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- 2025-12-22 13:05:16
- Company
- AbbVie Korea seeks to grow to ₩KRW 300B with biodrugs
- by Whang, byung-woo Mar 31, 2025 05:59am
- AbbVie Korea, which successfully passed on the risk of Humira (adalimumab) with its later products is aiming to make another leap forward with its innovative pipeline. The company is working to improve its capabilities by balancing the 3 key factors - sales growth, R&D, and social contribution. AbbVie Korea was established in 2013 as the Korean affiliate of AbbVie, headquartered in North Chicago, Illinois, USA. Its major business units include ▲the Immunology Business Unit (rheumatoid diseases, psoriasis, atopic dermatitis, inflammatory bowel diseases, etc.), ▲the Specialty Business Unit (hepatitis C, chronic migraine, etc.), and ▲the Oncology Business Unit, each of which has a solid portfolio. AbbVie eliminates the risk of Humira... Skyrizi and Rinvoq shows shared growth AbbVie’s representative product has long been Humira, a blockbuster immune disease treatment. It was a highly symbolic product as it has been the global No. 1 specialty drug in the market for the past 10 years. However, in recent years, Humira has also been AbbVie’s biggest concern as well. With the looming entry of Humira biosimilars upon the expiration of its patent, there were doubts about whether the company would be able to address Humira’s expected sales gap. In fact, when competition with biosimilar products intensified upon the expiry of Humira's North American patent in 2023, there were concerns about the company’s sales recovery, as sales fell by USD 5.4 billion (about KRW 7 trillion) year-on-year. To conclude, the company has eliminated Humira’s sales risk. Although sales of Humira were inevitably reduced, the loss was quickly made up due to the growth of the company’s follow-up drugs, next-generation immune disease treatments ‘Rinvoq’ (Upadacitinib) and ‘Skyrizi’ (Risankizumab). According to the 2024 Global Pharmaceutical Sales Rankings, Skzrizi recorded sales of USD 11.72 billion (KRW17.2237 trillion), a 50.9% increase from the previous year, ranking seventh among all products. This year, Skyrizi’s sales are expected to reach USD 13.72 billion (KRW 20.162.9 trillion) Rinvoq’s sales target is also up to USD 2 billion (about KRW 2.9 trillion) for this year and 2026, the success of these two follow-up drugs is demonstrating AbbVie’s strong foothold in the field of immune diseases. Thanks to the growth of Skyrizi and Rinvoq, AbbVie recorded USD 54.5 billion in sales in 2024, ranking second in the global pharmaceutical industry in terms of sales. The stock price also reflected this expectation of sales, recording a high growth of over 34% as of March 1, 2025, compared to two years ago, March 1, 2023. In response to this, Robert Michael, CEO of AbbVie, said, “We expect net profit to exceed the previous high, in just 2 years after the expiration of the Humira patent in the United States.” Unlike how other pharmaceutical companies usually take 9-11 years to recover sales after the expiration of their blockbuster patents, AbbVie’s sales are expected to recover in just two years, successfully turning the crisis of patent expiration into an opportunity. The company’s new drugs still lack influence in Korea... The cross-administration reimbursement approval for atopic dermatitis drugs expected to be beneficial Even in the domestic market, the sales fluctuations of Humira have decreased, while sales of Rinvoq and Skyrizi grew rapidly. According to the market research institution IQVIA, Humira recorded sales of KRW 104 billion in 2020 and surpassed the KRW 100 billion mark, but saw its sales drop to KRW 91.2 billion in 2021. This is the combined result of the drug price cuts and market competition following the launch of biosimilars in Korea in June 2021. Since then, Humira has recorded sales of KRW 85.8 billion in 2022 and KRW 86.6 billion in 2023 and entered a stable sales period. In this situation, Skyrizi recorded sales of KRW 27.9 billion in 2023, an increase of KRW 11.4 billion from KRW 16.5 billion in 2022, while Rinvoq also recorded sales of KRW 20.7 billion, an increase of KRW 9.2 billion from KRW 1.1 billion in 2022. Although the overall scale of the drugs’ sales is still small compared to Humira's, when considering that the sales of ‘Rinvoq+Skyrizi’ have reached half the level of Humira's, rising from KRW 28 billion in 2022 to KRW 48.6 billion in 2023, there is a good chance that it will overtake Humira's sales within a few years. In particular, there are high expectations on Rinvoq’s growth , as reimbursement for cross-administration between biological drugs and JAK inhibitors is now granted for severe atopic dermatitis in Korea. The reimbursement approval for cross-administration of the drugs is expected to change the monopoly made by the biological drugs that entered the market the earliest. Many predict that Rinvoq will be the biggest beneficiary, and the drug is expected to continue its strong growth. However, the company is concerned that the overall sales growth of AbbVie Korea is not as large as expected. According to the audit report disclosed on the Data Analysis, Retrieval, and Transfer System, DART, AbbVie Korea's posted KRW 234.7 billion in sales in 2023. Its operating profit was KRW 11.5 billion. This is an increase of about KRW 80 billion compared to KRW 154.6 billion in 2022, but this is no major change, considering its absorption merger with Allergan Korea last year. As such, the audit report released in early April is expected to be an indicator of whether the sales of Humira, which entered a stable period in 2024 and the growth of new drugs will be able to create synergies. AbbVie expands its portfolio... Strengthening global competitiveness Nevertheless, the reason why the industry has high expectations for the future of AbbVie is because it is expanding its pipeline along with its strong position in the field of immunology. Following the launch of Venclexta, a treatment for acute myeloid leukemia and chronic lymphocytic leukemia, the company is working to get Epkinly, a treatment for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) it received approval last year, reimbursed in Korea. In addition, Elahere (mirvetuximab soravtansine), for which the company recently announced the results of a global Phase III clinical study, is also attracting attention as the first-in-class drug. Ovarian cancer is mostly detected in the late stages, and platinum-based chemotherapy is considered as its first-line treatment. However, there is no other available treatment option if resistance develops during the first treatment, so Elahere is expected to play an important role in the treatment of platinum-resistant ovarian cancer in the future. In addition, the company has signed a license agreement with the Danish company Gubra to develop a new drug for the treatment of obesity and secured GUB014295, a long-acting amylin analogue, which is regarded as the next generation of obesity treatment. AbbVie Korea Meanwhile, since its foundation, AbbVie Korea has been steadily practicing sharing and volunteer activities for patients with rare and intractable diseases and the underprivileged, striving to fulfill its corporate social responsibility. The company’s representative social contribution program is the “Week of Possibilities,” which has been participated in by employees around the world since its founding in 2013. Specifically, the company has been carrying out various activities, including pop art portraits that brightly depict patients with rare and incurable diseases whose self-esteem has been lowered due to a long period of illness, a mosaic of air-purifying plants (scandia moss) for climate-vulnerable groups, and tree planting to reduce global warming and create healthy forests together. In addition, A-Walk, which was launched in 2016, is a walking campaign by employees to help patients and has been praised for contributing to the improvement of employees' health and strengthening teamwork through innovative ideas. Under the program, when employees achieve their target number of steps, matching donations are made for patients. Last year, the event was expanded to include employees from 8 Asian countries who participated in A+Walk and donated to patient organizations in each country.
- Company
- Handok closer to commercialize new innovative drugs for BTC
- by Nho, Byung Chul Mar 31, 2025 05:59am
- Biliary tract cancer (BTC) is known for being difficult to treat. The five-year survival rate is 29.4%, which is the second lowest of all cancer types. Early diagnosis of BTC is difficult, and treatment for BTC is extremely limiting despite of the high risk. Fortunately, the situation is changing. New treatments are being approved in South Korea and new drugs are being developed actively. For instance, Handok's pharmaceuticals are showing potential for treating BTC. Currently, standardized second-line treatments are not available for BTC when the first-line treatment fails. Due to difficulties in early diagnosis, only 25% of the patients are operable at the diagnosis, and patients show a high recurrence rate of about 60%. The second-line treatment for BTC has been limited to chemotherapy in combination with a first-line treatment, used regardless of the patient's condition. Even if patients undergo second-line treatment, patients have poor prognosis due to low response rates and life expectancy. In 2023, Handok obtained the domestic approval of Pemazyre, which can be used as a second-line treatment for BTC. Pemazyre is indicated for patients with 'locally advanced or metastatic BTC who have FGFR2 gene fusions.' Pemazyre is the first BTC-targeted treatment approved in South Korea. Pemazyre demonstrated significant data based on the Phase 2 FIGHT-202 clinical trial. The primary endpoint, the combination therapy's Overall Response Rate (ORR), was 37%. Although the study involved patients with advanced disease after first-line treatment or above, the drug showed favorable effects. Pemazyre has been used in the U.S., Europe, and Japan. It is expected to be reimbursed this year. Handok has been putting efforts into introducing its new BTC treatment, HDB001A. In 2019, Handok entered into a strategic partnership with ABL Bio, the original developer of HDB001A, and secured domestic commercialization rights for the product. Subsequently, Handok made a US$ 5 million equity investment in the American biotech venture TRIGR Therapeutics, which had obtained global commercialization rights (excluding Korea and China) from ABL Bio in 2018. In 2021, TRIGR Therapeutics was merged into Compass Therapeutics. Handok and Compass Therapeutics are collaborating to develop HDB001A for BTC indication. Handok conducted a Phase 2 clinical trial in South Korea in 2021 involving BTC patients and secured significant data. The efficacy evaluation of this Phase 2 study showed that the ORR for patients receiving a combination of HDB001A and paclitaxel was 37.5% in second- and third-line treatments and a 63.6% ORR in second-line treatment. These results were presented at the 2023 ASCO GI Symposium. A view of Handok Future Complex, an integrated R&D center located in Magok district in Seoul. Building on the significant Phase 2 results of HDB001A (Compass Therapeutics project name: CTX-009) led by Handok, Compass Therapeutics has been conducting the U.S.-based Phase 2/3 trial COMPANION-002 to evaluate HDB001A (CTX-009) as a second-line treatment for BTC. COMPANION-002 is designed to compare the combination therapy of HDB001A (CTX-009) with paclitaxel against paclitaxel monotherapy in 150 patients with metastatic or recurrent BTC, with top-line results expected to be announced later this month. HDB001A (CTX-009) development is progressing rapidly. Handok has swiftly advanced its Phase 2 clinical trial in South Korea through close collaboration with researchers, providing the clinical protocol and data that enabled Compass Therapeutics to secure global Phase 2/3 approval from the FDA quickly. In addition, HDB001A (CTX-009) received Fast Track designation from the FDA in 2024, further accelerating its development. Handok plans to use the results from the COMPANION-002 study as clinical data for domestic approval of HDB001A (CTX-009) and launch it as Handok's proprietary anticancer therapy within two years. Handok also collaborates with global companies such as Jazz Pharmaceuticals and Incyte to introduce anticancer treatments in areas with unmet needs. Currently, it exclusively supplies the domestic market with its therapies for hepatic vein occlusion 'Defitellio,' high-risk acute myeloid leukemia 'Vyxeos,' intrahepatic cholangiocarcinoma 'Pemazyre,' and diffuse large B-cell lymphoma 'Minjuvi.' In addition, Handok is strengthening its internal research capabilities and developing new anticancer agents using its dual-targeting platform and targeted protein degradation platform. In April 2024, the company presented poster data on its new lung cancer therapeutic, 'HDBNJ-2812,' at the American Association for Cancer Research (AACR 2024). In April, another poster presentation on its in-house new drug development is scheduled for AACR 2025. Moreover, in March 2024, Handok launched collaborative research on next-generation innovative new drugs with partners Genexine and ToolGen.
- Policy
- Advanced biodrugs subject to reimb eval before approval
- by Lee, Jeong-Hwan Mar 31, 2025 05:59am
- 'Advanced biopharmaceuticals' will be added to the group of drugs that can receive drug reimbursement evaluations before receiving the government's official marketing authorization. The revision comes into effect from April 1st. On the 28th, the MOHW announced this through a notice of the product groups subject to the approval - insurance drug price evaluation linkage system. The current laws and regulations only allow the linkage between approval and evaluation of insurance drug prices for new drugs and orphan drugs in accordance with the Regulations on Approval and Review of Pharmaceutical Products, the Regulations on Approval and Review of Biological Products, and the Regulations on Approval and Review of Herbal Medicinal Preparations (Raw Drugs). The MOHW has decided to apply the approval-insurance drug price evaluation linkage system to advanced biopharmaceuticals based on the ‘Act on the Safety and Support of Advanced Regenerative Medicine and Advanced Biopharmaceuticals’ starting next month. As a result, companies with advanced biopharmaceuticals can now apply for drug reimbursement evaluations for their respective products before marketing authorization by submitting a copy of the manufacturing (import) item license as the safety and efficacy review report notified by the Ministry of Food and Safety. The approval-insurance drug price evaluation linkage system is one of the fast-track reimbursement systems for medicines implemented by the government to improve patient access to new drugs.
- Company
- Novartis' 'Leqvio' for dyslipidemia lands at Big 5 hospitals
- by Eo, Yun-Ho Mar 31, 2025 05:58am
- Product photo of LeqvioThe new drug Leqvio, a twice-yearly treatment for dyslipidemia, is now available for prescriptions at tertiary general hospitals. According to industry sources, Novartis Korea's siRNA drug Leqvio (inclisiran) passed the drug committees (DC) of the 'Big 5' hospitals, including Samsung Medical Center, Seoul National University Hospital, Asan Medical Center in Seoul, and Sinchon Severance Hospital. Considering that the drug was approved in June last year, prescription settings are relatively established stably. The remaining issue is the drug's reimbursement status. Novartis applied for reimbursement listing immediately after obtaining approval for Leqvio. However, the company has shown a difference in opinion against the government regarding reimbursement criteria during the review process. The main issue under discussion for setting reimbursement criteria is whether the drug's indication to 'reduce cardiovascular events in patients with atherosclerotic cardiovascular disease (ASCVD)' would be approved. The competing product 'Repatha (evolocumab)' has already been reimbursed, so the government may not see expediting Leqvio's reimbursement as an urgent agenda. Repatha is currently approved in 41 countries, and Leqvio in 39 countries. Notably, Leqvio can be administered by healthcare professionals in hospitals twice a year. This reduces the number of required injections and ensures professional administration instead of self-injection. In fact, among patients (including those with atherosclerotic cardiovascular disease, ASCVD) who have received Leqvio for up to 6.8 years, 78.4% have reached their target LDL-C levels. A U.S. real-world study found that ASCVD patients with high drug adherence (fully adherent) experienced a 27% lower risk of major adverse cardiovascular events (MACE) compared to those with lower adherence. Moreover, the high-adherence group incurred lower annual healthcare costs than the low-adherence group, indicating that the dosing convenience provided by Leqvio not only reduces the risk of recurrent cardiovascular events but also alleviates the economic burden on ASCVD patients. If the reimbursement criteria for Leqvio in ASCVD are not set, official approval would eventually have to await the results of a cardiovascular outcome trial (CVOT), a process that could take several years. For instance, the market for statin-ezetimibe combination products alone is estimated at around KRW 1 trillion, and when combined with the funding allocated for statins and PCSK9 inhibitors, the total expenditure on LDL-C lowering could range from KRW 1.5 trillion to 2 trillion. Yet, only 24% of ASCVD patients in Korea are currently achieving their LDL-C targets. Professor Suh Jon of the Department of Cardiology at Soonchunhyang University Bucheon Hospital said, "For high-risk patients, drug adherence in lipid-lowering therapy is crucial. In reality, adherence to current treatment options is low, with only about 3 out of 10 patients reaching their LDL-C targets. It clearly shows an unmet need for a new treatment option in lipid-lowering therapy."
- Company
- Ono Pharma Korea appoints Kan Sato as new CEO
- by Eo, Yun-Ho Mar 31, 2025 05:58am
- Ono Pharma Korea has appointed a new leader. According to the related industry, Ono Pharma Korea recently appointed Sato Kano as its new CEO following the resignation of former CEO, Ho-jin Choi. Choi, who led the company for four and a half years since his appointment in October 2020, has stepped down. Choi joined Ono Pharmaceutical in 2014 as the head of sales and marketing and contributed to the launch and reimbursement of the PD-1 inhibitor immuno-oncology drug 'Opdivo' in Korea. He previously worked at J&J Korea, AstraZeneca Korea, and Allergan Korea, and completed an MBA at Thunderbird School of Global Management in the United States. Kan Sato, the newly appointed head of the Korean subsidiary, is a graduate of the Glovis University Graduate School of Management in Japan. He has previously worked as a manager in the International Business Department of Ono Pharmaceutical's Taiwan subsidiary and as a manager of the International Business Department at the company's headquarters, and has now taken on the role of leading the Korean subsidiary. With the appointment, Ono Pharmaceutical Korea has transitioned to a Japanese head system for the first time in about 6 years since the appointment of Min-yeol Yang as CEO in July 2019.
- Policy
- "Will maintain stability of essential·short supply drugs"
- by Lee, Jeong-Hwan Mar 28, 2025 06:39am
- The government will reportedly provide necessary administrative support for a stable supply of essential drugs and medications and improve the system so that innovative new drugs and new medical devices can quickly introduced into medical practices. Preferential pricing for national essential drugs that use domestically sourced raw materials will be implemented in the first half of this year. In contrast, the government will continuously increase the prices of drugs that are in supply instability. For innovative new drugs, specific innovation criteria will be applied during cost-effectiveness evaluations, and the policy of offering preferential pricing for drugs developed by companies with a high proportion of R&D investment will be maintained. Additionally, detailed timelines have been established for initiatives aimed at ensuring fair compensation for essential medical services and for innovating non-reimbursable and private insurance to safeguard the sustainability of the National Health Insurance budget. On May 27, the Ministry of Health and Welfare (MOHW) convened the 6th Health Insurance Policy Review Committee for 2025. It reviewed and approved this year’s implementation plan under the '2nd National Health Insurance Comprehensive Plan (2024–2028).' Maintaining stability of essential drugs·providing preferential pricing of innovative new drugs The government will continue to ensure a stable supply of essential medicines and therapeutic materials while improving the regulatory system to enable the rapid market entry of innovative new drugs and medical devices. To secure supply stability, the government will implement preferential pricing to nationally essential drugs that use domestically sourced raw materials, and drugs with supply instability will have their prices promptly increased continuously. In addition, a system for monitoring, analyzing, and addressing shortages of therapeutic materials will be established. Establishment of monitoring·analyzing materials of supply instability and response measures For innovative new drugs, cost-effectiveness evaluations will incorporate specific innovation criteria (revised on August 2024). Drugs developed by pharmaceutical companies with a high R&D investment ratio will receive preferential pricing. Innovative medical devices that have undergone an extended deferment period and rigorous clinical evaluation and have subsequently received MFDS approval will be allowed immediate market entry. The government will also expand the access to and use of National Health Insurance data for public interest research, scientific studies, and self-directed health management while supporting international cooperation through organizations such as the WHO and OECD in matters related to health insurance systems and initiatives. Enhancing the Supply of Essential Medical Care·Ensuring Fair Compensation To eliminate low-reimbursement structures and address overall imbalances in health insurance fees, more than 1,000 fee items for surgeries, procedures, and anesthesia will receive targeted increases by the first half of this year. In particular, fees in high-difficulty areas and resource-intensive, such as pediatric and emergency services, will be significantly raised, with rapid adjustments planned for over 2,000 low-reimbursement items by 2027. Furthermore, the cost survey framework will be strengthened by establishing a fee-determination system linked to conversion indices and relative value scores, developing standardized cost-calculation guidelines, and expanding the panel hospital network. Reimbursement for high-difficulty medical procedures, such as additional age-based fees for pediatric surgery, will be reinforced, and public policy fee support for maintaining maternity care infrastructure will continue. The performance of pilot projects for alternative payment systems, which offer differential reimbursement based on the quality and outcomes of care rather than volume, will be evaluated, with ongoing efforts to sustain their implementation. Closing medical care access gaps and ensuring a healthy life To provide uninterrupted healthcare, long-term care, and support services across each region's acute, recovery, and chronic phases, the government will strengthen local medical institutions and expand integrated healthcare and care support. To establish a regionally comprehensive essential healthcare system, the government will provide support to key regional hospitals—such as national university hospitals and general hospitals—through funding for faculty salaries (KRW 26 billion) and for facilities and equipment (KRW 81.5 billion), as well as low-interest loans of KRW 120 billion for any additional necessary resources. These measures aim to enhance institutional capacity, expand the infrastructure for recovery-phase healthcare institutions, and reinforce long-term care support systems (including nursing and caregiving services) in preparation for an aging society. Efforts to promote routine health management to prevent complex and chronic diseases will be strengthened, with additional support provided in high-demand areas such as mental health, women's and pediatric care, and end-of-life care. Moreover, ongoing measures will continue to strengthen the healthcare safety net to address underserved areas. The government will strengthen the healthcare safety net to close access gaps. This includes the ongoing promotion of pilot projects for primary care for individuals with disabilities and in dental care, as well as the expansion of reimbursement for treatments targeting severe and rare diseases (with 20 new items expected to be added and the reimbursement scope broadened for 10 additional items), all designed to enhance access to healthcare for vulnerable populations and alleviate their financial burdens. Enhancing the financial sustainability of National Health Insurance The National Health Insurance system will be fostered sustainably by managing medical supply by ensuring adequate hospital beds, installing·operating high-quality medical equipment, and encouraging appropriate healthcare utilization through demand management. Non-reimbursable services and indemnity insurance management will also be strengthened to promote appropriate healthcare usage. For non-reimbursable services prone to overuse, measures such as applying managed reimbursement and requiring pre-service explanations and informed consent will be enforced. Reimbursement for non-reimbursable services related to cosmetic or plastic surgery will be limited, especially if provided alongside reimbursable services. Furthermore, to rationalize the co-payment coverage under private insurance and prevent distortions in the healthcare system, non-reimbursable services will be appropriately covered. At the same time, review processes are strengthened and transparency is enhanced. Moreover, financial management transparency will be boosted by expanding the disclosure of financial indicators, such as fund operation status (March) and financial settlement status (May), publishing annual five-year financial forecasts, and enhancing the accuracy of short-term forecasts, all aimed at improving the overall management framework. The MOHW stated, "Through the '2nd National Health Insurance Comprehensive Plan (2024–2028), we plan to reach a goal for strengthening essential medical care and establishing sustainable National Health Insurance," adding, "We will also integrate these initiatives with the '2nd Healthcare Reform Implementation Plan' and other reform projects and effectively implement."
- Opinion
- [Reporter's View]Unifying the price of pneumococcal vaccines
- by Eo, Yun-Ho Mar 28, 2025 06:38am
- The National Immunization Program (NIP) is the ideal “goal” for vaccine-holding pharmaceutical companies. This is because the government's policy of purchasing vaccines and providing them free of charge to the public, above all, ensures stable sales. Therefore, when the government announces that it has selected a preventive vaccine for a specific disease for NIP, companies with relevant vaccines begin to compete fiercely. Companies deploy various strategies to increase market share within the set market as well as to be selected for NIP. The National Immunization Program (NIP) of pneumococcal vaccines has recently been in the spotlight. The new addition of 'Prevnar 20' from Pfizer Korea, the original leader in the market, has stirred the battle between multinational pharmaceutical companies' premium vaccines. Pfizer’s pneumococcal vaccine pipeline, which ranges from Prevnar and Prevnar 13, has virtually dominated Korea’s market. In this market, a new 15-valent vaccine, MSD's Vaxneuvance, joined as a new player and driven change, so Pfizer is aiming for the throne again with its new 20-valent vaccine. At the core of the claim of the “superiority” of these new vaccines is serotype coverage. If 13 serotypes are covered, it is called a 13-valent vaccine; if it covers 15 it is a 15-valent, and 20 a 20-valent vaccine. The general perception is that a vaccine that covers more serotypes has a relatively higher level of preventive power. However, a higher serotype coverage does not necessarily mean better preventive power. However, the fact that a product “covers more serotypes” to prevent the same disease resonates with the consumers. In the NIP market, the vaccine with the highest price has always been the winner. However, there has been an interesting change in the stance of pharmaceutical companies entering the NIP with their pneumococcal vaccines. The companies have decided to supply their newly developed products at the same price as their existing vaccines. This is called price unification. The reason why the change is interesting is this: When Prevnar 13 was introduced to the NIP, Pfizer insisted on differentiating it from its strong competitor, GSK Korea's 10-valent vaccine ‘Synflorix,' and demanded a dual pricing system, which was implemented. The same goes for MSD. This company also requested a different price from GSK's 'Gardasil' and ‘Cervarix,' which are quadrivalent vaccines, when they entered the NIP for HPV vaccines. This is called the dualization of prices. The dualization of prices means the government's discrimination in the purchase price of NIP vaccines. If the prices of the 2 vaccines granted by the government are different even though they are free vaccines, the majority will choose to take the higher-priced option. The result was clear. However, for some reason, neither MSD, when it entered the market with its 15-valent vaccine, at a time when the 13-valent vaccine was the best, nor Pfizer, when it launched its 20-valent vaccine, demanded a price differentiation for their more serotype coverage. Both pharmaceutical companies chose to standardize their prices. Even though they have pride in their follow-up products. This is a reflection of the correct market logic. The situation in the pneumococcal vaccine market is different from the time when there was a price dualization. Rather than taking the time to raise the price of both the 15-valent and 20-valent vaccines, the companies decided to enter the market as quickly as possible. It is only natural for a company to pursue profit. The strategy may vary depending on the strategic decision to attract sales by competing with competing products. Before, the strategy was ‘dualization of price,' but now it is 'unification.' However, the message of 'for the health of the people' does not seem to be the reasoning behind the companies’ choice of unifying the price.
- Company
- Lotte Biologics’ CMO business makes smooth progress
- by Chon, Seung-Hyun Mar 28, 2025 06:38am
- Lotte Biologics has been making smooth progress, building a new plant since its launch. Three years after its launch, it has received a total of KRW 800 billion from its parent company and is speeding up the construction of its Songdo plant. The US plant, which was acquired 3 years ago, also generated more than KRW 200 billion in sales every year. On the 27th, according to the Financial Supervisory Service, Lotte Biologics decided on the 26th to issue KRW 210 billion in paid-in capital to its shareholders. The new shares will be issued to Lotte Biologics shareholders in the form of 3,231,000 shares. The new shares to be issued will account for 35.8% of the total number of shares issued before the capital increase, which is 9,017,500 shares. The issue price of new shares is KRW 65,000 per share. Lotte Biologics, which was launched in June 2022, is owned by Lotte Corporation and Lotte Holdings, which have 80% and 20% stakes, respectively. Lotte Corporation and Lotte Holdings are estimated to have invested KRW168 billion and KRW 42 billion, respectively, in this paid-in capital increase. Lotte Corporation said, “We will invest KRW 168 billion to maintain control over Lotte Biologics and enhance its business competitiveness.” Lotte Biologics Lotte Corporation entered the biopharmaceutical industry in May 2022 by acquiring the BMS plant in eastern New York for USD 160 million (about KRW 200 billion). The BMS plant is a production facility dedicated to biopharmaceuticals, with an annual production capacity of 35,000 liters. Lotte also signed a USD 220 million Contract Manufacturing Organization (CMO) contract with BMS for biopharmaceutical production. In June 2022, Lotte Holdings officially entered the biopharmaceutical business by launching Lotte Biologics. Lotte Biologics will use the funds it has raised this time to build a factory in the Songdo Bio Campus. Lotte Biologics signed a memorandum of understanding (MOU) with the Incheon Metropolitan City and the Incheon Free Economic Zone in June 2023 to build a mega plant in Songdo, Incheon. Lotte Biologics plans to build 3 mega plants with a total capacity of 360,000 liters by 2030. Lotte Biologics began construction of Plant 1 in the Bio Campus in Songdo, Incheon, in March last year, and aims to obtain GMP approval by the second half of 2026 and start operations in 2027. This is the fourth paid-in capital increase made since Lotte Biologics' launch. Lotte Biologics conducted a paid-in capital increase through allocation to shareholders of KRW 210.6 billion in December 2022. In March 2023, it raised KRW 212.5 billion through a paid-in capital increase. Lotte Biologics also decided to conduct a paid-in capital increase of KRW 150.1 billion in June last year. When this capital increase is completed, Lotte Biologics will have raised a total of KRW 783.2 billion from its parent company through 4 paid-in capital increases since its launch. Lotte Biologics was launched with a capital of KRW 13 billion and has received a total of KRW 796.2 billion in investment from its parent company. The company has been generating steady profits from the BMS plant it acquired at the time of its launch. Lotte Biologics inherited the existing CDMO contract when it acquired the BMS plant. The drugs that BMS was producing will continue to be produced for the next three years after Lotte acquired the plant. It is reported that the BMS's immuno-oncology drugs 'Opdivo' and 'Yervoy', the kidney transplant immunosuppressant ‘Nulojix,’ and the multiple myeloma treatment ‘Empliciti’ were produced at the Syracuse plant. Lotte Biologics has set a goal of achieving sales of KRW 1.5 trillion by 2030. Lotte Biologics recorded sales of KRW 234.4 billion and an operating loss of KRW 66.3 billion last year. Lotte Biologics generated its first sales of KRW 228.6 billion in 2023. The cumulative sales of Lotte Biologics since its launch have been tallied at KRW 463 billion. Lotte Biologics announced its CDMO business vision at the JP Morgan Healthcare Conference in January. CEO James Park presented the successful CDMO transformation of the Syracuse Bio Campus in New York and the blueprint for the Songdo Bio Campus. He expressed an ambition to accelerate Lotte Biologics’ leap into the global CDMO market, unveiling its innovative proprietary ADC platform SoluFlex Link, and announcing plans to provide an ADC one-stop service in collaboration with finished drug product partners in North America. SoluFlex Link is an ADC platform that uses a unique linker technology jointly developed by Lotte Biologics and Kanaph Therapeutics, a drug fusion technology bioventure. The company believes SoluFlex Link improves instability, which is a major drawback of antibody-drug conjugates (ADCs) and can be used with various antibodies and payloads. “New ADC drug developers can conduct various research and development with this technology,” said Lotte Biologics. “We believe that can offer an optimized solution for the development and production of next-generation ADCs because it can increase production yield and treatment efficiency.”
- Company
- Shaperon discusses licensing out Nugel technology to Europe
- by Lee, Seok-Jun Mar 28, 2025 06:38am
- On the 27th, Shaperon announced that it has recently entered into discussions with global pharmaceutical companies about licensing out its next-generation atopic dermatitis treatment, NuGel, at Bio Europe Spring 2025, which was held in Europe. The company emphasized that it is accelerating the process of securing the company’s fiscal soundness by generating revenue through the commercialization of its technology, especially since it has made considerable progress during discussions with some large pharmaceutical companies. Shaperon held partnering meetings with a total of 27 companies, including large global pharmaceutical companies and global leaders in the field of dermatology at Bio Europe. Discussions were made around Nugel, the company's core pipeline. The large European pharmaceutical companies that had first meetings at this event also showed interest in Nugel and Shaperon’s major pipelines, including its preclinical alopecia areata treatment and treatment for idiopathic pulmonary fibrosis. Through this conference, Shaperon received requests from a number of global pharmaceutical companies that it had previously been in contact with and received on-site inspection requests on Nugel’s technical data, moving past the confidentiality agreement stage. The company explained that its interest in Nugel has increased considerably since the results of Part 1 of the Phase IIb clinical trial, which was recently completed in the United States, were positively received by many pharmaceutical companies. Europe is a key market that accounts for about 28% of the global atopic dermatitis treatment market. Many of the companies leading the development of atopic dermatitis treatments are based in Europe. “As several companies have expressed interest and are actively discussing the matter, we expect to see tangible commercialization results in the near future,” said a Shapreon official. “We plan to further accelerate the commercialization of Nugel through follow-up discussions with the pharmaceutical companies that are currently in talks.” Nugel is a treatment for atopic dermatitis that targets the ‘GPCR19 receptor’. It is characterized by its superior efficacy and safety compared to existing treatments through the inflammatory complex modulating mechanism of action that encompasses innate and adaptive immunity. Shapreon has begun recruiting patients for Part 2 of the Phase IIb trial in the United States, which is currently being conducted on 177 atopic dermatitis patients and is expected to receive the final report on Phase IIb in the first half of next year.
- Policy
- "Regulatory hurdle eliminated to simply refund-type RSA"
- by Lee, Jeong-Hwan Mar 28, 2025 06:37am
- The government saw eliminating regulatory hurdle as a success in exempting the efficacy·cost-effectiveness evaluation procedure during the 'third-contract termination evaluation' for pharmaceuticals on the basic refund-type RSA for over 10 years. Even drugs that have been subject to fines or other administrative sanctions can still have their prices increased through negotiations with the National Health Insurance Service (NHIS) if supply shortages disrupt patient care. For example, if a pharmaceutical company that produces plasma fractionation products can prove production cost increases based on additional research into pricing models for raw plasma and related inputs, the government covers not only past losses but also future cost escalations, a policy to raise prices accordingly. This measure is regarded as a notable case of eliminating regulatory hurdle. On March 25, the government convened the 6th Bio-Health Innovation Commission at the ARPA-H Promotion Team conference room on the 16th floor of City Tower in Jung-gu, Seoul, chaired by Director Kim Young-tae, Vice Chairman from the private sector and Director of Seoul National University Hospital, to discuss improvements to so-called "killer regulations." The Ministry of Health and Welfare (MOHW) suggested several regulatory improvement initiatives, including enhancements to the repeated re-evaluation process for risk-sharing agreements, revisions to the evaluation criteria for drug price caps, and establishment of a cost-calculation methodology for plasma fractionation products. Under revised guidelines, drugs subject to a basic refund-type RSA contract that has been used for more than 10 years can exempted from the utility and cost-effectiveness assessment during the 'third-contract termination evaluation.' The MOHW believes these changes will help resolve issues such as the devaluation of new drugs due to repeated re-evaluation under risk-sharing agreements and the consequent delays in the domestic introduction of new therapies. As of January of this year, the MOHW improved the evaluation criteria so that even drugs facing administrative sanctions, such as fines, can be considered for ceiling price adjustments to enhance patient treatment access and ensure pharmaceutical access. In cases where drug supply shortages may disrupt patient care, it has become possible to negotiate with the NHIS to raise drug prices. Furthermore, the government implemented the regulatory revision to improve plasma fractionation products' stable supply and cost-effectiveness. After a decision by the Health Insurance Policy Deliberation Committee, a change has been made to the price ceiling for plasma fractionation products that are already listed. If a manufacturer can substantiate, based on additional research into pricing models for raw plasma and similar inputs, that cost-increasing factors exist, then prices may be raised not only to cover past losses but also to account for future cost escalations. The MOHW has also relaxed the criteria for accepting efficacy evidence in high-risk advanced regenerative medicine clinical trials. In order to alleviate the burden associated with such high-risk studies of advanced regenerative medicine, the 'Guidelines for Reviewing and Preparing Advanced Regenerative Medicine Clinical Trial Plans' have been revised to establish exception criteria for safety and efficacy evidence. Through these measures, institutions conducting regenerative medicine trials will be able to choose appropriate testing methods that can adequately demonstrate safety and efficacy, even if there are variations in administration routes or methods, provided that additional supporting data justifying changes in clinical design are submitted in line with the specific characteristics of each study. Monitoring implementation of Bio-Health Training Strategies An assessment of the progress of 81 bio-health training projects, managed by nine ministries in 2024, revealed that a total of 44,800 bio-health professionals have been trained. This figure far exceeds the target of 22,100 reported to the 2nd Bio-Health Innovation Commission last year. The government analyzed that this substantial increase is due to growing interest in the bio-health sector, which has led to the establishment of new courses, increased demand for education, and an expansion of educational institutions. In detail, in one of the four major areas of bio-health human resource development, such as "industry-based school education," enhanced practical training and strengthened industry-academia linkages have produced approximately 16,400 professionals. In addition, around 20,000 individuals have been trained in the area of production and regulatory science, including workforce development (through institutions like K-NIBRT), regulatory science, and continuing education for current employees. Furthermore, to support the NEXT semiconductor leap through core research human resource development, via initiatives in AI-driven drug development, specialized graduate schools, and programs for physician-scientists, about 8,000 professionals have been trained, and projects aimed at stimulating local employment and linking job creation with start-up support have also been successfully advanced. This year, in line with the plans of the various ministries, 10 of the original 81 projects that have either been completed or will not be pursued this year will be excluded, while 7 new projects will be initiated. In total, 26,900 professionals are planned to be trained across 78 projects. Additionally, the government will focus on expanding interdisciplinary education, practical talent development programs, and initiatives for training professionals in new technology sectors within school curriculum. Furthermore, the Bio-Health Innovation Commission has reviewed research findings reflecting input from industry and academic experts on the persistent mismatch between the supply and demand of bio-health professionals, and is now discussing future strategies based on these insights. The research identified the primary factors contributing to the human resource mismatch as a lack of industry input in university curriculum, a skewed focus in human resource development that leaves a gap in understanding specialized fields such as new technologies, and a shortage of expert personnel (professors and instructors). In response, the Commission agreed on the importance of cultivating professionals tailored to corporate needs, training professionals to meet future demands in new technologies, and training globally competitive expert instructors. Going forward, the government plans to publish a '2025 Bio-Health Talent Development Business Guide' in May to boost awareness and participation among job seekers, schools, and educational institutions regarding these talent development initiatives. Going forward, the government plans to publish a '2025 Bio-Health Talent Development Business Guide' in May to boost awareness and participation among job seekers, schools, and educational institutions regarding these talent development initiatives. Director Kim stated, "At today’s meeting, we were able to discuss topics on a government-wide support plan to maximize industry capabilities by reviewing the implementation status of bio-health human resource development projects and improvements in regulatory issues," adding, "We will continue to monitor these issues regularly at the level of the Bio-Health Innovation Commission and strive to ensure that today’s discussions are reflected in government policies, aimed to achieve clear outcomes."
