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- 2025-12-19 14:19:16
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- Biotech firms with net loss overestimate their performance
- by Cha, Jihyun Nov 12, 2025 06:19am
- While Korean biotech and healthcare companies are using the Technology Exception Listing system to challenge the Initial Public Offering (IPO) market, there have been concerns over their valuation methods. Critics argue that some companies are excessively inflating their valuations by presenting overly optimistic estimates of future performance or by selecting comparables that are significantly larger and established at the public offering price. All 2024 listed biotech companies are in deficit, but the futue estimated earnings used for IPO price show tens of billions in surplus According to the Financial Supervisory Service (FSS) on the 12th, a total of 10 biotech and healthcare companies have been listed through the Technology Exception Listing system this year. Starting with Orum Therapeutics in February, OrganoidSciences, ROKIT Healthcare, ImmuneOncia, and IntoCell were listed in May. GC Genome debuted on the stock market in June, followed by Neurofit and Protina in July. G2GBIO and Graphy entered the KOSDAQ market in August. Other companies are also pursuing listings through the Technology Exception Listing system, with Curiosis, AimedBio, Rznomics, QuadMedicine, and LivsMed having submitted IPO registration statements to the Financial Services Commission. The Technology Exception Listing system is a regulatory measure designed to lower the listing barrier for companies with technology and growth potential but that lack profitability. It is considered the primary IPO channel for biotech companies that invest massive amounts in new drug development without clear revenue streams. Most companies listed via the Technology Exception Listing system use the Relative Valuation Method to calculate their public offering price. The prevalent method involves applying the Price-to-Earnings Ratio (PER) of comparable listed companies in the same industry to the listing applicant's estimated future earnings. The PER, calculated by dividing the stock price by earnings per share, is an index that comprehensively reflects a company's profitability, risk, and market valuation from its operating activities. Thus, future growth potential, rather than current earnings, becomes the core criterion for the public offering price. However, the problem is that the public offering price is often calculated higher than its actual value due to questionable practices in estimating future earnings and selecting comparable companies. An analysis of the registration statements of 15 biotech and healthcare companies that listed or are pursuing listing via the Technology Exception Listing system this year showed that not a single company was profitable in 2024. All 15 surveyed companies were in a net loss position. Despite this, most of these companies projected they could achieve a net profit of KRW 10-90 billion within 2-3 years. They claim significant results can be achieved through early technology exports from underdeveloped pipelines, product approvals, and product sales. "2025 Biotech and healthcare companies that were listed using the Technology Exception Listing system. Their estimated profit and the actual net profit when listed"; COLUMN1 (COMPANIES): Orum Therapeutics, OrganoidSciences, ROKIT Healthcare, ImmuneOncia, IntoCell, GC Genome, Neurofit, Protina, G2GBIO, Graphy, Curiosis, AimedBio, Rznomics, QuadMedicine, and LivsMed; COLUMN2 (2024 NET PROFIT in KRW 100M); COLUMN3 (FUTURE ESTIMATED NET PROFIT). (source: Financial Supervisory Service) AimedBio reported the highest future estimated net profit, projecting KRW 87.1 billion by 2029. This is an aggressive target, considering AimedBio recorded a consolidated net loss of KRW 3.3 billion last year. LivsMed, which recorded a consolidated net loss of KRW 13.9 billion last year, projected an estimated net profit of KRW 71 billion by 2027. Rznomics, which recorded a separate net loss of KRW 18.9 billion last year, projected net profits of KRW 35.3 billion in 2027, KRW 2.9 billion in 2028, and KRW 67.2 billion in 2029. G2GBIO showed the largest gap between current earnings and future estimates. G2GBIO reported a separate net loss of KRW 83.3 billion last year, yet the company projected a net profit of KRW 40 billion by 2029. ImmuneOncia projected KRW 51.7 billion by 2028; Neurophit projected KRW 9.1 billion in 2027 and KRW 28.9 billion in 2028; and IntoCell projected KRW 24 billion in net profit by 2027, all of which were used as bases for calculating their public offering prices. Orum Therapeutics was the only surveyed company that reflected actual earnings, not future estimates, in its public offering price calculation. The company calculated its corporate value using net profit based on its Last Twelve Months (LTM) ending Q3 2024 (which combined performance from Q4 2023 to Q3 2024). This allowed the company to set its public offering price based on actual earned revenue, primarily driven by technology fees from a large-scale technology export agreement with a global big pharma, rather than on mere projections. However, whether the proceeds from technology exports are one-time or sustainable still needs to be assessed. Although not included in the public offering price calculation, Orum Therapeutics projected it could achieve KRW 75.2 billion in sales and KRW 34.7 billion in net profit in 2026. This calculation is based on the premise of securing additional technology export agreements alongside the inflow of milestones from existing contracts. Comparison to big pharma, multi-trillion-won global firms included...overvaluation has been pointed out Analysis suggests that not only are the future earnings projections presented by the listing companies overly optimistic, but the selection of comparable companies also lacks justification. A review of the similar companies selected by the 15 surveyed firms shows a high proportion of major pharmaceutical companies like Hanmi Pharmaceutical, Chong Kun Dang, and Daewoong Pharmaceutical. Unlike the pre-listing companies, which are not generating profit, these comparables boast annual revenues exceeding KRW 1 trillion. A significant number of firms also presented overseas companies as comparables. GC Genome, the genomics analysis affiliate of Green Cross Group, selected four comparable companies, including the domestic firm Boditech Med, along with Revvity, Hologic, and Diasorin. Except for KOSDAQ-listed Boditech Med, the other three companies in GC Genome's peer group are overseas-listed global diagnostic firms with annual revenues in the trillions of KRW. Protina also included Danaher and Revvity in its peer group, and Graphy selected all overseas firms as comparables, including Align Technology, Straumann Holding AG, and Modern Dental Group. Curiosis and LivsMed also included a large number of major global companies with net profits in the trillions of KRW in their comparable groups. Comparables and PER discount rate of biotech and healthcare companies listed in 2025 using the Technology Exception Listing system. COLUMN1 (COMPANIES): Orum Therapeutics, OrganoidSciences, ROKIT Healthcare, ImmuneOncia, IntoCell, GC Genome, Neurofit, Protina, G2GBIO, Graphy, Curiosis, AimedBio, Rznomics, QuadMedicine, and LivsMed; COLUMN4 (per-share valuation calculation). (source: Financial Supervisory Service) The inclusion of conglomerate companies in the comparable groups also led to higher PERs in the per-share valuation calculation. LivsMed's calculated PER, based on the market value of its peer group, was 45.5 times, the highest applicable PER among the 15 surveyed companies. This was followed by Rznomics (29.6 times), Graphy (29.0 times), G2GBIO (28.1 times), and QuadMedicine (27.5 times). Emerging-technology companies cannot set the public offering price on their own. The estimated earnings and comparable companies are determined through consultation between the company and the listing underwriter, based on a comprehensive consideration of the listing applicant's technology and market outlook. Furthermore, the final public offering price is confirmed only after a second step involving institutional investor demand forecasting, followed by applying a discount rate to the estimated earnings to determine the desired public offering price range. However, the market assessment is that the public offering prices for biotech and healthcare companies are being set at an excessively unrealistic level. Indeed, the majority of emerging-technology biotech companies fail to achieve the earnings estimates presented in the public offering price calculation. Experts commonly point out that biotech companies, which lack visible earnings such as sales or profits, are more likely to overestimate their public offering price than conventional companies.
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- Celltrion completes review for acquiring Lilly pharma plant
- by Choi, Da-eun Nov 12, 2025 06:19am
- Celltrion announced on the 11th that it has completed the merger review process under the Premerger Notification Office (PNO) of the U.S. Federal Trade Commission (FTC) for its acquisition of Eli Lilly's manufacturing facility in Branchburg, New Jersey, USA. This is the final regulatory step, following the merger approval from the Irish government on October 31st (local time). With this approval, all necessary regulatory reviews for the factory acquisition have been finalized. The merger review process evaluates whether an acquisition restricts competition. Celltrion was subject to review in the U.S. under the Hart-Scott-Rodino Act (HSR Act) as well as in Ireland due to meeting certain revenue thresholds. With the completion of this procedure, Celltrion plans to finalize the 'Deal Closing' within the year as scheduled. Immediately upon completion of the deal, Celltrion will commence the Post-Merger Integration (PMI) process to achieve rapid organizational unification without disruption to operations. The company will also implement customized programs to support local employees. This acquisition secures three major strategic advantages for Celltrion: △resolving tariff risks through establishing a U.S. production hub △mitigating geopolitical uncertainties △expanding its U.S. Contract Manufacturing Organization (CMO) business. Notably, by centering its operations at the Branchburg facility, Celltrion expects to meet the growing CMO demand in the U.S. and generate revenue immediately upon acquisition through its existing CMO contract with Eli Lilly. The Branchburg plant is a large campus spanning approximately 45,000 pyeong. Celltrion plans to invest an additional KRW 700 billion or more in the 11,000 pyeong of idle land within the facility, expanding its production capacity to 1.5 times the size of its Plant 2 in Songdo, Incheon. Celltrion employee stated, "Celltrion has completed all necessary regulatory processes to acquire the U.S. facility, securing a stepping stone for challenging the global market," and added, "We plan to put efforts into company growth and enhance shareholder value by strengthening the competitiveness of global pharmaceutical production."
- Company
- HanAll, ‘US Immunovant’s HL161 development is on track'
- by Kim, Jin-Gu Nov 12, 2025 06:18am
- HanAll Biopharma’s US partner Immunovant announced the clinical progress of its autoimmune disease treatment candidate ‘HL161’ in a financial report released on November 10 (local time). HL161 is an autoimmune disease treatment candidate developed by Hanall Biopharma. It licensed out the technology to Roivant Sciences, the parent company of Immunovant, which is currently developing HL161 in two distinct pipelines: batoclimab (Immunovant code name IMVT-1401) and imeroprubart (Immunovant code name IMVT-1402). The next-generation FcRn inhibitor imeroprubart is being clinically developed across six autoimmune indications — Graves' disease (GD), difficult-to-treat rheumatoid arthritis (D2T RA), myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), Sjögren's syndrome (SjD), and cutaneous lupus erythematosus (CLE) — with all studies progressing as planned. In 2026, it plans to sequentially release early data from the pivotal rheumatoid arthritis trial and topline results from the Proof-of-Concept (PoC) trial for cutaneous lupus erythematosus (CLE). In 2027, it will release topline results from the pivotal trials for refractory rheumatoid arthritis, Graves' disease, and myasthenia gravis. Immunovant is conducting 2 Phase III trials of batoclimab for thyroid eye disease (TED). The company stated that the first trial is expected to be completed as scheduled within December this year. However, it plans to announce the combined data from both trials in the first half of next year, rather than releasing the first trial results at year-end. The second trial is expected to be completed before the first half of next year. HanAll Biopharma plans to announce topline results as each clinical dataset becomes available, following close discussions with Immunovant. Seungwon Jeong, CEO of HanAll Biopharma, stated, “We will transparently share the results of our clinical programs through collaboration with our partners. Based on the thyroid eye disease data, we plan to continue preparations for the commercialization of batoclimab in Japan.”
- Company
- Eun Jin Bae appointed Director of Sanofi’s Global MA team
- by Eo, Yun-Ho Nov 11, 2025 06:09am
- Eun Jin Bae, Sanofi Korea Eun-jin Bae (44), MCO Head of Market Access at Sanofi Korea, has been promoted to the global headquarters Market Access team. According to industry sources, Bae, who previously served as MCO Head of Market Access for Korea and the Australia/New Zealand cluster, was officially appointed Director of Sanofi’s Global Market Access team as of October. This appointment is drawing attention as it was achieved through individual initiative rather than Sanofi Group's internal promotion process. Bae is a seasoned marketing access expert with 17 years of experience since beginning her pharmaceutical career in 2010 at Roche Korea. Since 2021, she has led Sanofi Korea’s Market Access division, spearheading reimbursement listings for various products, including the atopic dermatitis treatment Dupixent. Bae earned her Bachelor of Pharmacy from Kyung Hee University and a Master’s degree in Pharmacoeconomics/Public Policy from Sookmyung Women’s University’s Graduate School of Clinical Pharmacy.
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- Imfinzi nears reimb for biliary tract cancer in Korea
- by Son, Hyung Min Nov 11, 2025 06:09am
- Immunotherapy Imfinzi Inj The immunotherapy drug Imfinzi has cleared the Drug Reimbursement Evaluation Committee review and has taken one step closer to expanding reimbursement for biliary tract cancer. Beyond biliary tract cancer, Imfinzi has also shown efficacy in hepatocellular carcinoma and gastric cancer, signaling its potential across the spectrum of gastrointestinal cancers. According to industry sources on the 11th, the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee recently approved the reimbursement appropriateness of AstraZeneca's ‘Imfinzi (durvalumab)’. The specific indication is as a first-line treatment for patients with advanced or metastatic biliary tract cancer, in combination with gemcitabine and cisplatin. Imfinzi is an immuno-oncology drug that targets PD-L1. It has been approved for multiple cancer types, including non-small cell lung cancer, small cell lung cancer, hepatocellular carcinoma, endometrial cancer, and bladder cancer, in addition to bile duct cancer. However, except for non-small cell lung cancer, it is currently not reimbursed in Korea, limiting patient access. The DREC approval is significant as it raises potential for expanding access in the treatment of gastrointestinal cancers, where treatment gaps have persisted. First reimbursable new drug for biliary tract cancer to be introduced in a decade Immunotherapy Imfinzi InjBiliary tract cancer has long been one of the most challenging areas in oncology drug development. Although the patient population is smaller than that of other cancers, early detection is difficult, and the disease is characterized by rapid invasion and frequent recurrence, yielding a 5-year relative survival rate of only 28.9% (2017–2021) in Korea. The mortality rate stands at 11.6%. Another reason for the low survival rate is the limited treatment options available. For locally advanced or metastatic biliary tract cancer where surgery is not feasible, and after failure of first-line therapy, there is a shortage of treatment options available as second-line therapies. In this context, in 2022, Imfinzi was approved as a first-line therapy in combination with chemotherapy, demonstrating the potential for improving long-term survival in biliary tract cancer patients. Imfinzi demonstrated an improved 3-year long-term survival rate compared to the control group in clinical trials, with particularly pronounced effects observed in the Korean patient cohort. Notably, no new drugs for biliary tract cancer have been reimbursed in Korea over the past decade. The Imfinzi combination therapy also offers the advantage of higher overall survival (OS) rates in Korean patients. According to the study results at the time, the 2-year survival rate for the Korean patient group receiving the Imfinzi combination therapy was 38.5%, more than double the 14.1% survival rate in the group receiving chemotherapy alone. Furthermore, the 36-month survival rate was 21.0% for the Imfinzi combination group, more than double the 8.8% in the chemotherapy group. Expanding to hepatocellular carcinoma and gastric cancer... ‘Immunotherapy combination’ competition intensifies During the same reimbursement review, Imfinzi also demonstrated potential as a first-line therapy for hepatocellular carcinoma in combination with Imjudo (tremelimumab), a CTLA-4–targeting immuno-oncology drug. The Imfinzi–Imjudo immunotherapy regimen has already entered the Korean market. Imfinzi, a PD-L1-targeted immune checkpoint inhibitor, was launched domestically in May as a liver cancer treatment in combination with the CTLA-4-targeted Imjudo. The Phase III HIMALAYA study demonstrated the efficacy of the Imfinzi and Imjudo combination. The trial compared the efficacy and safety of the Imfinzi + Imjudo combination versus Bayer's Nexavar in 1,171 patients aged 18 years or older with previously untreated, unresectable HCC. The study showed that Imfinzi + Imjudo reduced the risk of death by 22% compared to Nexavar alone. Median overall survival was 16.4 months versus 13.8 months, respectively. The Imfinzi–Imjudo combination is expected to face stiff competition from Roche’s Tecentriq-Avastin combination regimen. Imfinzi is considered to carry a lower bleeding risk. In contrast, Roche's already approved combination of the immuno-oncology drug Tecentriq and the targeted therapy Avastin is known to cause bleeding issues at a relatively high frequency due to Avastin. Liver cancer patients often have impaired liver function, increasing their bleeding risk. However, as the Imfinzi combination therapy carries a lower bleeding risk, it offers the advantage of enabling immediate endoscopic treatment. The expansion of Imfinzi's indications for gastrointestinal cancers is extending beyond bile duct and liver cancers to include gastric cancer. The final analysis of the Phase III MATTERHORN trial that was presented at the recent European Society for Medical Oncology (ESMO) Annual Congress 2025 in Berlin, Germany, confirmed that Imfinzi neoadjuvant and adjuvant therapy statistically significantly improved overall survival (OS). This study is considered the first instance of an immunotherapy demonstrating a survival benefit as neoadjuvant and adjuvant therapy for gastric cancer. The study enrolled patients with resectable locally advanced gastric cancer (stages II–IVA) and gastroesophageal junction cancer, and patients received Imfinzi plus FLOT combination therapy pre-surgery, followed by maintenance Imfinzi post-surgery. The Imfinzi combination group reduced the risk of death by 22% compared to the control group, with consistent survival benefits observed regardless of PD-L1 expression levels. Event-free survival (EFS) was also improved, reducing the risk of disease progression or recurrence by 29%. The pathological complete response (pCR) rate was also more than double in the Imfinzi group (19%) compared to the control group (7%).
- Company
- UCB "Korea is a key country globally…patient access"
- by Hwang, byoung woo Nov 11, 2025 06:08am
- The regulatory strategy of global pharmaceutical companies is changing to enhance access to new drugs in the treatment landscape for rare and intractable diseases. The trend is a 'regulatory science approach' that goes beyond simply meeting approval requirements. It now involves incorporating patient-reported treatment experience and quality-of-life (QoL) measures into regulatory and evaluation processes from the early stages of development. In line with the current trend, UCB is restructuring its global regulatory strategies, focusing on a patient-centric approach across clinical design, evaluation variables, and regulatory cooperation. DailyPharm met with Susanne Dorn, Senior Vice President and Head of Global Regulatory Affairs at UCB, to discuss the shift toward patient-centric regulatory strategies and the direction of collaboration in the Korean market. Changes in regulatory strategy, strengthening patient-centric access Susanne Dorn, Head of Global Regulatory Affairs at UCBSusanne Dorn evaluated that the regulatory function within pharmaceutical companies is shifting from merely meeting requirements to a scientific discussion focused on delivering value to patients. She said, "In rare and intractable diseases, it is difficult to secure sufficient evidence using conventional clinical trial designs alone," and explained. "Therefore, an approach that sets the actual difficulties and burdens experienced by patients and their families during the treatment process as variables in the clinical design stage is becoming critical." According to Dorn, UCB is incorporating everyday patient experiences, such as the degree of functional recovery, the burden of taking medicine, and the long-term sustainability of treatment, into its clinical trial endpoints. She said, "UCB sets investment priorities and establishes strategies to simultaneously meet regulatory requirements and deliver tangible value to patients during the drug development process," and emphasized, "The patient's story is not just a reference, but it is the motivation and starting point for why we must continue developing this therapy." Dorn also noted the expansion of the regulatory environment toward Regulatory Science, shifting from an approval-procedure focus to one centered on scientific evaluation. "Given the increasing complexity of diseases, it's crucial to set appropriate endpoints and find the optimal pathway from the product development stage," she stressed. "In areas where the total population is small, such as rare diseases or pediatrics, an efficient evaluation design that maintains scientific evidence is necessary." It means that the importance of developing faster, more efficient evaluation methods while maintaining scientific integrity through collaboration with regulatory authorities aligns with the discussion of utilizing Real-World Data (RWD). Dorn added, "Regulatory agencies in various countries are actively considering new evaluation methods like expedited approval, and UCB is collaborating closely with them." "Korean approval success provides crucial global insights" UCB's regulatory perspective is drawing attention because the company has recently achieved success in new drug approvals in Korea. Starting with the psoriasis treatment Bimzelx (approved August 2024, reimbursed June 2025), the company has continued its success with the systemic myasthenia gravis treatments Zilbrysq (approved November 2024) and Rystiggo (approved April 2025). Regarding these successes, Dorn said, "Korea is a vital country in the global market, and we are extremely proud of the achievements made in the short span of the last one or two years. We see the effort to resolve unmet needs through a patient-centric approach in neurology and immunology as highly exemplary." UCB is pursuing collaborations that leverage the environments and strengths of each country in line with its global strategy. The recent experience in Korea is considered crucial for the execution of the global strategy. "Based on these experiences, we are deliberating on how to implement successful cases from the U.S. and Europe even more effectively in the Korean market," she emphasized. "This visit to Asia is also intended to broadly understand institutional differences between countries and further strengthen global collaboration." UCB is also currently preparing for the domestic approval of its Dravet syndrome treatment candidate. The drug has been selected as a target for the MFDS's Concurrent Approval-Evaluation-Negotiation Pilot Program, which is noteworthy. Dorn stressed, "Dravet syndrome is a severe intractable disease that impacts the entire daily life of not only the children affected but also their caregivers and siblings. The treatment goal is not just to reduce seizure frequency and manage comorbidities but also to restore the family's quality of life." She said, "Access to innovative treatments is not only a matter of drug price or budget discussions; it is a matter of the time remaining for patients," and added, "UCB will collaborate with Korea's institutional efforts and do its utmost to create an environment where innovative treatments genuinely change the lives of patients and their families." Dorn concluded by stating that the global headquarters and the Korean branch will work closely together to expand patient access to patient-centric, innovative treatments continuously. "Our goal is to create an environment where Korean patients can rapidly benefit from innovative treatments through efforts, including regulatory collaboration and clinical evidence generation," she added. "UCB will continue to accurately identify unmet patient needs and fulfill its role as a partner contributing to the improvement of the treatment environment."
- Company
- Yuhan-Janssen Korea to jointly sell 'Leclaza + Rybrevant'
- by Son, Hyung Min Nov 11, 2025 06:08am
- (from left) Christian Rodseth, Managing Director of North Asia for Johnson & Johnson Johnson & Johnson's Korea-based pharmaceutical unit, Janssen Korea (CEO Chris Rodseth), announced that it will jointly conduct domestic promotion for the non-small cell lung cancer treatment combination therapy, Leclaza (lazertinib) + Rybrevant (amivantamab), with Yuhan Corporation (Yuhan). Previously, promotional activities for the Leclaza + Rybrevant combination therapy were led by Johnson & Johnson, which holds the global rights. Through this new agreement, the promotion will be conducted jointly with Yuhan. Yuhan had previously been responsible for promoting Leclaza monotherapy and will now expand its role to include co-promotion of the combination therapy. The Leclaza + Rybrevant combination therapy received approval from the Ministry of Food and Drug Safety (MFDS) this January for the first-line treatment of non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. Christian Rodseth, Managing Director of North Asia for Johnson & Johnson's pharmaceutical sector, said, "Through this strategic partnership with Yuhan, we hope that more NSCLC patients in Korea can benefit from the treatment of this combination therapy." Rodseth added, "Johnson & Johnson is dedicated to changing patients' lives through science and innovation, and we will do our best to provide better treatment opportunities to patients based on close collaboration and communication with Yuhan." In addition to Leclaza monotherapy, for which Yuhan holds the rights and conducts promotion in Korea, Johnson & Johnson will exclusively conduct promotion for: second-line or later treatment of adult NSCLC patients with EGFR exon 19 deletion or exon 21 (L858R) substitution mutations, and first-line treatment of adult NSCLC patients with EGFR exon 20 insertion mutations. Johnson & Johnson will also supply Rybrevant exclusively.
- Company
- NSCLC standard treatment options undergo major change
- by Son, Hyung Min Nov 11, 2025 06:07am
- YuhanThe Leclaza + Rybrevant combination therapy has been recommended as the first-line treatment option by the National Comprehensive Cancer Network (NCCN) guidelines, based on its clinical utility. With Tagrisso also listed as a preferred therapy in combination with platinum-based chemotherapy, combination therapy is expected to become the major strategy in first-line treatment for EGFR-positive non-small cell lung cancer (NSCLC). According to industry sources on November 8, the NCCN recently revised its NSCLC treatment guidelines, including the combination of Yuhan's 'Leclaza (lazertinib)' and Janssen's 'Rybrevant (amivantamab)' as a Category 1 Preferred, first-line recommendation for EGFR-positive NSCLC. Consequently, experts preferentially recommend combination therapy as first-line treatment when an EGFR exon 19 or exon 21 mutation is identified in NSCLC. The Leclaza + Rybrevant combination therapy, which was first listed as a general recommendation last year, achieved the significant result of being changed to a Preferred recommendation in just about a year. This opens the door to recognition of combination therapy as a Standard of Care (SOC) globally. The NCCN provides guidelines for the diagnosis, treatment, and prognosis of cancer. This organization is a federation of 32 institutions, including U.S. National Cancer Centers and research institutes, and healthcare professionals worldwide refer to NCCN as a primary guide for cancer care and treatment. The reason the Leclaza + Rybrevant combination therapy was listed as a Preferred recommendation by the NCCN is that it secured sufficient efficacy results. Leclaza is a new EGFR-positive NSCLC drug developed by Yuhan, a 3rd-generation tyrosine kinase inhibitor (TKI) targeting exon 19 and exon 21 (L858R) mutations. Johnson & Johnson secured the global rights to Leclaza and has been conducting clinical research to evaluate its efficacy in combination with Rybrevant, a targeted treatment option that targets exon 20 and the MET mutation. The final overall survival (OS) analysis of the Leclaza + Rybrevant combination therapy showed superior OS compared to 'Tagrisso (osimertinib)' monotherapy. This combination therapy is currently expected to secure the longest OS results among all pivotal clinical studies for EGFR-positive targeted therapies. In the trial, the combination therapy group showed a statistically significant improvement in survival compared with the Tagrisso monotherapy group (p< 0.005). In detail, the median OS for the Leclaza + Rybrevant group was not estimable (42.9 months-NE). In contrast, the Tagrisso group showed an OS of 36.7 months. Based on the distribution of survival indices, the Leclaza + Rybrevant group is expected to extend OS by at least 12 months compared with the Tagrisso group. These study results were recently published in the New England Journal of Medicine (NEJM), attracting significant attention from the academic community. Previously, Tagrisso monotherapy, a 3rd-generation TKI targeting EGFR exons 19 or 21, had been recommended as the Preferred treatment option in major guidelines, such as the NCCN guidelines. However, the Leclaza + Rybrevant combination therapy, which is a 3rd-generation TKI similar to Tagrisso, demonstrated superior results compared to Tagrisso monotherapy, suggesting potential changes in key cancer treatment guidelines. The Leclaza + Rybrevant combination therapy is achieving significant success in both the OS results, which were identified as the key to commercialization, and its NCCN guideline listing. As the NCCN guidelines have been revised, the Leclaza + Rybrevant combination therapy has been recommended as the first-line treatment option. Tagrisso + platinum-based chemotherapy receives the priority recommendation…combination with Rybrevant possible AstraZenecaTagrisso was also recommended as a preferred therapy in combination with platinum-based chemotherapy, alongside its monotherapy use. While Tagrisso became the SOC for first-line EGFR-positive NSCLC through monotherapy, the Leclaza + Rybrevant combination therapy joined the competition. AstraZeneca received approval for Tagrisso in combination with platinum-based chemotherapy as a first-line EGFR-positive treatment. The company aims to extend survival by using chemotherapy, previously a second-line treatment, at an earlier stage. The Tagrisso + platinum-based chemotherapy combination therapy demonstrated efficacy compared with Tagrisso monotherapy in the FLAURA2 study. The clinical results showed that the combination therapy recorded an OS of 47.5 months, longer than Tagrisso monotherapy's 37.6 months. The median Progression-Free Survival (PFS) based on the investigators' assessment was 25.5 months, an extension of 8.8 months compared with Tagrisso monotherapy at 16.7 months. AstraZeneca is confirming the possibility of combining its targeted therapies with various options. The company is currently conducting combination trials of Tagrisso with the Antibody-Drug Conjugate (ADC) 'Datroway (datopotamab)' and the targeted therapy 'savolitinib'. In addition, AstraZeneca is conducting a clinical trial in collaboration with the global Contract Research Organization (CRO) Parexel to assess the combination potential of Tagrisso and Rybrevant. The Phase 2 OSTARA study began in July 2023 and is evaluating the efficacy and safety of the Tagrisso + Rybrevant combination therapy as a first-line treatment for EGFR-positive NSCLC. With the efficacy of the Rybrevant + Leclaza combination therapy validated, AstraZeneca also plans to confirm the potential of combining Tagrisso with a targeted therapy.
- Company
- HAE treatment 'Takhzyro' closer to reimbursement
- by Eo, Yun-Ho Nov 10, 2025 06:08am
- Product photo of Takhzyro (lanadelumab) A hereditary angioedema (HAE) treatment, 'Takhzyro,' appears closer to insurance reimbursement listing, approximately five years after acquiring domestic approval in South Korea. Takeda Korea's Takhzyro (lanadelumab) has recently passed the Drug Reimbursement Evaluation Committee (DREC). This is the first achievement since receiving approval from the Ministry of Food and Drug Safety (MFDS) in February 2021. Attention has been drawn to whether Takhzyro will successfully undergo drug pricing negotiations with the National Health Insurance Service (NHIS) to become a new treatment option for the HAE area, where treatments are lacking. HAE is a rare disorder caused by dysfunction of the C1-esterase inhibitor (C1-INH) protein, resulting in recurrent, unpredictable, and sudden swelling in different parts of the body. Upper airway edema can restrict breathing and lead to asphyxiation. Gastrointestinal tract swelling can cause emergency events, such as severe pain and intestinal obstruction. Approximately 40% of patients have their first episode before age 5, and 75% before age 15. However, most individuals undergo a 'diagnostic odyssey' and receive an accurate diagnosis only as adults. This is why the number of diagnosed cases in South Korea was only 200-250 as of last year, despite an estimated total of approximately 1,000 patients. In fact, it takes an average of 19 years to get diagnosed. Even after the diagnosis, patients are exposed to unpredictable HAE attacks and emergencies. However, in South Korea, patient access to treatments that provide fundamental care has been low. Therefore, the medical field has been consistently requesting reimbursement listing for Takhzyro. It remains to be seen whether drug price negotiations with the NHIS for Takhzyro will be successfully concluded and emerge as a new treatment option for HAE, where therapeutic agents are scarce. Meanwhile, Takhzyro demonstrated efficacy in the Phase 3 HELP study. The study results showed that the group receiving Takhzyro every two weeks reduced the average monthly attack frequency of HAE attacks by 87% compared with the placebo group, while the group receiving Takhzyro every four weeks achieved a 74% reduction.
- Company
- GSK seeks reimb for self-injectable form of its asthma drug
- by Eo, Yun-Ho Nov 07, 2025 06:17am
- The self-injectable formulation of the antibody drug ‘Nucala’ is aiming to enter Korea’s insurance reimbursement system. GSK Korea recently filed for insurance reimbursement of its Nucala Autoinjector (mepolizumab), an anti-IL-5 (interleukin-5) antibody for treating eosinophilic diseases. Nucala Autoinjector was approved in Korea last March and was released as a non-reimbursed drug this month after securing a distribution network and supply volume. It remains to be seen whether Nucala, which has established its position in the field of eosinophilic asthma, can successfully secure reimbursement coverage for the new formulation upon its launch and expand its influence in Korea. The new autoinjector formulation is approved not only for severe eosinophilic asthma in adults and adolescents (12 years and older), but also ▲ eosinophilic granulomatosis with polyangiitis (EGPA) in adults, and ▲ hypereosinophilic syndrome (HES) in adults. This medication is a self-administered injection used to treat eosinophilic diseases. It is indicated as add-on maintenance therapy in adolescents and adults aged 12 years and older with severe eosinophilic asthma (SEA), as add-on maintenance therapy in adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), and as add-on maintenance therapy in adult patients with hypereosinophilic syndrome (excluding HES, FIP1L1-PDGFRα positive patients). The autoinjector formulation enables patients to self-administer injections conveniently at home. This is evidenced by a self-injection success rate exceeding 96%, high patient preference, and ease of use. Meanwhile, Nucala has been enhancing its competitiveness by securing an indication for chronic obstructive pulmonary disease (COPD). The drug obtained additional approval from the U.S. FDA in May as an “add-on maintenance therapy for adult patients with COPD with an eosinophilic phenotype.” This approval was based on the results of the Phase III MATINEE and METREX studies. In these studies, among a broad spectrum of COPD patients with an eosinophilic phenotype, the Nucala treatment group showed a significantly lower annual rate of moderate-to-severe exacerbations compared to the placebo group.
