42.9 billion, while generics totaled KRW 49.4 billion.
- Company
- Samjin Pharm and Sanofi collide in the influenza vaccine mkt
- by Hwang, byoung woo Sep 17, 2025 06:12am
- With the influenza (flu) vaccination season approaching, competition in the vaccine market for adults aged 65 and over is anticipated. The government has switched the National Immunization Program (NIP) vaccine to a three-valent vaccine and lowered the procurement price. The introduction of the four-valent vaccine in the non-reimbursed medicine market is likely to be a variable. (from left) product photo of Fluad Quad and Efluelda According to the Korea Disease Control and Prevention Agency (KDCA), the 2025-2026 seasonal influenza National Immunization Program (NIP) will begin on the 22nd of this month and run until April of next year. Free vaccinations will be provided to high-risk groups, including children aged 6 months to 13 years (born between January 1, 2012, and August 31, 2025), pregnant women, and individuals aged 65 and over (born before January 1, 1956). Considering that influenza vaccinations typically begin with the NIP, the competition between Samjin Pharm-CSL Seqirus and Sanofi is expected to heat up from October. Samjin Pharm-CSL Seqirus and Sanofi are aiming to expand their market influence by promoting an adjuvanted vaccine and a high-dose vaccine, respectively. First, Samjin Pharma, in cooperation with CSL Seqirus, is scheduled to supply 'Fluad Quad,' an adjuvanted vaccine for elderly individuals, and 'Flucelvax Quad,' the cell-based flu vaccine. Samjin Pharma offers a specialized line of prescription drugs for treating chronic diseases and product lines related to pediatrics, such as Trestan. The company anticipates synergy with its existing sales capabilities. A Samjin Pharma official said, "The company has long strived to provide good treatments for chronic disease patients, who are a high-risk group for influenza," and added, "As our product portfolio is focused on chronic disease treatments, we intend to ensure that Fluad Quad, an adjuvanted influenza vaccine, can be administered to the chronic disease patients we have been focusing on." Sanofi is expected to pursue a continuous market strategy, building on its efforts from last year. Sanofi has already been prepared for inclusion of its product in the NIP, including the publication of a cost-effectiveness analysis in the international journal 'Human Vaccines & Immunotherapeutics' in November 2023, which compares its high-dose vaccine with a standard-dose vaccine using national health insurance big data. A Sanofi official emphasized, "Efluelda is the only product among the high immunogenicity flu vaccines recommended by the Korean Society of Infectious Diseases that has proven preventive efficacy in a randomized clinical trial," and added, "Efluelda will contribute to reducing the socioeconomic burden caused by influenza and pneumonia in adults aged 65 and over." The premium vaccine market for adults aged 65 and over has been increasing. One of the variables is the shift of the NIP vaccine to a three-valent formulation. Previously, a four-valent vaccine containing antigens for four types of viruses, including influenza A virus (H1N1 and H3N2) and influenza B virus (Victoria and Yamagata), was used in the NIP. However, based on the World Health Organization's (WHO) recommendation earlier this year, this season's vaccine will be a three-valent vaccine that excludes the influenza B/Yamagata virus antigen. Consequently, the procurement price has been lowered compared to the previous four-valent vaccine, and the four-valent vaccine that was previously administered will now be a non-reimbursed vaccine. It means that the adjuvanted vaccine and high-dose vaccine, which previously competed with the NIP-included four-valent vaccine, will now have to compete for market share with both the NIP-included three-valent vaccine and the (non-reimbursed) four-valent vaccine. Both the adjuvanted vaccine and the high-dose vaccine claim to offer higher preventive efficacy in elderly individuals than the conventional influenza vaccine, but a price barrier could be an issue. However, a prediction also exists that, in the long run, as both vaccines aim to enter the NIP, they will focus on expanding the market for vaccines specifically designed for elderly individuals, rather than just competing with each other. In a previous press conference, Professor Choi Min-joo of the Department of Infectious Diseases at Korea University Guro Hospital said, "Research results indicate that the switch from a standard influenza vaccine to an adjuvanted vaccine is a rational choice not only in terms of medical benefits but also from an economic perspective," and added, "These results suggest that an adjuvanted vaccine like Fluad could be a worthy subject for policy consideration in future discussions for selecting NIP vaccines for the elderly." An individual from the vaccine industry said, "The promotions by Samjin Pharma-CSL Seqirus and Sanofi will likely involve considering various factors beyond simple market share competition, including their products' potential inclusion in the NIP and vaccination patterns." They added, "Since both companies are already emphasizing not only their vaccination efficacy but also their cost-effectiveness through research, We believe they will consider growing the overall market pie."
- Company
- Jemperli nears final hurdle for reimb in endometrial cancer
- by Eo, Yun-Ho Sep 17, 2025 06:11am
- The immunotherapy Jemperli is on the verge of securing expanded reimbursement coverage for endometrial cancer in Korea. According to industry sources, GSK Korea has recently finalized drug price negotiations with the National Health Insurance Service (NHIS) for the PD-1 inhibitor Jemperli (dostarlimab). The only step remaining is review by the Health Insurance Policy Deliberation Committee. Specifically, the indication for reimbursement is extended to the treatment of newly diagnosed recurrent or advanced high microsatellite instability (MSI-H)/mismatch repair-deficient (dMMR) endometrial cancer. Currently, the first-line standard of care for endometrial cancer is platinum-based chemotherapy combining paclitaxel and carboplatin. However, one in four patients relapses or progresses after this therapy. With the number of recurrent/advanced cases increasing but effective options lacking, the 5-year survival rate remains under 20%. Jemperli was first listed for reimbursement in December 2023 as a second-line treatment for recurrent/advanced (FIGO stage IIIB and above) endometrial cancer that had progressed during or after platinum-based chemotherapy. Since then, efforts have been made to add a first-line indication and expand reimbursement. The drug’s efficacy in the first-line setting was confirmed through the Phase III RUBY trial. The RUBY trial enrolled 494 patients with advanced or recurrent endometrial cancer, comparing Jemperli plus platinum-based chemotherapy (carboplatin + paclitaxel) against placebo plus chemotherapy. Designed with more than 3 years of treatment follow-up—given that the average survival under standard platinum therapy is less than 3 years—the primary endpoints were progression-free survival (PFS) and overall survival (OS) per RECIST (Response Evaluation Criteria in Solid Tumors). Results showed that the Jemperli combination reduced the risk of death by 31% versus the control group across the overall advanced/recurrent patient population. Over a median follow-up of 37 months, the median OS in the Jemperli arm was 44.6 months, compared to 28.2 months in the control arm, extending survival by 16.4 months and lowering the risk of death by 31%. Jae Kwan Lee from the Department of Obstetrics & Gynecology at Korea University Guro Hospital, said, “Endometrial cancer carries a high risk of recurrence even after initial treatment, so effective first-line options are crucial. The RUBY trial is recognized as a landmark study that demonstrated the long-term efficacy of immunotherapy in this setting.” He added, “Jemperli in combination with platinum chemotherapy is the only immunotherapy available in Korea to show an OS benefit in endometrial cancer. Importantly, the trial included high-risk groups, such as patients relapsing more than 6 months after chemotherapy and those with carcinosarcoma, yet still demonstrated significant clinical value.”
- Company
- Vivozon "Joint sales of Unafra with Daiichi Sankyo"
- by Kim, Jin-Gu Sep 17, 2025 06:10am
- Vivozon has chosen Daiichi Sankyo Korea as its co-promotion partner for Unafra Inj (opiranserin). The pharmaceutical industry points to two key reasons for this partnership: a synergy in sales and marketing for postoperative patient care, and the potential for Daiichi Sankyo Korea to play a positive role in Unafra's global market entry. Joint sales promotion of Unafra Inj: synergy between product·sales expected in 'postoperative patient care.' On September 16, Vivozon announced that it had signed a co-promotion and sales agreement with Daiichi Sankyo Korea for the distribution, marketing, and sales of Unafra in Korea. Under the terms of the agreement, Vivozon will supply the finished product, and the two companies will share the responsibilities of distribution, sales, and marketing. Vivozon announces signing a co-promotion and sales agreement with Daiichi Sankyo Korea for its Unafra. Unafra received the marketing authorization as the 38th new Korean drug in December of last year. Around the time of the product's approval, Vivozon began searching for a co-promotion partner. For Vivozon, securing a domestic sales partner was crucial. Its existing sales team of about 30 people handled promotion and sales for regional hub hospitals, but this was insufficient for a stable landing of the new drug. To effectively sell Unafra, which is approved for postoperative pain management, a sales team specializing in large hospitals was needed. Consequently, the company focused on securing a partner while also expanding its own sales force. It is reported that several other pharmaceutical and biotech companies showed interest, but Vivozon ultimately chose Astellas Pharma Korea. A Vivozon official stated, "With the Unafra's approval set, we added about 10 sales representatives dedicated to the product. With this partnership, we will now begin full-scale sales of Unafra," and added, "Daiichi Sankyo Korea will be responsible for sales and marketing at general hospitals with over 300 beds, while both companies will jointly handle sales and marketing for hospitals and clinics with fewer than 300 beds." Daiichi Sankyo Korea's product portfolio, which targets postoperative patients, is also considered a background to the partnership. Daiichi Sankyo Korea holds 'Nasea (ramosetron),' a preventive medication for nausea and vomiting, and 'Taleaje (mirogabalin),' a treatment for neuropathic pain. Both products are primarily used for pre- and postoperative patient management, creating a potential synergy with Unafra, which targets postoperative pain management. The global pharma Daiichi Sankyo Korea's support is expected for global expansion From the development stage, Vivozon set its goal on the global market for Unafra. The decision to choose Daiichi Sankyo Korea as a partner is interpreted as a move that extends beyond mere domestic sales and marketing collaboration, with the company also seeking practical and strategic support for its global expansion. Vivozon has established a two-track global entry strategy. For the U.S., Europe, and China, the goal is to enter the market through technology transfer. The company plans to out-license the drug to companies with local clinical and new drug approval experience. In the U.S. market, the largest, a local Phase 3 clinical trial for the injectable formulation is underway, and U.S. Food and Drug Administration (FDA) product approval remains a key hurdle. For Southeast Asia, the Middle East, North Africa, Latin America, and Russia/Eurasia, the company's policy is to secure regional export partners. It is reported that specific discussions are underway with several companies. During this full-scale global expansion, Daiichi Sankyo Korea's expertise in global clinical trials, approvals, and supply chain management can enhance the company's business credibility in negotiations for technology transfer to the U.S. and Europe, local clinical trial design and operation, and large-scale production and supply planning. Daiichi Sankyo Korea also has a global network, regional subsidiaries, and distribution channels, which could be instrumental in connecting with local partners and verifying distribution networks. It is expected that the company's network will play a crucial role in facilitating communication with local pharmaceutical companies and distributors when searching for regional export partners in areas such as Southeast Asia, the Middle East, and Latin America. A Vivozon official stated, "We expect this partnership with Daiichi Sankyo Korea, a global pharmaceutical company, to have a positive impact on Unafra's overseas expansion."
- Company
- Did companies pre-stock inventories in the U.S.?
- by Kim, Jin-Gu Sep 17, 2025 06:10am
- The surge in Korean pharmaceutical exports to the United States—driven by concerns over possible tariffs—returned to normal levels within 2 months. Industry observers suggest that companies may have frontloaded shipments to secure inventories in the U.S. market. While exports have declined, some note that since tariff risks remain unresolved, shipments to the U.S. could spike again at any time. August U.S. exports total USD 95.43 million…79% drop in just 2 months According to Korea Customs Service data released on the 16th, exports of Korean pharmaceuticals to the US in August reached USD 95.43 million (approx. KRW 130 billion). This represents a 4% increase compared to August 2024 (USD 91.75 million). This trend sharply contrasts with the previous 3 months, during which exports surged. Monthly pharmaceutical exports to the US in the past 2 years In May, exports rose 35% year-on-year to USD 184.35 million (KRW 260 billion). In June, exports hit a record USD 458.38 million, nearly equal to the previous 4 months combined. In July, exports more than doubled year-on-year (+120%), reaching USD 136.21 million. However, by August, exports increased only 4% year-on-year, effectively returning to typical levels. Compared with June, exports fell 79%, shrinking to one-fifth in just 2 months. The share of US exports in Korea’s overall pharmaceutical exports also fell—from 49% in June to 15% in August, returning to a level similar to the 2024 annual average of 18%. Did companies sufficiently secure local inventory...levels return to previous years' levels Analysts attribute the decline to companies having already secured sufficient inventories in the U.S. in response to tariff risks. Amid fears of potential US tariffs on pharmaceuticals, Korean companies boosted shipments to build local stockpiles. Once inventories were secured, exports normalized in August. In April, US President Donald Trump announced reciprocal tariffs globally, though pharmaceuticals were initially exempt. On July 30, the US and EU agreed to impose a 15% tariff on pharmaceuticals. However, tariff rates on Korean medicines remain undecided. With risks ongoing, Korean pharmaceutical and biotech firms have taken proactive measures. For example, Celltrion reportedly secured a 2-year supply of inventory in the US and is investing KRW 700 billion to acquire a local biopharmaceutical manufacturing facility. Companies with significant U.S. export shares, including Celltrion, are known to have employed similar strategies. As inventory levels in the U.S. were sufficiently secured during this process, it is suggested that export volumes likely returned to normal levels in August. However, some observers note that since tariff risks have not been fully resolved, pharmaceutical exports to the U.S. could increase again after September. A pharmaceutical industry insider stated, “The large volume exported in June and July may have accumulated as inventory within the U.S. Consequently, the need for additional procurement decreased in August, and export performance may have been adjusted. However, as the tariff risk has not yet been fully resolved, exports of domestic pharmaceuticals to the U.S. could fluctuate again around the time of the U.S. government's official announcement.”
