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- 2026-05-01 23:17:57
- Company
- Yuhan’s anticancer drug Leclaza secures European approval
- by Cha, Jihyun Jan 02, 2025 06:10am
- Pic of Yuhan Corp Yuhan Corp’s new anti-cancer drug Leclaza (Lazertinib) has crossed the European threshold. The European Commission (EC) approved the drug a month after receiving a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). As a result, the company will receive a USD 30 million European launch milestone. According to industry sources on the 31st, the EC granted final marketing authorization to the combination of Yuhan Corp’s non-small cell lung cancer drug Leclaza and Johnson & Johnson's Rybrevant (amivantamab) as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a confirmed epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutation. The CHMP had previously issued a positive opinion recommending approval of the combination on March 14th. The final approval of the combination comes just 1 month after the CHMP's recommendation. The approval is based on results from the Phase III MARIPOSA study. In the study, the combination of Rybrevant-Leclaza reduced the risk of disease progression or death by 30% compared to Tagrisso (osimertinib) monotherapy. In addition, progression-free survival (PFS) was 23.7 months, compared to 16.6 months with osimertinib, and duration of response (DOR) was 25.8 months, 9 months longer than Tagrisso's 16.8 months. Even in high-risk patients with TP53 mutations, brain metastases, or liver metastases, the combination of Rybrevant and Leclaza demonstrated a consistent PFS benefit over Tagrisso, with a trend toward superior overall survival (OS). This renders Leclaza the first homegrown anticancer drug to be marketed in Europe following approval in the U.S. The Rybrevant-Leclaza combination was previously approved by the U.S. Food and Drug Administration (FDA) in August. In Korea, it was approved by the Ministry of Food and Drug Safety in January 2021 for the treatment of non-small cell lung cancer. As the Rybrevant-Leclaza combination passed the European threshold, the company will receive the European launch milestone of USD 30 million (approximately KRW 44.2 billion). This brings the total amount received from Janssen for the export of Leclaza technology to USD 240 million (approximately KRW 353.7 billion). In November 2018, the company received USD 50 million in upfront payment for the export of Leclaza’s technology. In April 2020, Yuhan Corp received a milestone payment of USD 35 million from Janssen. At that time, Johnson & Johnson paid Yuhan Corp an additional milestone payment after initiating clinical trials for the Rybrevant and Leclaza combination. In November 2020, Johnson & Johnson paid an additional milestone of USD 65 million to Yuhan Corp as it began recruiting patients for the trial. Subsequent successful completion of the trial and FDA approval resulted in an additional USD 60 million in additional milestone payments. Sales royalties are also expected to be recognized once the Rybrevant-Leclaza combination is launched in Europe. The royalty rate on sales of Leclaza is expected to be in the range of 10% to 12%. Lung cancer is the leading cause of cancer-related death, which causes an estimated 1.8 million deaths worldwide each year. Patients with non-small cell lung cancer, which is targeted by the Rybrevant-Leclaza combination, account for 80-85% of lung cancer patients. In addition, Yuhan Corp may receive additional milestones upon regulatory approval in Japan, China, and other Asian countries. The total amount of additional technology fees that Yuhan may receive for future development and sales of Leclaza amounts to USD 740 million.
- Policy
- ICER threshold for anticancer drugs set same as in 2024
- by Lee, Tak-Sun Jan 02, 2025 06:10am
- The Health Insurance Review and Assessment Service released the results of the incremental cost-effectiveness ratio (ICER) of drugs submitted for pharmacoeconomic evaluation from 2019 to 2023, which has shown a decrease in the maximum ICER threshold set for anticancer drugs. The ICER threshold did not appear to have changed much from the previous year, as the review results of the breast cancer drug Enhertu, which was reimbursed in April and was known to have significantly exceeded the ICER threshold, were not reflected in the results. On December 30, HIRA released the ICER threshold values of 19 drugs evaluated from 2019 to 2023. At the end of every year, HIRA discloses the past 5-year ICER values from the previous year. According to the evaluation results, the median threshold value of 8 general drugs was KRW 27.66 million, ranging from KRW 12.06 million to KRW 36.1 million. In the case of the 8 anticancer drugs, the median threshold was KRW 39.93 million, ranging from KRW 25.88 million to KRW 47.92 million. For the 3 rare disease drugs, the median threshold was not disclosed to avoid identifying individual drug evaluation results. However, the minimum threshold was KRW 23.61 million and the maximum threshold was KRW 39.97 million. Compared to the ICER threshold published in 2023, there is less fluctuation, around KRW 10 million. The data released the previous year were based on ICER thresholds for 20 drugs evaluated from 2018 to 2022. Its results showed that the median price of 5 general drugs was KRW 25.67 million, ranging from KRW 17.78 million to KRW 35.29 million. At the time, the median ICER threshold of the 10 anticancer drugs was KRW 39.99 million, ranging from KRW 24.96 million to KRW 47.92 million, and the median ICER threshold of the 5 rare disease drugs was KRW 39.97 million, ranging from KRW 23.61 million to KRW 47.29 million. Compared to this year's results, the median ICER threshold of general drugs increased by KRW 1.99 million, while the minimum threshold decreased by KRW 5.72 million. The maximum value increased by KRW 0.81 million. In the case of anticancer drugs, the median ICER threshold decreased by KRW 60,000, while the minimum ICER threshold increased by KRW 0.92 million. The maximum remained the same. For rare disease drugs, the minimum ICER threshold remained the same, while the maximum ICER threshold decreased by KRW 7.32 million. The maximum ICER threshold for anticancer and rare disease drugs remained the same or decreased from the previous year. In August, HIRA revised the detailed evaluation criteria for drugs subject to negotiations, including new drugs, to establish an innovativeness requirement for drugs subject to flexible ICER threshold evaluations. Previously, the ICER threshold was “not to be used as an explicit threshold, but to be used flexibly for evaluations by referring to the results of previous deliberations that consider the severity of the disease, the burden of disease on society, the impact on quality of life, and innovation.” Upon revision, a new drug's innovativeness is recognized if it meets all 3 of the following requirements: ▲ there is no substitute or therapeutically equivalent product or treatment; ▲ a significant clinical improvement is identified in the outcome indicator, such as prolongation of survival; ▲ it falls under Article 35(4)(2) of the Pharmaceutical Affairs Act and is recognized by the MFDS as a new drug or equivalent drug approved through expedited review by the MFDS. A flexible review of high-priced new drugs is expected with the clarification of the flexible ICER threshold evaluation requirements. In April, HIRA reviewed and granted reimbursement for the breast and gastric cancer drug Enhertu Inj (trastuzumab deruxtecan, Daiichi Sankyo). At the time, it was reported that Enhertu’s ICER threshold greatly exceeded the maximum value of the existing ICER threshold set for anticancer drugs. Last year and this year, the maximum ICER threshold for anticancer drugs was KRW 47.92 million. Accordingly, it is expected that the ICER value in 2025, which will reflect the results of this year's evaluations, will show a significant increase in the ICER threshold set for anticancer drugs.
- Company
- K-Bio to showcase CDMO·new drugs at the JP Morgan
- by Son, Hyung Min Jan 02, 2025 06:10am
- The Korean pharmaceutical and biotech industry is set to participate in the new year's first global event, the JP Morgan Healthcare Conference. Attention has been drawn to what the Korean pharmaceutical and biotech industry will accomplish during the event, which will include discussions of blockbuster technology transfers and partnering agreements. According to industry sources on January 2, Samsung Biologics, Lotte Biologics, Celltrion, Bridge Biotherapeutics, Onconic Therapeutics, and others will attend the JP Morgan Healthcare Conference. The Healthcare Conference, hosted by the US investment bank JP Morgan, is the largest pharmaceutical and biotech industry investment event, where venture capitals (VC) and hedge funds attend. The event will be held in San Francisco, US, for four days from January 8. Korean CDMO companies gear up to land contracts During the event, Samsung Biologics, Lotte Biologics, Celltrion, and other participants will showcase their contract development and manufacturing organization (CDMO) competitiveness. Samsung Biologics will showcase its biopharmaceutical CDMO competitiveness based on its new manufacturing plant, Plant 5, which will be completed in April. The company is constructing a plant at the Bio Campus in Songdo, Incheon, for antibody-drug conjugates (ADC) production, which is aimed to be completed within this year. Samsung Biologics currently has a total production capacity of 600,000 liters. The company has invested KRW 1.98 trillion in constructing Plant 5 in Songdo. Samsung Biologics will hold a total capacity of 784,000 liters across Plant 1-5. Celltrion will showcase its new drug development achievements, including a new ADC anti-cancer drug, and CDMO vision. The company unveiled the new ADC drug result of the Phase 1 clinical trial at the 'World ADC 2024' held in November last year. Celltrion Celltrion is conducting a clinical trial for 'CT-P70,' an ADC candidate product for non-small cell lung cancer (NSCLC), and 'CT-P71,' which targets many solid cancer indications, including bladder cancer. The safety of these new drug candidates has been confirmed in a phase 1 clinical trial and a pre-clinical trial, respectively. Additionally, Celltrion will initiate the business operations of its subsidiary, 'Celltrion BioSolutions,' which was launched in December 2024. Celltrion aims to build manufacturing facilities and a research center and generate sales from 2028. Lotte Biologics will attend the conference and plans to showcase its CDMO competitiveness. The company plans to build three bio plants in Songdo by 2023 with a total production capacity of 360,000 liters for antibody pharmaceutical production. The new Plant 1 will have a cell culture system and an API system for producing clinical agents. The company will design a 3,000-liter bioreactor capable of fulfilling the demand for both stainless steel bioreactors (cell culture system) and high-potent active pharmaceutical ingredients (HPAPI). Lotte Biologics aims to achieve global biopharmaceutical production competitiveness by investing up to KRW 4.6 trillion by 2030. To showcase achievements in new drug development…will this result in out-licensing opportunities? Onconic Therapeutics and Bridge Biotherapeutics have been officially invited to the JP Morgan Healthcare Conference, where they will showcase their competitiveness in new drug development. Onconic Therapeutics launched 'Ja Q Bo Tab,' a P-CAB for the treatment of gastroesophageal reflux disease (GERD), last year. Ja Q Bo Tab has been designated the 37th new drug in Korea. Additionally, Onconic Therapeutics successfully out-licensed Ja Q Bo to twenty-one foreign countries. Onconic Therapeutics plans to focus on holding strategic meetings with global pharmaceutical companies and investors during the upcoming JP Morgan Healthcare Conference. In addition to Ja Q Bo, the company plans to introduce the targeted anticancer agent, 'nesuparib,' to the global market. Onconic Therapeutics has been developing 'nesuparib,' a dual-targeting inhibitor of PARP·tankyrase, as the follow-up pipeline after Ja Q Bo. Bridge Biotherapeutics plans to present its key R&D projects, including the idiopathic pulmonary fibrosis (IPF) treatment candidate 'BBT-877,' and potential company growth strategy. BBT-877 is an innovative new drug candidate that selectively inhibits the new targeted protein autotaxin. Autotaxin is a protein involved in pathophysiological mechanisms, such as tumorigenesis, by binding with receptors in the cell. Bridge Biotherapeutics has completed enrolling 120 patients in the Phase 2 clinical trial for BBT-877. The comparative Phase 2 clinical trial will evaluate the effectiveness, safety, and drug tolerance by administering BBT-877 and placebo in patients with IPF. STCube will hold business meetings with multinational pharmaceutical companies to out-license 'nelmastobart.' The company is developing the candidate immune checkpoint inhibitor nelmastobart, which targets a new biomarker, BTN1A1. BTN1A1 is a protein that regulates the immune responses to cancer cells by suppressing the activity of T cells, which are immune cells. This biomarker is not expressed in healthy cells but is strongly expressed in cancer cells. BTN1A1 expression is mutually exclusive to that of PD-L1. By targeting BTN1A1, STCube is developing an immune checkpoint inhibitor that could be a new treatment option for intractable cancer. D&D Pharmatech will showcase the glucagon-like peptide 1 (GLP-1) receptor agonist for obesity. In November, D&D Pharmatech began the clinical trial for DD02, an oral GLP-1 drug for obesity, through its US partner, Metsera. D&D Pharmatech also plans to showcase the new drug candidate for treating MASH, DD01, which is undergoing a phase 2 clinical trial.
- Opinion
- [Reporter’s View] The dilemma of companion diagnostics
- by Whang, byung-woo Dec 31, 2024 05:56am
- A drug is available but unusable. This is the story of the Claudin 18.2 targeted gastric cancer drug Vyloy (zolbetuximab). This is not the typical situation where a breakthrough drug is approved but is inaccessible due to its high price. The problem is companion diagnostics (CDx). In order to use a Vyloy, which targets Claudin 18.2, it is essential to first confirm that the patient's tumor is Claudin 18.2 positive. For this reason, the MFDS approved the companion diagnostic device, VENTANA CLDN18 (43-14A) RxDx Assay from Roche Diagnostics Korea, on the same day that Vyloy was approved. However, the device’s launch in Korea has been delayed due to the issue of whether the companion diagnostic technology requires evaluation as a new health technology. In Korea, new biomarkers must pass a new health technology evaluation by the National Evidence-based healthcare Collaborating Agency (NECA) before they can be used in practice. Late last month, the National Evidence-based healthcare Collaborating Agency (NECA) held a meeting of its expert evaluation committee to discuss Vyloy’s companion diagnostic agenda and put the decision on hold. Whether the Claudine 18.2 companion diagnostic will be classified as an existing technology for reimbursement determination or a new technology for NECA’s new health technology evaluations is expected to be decided upon early next year. As the process is bound to take time, the industry expects the process to take up to 15 months if the companion diagnostic receives new health technology evaluations. Clinics had been preparing to prescribe Vyloy upon its launch next January, but this has become impossible. Astellas is also reportedly struggling to decide on the timing of the drug’s launch. For now, experts have believed Vyloy holds significance in the treatment of gastric cancer. It could be a turning point in the treatment of locally advanced or metastatic gastric cancer in Korea, where treatment options have been limited. In particular, the number of patients who can benefit from the treatment is not small, with 30 to 40 percent of new patients testing positive for Claudin 18.2. The Vyloy case is likely to be repeated in the future, given the development of new drugs, such as cancer drugs that target specific targets. This is why experts are calling for an overhaul of the current companion diagnostic system. As technology advances, changes to the system are essential. We need to take a long-term view to allow patients to benefit from new drugs as quickly as possible.
- Policy
- Once-weekly insulin 'Awiqli' wins nod in KOR
- by Lee, Hye-Kyung Dec 31, 2024 05:56am
- Product photo of Novo NordiskA once-weekly insulin to treat patients with adult diabetes has been approved in South Korea. On December 23, the Ministry of Food and Drug Safety has approved Novo Nordisk's 'Awiqli Pre-Filled Pen 700 Units/mL (insulin icodec, recombinant).' This drug is a once-weekly subcutaneous injection of insulin, providing a more convenient treatment option than the daily injections of conventional insulin. Patients with type 1 diabetes must use Awiqli in combination with bolus insulin to meet their insulin requirements during meals. For type 2 diabetes, Awiqli can be administered as a monotherapy or in combination with oral antidiabetic agents, GLP-1 receptor agonists, and bolus insulin. According to the results of the 'Advisory on the Safety·Effectiveness of Insulin Formulations' released by the Central Pharmaceutical Affairs Advisory Committee (CPAC) on December 24, discussions highlighted the unmet medical needs of type 1 diabetes patients who face daily inconveniences from lifelong injections and the potential benefits of a once-weekly injection regimen. "Long-term maintenance agent will benefit patient convenience and drug adherence," a committee member stated. "We have a previous case of sustained osteoporosis treatment with extended treatment interval." However, concerns were raised that the once-weekly formulation does not maintain consistent blood levels and exhibits a rapid release between days 2 and 4, which increases the risk of hypoglycemic episodes. It was noted that careful management is necessary to mitigate these risks of hypoglycemic episodes. The committee recommended establishing measures to prevent overlooking the risks of hypoglycemic episodes. "Data indicate that the drug does not show pharmacokinetic variations based on albumin levels, considering normal albumin concentrations and the drug's peak plasma concentration," the MFDS stated. "Overall, all committee members agreed on recognizing the drug's safety and effectiveness. However, it is essential to emphasize caution regarding the risk of hypoglycemic episodes in the provided instructions for use," the CPAC chairperson commented. The MFDS concluded that while Awiqli is not subject to a conditional Phase 4 approval, it will require post-marketing surveillance (reexamination) and the implementation of a Risk Management Plan (RMP) as part of its approval conditions.
- Policy
- Approval of the 48hr Nurtec ODT for migraine imminent in KOR
- by Lee, Hye-Kyung Dec 31, 2024 05:55am
- ‘Nurtec (Rimegepant),’ which is used for both the treatment and prevention of migraine, will soon receive marketing authorization in Korea. According to industry sources on the 31st, the Ministry of Food and Drug Safety completed the safety and efficacy review of Pfizer's Nurtec Oral Disintegrating Tablet 75 mg. Pfizer submitted a marketing authorization application for Nurtec last year, and upon the completion of the safety and efficacy review, the drug is expected to be approved soon in Korea. Nurtec is the only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved for the prevention and treatment of acute migraine in adults in the U.S. in 2021, and is approved in Israel, Kuwait, the United Arab Emirates, Europe, and China as an oral acute and prophylactic treatment for migraine. Pfizer acquired the US-based neurological disease-specializing company Biohaven and its pipeline of calcitonin gene-related peptide (CGRP) inhibitors including zavegepant, in May for USD 11.6 billion. Nurtec restores pain to normal in acute migraine patients within an hour, with efficacy lasting up to 48 hours. The drug is an orally disintegrating tablet that is administered under the tongue without water, allowing easy intake. When Nurtec was approved in China in January this year, the approval was based on the results of a Phase III study (NCT04574362) conducted in South Korea and China. The trial met its primary endpoint of freedom from pain and resolution of most migraine-related most bothersome symptoms (MBS), including nausea, sound phobia, or photophobia, in 2 hours after oral administration. In the Phase III study, which included 1,431 patients at 13 centers in South Korea, including Seoul National University Hospital, and 73 centers in China, pain relief 2 hours after dosing was 20% with Nurtec and 11% with placebo, and improvement in migraine-related MBS was 50% with Nurtec and 36% with placebo.
- Policy
- 29 new drugs with 45 ingredients reimb this year
- by Lee, Tak-Sun Dec 31, 2024 05:55am
- This year, 45 new drugs with 29 ingredients were listed for reimbursement benefits under Korea’s health insurance. Among them, the only homegrown new drug was 'Zastaprazan citrate', a P-CAB-based gastroesophageal reflux disease treatment. As of the 30th, 45 new drugs were listed for reimbursement in Korea’s National health insurance system from January to December 2024, improving patient access. In January alone, five 5 drugs were reimbursed, including the anti-cancer drugs ‘Braftovi Cap,’ and ‘Bosulif Tab,’ ulcerative colitis treatment ‘Zeposia Cap,’ asthma and COPD treatment ‘Trimbow Inhaler,’ and neurofibromatosis treatment ‘Koselugo Cap.’ In February, two new drugs, ‘Kerendia Tab’ for chronic kidney disease and ‘Luxturna Inj’ for inherited retinal dystrophy, were approved, followed by ‘Trelegy 200 Elllipta Inhaler’ for asthma in March. In April, four new drugs were covered by health insurance, including cytomegalovirus treatment ‘Livtencity Tab,’ plaque psoriasis treatment ‘Sotyktu Tab,’ and anticancer drugs ‘Poteligeo Inj,’ and ‘Enhertu Inj.’ In May, the atopic dermatitis treatment ‘Adtralza Prefilled Syringe’ and the iron deficiency treatment ‘Ferrinject Inj’ were covered, and in June, morning sickness treatment ‘Diclectin Enteric-coated Tab’ were covered for the first time under the government's health insurance program. New Drugs reimbursed in 2024 in Korea, (number of items) New drug approvals continued into the second half of the year. In July, 3 new drugs were introduced, including the eosinophilic asthma treatment ‘Fasenra Prefilled Syringe,’ the hemophilia treatment ‘Idelvion Inj,’ and the anti-cancer drug ‘Xpovio Tab.’ In August, the CAPS treatment ‘Ilaris Inj’ and schizophrenia and bipolar disorder treatment ‘Latuda Tab’ were listed. No new drugs were listed in September, but five came out at once in October. The glaucoma treatment ‘Rhopressa Eye Drops,’ secondary hyperparathyroidism treatment ‘Orkedia Tab,’ the domestic new drug GERD treatment ‘Jaqbo Tab,’ COVID-19 treatment ‘Paxlovid Tab’ and ‘Veklury Inj’ were covered by health insurance, reducing the financial burden on the patients. In November, ‘Empaveli Inj,’ a treatment for paroxysmal nocturnal hemoglobinuria, was added to the list, and in December, new drugs such as ‘Vyxeos Liposome Inj,’, a treatment for acute myeloid leukemia, ‘Qarziba,’ a treatment for neuroblastoma, and ‘Camzyos Cap,’ a treatment for obstructive hypertrophic cardiomyopathy, were added to the reimbursement list. Of the new drugs on the list, 12 were covered by risk-sharing agreements, which accounts for more than 40% of the total listed items. Ten drugs accepted the average price of alternative drugs and skipped insurance price cap negotiations and only negotiated on the estimated claim amount. Next January, apremilast, an ingredient used for psoriatic arthritis and psoriasis, will be reimbursed for the first time. The five drugs that will be reimbursed are all generics. The original apremilast-based drug was Amgen's Otezla Tab, but it failed to gain reimbursement and was withdrawn from the Korean market. This is the first time that a group of domestic generic companies have entered Korea’s health insurance reimbursement market.
- Policy
- Yungjin Pharm wins the 1st trial against Ofev
- by Kim, Jin-Gu Dec 31, 2024 05:44am
- Yungjin Pharm has won the usage patent dispute for Ofev (nintedanib), a treatment for idiopathic pulmonary fibrosis (IPF). Based on the victory, Yungjin is one step closer to the early launch of its generic version of Ofev. The pharmaceutical industry suggests this decision is significant beyond Yungjin Pharmaceutical's avoidance of Ofev's usage patent. It may serve as a patent-avoidance strategy for generics. Yungjin Pharm wins the first trial for Ofev's usage patent…brings closer to the early launch of generic According to the pharmaceutical industry on December 20, the Korean Intellectual Property Trial and Appeal Board (IPTAB) recently issued a decision of 'claim upheld' in a passive rights scope confirmation trial filed by Yungjin Pharm against Boehringer Ingelheim regarding the usage patent of 'Ofev Soft Cap.' In September, Yungjin Pharm filed claims for a passive rights scope confirmation trial against the usage patent of Ofev. Following that, Cosmax Bio and Daewoong Pharmaceutical also filed claims for the same avoidance trials. Among these companies, Yungjin Pharm was the first to win.. Product photo of OfevOfev is protected by at least three patents: a substance patent expiring in January 2025, a usage patent expiring in September 2026, and a formulation patent expiring in June 2029. Only the substance patent is listed in the Ministry of Food and Drug Safety's (MFDS) patent registry, while the usage·formulation patents are unlisted patents. Having won the first trial for the usage patent, Yungjin Pharm is now closer to the early launching its generic version of Ofev. On December 12, Yungjin Pharm received approval for its generic version of Ofev as 'Nintebro.' The generic can be launched after the substance patent expires on January 25. The unlisted formulation patent remains to be solved but nullifying the substance patent is easier than the substance patent or usage patent. Yungjin Pharm is expected to enter the KRW 5.7 billion (USD 4.3 million) nintedanib market with the sole generic version of Ofeb if it launches its product. According to pharmaceutical market research firm IQVIA, Ofev's sales in 2023 totaled KRW 5.7 billion. Despite not being covered by national health insurance, Ofev has steadily increased its sales, reporting KRW 1.8 billion in 2020, KRW 3.3 billion in 2021, KRW 5.6 billion in 2022, and KRW 5.7 billion last year. A single clause in the generic's indication was the key to determining the patent dispute outcome The pharmaceutical industry closely examines the reasons behind Yungjin Pharm's victory in the usage-patent dispute. This success is due to the company's innovative strategy to address the usage-patent conflict, setting it apart from traditional methods. The key to the victory was the MFDS' acknowledgment of the 'exclusion clause.' Nintebro approval was the first time the MFDS has acknowledged 'excluding X.' Ofev is approved for the following indications: ▲Treatment of IPF ▲Delay of pulmonary function decline in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) ▲Treatment of chronic fibrosing interstitial lung diseases with a progressive phenotype (excluding IPF). For Nintebro, it is approved for the following indications: ▲Delay of pulmonary function decline in patients with SSc-ILD ▲Treatment of chronic fibrosing interstitial lung diseases with a progressive phenotype, excluding IPF. Boehringer Ingelheim Yungjin Pharm The analysis suggests a key element in the trial outcome in this usage-patent dispute was the 'excluding IPF' clause in Nintebro's second indication. Yungjin Pharm strategically focused on the remaining indications of Ofev, deliberately excluding IPF to circumvent the drug's usage patent. If the MFDS had not acknowledged the 'exclusion clause,' Yungjin Pharm's strategy may not have been successful. Even if the company removed Ofev's first indication, IPF could be interpreted as being included within Ofev's third indication. In other words, if Yungjin Pharm had not included the exclusion clause in the Nintebro indication, the company would have won the avoidance only if it had deleted Ofev's first and third indications. However, the MFDS recognized the wording 'excluding IPF' for Nintebro's second indication, which Yungjin Pharm strategically emphasized during the patent dispute. Ultimately, the Korean IPTAB accepted Yungjin Pharm's argument, ruling that Nintebro did not infringe on Ofev's usage patent. MFDS has acknowledged the 'excluding X' clause for the first time…will this become the new patent avoidance strategy? Until now, the MFDS has not acknowledged phrases such as 'excluding X' in the indication section during the drug approval process. Generic manufacturers have repeatedly requested MFDS to acknowledge such exclusion clause to circumvent originator companies' specific use patents. However, until now, only the deletion of certain indications was permitted, which was a more passive approach. In the Nintebro case, the MFDS broke from its traditional practices, approving an active approach that recognizes indications excluding certain conditions for the first time. The pharmaceutical industry positively views this precedent as a new strategy for patent avoidance. If generic manufacturers focus on obtaining approval for exclusionary language such as 'excluding X' during the regulatory process, they could secure a significant advantage in subsequent usage patent challenges. "Previously, avoiding patent infringement was difficult if the 'active exclusion clause' was not included in the efficacy and effectiveness section of a generic," Park Jong Hyuk, Yungjin Pharm's patent attorney, said. "The company received the ruling by including the exclusion clause in the efficacy and effectiveness section of the generic. It will now open a new door for avoiding patient group-specific discovery," Park said. Industry experts view that the recent ruling is expected to expand access to nintedanib for patients with rare pulmonary diseases in South Korea. Ofev has not yet been listed for reimbursement under the national health insurance system, leaving patients to pay approximately KRW 3 million monthly for the medication. The high cost has prompted a public petition for its inclusion in the reimbursement list. Now, the generic version of Ofev can be launched earlier. Patients will be able to access medication at a lower price.
- Policy
- K-CAB, Enteresto, Olumiant, Rinvoq signs PVA agreements
- by Lee, Tak-Sun Dec 30, 2024 05:57am
- HK.InnoN The domestic P-CAB-based gastroesophageal reflux disease treatment 'K-CAB Tab (tegoprazan, HK Inno.N) and heart failure treatment 'Entresto Film Coated Tab (sacubitril-valsartan-sodium salt complex) the oral JAK inhibitors Olumiant Tab (baricitinib, Lilly), and Rinvoq ER Tab (Upadacitinib hemihydrate, AbbVie) have agreed on a price-volume agreement (PVA) upon negotiations with the National Health Insurance Service. As a result, the refund rate for K-CAB was adjusted, while the price of Entresto and Olumiant will be reduced next month. According to industry sources on the 27th, 3 products recently agreed to a ‘PVA B type’ negotiations with the NHIS to adjust reimbursement and the price ceiling amounts. Since 2021, K-CAB has been reimbursed under a refund-type PVA agreement with the NHIS. Under the agreement, the pharmaceutical company refunds the NHIS for the increase in usage amount instead of reducing the upper limit amount. The new agreement is likely to have adjusted the refund amount for K-CAB. Since the reimbursement agreement, K-CAB has undergone 2 PVA negotiations with the NHIS and the company refunded an amount to make up for its increased usage. By adjusting the refund rate, it has maintained its price ceiling of KRW 1,300 per tablet since its listing in 2019. The price of the heart failure drug Entresto will be reduced to KRW 1,599 per tablet from KRW 1,683 per tablet for 3 products through the PVA. Entresto’s sales had been KRW 59.4 billion in 2023 according to IQVIA, up 29% YoY. Lilly's Olumiant was also unable to escape PVA negotiations due to increased usage this year. Olumiant also generated KRW 17.9 billion in sales last year, up 16% YoY. The deal will lower the price of the 4mg tablet from KRW 20,635 to KRW 20,172 and the 2mg tablet from KRW 13,757 to KRW 13,448. Another JAK inhibitor, Rinvoq XR tablets, will also see its price ceiling reduced through PVA type B negotiations. The price of the 15mg product will go from KRW 19,831 to KRW 18,740, and the 30mg product will go from KRW 31,628 to KRW 29,850. Rinvoq XR tablets generated KRW 20.7 billion in sales last year, up 81% YoY, according to IQVIA. Type B negotiations will be conducted when the insurance price ceiling has been adjusted through Type A negotiations, or 4 years have passed since the ceiling amount has been adjusted by negotiation without Type A negotiations and the claims of the same product group have increased by 60% or more than 10% from the previous year's claims more than four years after the date of first listing or the date the ceiling amount was adjusted by negotiation, and the increased amount exceeds KRW 5 billion. Two other products, including Janssen's autoimmune disease treatment Tremfya prefilled syringe Inj (guselkumab), will also receive a price cut through PVA Type B negotiations. This is the second year the price reductions were made in a row. For the second year in a row, the insurance price ceiling for Tremfya Prefilled Syringe and Tremfya One-Press Auto-Injector will be adjusted from KRW 1.5493 million to KRW 1.524511 million. Five products of Sanofi's hemophilia B treatment Alprolix will also have their insurance price ceiling reduced from KRW 1,081 to KRW 1,088 through PVA type B negotiations. The price adjustments will be made effective January 1, 2025.
- Policy
- 7 pharmas newly win 'Innovative Pharmaceutical
- by Lee, Tak-Sun Dec 30, 2024 05:57am
- Seven pharmaceutical companies, including Dong-A ST, have newly acquired the 'Innovative Pharmaceutical Companies Certification.' Five companies, including Ildong Pharmaceutical, received extensions on their certifications. The Ministry of Health and Welfare (MOHW) announced the result of reviewing the 'Innovative Pharmaceutical Companies Certification' candidates for 2024 through the Pharmaceutical Industry Development and Support Committee meeting held on December 27 (Friday). The result of reviewing the According to the 'Special Act on Pharmaceutical Industry Development and Support,' the MOHW has been issuing companies that have invested substantially in R&D and those demonstrating superior R&D outcomes for new drugs the 'Innovative Pharmaceutical Companies Certification' since 2012. For instance, the standards for companies based on their pharmaceutical sales are as follows: 7% spending in R&D investment for companies with sales of KRW 100 billion or below, 5% spending in R&D investment for companies with sales of KRW 100 billion or more, and 3% spending in R&D investment in companies that have obtained the U.S·Europe GMP (good manufacturing practice). The 'Innovative Pharmaceutical Companies Certification' for new types is conducted every two years, and for extension cases, it is conducted every three years. When certified, companies can maintain the status for three years. Those certified receive benefits, including added points for participating in government-funded R&D projects, drug price advantages, tax benefits, and regulatory approval support. This round of review for the 'Innovative Pharmaceutical Companies Certification' included both new certification and extension of certification. Twenty-five companies were candidates for new certifications. Seven pharmaceutical companies have passed the certification review, including Dong-A ST, Amgen Korea, Onconic Therapeutics, Curocell, Hanall Biopharma, SK Bioscience, and SK Biopharm. For Dong-A ST, the company won the title again five years after failing the cut due to rebate issues in 2019. List of companies certified as innovative pharmaceutical companies (49 companies as of December 28, 2024). 33 general companies, 12 biotech venture companies, and 4 foreign pharmaceutical companies received the title. For extension reviews, five companies were considered for the review, including Alteozen, ABL Bio, Ildong Pharmaceutical, AstraZeneca Korea, and Janssen Korea, and they all passed. As a result, a total of 49 companies received notifications for obtaining the title of innovative pharmaceutical companies. "Innovative pharmaceutical companies have played a crucial role in advancing the Korean pharmaceutical industry by investing more in R&D than other pharmaceutical companies," Director General Jung Eun-young of the Bureau of Health Industry, MOHW, said. "We will continue to establish support systems and improve policies to encourage these companies to continue to expand their R&D investments, enhance innovativeness, and create values."
