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- 2026-04-03 19:58:43
- Opinion
- [Reporter’s View] Addressing the Drug Shortage Issue
- by Kim JiEun Aug 28, 2025 06:09am
- With the bill that revises the Pharmaceutical Affairs Act, centered on simplifying generic substitution notifications, recently passing the NA Health and Welfare Committee's Legislative Subcommittee review, the Korean Medical Association readily voiced its opposition. This amendment primarily expands the scope of post-substitution notifications from pharmacies to include the information system operated by the Health Insurance Review and Assessment Service (HIRA). If passed, it is expected to provide the legal basis for implementing the simplified generic substitution notification enforcement rules under the Pharmaceutical Affairs Act, scheduled to take effect on February 2 next year. As soon as the amendment cleared the National Assembly's subcommittee hurdle, the KMA readily protested, calling it a harmful law that facilitates generic substitutions, and immediately demanded its withdrawal. The KMA used the term ‘arbitrary generic substitutions,’ arguing that implementing a related system would disregard physicians' prescribing authority. This reaction from doctors was not unexpected. Medical associations, including the KMA, have consistently opposed not only international nonproprietary name prescribing but also any systemic improvements related to simplifying generic substitutions. The reasons doctors have consistently cited for opposing the promotion of generic substitutions include threats to patient safety from pharmacist-initiated prescription changes, the undermining of doctors' prescribing authority, and the consequent collapse of the separation of prescribing and dispensing. Setting aside the claim that it would undermine physicians' prescribing authority, the argument that promoting generic substitution threatens patient safety and undermines the foundation of the separation of medical and pharmaceutical practices is difficult to accept. The drug supply issue has persisted for over five years since the spread of COVID-19. Even if the severity of the issue has lessened somewhat compared to the COVID period, unpredictable drug shortages continue to occur simultaneously and persistently. As a result, not only the pharmaceutical and distribution industries but also pharmacies are devoting a significant portion of their operations to securing drug inventories and managing supply. Had it not been for the efforts of frontline pharmacists to secure drug inventories during the severe COVID-era shortages, along with attempts at generic substitutions and patient understanding, the patients’ ‘pharmacy runaround’ – which might have otherwise been a temporary issue – could very well have escalated into a major societal problem threatening patient safety. Drug shortages and out-of-stock issues have persisted for years without effective countermeasures, yet the government has failed to present clear alternatives, and relevant legislation remains indefinitely stalled in the National Assembly. In this process, this reporter must ask: What voices have doctors, who emphasize maintaining prescription authority, raised for patient safety? What alternatives have they proposed? Claiming rights inevitably entails corresponding duties and responsibilities. To secure the authority to prescribe medications, there must also be a duty and responsibility to contribute to creating an environment where prescribed drugs can be delivered to patients without incident. Asserting rights without responsibility can only be perceived as an abuse of authority. The government must now focus its full efforts on establishing the institutional foundation to ensure that generic substitutions—which it has sought to promote, even introducing incentive systems—can truly become ‘activated,’ without being swayed by the claims of specific professions.
- Company
- New ADC drug introduced…expands treatment options
- by Son, Hyung Min Aug 28, 2025 06:09am
- New global drugs are awaiting entry into Korea’s antibody-drug conjugate (ADC) market one after another. Following Daiichi Sankyo Korea's application for domestic approval of the ADC anticancer drug ‘Datroway,’ AbbVie Korea is also proceeding with the approval process for its ovarian cancer-targeted ADC ‘Elahere.’ The industry anticipates that the commercialization of these two new drugs will significantly accelerate the competitive landscape for ADCs in Korea. According to industry sources on the 25th, Daiichi Sankyo Korea has completed its application for the domestic approval of its ADC anticancer drug Datroway and is awaiting approval. The indication is for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. The company expects approval early next year. ADC anticancer drug Datroway Dartroway is an ADC being co-developed by Daiichi Sankyo and AstraZeneca. AstraZeneca has prior experience commercializing the HER2-targeted ADC ‘Enhertu’ with Daiichi Sankyo. Previously, AstraZeneca secured the development and sales rights for Enhertu through a total USD 6.9 billion (KRW 8.418 trillion) contract with Daiichi Sankyo. In 2020, AstraZeneca paid Daiichi Sankyo USD 1 billion (KRW 1.22 trillion) as an upfront payment to obtain the development rights for Datroway. The total contract value, including development milestones and commercialization milestones, amounts to USD 6 billion (KRW 7.32 trillion). TROP2, which Datroway targets, is rapidly emerging as a global ADC target. The TROP2 protein is overexpressed in various cancers, including breast cancer and non-small cell lung cancer. Datroway binds to this protein and delivers a cytotoxic drug into cancer cells, inducing cell death. It maintains the efficacy of existing cytotoxic anticancer drugs while reducing damage to normal cells. The first novel drug to reach commercialization with this mechanism was Gilead's Trodelvy. Trodelvy has been approved as a TROP2-targeted breast cancer treatment in the US, Europe, and South Korea. Subsequently, Datroway entered the market, adding indications for breast cancer and non-small cell lung cancer. Datroway demonstrated efficacy in the Phase III TROPION-BREAST01 clinical trial. This study was a randomized 1:1 trial comparing the Datroway group with the investigator-selected chemotherapy group (eribulin, vinorelbine, capecitabine, or gemcitabine) in patients with previously treated, unresectable or metastatic hormone receptor-positive (HR+/HER2-) breast cancer. The study included 723 patients with a median age of 56 years. Key endpoints included progression-free survival (PFS), defined as the time without disease progression as assessed by blinded independent central review (BICR) per RECIST 1.1, and overall survival (OS), defined as the time from treatment initiation to death. Results showed the median PFS in the Datroway group was 6.9 months. This was longer than the 4.9 months observed in the chemotherapy group. Although the OS data were immature, a trend favoring Datoray was observed. AbbVie's first ADC ‘Elahere nears domestic commercialization ADC anticancer drug Elahere AbbVie is also awaiting approval for a new ADC. AbbVie has applied for domestic approval of ‘Elahere’ targeting the ovarian cancer indication. AbbVie acquired Elahere in November 2023 by purchasing the US biotechnology company Immunogen for USD 10.1 billion (approximately KRW 13.1 trillion). Elahere is an ADC targeting ovarian cancers expressing FRα (folate receptor alpha). Its mechanism involves delivering the potent cytotoxic drug DM4 into cancer cells to destroy the tumor. It is particularly gaining attention as a new option for ovarian cancer patients resistant to platinum-based anticancer drugs. This treatment was also designated as an orphan drug in Korea this January. For epithelial ovarian cancer, which accounts for 90% of ovarian cancers, taxane-based drugs like paclitaxel and platinum-based anticancer drugs like carboplatin and cisplatin are primarily used. However, for recurrent ovarian cancer resistant to platinum-based drugs, response rates to standard chemotherapy have generally been low, significantly limiting improvements in survival rates. Elahere demonstrated its potential as a new alternative through the Phase III MIRASOL study, conducted in patients with platinum-resistant ovarian cancer. The confirmatory Phase III MIRASOL study enrolled 453 patients with platinum-resistant epithelial ovarian cancer. The trial compared the Elahere group with the standard chemotherapy group. At a median follow-up of 30.5 months, Elahere demonstrated an improvement in median PFS of 5.59 months compared to 3.98 months in the standard therapy group. This represented a 37% reduction in the risk of disease progression or death. The objective response rate (ORR), which measures the proportion of patients with tumor size reduction over a set period, was also higher in the Elahere group at 41.9%, compared to 15.9% in the standard therapy group. Overall survival (OS) was also longer with Elahere at 16.85 months, reducing the risk of death by 32% compared to 13.34 months in the standard therapy group. Regarding safety, eye-related adverse events, fatigue, and abdominal pain were reported, but these were generally considered manageable. Based on these results, Elahere received full approval in the United States in March of last year and obtained marketing authorization in Europe in November of the same year.
- Policy
- Reimb listing approved for the first generic of 'Angeliq'
- by Lee, Tak-Sun Aug 27, 2025 06:07am
- Bayer The first generic of Angeliq Tab (drospirenone·estradiol, Bayer), a hormone-based medicine for use in postmenopausal women, will be included in the reimbursement listing. Analysis suggests that the commercialization of domestically produced generic is significant, considering that there had been supply issues related to Angeliq, which is an imported medicine. According to industry sources on August 26, Dalim BioTech's 'Anzeno Tab' will be added to the reimbursement list on September 1 with a ceiling price of KRW 5,565. The product is manufactured directly by Dalim BioTech. Anzeno Tab is a generic drug with the same active ingredients as Bayer's Angeliq Tab. Angeliq is approved for ▲Hormone replacement therapy for estrogen deficiency in women who are at least one year post-menopause, and for the ▲Prevention of osteoporosis in post-menopausal women who are intolerant of or have contraindications to other approved drugs and have an increased risk of fracture. Based on 2024 UBIST data, Angeliq's outpatient prescription sales amounted to KRW 12 billion. Because it is a hormonal drug requiring a separate manufacturing facility had previously prevented generic products from entering the market. Consequently, when supply issues arose with the imported original drug, Angeliq, pharmacies had no identical alternatives, leading to significant difficulties. Alternative prescriptions with similar drugs were the only option, resulting in a continuous demand for generic development. In 2021, the persistent shortage of Angeliq due to production delays at Bayer's Berlin plant caused difficulties for pharmacists. With the launch of this in-house-manufactured generic, the issue of supply instability is expected to be largely resolved. The price of Anzeno Tab was set at KRW 5,565, which is 53.55% of Angeliq's price, without any additional premium, as it met all the required criteria. Angeliq Tab's current ceiling price is KRW 10,393.
- Company
- Jaypirca’s reimbursement imminent in Korea
- by Eo, Yun-Ho Aug 27, 2025 06:07am
- The BTK inhibitor Jaypirca is likely to be listed for reimbursement soon. According to Dailypharm coverage, the National Health Insurance Service (NHIS) and Lilly Korea recently completed price negotiations for Jaypirca (pirtobrutinib), a treatment for relapsed or refractory mantle cell lymphoma (MCL). As a result, Jaypirca’s reimbursement agenda is scheduled to be submitted to the Health Insurance Policy Deliberation Committee in September, with listing expected in October. Jaypirca was approved by the Ministry of Food and Drug Safety in August last year as a monotherapy for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously received two or more treatments, including a BTK inhibitor. Prior to its approval, there were no approved medications available for patients with relapsed or refractory MCL whose disease progressed after treatment with existing BTK inhibitors in Korea. Jaypirca is the first and only reversible BTK inhibitor that has demonstrated clinical efficacy in patients with relapsed or refractory MCL following treatment with one or more BTK inhibitors. It also exhibits a 300-fold higher selectivity for BTK compared to most kinases (98%) included in preclinical studies. The BRUIN Phase I/II clinical trial, the study that became the grounds for Jaypirca’s approval, evaluated the clinical efficacy and safety of Jaypirca in adult patients with relapsed or refractory mantle cell lymphoma who had previously received treatment with one or more BTK inhibitors. In the primary analysis set (PAS) of 90 patients who had previously received treatment with one or more BTK inhibitors, the overall response rate (ORR) was 56.7%, with a median duration of response (DoR) of 17.6 months. The most common adverse reactions following Jaypirca administration were fatigue (26.3%), neutropenia (22.8%), diarrhea (22.1%), and bruising (19.0%). The incidence of treatment discontinuation due to adverse reactions was 1.2%, and the incidence of dose reduction due to adverse reactions was 3.3%. Meanwhile, based on the response rate results, Jaypirca was approved through the U.S. FDA's accelerated approval process in January last year. In Korea, it was designated as an orphan drug in June last year for use as monotherapy in adult patients with relapsed or refractory MCL who had previously received treatment with a BTK inhibitor.
- Company
- Targeted therapies and antibody drugs enter clinical trials
- by Son, Hyung Min Aug 27, 2025 06:07am
- Korea’s pharmaceutical and biotech industry is accelerating new drug development for pancreatic cancer, a cancer regarded as one of the most intractable cancers. Onconic Therapeutics, Prestige Biopharma, and Aptamer Sciences have each started clinical trials, making their bid into the field. The company plans to test the commercial viability of various mechanisms in the area, including antibody-drug conjugates (ADCs), targeted anticancer agents, and antibody-based novel therapies. Pancreatic cancer is difficult to detect at an early stage and has a poor prognosis, with a five-year survival rate of only 12.6 percent — the lowest among the nation’s top ten cancers. Given the limited success seen with existing therapies, there is a growing consensus that the development of new drugs is urgently needed. Onconic Therapeutics applies to initate Phase II trial in Korea According to industry sources on the 26th, Onconic Therapeutics has recently submitted an Investigational New Drug (IND) application to the Ministry of Food and Drug Safety for a Phase II clinical trial of its anticancer drug candidate Nesuparib. Nesuparib is a novel drug candidate with a dual mechanism of action, simultaneously inhibiting poly (ADP-ribose) polymerases (PARPs) and tankyrases (TNKS). The compound is currently being evaluated as both a monotherapy and as combination therapy across multiple indications, including pancreatic, endometrial, and gastric cancers. It has also been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for pancreatic and gastric cancers. Onconic Therapeutics has confirmed the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D) for its anticancer candidate in a Phase Ib clinical trial involving patients with advanced or metastatic pancreatic cancer. This multicenter, open-label, Phase Ib dose-escalation study enrolled up to 48 patients with locally advanced or metastatic pancreatic cancer. Participants were divided into two cohorts - Arm A, which received Nesuparib in combination with the FOLFOXIRI regimen (oxaliplatin, leucovorin, irinotecan, and 5-fluorouracil (5-FU)), and Arm B, which received Nesuparib in combination with gemcitabine and nab-paclitaxel. Onconic Therapeutics described the results of the Phase Ib trial as encouraging and announced its intention to present the findings at upcoming major international oncology conferences. New antibody drug development active in the industry… companies also see potential in combination therapies Korea’s pharmaceutical and biotech industry is stepping up its efforts in the field, with companies pursuing a wide range of new drug candidates, including antibody-drug conjugates (ADCs) and novel antibody therapies. Aptamer Sciences recently unveiled preclinical data for its ADC candidate AST-203, which targets TROP2, a protein commonly expressed in breast, pancreatic, gastric, and lung cancers. AST-203 selectively binds to TROP2-positive tumors, penetrates cells, and releases the microtubule inhibitor MMAE to induce tumor cell death. Structurally, AST-203 is composed of an anti-TROP2 antibody linked to the cytotoxic microtubule-inhibiting payload MMAE via a VC-PAB linker. MMAE is the same payload used in Padcev, the ADC therapy developed by Astellas and Seagen. ADC therapy TROP2 acts as an intracellular calcium signal transducer involved in cell proliferation and survival. Among TROP2-targeting new drugs, only two commercialized products exist: Gilead's ADC Trodelvy and Daiichi Sankyo/AstraZeneca's Datroway. Both products have only secured indications for breast cancer. Because TROP2 is highly expressed in breast, non-small cell lung, colorectal, and pancreatic cancers, the later entrants have been actively conducting clinical studies to tackle such major solid tumors. Aptamer Sciences is leveraging its proprietary ADC platform, “Aptamer,” to address the limitations of conventional ADCs. Aptamers are roughly one-tenth the size of antibodies, enabling deeper penetration into tumor tissue and faster delivery to target cells, enhancing therapeutic efficacy. In preclinical studies using tumor spheroid models (three-dimensional cultured cell aggregates), AST-203 demonstrated a 6.7-fold higher tumor penetration rate compared with Trodelvy. Prestige Biopharma has entered a clinical trial in the U.S for its antibody drug candidate PBP1510. PBP1510neutralizes the PAUF protein, a key driver overexpressed in pancreatic ductal adenocarcinoma (PDAC) that is a major target in pancreatic cancer. Through its Phase I trial, the company aims to assess the safety and tolerability of PBP1510 in combination with gemcitabine. NeoImmuneTech's NT-I7 received FDA orphan drug designation this year for pancreatic cancer. NT-I7 is an anti-cancer drug candidate targeting IL-7, which organizes T-cell development and function, and targets various indications. Immuno-oncology drugBeyond pancreatic cancer, NT-I7 previously received ODD from the FDA for CD4 lymphopenia (2019), progressive multifocal leukoencephalopathy (2020), and glioblastoma (2023). NeoImmuneTech is currently conducting a Phase II trial evaluating NT-I7 in combination with Keytruda. The trial enrolled 50 patients with previously treated metastatic colorectal cancer and 48 with pancreatic cancer. Interim data showed partial responses (PRs) in three of the 48 pancreatic cancer patients, with a median overall survival (OS) of 11.1 months.
- Company
- Co-promotion discussed for the diabetes drug Mounjaro
- by Kim, Jin-Gu Aug 27, 2025 06:07am
- Product photo of Mounjaro The possibility of a co-promotion partnership between Eli Lilly and Korean pharmaceutical companies for 'Mounjaro,' the treatment of diabetes and obesity, continues to be discussed. While Lilly Korea officially maintains a 'direct sales' policy, it is reported that they are also conducting undiscloed discussions for potential partnerships. It is anticipated that the decision on co-promotion will become clearer around the time Mounjaro becomes reimbursed for the diabetes indication. According to industry sources on August 26, Lilly Korea recently discussed the possibility of co-promoting Mounjaro with approximately ten domestic pharmaceutical companies. Key major pharmaceutical companies with nationwide sales networks are said to have participated in the discussions, exchanging ideas by proposing their sales strategies to Lilly Korea. However, Lilly Korea's official position of 'direct sales' remains unchanged. An official from Lilly Korea stated, "At the time of launch, Lilly will handle direct sales, and distribution will primarily be through distributors who have direct dealings with Lilly." In other words, it is interpreted as a move to maintain the principle of direct sales while leaving the door open for collaboration with domestic pharmaceutical companies through simultaneous undisclosed discussions. The pharmaceutical industry believes that Mounjaro's 'indications' are the reason why two sales models are being considered simultaneously. Mounjaro currently holds three indications: ▲Improving glycemic control in adult patients with Type 2 diabetes ▲Chronic weight management in adult patients ▲Treating moderate-to-severe obstructive sleep apnea in obese adults. With patient groups categorized for diabetes and obesity, the sales strategy must be differentiated. This situation differs from the global market. In the U.S., the same active ingredient (tirzepatide) is marketed separately as an obesity drug called 'Zepbound' and a diabetes drug called 'Mounjaro.' In Korea, however, it was approved as a single product under the name Mounjaro, without using the name Zepbound. Mounjaro is therefore sold as both an obesity and a diabetes drug. The consensus in the industry is that discussions regarding a co-promotion partnership with domestic pharmaceutical companies are focused on the diabetes treatment indication. It is reported that the diabetes indication was a key topic of discussion during the negotiation process. The pharmaceutical industry anticipates that Lilly Korea will pursue reimbursement for Mounjaro's diabetes treatment indication, targeting the first half of next year. If reimbursement is approved, it would be possible to separate the sales strategies for the diabetes and obesity markets. This means that Mounjaro for obesity treatment could be sold exclusively by Lilly Korea's in-house sales team. At the same time, a co-promotion system could be established with a domestic pharmaceutical company for Mounjaro's diabetes treatment. Consequently, the co-promotion partner is expected to be known around the time reimbursement is secured. The high market potential of Mounjaro is the reason for the strong interest from Korean pharmaceutical companies. Mounjaro achieved record-breaking sales in the global market immediately after its launch. As a diabetes drug, its globalsales reached $5.198 billion (approximately KRW 7 trillion) in the second quarter of this year. Zepbound, initially launched as an obesity drug, generated $3.381 billion (approximately KRW 4.7 trillion) in sales. In just three months, the combined sales of the two products amounted to nearly KRW 12 trillion. Considering Mounjaro's significant presence in both the diabetes and obesity markets, it is likely that Korean pharmaceutical companies will find it difficult to pass up this strategic opportunity. A co-promotion partnership could immediately lead to external growth and a synergistic effect with their existing diabetes treatment portfolios. The high potential for future indication expansion beyond diabetes and obesity is also an attractive factor. Currently, GLP-1 class drugs like Mounjaro and Wegovy are being actively investigated in clinical trials for conditions such as MetabolicDysfunction-Associated Steatohepatitis (MASH), cardiovascular diseases, and kidney diseases.
- Policy
- ‘80,000 Wegovy prescriptions issued per month’
- by Lee, Jeong-Hwan Aug 27, 2025 06:06am
- The popular obesity drug Wegovy, which was launched in Korea in October last year, has already been prescribed about 400,000 times within eight months, raising concerns over potential misuse and abuse. On the 25th, Rep. Kim Sun-min of the Rebuilding Korea Party disclosed the ‘Annual and Monthly Status of Wegovy Prescriptions based on DUR’ data submitted by the Health Insurance Review and Assessment Service (HIRA) and urged safe usage. According to the data, in 2023, the first month of release, the number of prescriptions flagged by the Drug Utilization Review (DUR) system for Wegovy was 11,368. This increased to 16,990 prescriptions the following month, November. The number then reached 21,457 prescriptions in December. This year, the numbers have increased by over 10,000 cases every month to record 22,051 in January, 31,512 in February, and 47,597 in March. Prescriptions then surged to 70,666 in April, then 88,895 in May. In June, the number slightly decreased to 84,848. This means that since its launch in October last year, Wegovy prescriptions averaged 43,931 per month, rising to an average of 57,594 per month this year. Saxenda prescriptions also showed a similar pattern. The number of Saxenda prescriptions in Korea, which was launched in 2018, was 138,353 in 2022, 171,230 in 2023, and 205,109 last year. Experts have pointed out that while these figures alone cannot determine the exact number of recipients—as one patient may have received multiple prescriptions—the steep increase in numbers clearly indicates a rising trend in the number of people receiving injections. Rep. Sun-min Kim stated, “The number of prescriptions via DUR data is exceeding 80,000 per month. Given the recent craze for obesity treatments, we expect significantly more people are actually receiving prescriptions.” Rep. Kim emphasized, “Given the frequent reports of adverse events, obesity treatments must be used safely under the thorough care of specialists.”
- Company
- CKD aims at developing next-generation·new anti-cancer drug
- by Son, Hyung Min Aug 26, 2025 06:06am
- Chong Kun Dang is speeding up investment in the new anti-cancer drug sector. The company aims to commercialize anti-cancer drugs by advancing its in-house pipelines for Antibody-Drug Conjugates (ADCs) and Cell and Gene Therapies (CGTs). Additionally, Chong Kun Dang is securing domestic rights for new drugs, including Chimeric Antigen Receptor T-cell (CAR-T) therapies, cancer vaccines, and targeted therapies. Accelerating Commercialization of New Anti-cancer Drugs...In-licensing New Drugs enters into Late-Stage Clinical Trials According to industry sources on August 26, patient enrollment in the Phase 2 clinical trial of namodenoson, a targeted therapy for which Chong Kun Dang holds domestic rights in Korea, has recently exceeded half of its target. In 2016, Chong Kun Dang signed an exclusive domestic supply and sales agreement for namodenoson with Israel's Can-Fite BioPharma. Namodenoson is a selective A3 adenosine receptor (A3AR) agonist with a mechanism that suppresses the progression of fibrosis. This new drug candidate has demonstrated safety and anti-tumor activity in preclinical models of pancreatic cancer. The current Phase 2a trial is a multi-center, open-label study evaluating the safety and pharmacokinetic (PK) activity of namodenoson in patients with advanced pancreatic adenocarcinoma whose disease has progressed after previous treatment. Patients are administered 25mg of namodenoson orally twice a day in 28-day cycles, and favorable safety results have been observed. Currently, namodenoson is being investigated in a Phase 3 clinical trial for hepatocellular carcinoma, a Phase 2b trial for Metabolic Dysfunction-Associated Steatohepatitis (MASH), and the Phase 2a trial for pancreatic cancer. It has received Orphan Drug Designation in the U.S. and Europe. It has also been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) as a second-line treatment for hepatocellular carcinoma. Its potential has also been confirmed for various other cancers, including colon cancer, prostate cancer, and melanoma. Chong Kun Dang has also secured the rights for a new CAR-T drug candidate. In June, Chong Kun Dang invested KRW 12.2 billion in the biotech company AbClon in Korea, becoming its second-largest shareholder with a 7.33% stake through a third-party share allocation capital increase. It was the first time in Chong Kun Dang's history that it has made an external investment of over KRW 10 billion. AbClon is a new drug development company co-founded by Korean and Swedish researchers in 2010 and was listed on the KOSDAQ in 2017. It has a diverse pipeline of drugs targeting various cancers, including gastric, colorectal, prostate, and hematological cancers, with products such as the HER2-targeted antibody therapy (AC101), bispecific antibody-based immunotherapy (AM105), and the CAR-T therapy (AT101). Chong Kun Dang has secured the priority right for the domestic sales of AbClon's hematological cancer CAR-T therapy, 'AT101,' which is under development. The company plans to expand its collaboration in the co-development and commercialization of CAR-T and bispecific antibody new drugs in the future. AT101 has entered a Phase 2 clinical trial, with the goal of submitting an expedited approval application in 2025. The two companies also plan to co-develop new drugs targeting HER2-targeted CAR-T (AT501), PSMA, CD30, and 4-1BB. Chong Kun Dang also has high hopes for the cancer vaccine sector. A Phase 3 clinical trial for the cancer vaccine 'Tedopi,' for which Chong Kun Dang holds sales rights, is underway in patients with non-small cell lung cancer. Chong Kun Dang in-licensed the domestic rights for Tedopi from OSE Immunotherapeutics, a company based in France, in 2019. Tedopi is a cancer vaccine for patients who have failed immunotherapy. A study in patients with advanced and metastatic lung cancer who failed previous treatments showed that Tedopi reduced the risk of death by 41% compared to chemotherapy. The confirmatory Phase 3 clinical trial is ongoing, and a study in pancreatic cancer patients is also being conducted. Active In-house Anti-Cancer Drug Clinical Trials In addition to securing new drug rights, Chong Kun Dang expects to see synergies with its own in-house anti-cancer drugs in the medium to long term. The company entered the ADC anti-cancer drug development field last February by signing a technology introduction agreement with Synaffix, a company based in the Netherlands, securing the rights to use three of its platform technologies. Recently, the company's ADC also successfully entered the clinical stage. The FDA approved the Phase 1/2a clinical trial plan (IND) for Chong Kun Dang's ADC new drug candidate, 'CKD-703,' last month. CKD-703 targets the hepatocyte growth factor receptor (c-Met), which is overexpressed in cancer cells, and is being developed for the treatment of solid tumors, such as non-small cell lung cancer. c-MET targeted by CKD-703 is a protein expressed by the epithelial-mesenchymal transition (MET) gene. c-MET is one of the proteins that transmit signals to cells and is considered a key cancer-causing gene, linked to the development of various solid tumors, including non-small cell lung, colorectal, gastric, and liver cancer. It is known that c-MET mutations are found in 6% of non-small cell lung cancer patients. With intense competition among subsequent products, including Daiichi Sankyo's 'Enhertu,' Astellas' 'Padcev,' and Gilead's 'Trodelvy,' Korean companies are also finally entering the clinical stage and are now at the point of verifying their commercialization potential as latecomers. Along with securing opportunities for global co-development through technology exports, some companies are also demonstrating their competitiveness by initiating clinical trials directly in global markets, such as the U.S. To date, there are no approved ADC new drugs that target c-Met, with AbbVie's 'Teliso-V' being the closest to commercialization. AbbVie achieved positive results in a Phase 2 trial announced last year and has since applied for accelerated approval to the FDA based on these findings. Amid the global competitive landscape, Chong Kun Dang plans to prove its commercialization potential by differentiating itself in areas such as toxicity management and treatment response rates. In April of last year, the company also signed a license-in agreement with Curigin, an RNAi-based gene therapy development company, for its candidate compound 'CA102,' which carries a bispecific shRNA. Chong Kun Dang has secured the global rights for Curigin's anti-cancer candidate 'CA102' and plans to proceed with exclusive R&D and commercialization, with superficial bladder cancer as its first indication.
- Policy
- MFDS will intensively monitor Wegovy and other obesity drugs
- by Lee, Hye-Kyung Aug 26, 2025 06:05am
- The Ministry of Food and Drug Safety (MFDS) has designated ‘Wegovy’ and other GLP-1-class obesity injectables as targets for intensive monitoring and plans to continuously monitor side effects in collaboration with the Korea Institute of Drug Safety & Risk Management. Th MFDS designates the intensive monitoring status to drugs with high safety concerns in Korea and abroad, or those of high social interest due to concerns about misuse, and intensively collects, analyzes, and reevaluates their adverse events. On the 25th, the MFDS emphasized that injectable GLP-1 class obesity drugs, which are currently attracting significant public attention, should only be used under the supervision of medical professionals for patients diagnosed with obesity, and only in accordance with the approved indication per prescription. Injectable GLP-1 class obesity drugs are prescription drugs indicated for adult obese patients with an initial body mass index (BMI)* of 30 kg/m2 or higher, or adult overweight patients with a BMI of 27 kg/m2 or higher but less than 30 kg/m2 and one or more weight-related comorbidities such as hypertension. According to clinical trial results, even when used within the approved indications, gastrointestinal adverse reactions (nausea, vomiting, diarrhea, constipation, etc.) and injection site reactions (rash, pain, swelling, etc.) are common, and serious adverse effects such as hypersensitivity reactions, hypoglycemia, acute pancreatitis, cholelithiasis, and fluid loss may occur. Also, some medications are contraindicated in patients with underlying conditions such as thyroid medullary cancer, so consultation with a healthcare professional is mandatory. In patients with type 2 diabetes, hypoglycemia and retinopathy may occur, so caution is particularly advised when administering such drugs to patients with relevant medical history. Obesity treatments are prescription-only drugs that must be used under a doctor's prescription with the guidance of a pharmacist. The MFDS urged the public not to purchase or distribute these medications through online platforms, overseas direct purchases, or personal sales. Additionally, the Ministry of Food and Drug Safety recently urged companies holding the marketing authorization rights for the relevant products to prevent misuse and prohibit false advertising, and informed medical professionals about the proper use of obesity treatment medications within their approved scope. The MFDS plans to publish an informational brochure (leaflet) in collaboration with the Korea Institute of Drug Safety & Risk Management, outlining the conditions for which obesity treatment drugs are used, proper administration methods, storage and disposal instructions, precautions during administration, and procedures for reporting adverse reactions (side effects). The MFDS stated, "We will continue to strengthen the provision of information to improve users' understanding of obesity treatment drugs and ensure their safe use."
- Company
- Expanded indication for Kisqali in early breast cancer
- by Son, Hyung Min Aug 26, 2025 06:05am
- Kisqali On August 22, Novartis Korea (CEO and President Byeong-jae Yoo) announced that its CDK 4/6 inhibitor, Kisqali, was approved for a new indication from the Ministry of Food and Drug Safety for use as an adjuvant therapy in patients with HR+ (hormone receptor-positive)/HER2- (human epidermal growth factor receptor 2-negative) Stage II and III early breast cancer who are at high risk of recurrence. Kisqali has now expanded indications from advanced and metastatic breast cancer to include early breast cancer, thereby broadening treatment options. The current expanded indication is based on the results of the global Phase 3 clinical trial, NATALEE. The NATALEE study was a randomized, multi-center, open-label clinical trial involving a total of 1,010 patients with HR+/HER2- early breast cancer from 20 countries worldwide. It evaluated the efficacy and safety of the Kisqali combination therapy group compared to the endocrine therapy monotherapy group. Clinical results showed that the primary endpoint, invasive disease-free survival (iDFS), was 88.5% for the Kisqali combination therapy group and 83.6% for the endocrine therapy monotherapy group at the 4th year, showing an absolute improvement of 4.9 percentage points. This gap widened over time, as the difference was 2.7 percentage points at the 3-year mark (90.8% vs. 88.1%). The risk of invasive disease progression or death was reduced by 28.5% in the Kisqali combination therapy group compared to the endocrine therapy monotherapy group. A consistent effect was observed regardless of lymph node involvement. Professor Yeon Hee Park of the Department of Hematology and Oncology at Samsung Medical Center said, "Patients with HR+/HER2- early breast cancer are still exposed to a risk of recurrence even with existing treatments, and a relapse has a high probability of progressing to distant metastasis, which is a great burden for patients," and added, "Through the NATALEE study, Kisqali showed an effect in reducing the risk of recurrence across a broad patient population, regardless of lymph node involvement. The confirmed superior tolerability due to its low-dose design is a significant advance in clinical practice." Byeong-jae Yoo, CEO and President of Novartis Korea, said, "Kisqali is an innovative drug that has demonstrated improved survival rates in the treatment of metastatic breast cancer. With this expanded indication for early breast cancer in Korea, we hope to reduce the burden of recurrence risk for patients and provide better treatment outcomes," and added, "Novartis will continue to lead patient-centered innovation and play a leading role throughout the breast cancer treatment journey in Korea." Kisqali was initially approved by the Ministry of Food and Drug Safety in October 2019 for the treatment of HR+/HER2- advanced or metastatic breast cancer in ▲pre-menopausal, peri-menopausal, or post-menopausal women as a first-line endocrine therapy in combination with an aromatase inhibitor and in ▲post-menopausal women as adjuvant therapy in combination with fulvestrant for first-line endocrine therapy or after disease progression on endocrine therapy.
