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- 2026-06-25 13:21:14
- Policy
- Chinese immunotherapy tislelizumab to soon arrive in KOR
- by Lee, Hye-Kyung Nov 15, 2023 05:39am
- A PD-1 cancer immunotherapy developed in China is soon expected to receive marketing approval in Korea. According to industry sources on the 14th, the Ministry of Food and Drug Safety has completed the drug safety and efficacy review for BeiGene Korea’s ‘Tevimbra 100mg (tislelizumab).’ If no issues were found during the safety and efficacy review, the authorities can immediately grant marketing authorization for the drug. If approved, the Chinese immunotherapy drug will be competing with MSD’s ‘Keytruda (pembrolizumab),’ and BMS’s ‘Opdivo (nivolumab).’ BeiGene Korea has been conducting Phase II and III trials in Korea since 2020. The company completed a Phase III clinical trial on patients with locally advanced unresectable NSCLC whose disease had not progressed after concomitant chemotherapy who were selected based on the PD-L1 expression status, to compare the ‘ociperlimab ((BGB-A1217)+tislelizumab (BGB-A317)’ combination with durvalumab. BeiGene had previously signed a collaboration and license agreement with Novartis worth USD 2.2 billion (approx. KRW 2.942 trillion) for the drug in June 2021 but mutually agreed to terminate the agreement in September this year. On the same day of the agreement termination, the European Commission (EC) approved tislelizumab as monotherapy for the treatment of adult patients with unresectable, locally advanced, or metastatic esophageal squamous cell carcinoma (ESCC) after prior platinum-based chemotherapy. BeiGene completed over 20 clinical trials for Tevimbra’s approval and secured positive results for 10 Phase III randomized trials and 4 Phase II trials. In China, the drug has 12 indications including non-small cell lung cancer, small cell lung cancer, liver cancer, stomach cancer, nasopharyngeal cancer, and bladder cancer.
- Company
- Will the new ADC breast cancer drug Trodelvy be reimb?
- by Eo, Yun-Ho Nov 15, 2023 05:39am
- ‘Trodelvy,’ another new ADC drug for breast cancer, is seeking reimbursement listing in Korea. According to industry sources, Gilead Science Korea has submitted an application for the reimbursement of its triple-negative breast cancer treatment Trodelvy (sacituzumab govitecan-hziy) on July 31, and the agenda is awaiting to be presented for deliberation by the National Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee on the 22nd. However, the key is in setting its drug price. Various treatment options that target different mechanisms of actions or genes have been introduced to the field of TNBC treatment, however, none has been reimbursed until now in Korea. In fact, another ADC, ‘Enhertu (trastuzumab deruxtecan)’ passed the CDDC review in May, but its reimbursement agenda has not been presented for deliberation to the Drug Reimbursement Evaluation Committee until now. Whether Trodelvy will be able to overcome the difficulties and succeed in being reimbursed in Korea remains to be seen. Trodelvy is an antibody-drug conjugate (ADC) that consists of a monoclonal antibody that binds to the cell surface antigen Trop-2 and ‘SN-38,’ a TOP1 inhibitor payload. The drug received approval from the Ministry of Food and Drug Safety in May to treat adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies, including at least one prior therapy for metastatic disease. Trodelvy is the only non-cytotoxic chemotherapy approved as a second line or higher line of treatment for the entire TNBC patient population in Korea. It can be used regardless of genetic mutations or biomarkers. The National Comprehensive Cancer Network (NCCN) guidelines recommend Trodelvy as a Category 1 preferred treatment option for adult patients with metastatic TNBC who have received prior treatment. Trodelvy’s clinical efficacy was confirmed through the Phase III ASCENT study. In the study, Trodelvy significantly reduced the risk of death by 49% compared with a treatment of physician’s choice (TPC) in patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Also, the Trodelvy arm showed a 57%
- Policy
- Drug price lawsuit recovery & refund, effective on the 20th
- by Lee, Jeong-Hwan Nov 15, 2023 05:39am
- Pharmaceutical company to reduce drug price, abusing lawsuit to reduce 'term profit' strategy In order to recover or refund the loss of drug costs as a result of the drug price-down lawsuit, the NHIS must notify the pharmaceutical company of the details such as the amount of refund, method, and the deadline for submitting opinions. The Corporation of Public Security shall refund the amount of the amount of loss to the pharmaceutical company within one year from the date of the administrative trial or administrative lawsuit's citation review, or judgment is confirmed. The amount of loss is calculated as 100% of the difference in the drug price in the case of a reduction, 40% of the difference in the drug price in case of suspension or exclusion, or reduction. On the 14th, the Ministry of Health and Welfare issued a partial revision of the Enforcement Rules of the National Health Insurance Act. The revised enforcement rules will take effect on the 20th, when the Drug Refund and Refund Act comes into effect. Specifically, the Ministry of Health and Welfare has established a new provision in the Enforcement Regulations of the Health Care Act, such as 'Collection and payment procedures for equivalent losses when disputes 60-2 drugs'. The relevant provision stipulated the matters that should be notified in advance when the Korea Medical Security Corporation collects or pays the amount of losses caused by the suspension or cancellation of drug price in accordance with paragraphs 1 and 2 of the health and 2 of the health security Act, which stipulates the Drug Expenses Repayment and Refund Act. In addition, the attached details such as the standard for calculating the amount of loss and the standard for calculating the added money corresponding to interest have been specified. The Corporation shall include in the notice the name (name or business name of the corporation), address, etc. of the pharmaceutical manufacturer, from the reduction of the upper limit on the cost of the drug care benefits, that is, the drug price is, but the title of the suspension or adjustment of the application of medical care benefits, and the drug manufacturer's name and address. Details such as the amount of loss caused by the drug price-down lawsuit, the calculation of the increase, the method of loss payment and payment, and the deadline must be notified in advance, and if you do not submit the opinion of the target pharmaceutical company, you must also present the processing law. At this time, the period for pharmaceutical companies subject to drug recovery should be 10 days or more from the date of receipt of notice from the Corporation. After the opinion submission period, the Corporation must send a payment notice when collecting (refunding) the loss, and a document stating the reason for payment, payment amount, payment method, and expected payment date at the time of payment (refund) to the target pharmaceutical company. The Corporation shall pay the loss to the pharmaceutical company within one year from the date the citation decision or judgment of the administrative trial or administrative lawsuit is finalized. The criteria for calculating losses and extra money are in accordance with Schedule 82 of the Enforcement Regulations, and other details related to recovery and refunds can be determined by the chairman of the Corporation after approval of the Minister of Welfare. According to Table 82, which stipulates the criteria for calculating the loss and the added money, 100% of the drug price difference that occurred during the period when the drug price was stopped due to the administrative trial committee or the court's suspension of execution in the case of the dispute over the drug price drop disposition, and 100% of the drug price difference that occurred during the period when the administrative trial or administrative lawsuit decision is finalized from the time of drug price. In the event of a dispute over suspension, exclusion, or reduction, 40% of the approximate price difference is a loss. With the promulgation of the revised enforcement rules of the Ministry of Welfare, all the work on sub-laws related to the drug price recovery and refund system scheduled to be implemented on the 20th has been completed. The Ministry of Health and Welfare expects that the implementation of the drug price reduction and refund system will reduce the number of indiscriminate suspension and cancellation lawsuits of drug price reduction, significantly reducing the amount of health insurance finances.
- Policy
- Enforcement rules for the recovery of drug price
- by Lee, Jeong-Hwan Nov 14, 2023 05:49am
- The amendment to the enforcement rules of the 'Refund and Refund Act', which was legislatively announced by the Ministry of Health and Welfare, was judged to be important in the preliminary review of the Regulatory Reform Commission, leaving only the procedure for confirming the enforcement rules as announced in the near future. According to the Ministry of Health and Welfare on the 10th, the sub-enforcement ordinance of the National Health Insurance Act, which stipulates the drug price recovery and refund law, was amended and promulgated on the 7th, followed by the enforcement rules soon. The main contents of the amendment to the Enforcement Rules of the Health Care Act previously announced by the Ministry of Health and Welfare are as follows. First, when the Health Insurance Corporation wins the drug administration dispute, the pharmaceutical company's refund will be set as the amount of 'the drug cost paid by the Health Insurance Corporation to the drug' minus the 'drug cost that the Corporation will pay if there was no decision to stop the execution of the court'. Conversely, when the pharmaceutical company wins, the Corporation's refund is the amount of 'the drug cost that the Corporation will pay if there is no adjustment such as drug price adjustment' minus 'the drug cost already paid by the Corporation'. Interest on the amount of loss (refund amount) due to drug disputes is subject to the interest rate of the national tax refund addition under the Enforcement Decree of the National Tax Collection Act. In addition to the matters specified in the amendment, the details necessary for collection and payment, such as the collection and payment procedures for losses, calculation criteria and periods, were determined by the Corporation. It decided that the enforcement rules of the Ministry of Welfare were not important enough to receive the main regulatory review, and passed the Ministry of Welfare with only a preliminary examination, and it went through the procedure of the Ministry of Legislation to be confirmed.
- Company
- Market for montelukast revive…overcomes impurity issue
- by Kim, Jin-Gu Nov 14, 2023 05:49am
- The market for asthma treatments containing the ingredient montelukast has succeeded in complete revival. This market shrank significantly in 2020-2021 due to the side effects issue and the COVID-19 outbreak, but made a rebound last year, and is expected to expand to the largest size ever this year. The market which remained stagnant for 2 years...is expected to revive completely after making a market rebound the previous year According to the market industry research institution UBIST on the 13th, the cumulative outpatient prescriptions of asthma treatments containing montelukast in Korea reached KRW 106.5 billion in Q3 this year. This is a 27% increase in 1 year from the KRW 83.6 billion made in the same period in the previous year. Montelukast is one of the most common ingredients used to treat allergic rhinitis and asthma. The original drug is Organon Korea’s ‘Singulair’. In Korea, MSD Korea received approval for the original drug in 2000, and around a hundred domestic pharmaceutical companies are selling generic versions with the same ingredient. The market was analyzed to have made a complete recovery this year. It had continuously grown until 2019 but then had greatly contracted in 2020-2021. In 2020, the prolonged COVID-19 crisis reduced hospital visits by children and adolescents, reducing prescriptions. During a similar period, the US Food and Drug Administration required a ‘Black box warning’ be attached to montelukast products regarding its neuropsychiatric side effects. Black box warnings are the highest level of warnings issued regarding side effects. Due to the overlapping unfavorable events, the market, which was worth KRW 119.9 billion in 2019, contracted to KRW 97.7 billion in 2020 and KRW 97.6 billion in 2021. Quarterly market size of montelukast asthma treatments But the market made a rebound last year. The market size expanded again to KRW 118.9 billion last year, which is a similar level to what it made in 2019. The market then continued to grow further this year. By quarter, it sold KRW 31.2 billion in Q1, KRW 34.7 billion in Q2, KRW 29.4 billion in Q3. The analysis is that the rise in influenza and cold patients by Q3 year has increased prescriptions to alleviate related symptoms. This is similar to how prescriptions for pseudoephedrine or cephalosporin-based antibiotics had increased during the same period. In the case of Singulair, the flagship product, the supply of some doses had even become temporarily suspended due to rising demand. In general, prescriptions for this ingredient used to be concentrated in the Q4 each year. For this reason, the industry predicts that the market for treatments with this ingredient will expand to KRW 140 to 150 billion by the end of this year. Unless there are any special issues, it is expected to expand to the largest scale ever. Sales of Singulair generics soar… Lukio 18%, Montezal 44%↑ Prescriptions for major montelukast products also increased at the same time. In the case of the original Singulair, its cumulative sales increased by 8% from KRW 20.2 billion in Q3 last year to KRW 21.9 billion in Q3 this year. Sales of its generic products had risen more rapidly. Sales of HK Inno.N’s Lukio increased by 18% from KRW 6.9 billion to KRW 8.1 billion during the same period. The price of Hanmi Pharmaceuticals Montezal increased by 18% from KRW 4.5 billion to KRW 6.4 billion. Changes in major montelukast asthma treatment prescriptions Sales of Boryung’s Asluka rose by 44% YoY to KRW 6.4 billion, Hutecs’ Singuldown by 58% to KRW 4.5 billion, Dong Kook’s Singulmon by 23% to KRW 3.7 billion, and Daewoong Bio’s Daewoong Montelukast by 78% to KRW 3.1 billion, respectively. The same goes for montelukast+levocetirizine combination drugs. Hanmi’s Monterizine is the only available combination drug. Monterizine’s cumulative prescriptions in Q3 reached KRW 11.2 billion, up 27% YoY compared with the KRW 8.8 billion raised in Q3 last year. Monterizine is also facing challenges due to the imminent entry of montelukast. 10 companies - Genupharma, Huons, Daehwa Pharmaceutical, DongKoo Bio&Pharma, Binex, Boryung Pharmaceutical, Daewon Pharmaceutical, Daewoong Pharmaceutical, Medica Korea, and Jeil Pharmaceutical – won the patent challenges against Hanmi Pharmaceuticals and owns generic exclusivity for Monterizine generics and waiting to release their generics.
- Policy
- Discussions on external drug price referencing reevals begin
- by Lee, Tak-Sun Nov 14, 2023 05:49am
- The National Health Insurance Review and Assessment Service will start collecting industry opinions for the external pricing reference system reevaluations next year. At the first meeting, the pharmaceutical industry is said to have expressed disapproval, complaining of fatigue accumulated from successive reevaluations. At the meeting on the 10th, the Ministry of Health and Welfare, HIRA, Korea Pharmaceutical and Bio-Pharma Manufacturers Association, Korea Research-based Pharmaceutical Industry Association, and working group members of pharmaceutical companies gathered to share opinions. At the meeting, the government reportedly explained the legitimacy and necessity of conducting reevaluations through external reference pricing. However, the pharmaceutical industry is said to have expressed resistance to the external reference pricing reevaluation itself due to difficulties experienced due to the accumulated burden from successive reassessments conducted this year, including the price ceiling standard requirement reevaluations, drug reimbursement adequacy reevaluations, actual transaction price survey, etc. At the meeting, the government only announced the principle of sequentially re-evaluating drugs for chronic diseases whose patents have expired starting next year was expressed, and did not share specific plans. However, it has been reported that reevaluations will be carried out by calculating the highest price of each country based on the adjusted price calculation standards of the A8 countries (US, UK, Germany, France, Italy, Switzerland, Japan, and Canada) that were newly set by through revised regulations this year and comparing it with the highest price in Korea. However, it has not been decided whether to adjust the average price using the highest prices of the A8 countries, the median price, or the average price excluding the highest and lowest price, and the government is said to be planning to decide this based on industry opinion. Accordingly, the pharmaceutical industry is expected to begin collecting opinions on adjusting the price method starting this week. An industry official explained, “We plan to run a simulation to see which of the four proposed methods, including using the adjusted average price, median price, and adjusted average price excluding the maximum and minimum prices, is more advantageous.” Industry officials said that too many agendas remain in need of review, such as details on subjects for drug price cuts, and that it would be difficult to complete collecting opinions on the remaining agendas in just one or two meetings. However, the government plans to make no change in its plan of finalizing its plan this year and starting reevaluations next year. As a result, is expected that the pharmaceutical industry meeting scheduled for this month will be held, and if necessary, additional meetings will be held to complete opinion collection and report the reevaluation plan at the Health Insurance Policy Deliberative Committee meeting scheduled for next month.
- Company
- Conquest of low survival gallbladder cancer
- by Nov 14, 2023 05:49am
- In the area of bile duct cancer, where survival rates are low and treatment options are scarce, new drug candidates from domestic pharmaceutical companies have been confirmed in clinical practice and are one step closer to commercialization. HDB001A, a new drug candidate for gallbladder cancer that Handok is developing, has recently been approved by a multi-national Phase 2/3 clinical trial plan (IND) in Korea. The company plans to compare and evaluate the effectiveness of Paclitaxel alone through the combination of HDB001A and platinum-based anticancer drug Paclitaxel. Handok emerged as a dark horse in the area as HDB001A entered a late clinical trial, along with the acquisition of domestic permission for the new gallbladder cancer drug , which was introduced from U.S. company Insight. Major bioventures plan to confirm their effectiveness through the combination of new drug candidates and immunocancer drugs under development. Genome & Company GEN-101, G Innovation GI-101, and SMT Bio SMT-NK are each undergoing clinical trials in combination with Keytruda. Handok confirms the validity of Phase 2 clinical trial Handok is collaborating with Compass Therapeutics in the United States to develop a treatment for bile duct cancer. HDB001A, which is being developed, is a new drug candidate for gall cancer developed by ABL Bio, a domestic company, and the domestic copyright is held by Handok and the global copyright is held by Compass. HDB001A is known to simultaneously target DLL4 and VEGFA and play a role in the formation of new blood vessels in tumor-fine environments. The company aims to obtain conditional approval from the Ministry of Food and Drug Safety through clinical results that will end next year. Last month, SMT-NK was recognized by the Ministry of Food and Drug Safety and obtained approval for the use of drugs for clinical trials in patients with bile duct cancer. G-I Innovation is undergoing clinical phase 1 in the United States to confirm the effectiveness of GI-101 and kitluda combination therapy. It aims to secure indications for solid cancer that include bile duct cancer. The company is confirming the possibility of commercialization through combination therapy with various immune anticancer drugs. 5-year survival rate of bile duct cancer 29%, Evaluation of lack of professional treatment options for bile duct cancer Bleduct cancer is one of the cancers that is difficult to diagnose early because there are no self-aware symptoms. The 5-year survival rate for bile duct cancer is 29%, which is lower than lung cancer (34%) and liver cancer (37%). As early diagnosis is difficult, treatment options are limited. In advanced bile duct cancer, platinum-based chemotherapy has been used as a standard treatment for the past 10 years. This is a first-generation anticancer drug, a cytotoxic anticancer drug that is used not only for bile duct cancer but also for lung cancer and colorectal cancer. Side effects are also known to be high. Secondary standard therapy includes FOLFOX, but it is also not a specialized treatment for bile duct cancer. Recently, immunoanticancer agents have secured encouraging data and are attracting expectations. The impinji developed by AZ was approved as the first treatment in the country in November last year. However, targeted treatments for bile duct cancer are still insufficient. It is noteworthy whether new drug candidates from domestic pharmaceutical companies can solve the unfulfilled demand of bile duct cancer patients.
- Policy
- Drug pricing adjustment guidelines to be established soon
- by Lee, Tak-Sun Nov 14, 2023 05:49am
- With the rise of drugs that show unstable supply and the consequent rise in drugs requesting pricing adjustments, the National Health Insurance Service plans to establish a guideline for smooth pricing adjustment negotiations and disclose it soon. The NHIS recently completed expert consultations and is currently revising the final draft. According to industry sources on the 13th, the NHIS had started establishing a guideline for the pricing adjustment negotiations to simplify materials requiring submissions and ensure accurate cost analysis. Also, the authorities had collected opinions from the industry after establishing a consultative body with the Korea Pharmaceutical and Bio-Pharma Manufacturers Association. Since October, the body has started to consult with experts to establish a guideline. Currently, the NHIS completed expert consultations, and final preparations to release the final draft are said to be in progress. An NHIS official explained, “We plan to release the pricing adjustment negotiation guidelines before the end of the year. Final work is currently in progress.” Due to the rise in the number of drugs with unstable supply and demand requesting pricing adjustments, the need for a clear pricing adjustment negotiation guideline has been increasing. Moreover, the drug subject to negotiations has also increased with the NHIS’s expansion of drugs subject to adjustment applications in 2021. Previously, only drugs that did not have alternative drugs or were necessary for medical treatment were able to apply for pricing adjustments, but from 2021, drugs with an administration cost lower than their alternatives and are necessary for medical treatment and drugs that only one other company owns a drug with the same administration route and ingredient can also apply for pricing adjustments. Recently, resolving the supply and demand instability has emerged as a government task, and drugs subject to pricing adjustment are being interpreted broadly. Starting with acetaminophen at the end of last year, prices of magnesium hydroxide and pseudoephedrine were also increased through pricing adjustment negotiations, and the application for the pricing adjustment of budesonide passed the Drug Reimbursement Review Committee, and will soon begin full-scale negotiations. The adjustment negotiations aim to facilitate a stable supply of drugs by conserving drug costs. However, there was much criticism around the large amount of data submissions required, as most of the data required aligns with those required for the Drug Shortage Prevention Program. In addition, there was an opinion that an accurate cost analysis is needed by setting a fixed ratio for the general management cost and profit. NHIS plans to comprehensively collect these opinions and reflect them in the guidelines. Once the guidelines are created, it is expected to simplify the required data submissions, clarify cost analysis, and facilitate smoother drug pricing negotiations. However, drugs with an unstable supply and demand that are currently undergoing drug negotiations undergo rapid negotiations within a month through prior consultation between the public and private sectors under the condition of increasing their supply, so attention is being paid to whether these will also be able to reach an agreement within the set guidelines.
- Policy
- Regeneron enters Phase 3 in Korea
- by Lee, Hye-Kyung Nov 13, 2023 05:23am
- FDA and EMA review begins in the second half of this year for CD20 and CD3 targeted treatments. Phase 3 clinical trials for Regeneron's new lymphoma treatment drug Odronextamab are being conducted in Korea. The Ministry of Food and Drug Safety recently submitted an application from ICON Clinical Research Korea for the efficacy and safety of Odronextamab (REGN1979), an anti-CD20/anti-CD3 bispecific antibody used in combination with Lenalidomide in subjects with relapsed/refractory follicular lymphoma and marginal zone lymphoma. A phase 3, open-label, randomized clinical trial (OLYMPIA-5) was approved to compare rituximab in combination with lenalidomide. It can be viewed as a clinical trial for approval of a wide range of indications as an initial treatment for lymphoma and additional treatment for B-cell non-Hodgkin lymphoma. Odronextamab is a type of CD20 Follicular lymphoma and diffuse large B-cell lymphoma are the most frequently occurring subtypes of B-cell non-Hodgkin lymphoma. The European Medicines Agency (EMA) received PanMAA in August for the treatment of adult patients with relapsed or refractory follicular lymphoma or relapsed or refractory diffuse large B-cell lymphoma that has progressed after at least two prior systemic treatments. Subsequently, the US FDA accepted the application for priority review approval as a third-line therapy for the same indication in September. The target date for final approval is reportedly March 31 next year. It is expected to be the fourth dual antibody treatment targeting CD20·CD3 to receive FDA approval, following Roche's 'Lunsumio', AbbVie's Epkinly, and Roche's Columvi. Lunsumio', the first CD20·CD3 targeting dual antibody treatment approved by the FDA, received product approval in Korea on the 3rd. Following Epkinly and Columvi, if Odronextamab receives FDA approval, it is expected to take steps for domestic approval.
- Company
- Novartis loses 2nd trial for its Entresto patent
- by Kim, Jin-Gu Nov 13, 2023 05:23am
- The second trial over Novartis’s heart failure treatment ‘Entresto (valsartan+ sacubitril) again ended with the victory of the Korean generic companies. If the companies succeed in winning the remaining 2 suits, the companies will be one step closer to the early release of their generics. Generic companies win first and second trials on Entresto’s composition and use patent According to industry sources on the 10th, the Patent Court of Korea ruled against the plaintiff (Novartis) in the second patent invalidation trial that Novartis filed against 10 generic companies, including Hanmi Pharmaceutical, on the 9th. The patent was a composition/use patent that was set to expire in July 2027. In April 2021, 10 companies including Hanmi Pharmaceutical filed an invalidation trial on the patent. In July of the following year, the Property Trial and Appeal Board (1st trial) ruled the claims valid. After losing the 1st trial, Novartis filed an appeal to the Patent Court of Korea to cancel the trial decision. However, the 2nd trial court also ruled in favor of the generic companies. As a result, the generic companies are now one step closer to the early release of their Entresto generics. If companies win the remaining 2 disputes awaiting 2nd trial rulings, they will be eligible for early release of their generics. However, if Novartis again appeals to the second trial decision and decides to take the matters to the Supreme Court, the dispute can be prolonged with the lingering burden of early release of generics. Generic companies can become one step closer to the early release of Entresto generics if they win the other 2 remaining trials A total of 3, including the ruling made on the 9th, are being tried in the 2nd trial. One is over a crystalline patent that expires in September 2027 and the other is over a salt/hydrate patent that expires in November 2026. In the case of the crystalline patent, Elyson Pharm and other companies filed trials to confirm the passive scope of rights on the patent in January 2021, starting the dispute. The generic companies triumphed in the 1st trial. The Intellectual Property Trial and Appeal Board ruled in favor of generic companies in December 2021, and Novartis, which appealed, filed a lawsuit with the Patent Court of Korea to cancel the decision. Currently, the generic companies and Novartis are awaiting the 2nd trial ruling. The Patent Court of Korea has designated the 21st of next month as the hearing date. The generic companies also won the 1st trial for Entresto’s salt/hydrate patent, and the companies are awaiting its 2nd trial ruling. Daewoong Pharmaceuticals had first filed a suit to invalidate the patent in April 2021. In March this year, the Intellectual Property Trial and Appeal Board ruled in favor of the generic companies, issuing a decision of partial valid and partial dismissal ruling. Novartis appealed the ruling and dragged the case to the second trial. The companies had also challenged Entresto’s 2 composition patents and 1 use patent. The generic companies also won those disputes, however, Novartis did not file an appeal after losing the 1st trials, finalizing the trial decisions. Quarterly prescriptions of Entresto Faced with the imminent entry of its generics, Entresto has been rapidly increasing its prescription performance. According to the market research institution UBIST, Entresto generated KRW 14.8 billion in outpatient prescriptions in Q3. This is a 36% YoY increase compared to KRW 10.9 billion in Q3 last year. Although 6 years have passed since its release in Q4 2017, the drug is still showing high growth. Its performance rose by over 30% every quarter YoY. Its sales exceeded KRW 5 billion in Q1 2020 and expanded to more than KRW 10 billion in Q2 2022. If the current trend continues, its quarterly sales are expected to exceed KRW 15 billion in Q4 this year.
