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- 2026-05-06 09:54:41
- Policy
- Samsung Bioepis receives approval for its Soliris biosimilar
- by Lee, Hye-Kyung Jan 23, 2024 06:02am
- Samsung Bioepis Samsung Bioepis has received approval for its Epysqli (eculizumab),’ a biosimilar of the ultra-high-priced rare disease treatment Soliris (eculizumab) in Korea. At the same time, it was granted first generic exclusivity until October 19th of this year, allowing Samsung Bioepis to market its biosimilar exclusively for the next nine months. In Korea, Soliris only has a patent for its 'method of treating hemolytic disease' that expires in February 2025, but the Patent Court of Korea cited a ruling by the Intellectual Property Trial and Appeal Board on December 22 last year and ruled IPTAB’s ‘invalidation ruling as legitimate.’ Among eculizumab biosimilars, Epysqli has become the first to receive approval in Korea, but Amgen’s ‘Bekemv’ was granted marketing authorization from the European Medicines Agency (EMA) in April last year. On the 19th, the Ministry of Food and Drug Safety approved Epysqli for paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Epysqli is a biosimilar of Soliris, which posts annual sales of about KRW 5 trillion ($3.76 billion) around the globe, and conducted a global Phase III trial on PNH patients from August 2019 to October 2021. It received final approval in June 2022, 19 months after applying for domestic marketing authorization. Soliris is an orphan drug, which means patents for each indication are protected separately. The patent for Soliris’s PNH indication, which is prescribed the most, expired in April 2020 in Europe and will expire in the U.S. in March 2027. Therefore, only the patent for the ‘method of treating hemolytic disease' that is set to expire in February 2025 remains for Soliris. In June 2022, Samsung Bioepis filed a patent invalidation trial against Soliris’s developer Alexion to the IPTAB while applying for the Epysqli trademark and marketing authorization, and received an invalidation ruling. Eculizumab is mainly prescribed for PNH, a condition that causes patients to pass blood-colored urine at night due to hemolysis, a phenomenon in which hemoglobin is released from red blood cells. It can be caused by mutations in the X chromosome, which is involved in the production of proteins that make up the red blood cell membrane. The exact incidence of PNH remains unknown. It mainly affects adults in their 20s and 30s. About 10% of all patients are children. Without treatment, 20% to 50% of patients die within 6 years of diagnosis, signifying its high treatment demand.
- Company
- SGLT2i+DPP4i combos' performance falls short of expectations
- by Kim, Jin-Gu Jan 23, 2024 06:02am
- A large number of 'SGLT-2 inhibitor (SGLT2i)+DPP-4 inhibitor (DPP4i)' combinations entered the market after Korea’s insurance reimbursement was extended to cover ‘SGLT-2 inhibitor + DPP-4 inhibitor’ combinations, however, their sales performance in the first year is falling short of expectations. Of the major products that have been on the market since May, only 3 generated more than KRW 2 billion in prescriptions by the end of the year. Of the more than 30 dapagliflozin+sitagliptin combination products released since September, most prescriptions sold less than KRW 100 million by the end of the year. In the field, prescribers are noting how the extended reimbursement is applied to the 3 drug combinations of SGLT2i+DPP4i+metformin. Therefore, rather than adding metformin to the newly launched SGTL2i+DPP4i two-drug combination drugs, prescribers have been mainly prescribing the combination by adding a single SGLT2i agent to existing DPP4i+metformin combination drugs. SGLT2i+DPP4i combo mkt size KRW 8.8 bil… Esglito>Zemidapa>Qtern According to the pharmaceutical industry on the 23rd, the outpatient prescription market for SGLT2i+DPP4i combination was KRW 8.8 billion last year. Behringer Ingelheim's Esglito (empagliflozin+linagliptin)’ has shown the highest prescription performance, generating KRW 2.7 billion in prescription sales in the 8 months following its reimbursement listing in May last year. This was followed by LG Chem's Zemidapa (dapagliflozin+Zemiglo) and AstraZeneca's Qtern (dapagliflozin+saxagliptin), each of which recorded KRW 2.1 billion. Qtern is being sold by Ildong Pharmaceutical in Korea. The rest of the combination drugs have all posted less than KRW 1 billion in sales. Chng Kun Dang’s ‘Exiglu-S Tab (dapagliflozin+sitagliptin) posted KRW 600 million, Dong-A ST’s Sugadapa (dapagliflozin+evogliptin) posted KRW 500 million, and AstraZeneca's Sidapvia (dapagliflozin+sitagliptin) for KRW 200 million. Of these, all products other than Sidapvia, have been sold in earnest since their reimbursement listing in May last year. Sidapvia was launched in September last year after the patent expiry of Januvia (sitagliptin). The drug is manufactured and supplied by SK Chemicals in Korea. Other dapagliflozin+sitagliptin combinations launched alongside Sidapvia have accumulated less than KRW 100 million in prescriptions from September until the end of the year. Industry expresses performance is 'below expectations'...Different response from when the 96 companies were approved The market was formed after reimbursement was extended to combination therapy in Korea for diabetes in April last year. At the time, the government extended reimbursement to the SGLT2i+DPP4i+metformin combination. In May, the SGLT2i+DPP4i combination drugs were approved The pharmaceutical industry had initially predicted that demand would rise for combination products, especially those that combined SGLT2i and DPP4i since it was the first time the combined use of SGLT2i and DPP4i was reimbursed in Korea. In fact, the pharmaceutical industry had shown great attention, with 96 companies receiving approval for the 2-drug combo around the period of the reimbursement expansion. In April, the patent for the flagship SGLT2i class drug Forxiga (dapagliflozin) expired. The companies that owned original DPP4i drugs rushed to launch combination products that contained dapagliflozin. In September, the patent for Januvia (sitagliptin), the flagship DPP4i class drug, also expired. The expiration of the patents for the top drugs in each class led to a flurry of launches of dapagliflozin+sitagliptin combinations. But now last year's outpatient prescription performance results are out, and the industry consensus is that the performance of the 2-drug combinations is a disappointment. Even when considering that it was the first year of sales, it was not up to expectations. When taking the dapagliflozin+sitagliptin two-drug combination as an example, 34 companies have launched their product since September, but their combined prescription sales amounted to only KRW 1.4 billion. The average prescription per company is less than KRW 50 million. Combination drugs that used original drugs fared similarly. Taking Esgliteo, the highest-selling drug last year that posted KRW 2.7 billion as an example, its components, the single-agent drugs ‘Jadiance (empagliflozin)’ and ‘Trajenta (linagliptin),’ generated prescription sales of KRW 58.1 billion and KRW 61.3 billion, respectively, last year. "Prescribing the more familiar DPP4i+metformin combination"...New combinations at a crossroads The industry has raised various interpretations on the lower-than-expected performance of the drugs. First of all, one analysis was that the new combination drugs were not well received in the field. The government's diabetes benefit extension was for the three-drug combination of SGLT2i+DPP4i+metformin. The SGLT2i-DPP4i two-drug combination by itself is not covered. As a result, prescribers were left to choose one of three options: SGLT2i+DPP4i combo and metformin, SGLT2i+metformin combo and DPP4i, or SGLT2i and DPP4i and metformin. The problem is that prescribers were relatively more familiar with the SGLT2i+metformin or DPP4i+metformin combinations that were already on the market, compared with the more newly introduced SGLT2i+DPP4i combinations. "To use the newly approved SGLT2i+DPP4i combinations, patients would need to change all of their existing medications, whereas DPP4i+metformin combinations require patients to add a single SGLT2i to their existing medications, so there is less patient resistance," explained one endocrinologist. "Also, the combination drugs are not very competitive price-wise when compared with prescribing each drug separately," he added. In the case of the dapagliflozin plus sitagliptin combination, supply issues with sitagliptin also played a role. In the case of sitagliptin, one contract manufacturer manufactures products for 10 or more companies. The production capacity of the contract manufacturers has reportedly become overwhelmed, manufacturing the ingredients for so many companies. Some companies are also reportedly having difficulty producing products for companies due to difficulty procuring raw materials that need to be imported from India. However, there is also industry opinion that it is too early to tell whether SGLT2i+DPP4i combination products will be successful in the market. As there is still a possibility that the sitagliptin contract manufacturers will be able to stabilize their supply, and as related products are in the early stages of their launch, there remains enough potential for future market expansion.
- Policy
- Korean patients pay ₩10.5M for ₩300M Luxturna
- by Lee, Tak-Sun Jan 23, 2024 06:02am
- Novartis Luxturna (voretigene neparvovec-rzyl, Novartis), the first gene therapy for Inherited Retinal Dystrophy (IRD), is set to be reimbursed from the 1st of next month and is expected to significantly reduce the burden of those suffering from IRD in Korea. Although the price limit for Luxturna had been set at KRW 325.8 million per vial, the out-of-pocket cost borne by each patient is expected to be about KRW 10.5 million with the insurance reimbursement. According to industry sources on the 22nd, Luxturna will be listed for reimbursement under the risk-sharing system with a price cap of KRW 325.8 million per vial from next month. Novartis has signed 3 types of risk-sharing agreements with the National Health Insurance Service, including the refund type, expenditure cap type, and performance-based refund type RSA. The drug is used for adult and pediatric patients who have sufficient viable retinal cells but have lost vision due to IRD caused by a mutation in the RPE65 gene. The number of affected by IRD is estimated to be around 9 per year. Novartis’s Luxturna is a one-shot treatment that can treat a disease with a single administration, and the third among one-shot treatments to receive reimbursement approval in Korea, following Kymriah and Zolgensma. Currently, Luxturna is listed in 6 of the A8 countries – the US, France, Japan, Italy, Switzerland, and the UK. The A8 adjusted average price is KRW 875.11 million for both eyes. In Korea, Luxturna will be listed at a lower price of KRW 652 million. If used on one eye, the total cost is KRW 325.8 million. If you apply the 10% copayment rate, the cost is KRW 32.58 million, but if you apply the out-of-pocket maximum system, the cost borne by the patient drops to KRW 10.5 million. The estimated claims amount for the drug in the first year is about KRW 5.86 billion based on the list price, but the NHIS expects the actual financial expenditure to be less than this, considering the risk-sharing agreement signed for the drug. In addition, to ensure cost-effectiveness, Novartis needs to submit long-term follow-up data from Phase III clinical studies. The data will be evaluated at the end of the risk-sharing agreement period. Luxterna applied for reimbursement upon its approval in September 2021 and received insurance reimbursement in 2 years and 4 months. Meanwhile, Novartis decided to lower the price of its chronic heart failure treatment ‘Entresto Film Coated Tab’ from KRW 1,690 to KRW 1,683 per tablet upon Luxturna’s reimbursement.
- Company
- Will Verzenio secure expansion for early breast cancer?
- by Eo, Yun-Ho Jan 23, 2024 06:02am
- Lily Korea ‘Verzenio’, which faced difficulties in expanding its reimbursement standards last year, is now drawing attention to see if it will pass the review this time. According to industry sources, Lily Korea’s CDK4/6 inhibitor Verzenio (abemaciclib) is expected to be considered for the Health Insurance Review and Assessment Service (HIRA)’s Cancer Disease Review Committee on the 31st. Their second attempt to expand the reimbursement is for Verzenio’s indication in early-stage breast cancer. Verzenio faced challenges in initial attempt to expand its indication for early-stage breast cancer when it was presented to the Cancer Disease Review Committee. Despite submitting the application and waiting for six months, Verzenio was presented to the committee in May of the previous year, but the result was ‘reimbursement standards non-established.’ After five months, Verzenio re-submitted its reimbursement application to the HIRA in October. After Verzenio was resubmitted, a national petition was posted on the Cheong Wa Dae public petition website in the same month, advocating for ‘the reimbursement of Verzenio as a targeted treatment for early-stage breast cancer’. In the most recent application, clinical evidence was added, including the five-year outcomes from the monarchE study, presented at the 2023 European Society for Medical Oncology (ESMO) Congress. The data used for the follow-up research were based on the four-year data presented at the 2022 San Antonio Breast Cancer Symposium held in December and an article published in The Lancet Oncology. The primary endpoints, which were invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS), showed clinically significant differences between the Verzenio treatment group and the control group (endocrine therapy alone) that was even more pronounced in five-year data compared to the four-year data. In year 5, the primary endpoint invasive disease-free survival (IDFS) demonstrated an approximately 8% difference. Verzenio appears to have a potential carry-over effect through the fifth year even after the completion of the two-year treatment period. Besides the endocrine therapy letrozole generic, Verzenio is the only treatment option available in HR+/HER2- type early-stage breast cancer. On November 18, 2022, Verzenio received expanded approval for its use in combination with endocrine therapy in the adjuvant treatment of patients with HR+/HER2- high-risk early-stage breast cancer and who have lymph node-positive recurrence. The following are specific indications: ▲Four or more lymph node metastases, ▲1-3 lymph node metastases with a tumor size of 5 cm or larger, ▲Histological grade 3 limited recurrent high-risk patients.
- Policy
- Luxturna, Kerendia, & Raspirin will get new reimb standards
- by Lee, Jeong-Hwan Jan 22, 2024 05:49am
- On the 19th, the Ministry of Health and Welfare (MOHW) gave an administrative notification on the “Partial amendment to the details (pharmaceuticals) on the application standards and methods of medical reimbursements.” New reimbursement standards will be established for Novartis’s Luxturna, a one-shot retinal dystrophy treatment, Hanmi Pharmaceutical’s Raspirin Cap, and Bayer’s Kerendia Tab 10 mg, as they are set to be listed for reimbursement. Reimbursement standards will be set for Takeda’s Obizur, a treatment for acquired hemophilia A, and Pfizer’s Zavicefta Inj, a new antibiotics drug, as they are in the process of reimbursement listing. On the 19th, the Ministry of Health and Welfare (MOHW) gave an administrative notice on the “Partial amendment to the details (pharmaceuticals) on the application standards and methods of medical reimbursements” and will collect opinions by the 29th. ◆Luxturna Inj= an ophthalmic drug Luxturna will be eligible for reimbursement for pediatric and adult patients with inherited retinal dystrophy caused by biallelic RPE65 mutations who meet all of the following conditions and have sufficient surviving retinal cells. Patients must have a genetic diagnosis of biallelic pathogenic or likely pathogenic RPE65 mutations. Reimbursement will be approved for patients who are aged four years or older but younger than 65 years at the time of administration. The maximum corrected visual acuity in both eyes should be 0.3 or less, or the visual field in both eyes should be less than 20 degrees. In addition, there must be enough surviving retinal cells, and all the following conditions must be met. The thickness of the posterior part of the retina in optical coherence tomography findings should exceed 100 μm. Based on fundus examination, the area in the posterior part of the retina without atrophy or pigment degeneration should be at least three times the size of the optic disk. The visual field measured with Goldmann III4e isopter or its equivalent should remain within the central 30 degrees of vision. Patients who have undergone intraocular surgery within the past six months or have had infections in or around the eyes will be excluded from the treatment group. Luxturna, a gene replacement therapy given as a single dose, is eligible for reimbursement once in a lifetime. It should be administered exclusively by a retinal specialist experienced in macular surgery. According to the revised standards for managing reimbursement of high-cost drugs, patients receiving Luxturna must provide reimbursement information on the reimbursement statement for four years, adhering to the specified reimbursement claim procedure, assessment claim form, statement format, and preparation guidelines. ◆Raspirin Cap= Reimbursement will be approved for patients who are being treated with a combination therapy of Aspirin and rabeprazole, meeting reimbursement standards. ◆Kerendia 10 mg= Reimbursement will be approved for adult patients with chronic kidney disease associated with type 2 diabetes who are receiving the drug in combination with a standard therapy (ACE inhibitor or angiotensin II receptor blocker) and meet all conditions, even if they have been stably treated with the maximum tolerated labeled dose of angiotensin-converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker for more than four weeks. However, patients in NYHA class II~IV with consistent symptoms will be excluded from reimbursement eligibility. ◆Obizur= Reimbursement for Obizur will be applied for the treatment of bleeding episodes in adults with acquired hemophilia A. The treatment is intended for patients who meet one of the following conditions: who have an antibody titer of greater than 5 Bethesda Units (BU), who have antibody titer of less than 5BU and a lack of clinical response to high doses of antihemophilic factor, or who have a recent history of an antibody titer of less than 5BU and who had a clinical response to Obizur after having a lack of clinical response to high doses of antihemophilic factor. Obizur can be administered to hospitalized patients and outpatients in hospitals. Treatment costs can be reimbursed when the drug is used according to the recommended methods of administration and dosage. Patients should also refer to precautions, including warnings, adverse reactions, and general precautions. Patients should be diagnosed and receive prescriptions by hematologists specializing in hematology-oncology in the department of internal medicine or hematology-oncology specialists in the department of pediatrics. ◆Zavicefta Inj= Reimbursement will be approved for patients with documented cases of complicated intra-abdominal infections, complicated urinary tract infections, or when carbapenem antibiotics have failed in treating hospital-acquired and ventilator-acquired pneumonia, or when multi-drug-resistant gram-negative bacteria or carbapenem-resistant intestinal bacteria are present. Additionally, a prescription recommendation must be attached. ◆Forxiga and Jardiance= Reimbursement for Forxiga (ingredient: dapagliflozin) 10 mg and Jardiance Tab (ingredient: empagliflozin) 100 mg, which are SGLT-2 inhibitor-mediated diabetes treatments, will be expanded for patients undergoing treatment for chronic heart failure. Specifically, reimbursement will be approved for patients having chronic heart failure with reduced left ventricular ejection function, falling into NYHA class Ⅱ∼Ⅳ, having a Left Ventricular Ejection Fraction (LVEF) of ≤ 40%, and undergoing a standard treatment with a stable dose.
- Company
- Sotatercept receives orphan drug designation in Korea
- by Eo, Yun-Ho Jan 22, 2024 05:49am
- Sotatercept, a new drug candidate for pulmonary arterial hypertension (PAH), has been designated an orphan drug in Korea. The Ministry of Food and Drug Safety recently announced the drug’s designation in the first orphan drug designation announcement it made in the new year. Sotatercept, which is being developed by Merck, is being regarded to have changed the treatment paradigm for PAH. The substance, which is a combination of a protein complex, activin, and the transforming growth factor-β (TGF-β), reverses disease progression by blocking abnormal signaling between cells in the pulmonary blood vessels. Pulmonary arterial hypertension is a condition characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation. which leads to heart failure. In Korea, about half of the patients with PAH die within 5 years. More than 10 drugs are available for the condition in Korea, including phosphodiesterase type 5 inhibitors and endothelin receptor antagonists, but many patients suffer from severe symptoms despite being on a combination of two or three drugs. The efficacy of the drug has been confirmed in the pivotal Phase III STELLAR trial. Patients were randomized 1:1 to sotatercept or placebo to assess the efficacy and safety of the drug. Results showed that the sotatercept group improved in 6-minute walk distance (6MWD, primary endpoint) by 40.1 m, compared with a decline of –1.4 m in the placebo group Also, 38.9% of patients in the sotatercept group achieved all of the multi-component improvement endpoints, the secondary endpoint of the study, which included an improvement of 30m or more in the six-minute walk test. This was 4 times longer than the 10.1% in the placebo group. The US FDA will decide whether to approve sotatercept by March 26, the target action date it had set under the Prescription Drug User Fee Act (PDUFA).
- Company
- First oHCM drug Camzyos applies for reimb in Korea
- by Eo, Yun-Ho Jan 22, 2024 05:49am
- The first-ever obstructive hypertrophic cardiomyopathy (oHCM) treatment, ‘Camzyos,’ is being reviewed for reimbursement in Korea. According to industry sources, BMS Korea has recently applied for the reimbursement listing of its new obstructive hypertrophic cardiomyopathy (oHCM) drug Camzyos (mavacamten). Therefore, whether the drug will be deliberated by the Health Insurance Review and Assessment Service within the first quarter of this year remains to be seen. Camzyos is the first and only cardiac myosin inhibitor that specifically targets excess cross-bridge formation of myosin and actin proteins, the main cause of oHCM. Camzyos can improve left ventricular hypertrophy and left ventricular outflow tract obstruction by separating myosin from actin and relaxing the over-contracted heart muscle. In the Phase III EXPLORER-HCM trial, which served as the basis for Camzyos’s approval, Camzyos achieved and improved the primary composite endpoint of the proportion of patients with decreased symptom burden (by NYHA class) and functional capacity (peak oxygen consumption, pVO2) by more than two times compared with placebo. In particular, 20% of the patients who received treatment with Camzyos achieved both primary endpoints, pVO2 improvement, and the NYHA class requirement. Also, the dynamic left ventricular outflow tract obstruction was reduced by over 4 times with the use of Camzyos. 7 out of 10 patients treated with Camzyos improved to the extent that they would not consider surgery, and showed consistent benefits over 30 weeks. oHCM is a rare disease that occurs when the left ventricular muscle of the heart becomes abnormally thick, obstructing blood flow through the aorta to the rest of the body. Its main symptoms are shortness of breath, dizziness, chest pain, fainting, etc., which appear in various ways and can increase the risk of various cardiovascular complications such as heart failure and atrial fibrillation There had remained a high unmet need for the treatment oHCM as its treatment focused more on symptom relief than fundamental cure. Treatment options such as beta-blockers and non-dihydropyridine calcium channel blockers can reduce the heart rate and myocardial contractility, but it is difficult to expect long-term improvement with these existing drug treatment options alone. Meanwhile, the European Society of Cardiology revised its HCM guidelines for the first time in nine years with the introduction of Camzyos and recommended it as a second-line treatment. Among all treatment options for oHCM, Camzyos received the highest level of evidence, level of evidence A. Previously, no other recommended drug option had a higher level of evidence than B.
- Policy
- Forxiga withdraws from the Korean mkt despite reimbursement
- by Lee, Tak-Sun Jan 22, 2024 05:48am
- The SGLT-2 inhibitor ‘Forxiga Tab,’ which its company plans to withdraw from the Korean market in the first half of the year, will now be reimbursed for chronic heart failure. However, the withdrawal of the drug from the market has put a damper on the reimbursement expansion. Even if it is reimbursed from next month, there will inevitably be a gap in the use of the treatment when stocks run out due to the discontinuation of its supply. Therefore, patients with heart failure in Korea are at risk of losing access to the treatment option of Forxiga despite the coverage expansion. The Ministry of Health and Welfare announced in a preliminary notice of revisions to the drug reimbursement standards that it will expand reimbursement for SGLT-2 inhibitors such as Forxiga and Jardiance to chronic heart failure from the 1st of next month. With the revision, Forxiga and Jardiance will be reimbursed for patients with chronic heart failure and a left ventricular ejection fraction of 40% or less who are receiving a stable dose of standard therapy. Here, standard therapy is defined as an ACE inhibitor or angiotensin Ⅱ receptor blocker (ARB) or sacubitril-valsartan in combination with a beta-blocker or aldosterone antagonist. Forxiga and Jardiance can also be used in combination with other standard therapies for heart failure. As a result, the treatment scope of Forxiga, which had mainly been used to treat patients with diabetes, was been extended to chronic heart failure. However, the reimbursement extension was overshadowed by the company's withdrawal from the domestic market in the first half of this year. AstraZeneca announced late last year that it would be withdrawing Forxiga from the domestic market in the first half of this year. Given the upcoming domestic supply disruption, patients with heart failure may be hesitant to use Foxiga even with the reimbursement extension. The patients will have to discontinue use of Forxiga the day the remaining stock runs out, On this, AstraZeneca Korea said, "We are in multi-faceted discussions with the health authorities on how to continue treatment for patients with chronic heart failure and chronic kidney disease who are using Forxiga. We currently have secured sufficient quantities for domestic supply for the year.” The problem is, other than Forxigna, none of the same-ingredient generics that have been released since April last year own the chronic heart failure indication. Upon Forxiga’s market withdrawal, generic versions of the same drug would have to be used, but this is difficult because the generic versions are not authorized or reimbursed for the chronic heart failure indication. This is because Forxiga’s patent for chronic heart failure does not expire until March 2040. Due to this, the reimbursement extension granted for SGLT-2 inhibitors is likely to benefit Boehringer Ingelheim Korea's Jardiance. Jardiance has yet to launch a generic, and other SGLT-2 inhibitor generic drugs do not have a chronic heart failure indication. Therefore, whether the health insurance authorities will find a way to maintain the use of dapagliflozin, Forxiga’s main ingredient, available for chronic heart failure, remains to be seen.
- Policy
- P3T for chin fat reduction injection ‘AYP-101’ approved
- by Lee, Hye-Kyung Jan 19, 2024 05:45am
- A Phase III trial for Amipharm's 'AYP-101', an injectable drug for submental fat reduction, will be conducted in Korea. On the 16th, the Ministry of Food and Drug Safety approved a Phase III clinical trial to ‘evaluate the efficacy and safety of AYP-101 in reducing submental fat in adults with moderate-to-severe convexity or fullness associated with submental fat. Amipharm had previously conducted a Phase II trial for the injection on 96 Koreans from August 2021 to June 2023 and will initiate the Phase III trial in Korea with the MFDS approval. AYP-101 is an injectable for submental fat reduction that selectively induces fat cell apoptosis and lipolysis. Its main ingredient is polyene phosphatidylcholine (PPC), a natural substance extracted from glycine max. merr (soybeans) at high purity. In 2018, Amipharm obtained a patent from the Korean Intellectual Property Office for "Composition and Manufacturing Method of Local Fat Reduction Injectable (AYP-101) without Pain, Edema and Side Effects. If commercialized, Amipharm expects AYP-101 will become the first new incrementally modified drug to be developed in Korea in the aesthetic field. AYP-101’s composition improves the disadvantages of existing PPC injections, which cause pain and swelling through a mechanism of action that brings about cell necrosis. PPC injections have previously been approved for cell membrane binding and regeneration in areas such as liver disease and dementia as ‘Lipobin Inj,’ but have been used off-label as lipolysis injections. Current treatment options for submental fat, also known as a double chin, are limited. Existing methods include off-label, mesotherapy cocktail injections performed under general or local anesthesia and surgical liposuction performed under general anesthesia. AYP-101 is expected to help expand the therapeutic area for the injection to patients who are interested in the non-surgical injectable method of localized fat reduction. Meanwhile, AMI Investment, an investment company established through a 6:4 joint venture between KPM Tech and Telcon, invested KRW 10 billion and acquired 810,000 shares (24.2% stake) of AmiPharm, and became the second largest shareholder. Amipharm holds a patent for 'Composition and Manufacturing Method for Injectable Drug Containing PPC without deoxycholic acid sodium’ that it obtained in Korea in 2014 and a patent for 'Composition and Manufacturing Method for Fat Decomposition Substance that contain PPC' in the United States in 2015.
- Policy
- Emerging candidate for Dir. of the Pharmaceutical Benefits
- by Lee, Jeong-Hwan Jan 19, 2024 05:45am
- Secretary Jung-min Yu (Left), Director Chang-Hyun Oh (Right). Chang-Hyun Oh (55/College of Pharmacy, Chung-Ang University), the incumbent director of the Pharmaceutical Benefits at the Ministry of Health and Welfare (MOHW), is expected to be succeeded by Jung-min Yu (passed the 51st civil service exam/Ewha Womans University), who is currently serving as Secretary in the Office of the Senior Secretary to the President for Social Policy while being transferred to the Presidential Secretariat. Oh is expected to rejoin the Ministry of Food and Drug Safety (MFDS) after his promotion. According to the sources in the pharmaceutical industry on the 17th, MOHW will make personnel changes for the position of Director of Pharmaceutical Benefits soon. The Division of Pharmaceutical Benefits is responsible for various aspects of domestic pharmaceutical reimbursements. Specifically, its responsibilities include conducting cost-effectiveness evaluations and setting the upper limit of healthcare benefits (insurance drug pricing) for pharmaceuticals seeking reimbursements, reassessing the drug prices of previously listed insured drugs, developing comprehensive plans for post-insurance management of insured drugs, and conducting research and investigations related to the insurance reimbursement system for pharmaceuticals. If Yu assumes the position of the Director of the Pharmaceutical Benefits, she will also oversee the practical implementation of the revised drug pricing system to ensure fair-value compensation for innovative new drugs, which was announced in December of last year, in addition to Yu’s responsibilities related to the division. Secretary Yu initially started her career in the MFDS, then moved to the Office for Governmental Policy Coordination, and later joined the MOHW. Subsequently, Yu was transferred from working as the Director of healthcare security management in May 2022 to take the position as Secretary in the Office of the Senior Secretary to the President for Social Policy and continued to work in that position. Yu has an extensive background in roles within the MOHW, including working in the Division of National Pension Policy, Committee on Low Birthrate, and the Division of Healthcare Policy. After serving as the Head of the Healthcare Delivery System Task Force, Yu was promoted to the position of Director of healthcare security management. In March 2021, while serving as Secretary at the MOHW, Yu was recognized from the Prime Minister for her proactive administration, which included implementing temporary telephone counseling and prescriptions to prevent the spread of Covid-19 outbreak in Korea. Director Oh is expected to rejoin the MFDS after his promotion. Oh, who graduated from Chung-Ang University, is a government official responsible for pharmaceutical matters. He previously transferred to the MOHW from the MFDS through a personnel exchange program.
