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- 2026-05-15 10:33:06
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- 3분기만에 1천억 '거뜬'...잘 나가는 K-신약 캐시카우
- by Chon, Seung-Hyun
- [데일리팜=천승현 기자] 국내 개발 의약품이 외래 처방시장 상위권에서 맹활약을 이어갔다. 한미약품의 복합신약 로수젯과 HK이노엔의 케이캡이 3분기만에 처방액 1000억원을 훌쩍 넘어섰다. 대웅바이오의 뇌기능개선제 글리아타민도 선전했다.19일 의약품 조사기관 유비스트에 따르면 비아트리스의 고지혈증치료제 리피토가 올해 3분기 누계 가장 많은 1468억원의 외래 처방금액을 기록했다. 작년 같은 기간보다 2.6% 감소했지만 선두 자리를 견고하게 지켰다. 리피토는 지난 1999년 국내 발매됐다. 국내 출시된 지 20년이 넘었고 100여개 제네릭과 다양한 조합의 복합제가 집중적으로리피토를 견제하고 있지만 여전히 처방 의약품 시장에서 강력한 영향력을 나타냈다. 특허만료 이후 제네릭의 집중 견제에도 처방 의약품 시장에서 강력한 영향력을 과시했다. 다만 최근 성장세는 주춤한 모습이다. 리피토는 지난 2018년부터 지난해까지 5년 연속 외래 처방금액 선두를 기록했다. 국내기업 한미약품과 HK이노엔이 자체 개발한 로수젯과 케이캡이 3분기만에 1000억원 이상을 올리며 선두권에서 고공행진을 이어갔다.로수젯은 지난 9월까지 누적 처방액이 전년보다 19.5% 증가한 1309억원을 기록하며 전체 2위에 이름을 올렸다. 2015년 말 출시된 로수젯은 로수바스타틴과 에제티미브 2개 성분으로 구성된 고지혈증 복합제다.로수젯은 시장 선점 효과와 스타틴·에제티미브 복합제 인기몰이로 가파른 성장세를 거듭하고 있다. 스타틴·에제티미브 복합제는 저밀도 지단백 콜레스테롤(LDL-C)을 낮추는 데 탁월한 효과를 보이는 데다 2개의 약을 따로 복용하는 것보다 약값 부담이 크지 않다는 이유로 선호도가 높아지는 추세다.로수젯은 지난 2020년 처음으로 처방액 1000억원을 넘어섰고 4년 연속 1000억원 돌파를 가볍게 확정지었다.로수젯의 분기별 처방액을 보면 2018년 3분기 처방액 112억원에서 올해 3분기 455억원으로 5년 새 4배 가량 뛰었다. 로수젯은 발매 이후 매 분기 신기록을 경신하며 꾸준한 상승세를 지속했다. 지난 2019년 3분기 처방액 200억원 넘어섰고 2021년 3분기와 지난해 4분기에 각각 300억원과 400억원을 돌파했다. 로수젯의 3분기 처방액 455억원은 선두 리피토와의 격차가 27억원에 불과했다. 케이캡은 3분기 누계 처방실적이 1141억원으로 전년보다 18.7% 성장했다. 케이캡의 지난 3분기 처방액은 400억원으로 전년동기대비 20.6% 뛰었다. 2020년 3분기 213억원에서 3년동안 88.1% 상승하며 성장세가 꺾이지 않고 있다. 지난 2018년 국내개발 신약 30호로 허가받은 케이캡은 '칼륨 경쟁적 위산분비억제제(P-CAB)’ 계열의 항궤양제다. 위벽 세포에서 산분비 최종 단계에 위치하는 양성자펌프와 칼륨이온을 경쟁적으로 결합시켜 위산 분비를 저해하는 작용기전을 나타낸다.케이캡은 기존 프로톤펌프억제제(PPI) 계열 제품보다 약효가 빠르게 나타나고, 식사 전후 상관 없이 복용이 가능한 점 등 장점을 앞세워 높은 성장세를 지속하고 있다. 케이캡은 출시 3년째인 2021년 처방액 1000억원을 돌파했고 지난해까지 2년 연속 1000억원을 넘어섰다. 올해는 일찌감치 처방액 '1000억원 클럽'에 이름을 올렸다.케이캡은 미란성과 비미란성 위식도역류질환에 이어 위궤양, 소화성 궤양·만성 위축성 위염 환자에서 헬리코박터파일로리 제균을 위한 항생제 병용요법, 미란성 위식도역류질환 치료 후 유지요법 등 5개 적응증을 순차적으로 확보했다. 당초 위식도역류질환에 이어 위궤양에 건강보험 급여가 적용됐고 최근 나머지 적응증도 모두 건강보험이 적용되면서 성장세가 더욱 높아진 것으로 분석된다.국내 개발 의약품 중 대웅바이오의 뇌기능개선제 글리아타민이 지난달까지 전년동기보다 23.5% 증가한 1150억원의 처방액을 올리며 전체 3위에 이름을 올렸다. 글리아타민은 효능 논란에 이은 급여축소, 환수협상 명령 등 고비를 겪고 있는데도 처방 시장에서는 오히려 영향력을 확대했다. 콜린알포세레이트 성분의 종근당글리아틴도 3월 누계 처방액이 전년보다 12.2% 증가한 827원으로 고공행진을 이어갔다.한국오가논의 고지혈증복합제 아토젯은 3분기 누계 처방액이 749억원으로 11.9% 증가하며 상위권에 포진했다. 아토젯은 아토르바스타틴과 에제티미브를 결합한 복합제다. 2021년부터 국내기업 100여곳이 아토르바스타틴·에제티미브 시장에 동시다발로 진입했지만 아토젯 시장은 더욱 견고한 상승세를 나타냈다. 아토젯은 종근당이 판매하고 있다.
- Company
- MSA left unmanaged despite being a rare neurological disorder
- by Son, Hyung Min
- Concerns are being raised that multiple system atrophy (MSA), a fatal neurodegenerative disease characterized by faster progression and a heavier disability burden than Parkinson’s disease, still remains outside an independent rare disease management framework in Korea.Unlike major overseas countries that operate separate registration and support systems, Korea still lacks even an accurate understanding of the patient population due to mixed disease coding and limited support measures.At the recent “Denmark-Korea Roundtable on MSA Care” held at the Embassy of Denmark in Korea, domestic and international experts discussed the clinical characteristics of MSA, diagnostic limitations, gaps in long-term care, and the need for rare disease designation. Experts on movement disorders from both Korea and Denmark attended the event to share their management systems.“Denmark-Korea Roundtable on MSA Care” event hosted by the Danish Embassy in Korea.Mikael Hemniti Winther, Ambassador of Denmark to Korea, said in his welcoming remarks, “Patients with rare and intractable neurological diseases require not only access to treatment but also long-term care and social support systems. “I look forward to Denmark and Korea sharing clinical experiences and policy models to further develop patient-focused care systems.”MSA is a progressive neurodegenerative disease in which multiple parts of the nervous system, including the basal ganglia, cerebellum, and brainstem, atrophy simultaneously. While it begins with symptoms similar to Parkinson’s disease, such as stiffness and slowed movement, as the disease progresses, autonomic nervous system abnormalities rapidly develop, including orthostatic hypotension, urinary dysfunction, sleep disorders, and respiratory difficulties.As a result, the disease shows limited response to levodopa-based therapies commonly used for Parkinson’s disease, while symptom progression is significantly faster. According to existing data, the average survival period for MSA patients is known to be approximately 6 to 10 years after symptom onset, and it is not uncommon for patients to require walking aids or wheelchairs within a few years of diagnosis.Professor Do-Young Kwon of the Department of Neurology at Korea University Ansan Hospital said, “Although MSA is rare enough to be classified as a rare disease, its clinical and social impact is extremely severe. MSA patients suffer not only from Parkinsonian symptoms but also cerebellar ataxia, autonomic dysfunction, and sleep disorders, and many progress to severe disability within a few years.”Currently, Korean healthcare big data estimates the number of MSA patients at fewer than 3,000 as of 2024. However, in actual clinical practice, many cases are reportedly registered and managed under the Parkinson’s disease code (G20). Academia views this code overlap as one of the major reasons why the true patient population and disease burden are not properly reflected.There are also significant differences in MSA management compared with other countries. The United States operates incentives for MSA drug development under the Orphan Drug Act, while Japan has established patient registration and medical expense support systems through its designated intractable disease framework. Europe likewise operates national-level management systems based on rare disease coding and research networks.In contrast, Korea does not manage MSA within a separate rare disease framework, leading to insufficient support systems tailored to the disease’s characteristics, including long-term rehabilitation, palliative care, and sleep and respiratory management.Rapid progression and complex symptoms…limits of treating MSA the same as Parkinson’s diseaseProfessor Sooyeon Yoo, Seoul Medical Center, Department of NeurologyProfessor Sooyeon Yoo of the Department of Neurology at Seoul Medical Center emphasized that diagnosing MSA itself is not easy.Professor Yoo explained, “MSA often presents symptoms very similar to Parkinson’s disease in the early stages. In some patients, characteristic autonomic nervous system abnormalities or imaging changes only appear after specific symptoms have progressed, so delayed diagnosis is common.”In clinical practice, it reportedly takes an average of 3-4 years to reach an accurate diagnosis. The problem is that during this period, patients may remain in a treatment gap without appropriate rehabilitation or long-term care planning.Professor Yoo said, “MSA patients experience severe declines in quality of life due to sudden fainting, falls, urinary dysfunction, and impaired temperature regulation. It places a significant psychological and financial burden not only on patients but also on their caregivers.”She added, “Since there is currently no fundamental treatment capable of slowing disease progression, it is important to establish support systems that integrate rehabilitation, respiratory care, sleep management, and palliative care over the long term. We need a structure within the public healthcare system that ensures patients receive continuous care.”Professor Jinyoung Youn of the Department of Neurology at Samsung Medical Center also pointed out the limitations of the current system, which manages MSA at the same level as Parkinson’s disease.Professor Jinyoung Youn, Department of Neurology, Samsung Medical Center“Many Parkinson’s disease patients are able to maintain daily life for long periods through medication management, MSA involves a much more rapid decline in physical function. There are currently no medications available to improve cerebellar symptoms.”He further explained that because MSA presents with a complex combination of symptoms, a single-department approach has clear limitations. In fact, some medications may alleviate Parkinson’s symptoms but exacerbate others, such as orthostatic hypotension or constipation.Professor Youn said, “It is common for drugs used to control one symptom to aggravate another. A multidisciplinary approach involving not only neurology but also urology, pulmonology, rehabilitation medicine, and sleep medicine is essential.”In particular, he pointed out that a significant portion of the rehabilitation, sleep therapy, respiratory support, and long-term care services required by MSA patients are still not adequately covered under the current system.Professor Youn noted, “MSA patients often develop the disease at relatively younger ages and tend to preserve cognitive function comparatively well. As a result, many do not fit well within existing long-term care facilities or dementia-centered caregiving systems.”The Danish case stood in contrast to Korea’s current reality.Professor Anne-Mette Hejl of Bispebjerg-Frederiksberg Hospital in Denmark stated, “In Denmark, neurologists, specialized nurses, physical and occupational therapists, and neuropsychology experts collaboratively manage MSA patients. Depending on the patient’s condition, services are linked to telemedicine, home care, and hospice care.”“Denmark-Korea Roundtable on MSA Care” event hosted by the Danish Embassy in Korea.In practice, Denmark operates a system that reduces caregiving burdens for patients and families through follow-up observations every 3 months, extended consultations, and connections to home-based services. When hospital visits become difficult, patients are transitioned to telemedicine and community-based care systems.To date, there are no treatments available that can fundamentally slow or halt the progression of MSA itself. Consequently, experts generally agree that the importance of early diagnosis, rehabilitation, respiratory and sleep management, and long-term care systems is becoming increasingly prominent.Meanwhile, global pharmaceutical companies continue to develop therapies aimed at suppressing MSA progression. Lundbeck’s “Amlenetug” has entered global phase 3 clinical trials, while Teva’s “Emrusolmin,” BioArctic’s “Exidavnemab,” and Alterity Therapeutics’ “ATH434” are also in clinical development stages.Experts believe that if disease-modifying therapies become available in the future, the importance of early diagnosis and national patient registration systems will grow even further.
- Company
- Curocell begins commercialization process for Korea's first CAR-T
- by Cha, Ji-Hyun
- Curocell is pursuing market entry following the approval of South Korea's first domestically developed chimeric antigen receptor T-cell (CAR-T) therapy. Based on its domestic R&D and manufacturing infrastructure, the company aims to improve patient access to the CAR-T treatment landscape that has previously relied mostly on overseas facilities. Furthermore, the company plans to strengthen its next-generation pipeline through a strategy of expanding indications.On May 14, Curocell held a press conference at the Four Seasons Hotel in Seoul to commemorate the approval of its CAR-T therapy, 'Rimqarto Inj' (ingredient name: anbalcabtagene autoleucel). The company unveiled Rimqarto's clinical value, domestic commercialization strategy, and directions for subsequent clinical development. The event was attended by Curocell CEO Gunsoo Kim, Professor Won Seog Kim of Hemato-oncology at Samsung Medical Center, Curocell Executive Director Seungwon Lee, and Su-hee Cho, Head of Curocell’s Clinical Development Center.Rimqarto is an autologous CD19-targeting CAR-T therapy that uses a patient's own T cells. The process involves collecting T-cells from the patient's blood, introducing genes that allow them to recognize cancer cells, proliferating them ex vivo, and reintroducing them into the patient. It has been designed with Curocell's proprietary OVIS platform, designed to maximize therapeutic effects by simultaneously suppressing the expression of PD-1 and TIGIT, immune checkpoint receptors that inhibit the anticancer activity of T cells.Previously, on April 29, the Ministry of Food and Drug Safety (MFDS) granted marketing authorization for Rimqarto as a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) after two or more lines of systemic therapy. With this, Rimqarto has been listed as the 42nd novel drug developed in Korea and the first CAR-T therapy developed by a Korean company.Curocell CEO Gunsoo KimCEO Kim shared in his opening remark that "The approval of Rimqarto is more than just one new drug entering the market. Curocell has step-by-step built a foundation that allows the entire process(from R&D to clinical trials, production, quality control, and licensing) to be performed domestically."CEO Kim emphasized that Rimqarto is a treatment option that can expand patient access in the CAR-T treatment landscape, which has been highly dependent on overseas supply. "For patients with relapsed or refractory DLBCL, treatment options are limited and disease progression can be rapid, making timely treatment critical," and added, "While existing CAR-T therapies faced barriers before reaching Korean patients in clinical settings, we will do our best to improve treatment accessibility and establish a stable supply base through Rimqarto."Professor Won Seog Kim, the first presenter, explained the unmet needs in DLBCL treatment and the clinical value of Rimqarto. According to Professor Kim, approximately 6,000-6,500 cases of malignant lymphoma occur annually in Korea, with DLBCL being the representative disease, accounting for 40% of cases. However, 35–40% of DLBCL patients experience recurrence after standard treatment, and patients reaching the third-line treatment stage number around 700 annually in Korea, carrying a poor prognosis.CAR-T therapies are considered an option that has changed the treatment paradigm in this relapsed/refractory DLBCL field. Professor Kim said, "In a patient group where the possibility of long-term survival was previously around 10%, data showed that CAR-T treatment could offer another treatment opportunity. For this reason, we could proceed quickly to obtain reimbursement, and added, "However, even with current commercial CAR-T therapies, the expectation for a complete cure remains at about 40%, leaving room for further improvement."Professor Kim presented Curocell's proprietary OVIS technology as Rimqarto’s distinguishment. One reason existing CAR-T therapies fail is that T-cells become exhausted or immune checkpoint mechanisms such as PD-1 or TIGIT become active, preventing the sufficient elimination of cancer cells."Curocell’s OVIS technology works by loading small RNA fragments into the CAR-T to suppress the expression of immune checkpoints like PD-1 and TIGIT," Professor Kim explained, "Rimqarto is a differentiated, next-generation CAR-T product in that it can overcome treatment failure caused byover-expression of immune checkpoints."On May 14, Curocell held a press conference to commemorate the approval of its CAR-T therapy, 'Rimqarto Inj' Clinical data also confirms Rimqarto’s competitiveness. In Phase 2 trial, Rimqarto demonstrated an objective response rate (ORR) of 75% and a complete response (CR) rate of 67% based on independent review committee evaluations. Regarding safety, the incidence of Grade 3 or higher cytokine release syndrome (CRS) was 9%, and neurotoxicity was 4%. Professor Kim said, "The response rate of over 75% and a CR rate of 67% as evaluated by the committee are highly encouraging results. It showed data that is manageable not only in terms of efficacy but also safety."Starting with this approval, Curocell plans to accelerate the commercialization of Rimqarto. Related to the core pillars of the commercialization strategy, Executive Director Lee Seung-won presented ▲rapid insurance reimbursement listing ▲expanding patient accessibility. "As CAR-T therapies are perceived as high-priced treatments, the speed of reimbursement listing is directly linked to patient access," Lee explained, " Rimqarto was selected for the parallel 'Approval-Evaluation-Negotiation' pilot project, listed on a track that can shorten the time from approval to reimbursement by approximately 90 days." Curocell is currently responding to supplementary data requests for the drug reimbursement evaluation and designing price-negotiation scenarios to support a reimbursed launch as early as September.The company will also pursue its domestic production base to build a supply chain and expand patient access. Lee stated, "Existing global CAR-T therapies involve a structure where a Korean patient’s cells are sent to an overseas manufacturing site and then brought back, which takes weeks and carries international transport risks. Rimqarto can achieve a fast 'vein-to-vein' time based on its domestic production facility." Curocell plans to establish a system within the year allowing Rimqarto treatment at 30 hospitals nationwide and will manage the entire process (from ordering to collection, manufacturing, delivery, and administration) through its online tracking platform, 'CuroLink.'On May 14, Curocell held a press conference to commemorate the approval of its CAR-T therapy, 'Rimqarto Inj' The company is also strengthening its next-generation pipeline by expanding Rimqarto's indications. As a follow-up development strategy, Curocell is considering expanding indications to adult acute lymphoblastic leukemia (ALL), systemic lupus erythematosus (SLE), and second-line treatment for DLBCL. Director Cho Su-hee explained, "There are currently no clear treatment options after standard therapy for patients over the age of 25, who make up the majority of adult ALL patients," and added, "Curocell has been preparing to expand the indication to adult ALL since 2022 and is currently in the final stages of Phase 1." The company plans to enter Phase 2 shortly and is also pursuing an expansion of clinical trials in Japan to strengthen global capabilities.The company is also pursuing expansion into autoimmune diseases and earlier lines of treatment. Director Cho stated, "To provide a better life for patients with lupus nephritis, we have started Korea's first autoimmune disease CAR-T clinical trial. Based on the experience of administering Rimqarto to lupus nephritis patients through "approval for use for therapeutic purposes," we expect encouraging results," and added, "Since Rimqarto showed a high response rate compared to other agents in third-line DLBCL, moving it up to second-line treatment would help even more patients."
- Company
- Rinvoq surpasses ₩100B in quarterly prescriptions
- by Kim, Jin-Gu
- Product photo of Rinvoq Extended-release tabletAbbVie’s Janus kinase (JAK) inhibitor autoimmune disease treatment, ‘Rinvoq (upadacitinib),’ has strengthened its leading position by surpassing KRW 10 billion in quarterly prescriptions. Competing products such as ‘Olumiant (baricitinib),’ ‘Xeljanz (tofacitinib),’ and ‘Cibinqo (abrocitinib)’ showed sluggish performance.The JAK inhibitor market is expected to face even fiercer competition. This is due to the addition of new products such as Pfizer’s ‘Litfulo (ritlecitinib)’ and LEO Pharma’s ‘Anzupgo Cream (delgocitinib),’ as well as the launch of generics following the expiration of Xeljanz’s substance patent late last year.Rinvoq strengthens monopoly in JAK inhibitor market through expanded indicationsAccording to the pharmaceutical market research firm UBIST, on the 13th, Rinvoq's outpatient prescription volume in the first quarter was KRW 10.4 billion. This is a 32% increase compared to the KRW 7.8 billion recorded in the first quarter of last year. This marks the first time Rinvoq’s quarterly prescription performance has exceeded KRW 10 billion.Rinvoq received domestic approval in June 2020. Among JAK inhibitors, it was released third following Xeljanz and Olumiant, but it rapidly expanded its influence. Since the fourth quarter of 2023, Rinvoq has risen to the top of the market. Since then, it has been strengthening its monopoly by widening the gap with competing products.In contrast, Rinvoq’s major competitors appear sluggish. Olumiant, the second-ranked product in the market, recorded KRW 4.5 billion in first-quarter prescriptions, a slight decrease compared to KRW 4.6 billion in the first quarter of last year.During the same period, Xeljanz decreased by 21% from KRW 3.5 billion to KRW 2.8 billion KRW. This was influenced by a price reduction following the listing of generics for reimbursement in November last year. The prices of two dosages of Xeljanz tablets were cut by 30%, while the price of Xeljanz XR extended-release tablets was reduced by 23%. ‘Cibinqo,’ which Pfizer launched as a successor to Xeljanz, decreased from KRW 1.6 billion to KRW 1.5 billion.Jyseleca, which entered the market as the fifth JAK inhibitor, is significantly improving its prescribing performance. In the first quarter of this year, it recorded KRW 1.8 billion in prescriptions, a 2.6-fold increase compared to the same period last year.Prescription volume changes for major JAK inhibitors (unit: KRW 100 million, source: UBIST). GREEN-Rinvoq, PINK-Olumiant, BLUE- Xeljanz, LIGHT GREEN- Jyseleca, PURPLE- CibinqoThe aggressive strategy of expanding indications is cited as the background for Rinvoq’s strengthened dominance. Currently, Rinvoq holds six indications ▲rheumatoid arthritis ▲psoriatic arthritis ▲axial spondyloarthritis (ankylosing spondylitis) ▲atopic dermatitis (adults and adolescents) ▲ulcerative colitis ▲Crohn’s disease. It has secured the most indications among JAK inhibitors.In addition, AbbVie recently succeeded in global Phase 3 clinical trials for alopecia areata, signaling the addition of a seventh indication. Besides alopecia areata, AbbVie is also pursuing expansions into subsequent immune disease indications such as vitiligo, hidradenitis suppurativa, systemic lupus erythematosus, and Takayasu arteritis.Its competitor, Xeljanz, has five indications ▲rheumatoid arthritis ▲psoriatic arthritis ▲ankylosing spondylitis ▲ulcerative colitis ▲polyarticular juvenile idiopathic arthritis ▲juvenile psoriatic arthritis. Olumiant holds four indications ▲rheumatoid arthritis ▲atopic dermatitis (adults and children) ▲alopecia areata (adults) ▲juvenile idiopathic arthritis. Cibinqo has only atopic dermatitis (adults and adolescents) as an indication, while Jyseleca has indications for rheumatoid arthritis and ulcerative colitis.Emergence of 6th and 7th JAK inhibitors and Xeljanz generics late last yearFiercer competition in this market is expected in the future with the addition of the sixth and seventh new JAK inhibitor drugs and Xeljanz generics.Recently, ‘Litfulo’ was launched as the sixth JAK inhibitor. This product received domestic approval in September 2024 and was released as a non-reimbursed drug in February of last year. Its indication is alopecia areata in adults and adolescents aged 12 and older. Pfizer now possesses three JAK inhibitors: Xeljanz, Cibinqo, and Litfulo.In September last year, LEO Pharma received approval for ‘Anzupgo Cream,’ the first topical JAK inhibitor in Korea, for the treatment of chronic hand eczema. LEO Pharma officially launched this product in March of this year. It is currently non-reimbursed.In November last year, a large number of generics containing the ingredient tofacitinib entered the market due to the expiration of the Xeljanz patent.A total of 59 companies have received approval for Xeljanz generics, and products from 14 companies, including Daewoong Pharmaceutical, Il-Yang Pharmaceutical, and Chong Kun Dang, are currently listed on the reimbursement list. However, the prescription volume remains still.
- Company
- GC Biopharma signs biopharma manufacturing MOU with Merck
- by Choi Da Eun
- GC Biopharma is joining hands with global science and technology company Merck Life Science to strengthen its competitiveness in biopharmaceutical manufacturing. Through the partnership, the companies aim to secure stable supplies of key raw and subsidiary materials while improving manufacturing process efficiency to strengthen global market responsiveness.GC Biopharma announced on the 14th that it signed a strategic memorandum of understanding (MOU) with Merck Life Science for cooperation in biopharmaceutical development and GMP manufacturing processes.The signing ceremony was held at Merck Korea headquarters in Gangnam, Seoul. Major officials from both companies attended, including Young-im Kim, head of Merck Life Science Process Solutions Business, and Woong Shin, head of Quality Management at GC Biopharma.Through this agreement, GC Biopharma plans to strengthen cooperation on the supply of major raw and subsidiary materials needed for biopharmaceutical production and establish a collaborative framework to improve manufacturing efficiency and supply stability.In particular, GC Biopharma expects to secure a stable production base for major global products, such as its plasma-derived therapy Alyglo and the Hunter syndrome treatment Hunterase, both launched in the U.S. market, and respond more flexibly to changes in global demand.Merck plans to provide a collaborative framework covering the entire production process, from raw material procurement to process technology support. In particular, the companies aim to proactively manage supply chain risks that may arise during the manufacturing process by stably supplying product batches that meet strict internal quality control standards.The two companies also plan to operate a regular technical and process consultation body to strengthen technical cooperation for manufacturing process efficiency. Through this, they intend to share the latest production technologies and process know-how to enhance quality competitiveness, while continuously seeking joint R&D opportunities to expand their cooperative relationship.Woong Shin, Head of Quality Management at GC Biopharma, stated, “Through close technical cooperation and process optimization, we will work to minimize risks across the entire manufacturing process and build a production system with global-level quality competitiveness.”Young-im Kim, head of Merck Life Science Process Solutions Business, said, “Through this collaboration, we will work to support an optimal manufacturing environment so that GC Biopharma’s key therapeutic products can be supplied stably.”
