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- 2026-05-18 16:29:41
- Policy
- Pts can participate in Phase III tx for terminal cancer
- by Lee, Tak-Sun Sep 30, 2021 05:57am
- The MFDS announced on the 29th that it has revised and distributed the "Guidelines for applying rapid screening of medicines" so that even early cancer patients can participate in clinical trials, considering the difficulty of recruiting large-scale phase 3 clinical trials for terminal cancer patients. However, even in the early stages of the disease, cancer, which can confirm clinical effects and safety at the end of the disease, is allowed, and domestic and foreign screening cases will be comprehensively reviewed and strictly applied after sufficient advice from experts. The MFDS permits patients who do not have a cure or who need a new treatment due to failure to comply with the effect or rapid progression on the condition of submitting data after completion of the test. The revision was made to give flexibility to phase 3 clinical trials of conditionally licensed anticancer drugs and expand treatment opportunities for patients by reflecting the screening criteria of overseas regulators such as the U.S. FDA and the EMA. The MFDS said it expects the revision to help carry out phase 3 clinical trials of conditionally licensed anticancer drugs and have a positive effect on rapid development of anticancer drugs and expansion of treatment opportunities for terminal cancer patients. The MFDS added that it will continue to communicate with the pharmaceutical industry and actively support drug development. Details can be found on the MFDS' website (www.mfds.go.kr) > statutes/data > statute information > civil service guidelines / civil petition guides.
- Policy
- 24 new drugs receive ₩177.9 billion benefit this year
- by Kim, Jung-Ju Sep 30, 2021 05:56am
- A total of 24 new drugs were newly listed or expanded reimbursement standards by this month, improving patient accessibility. Among new drugs that were already listed, reimbursement standards for 4 products were extended, improving coverage. Although only 10,000 patients in Korea will benefiting from the extension, the result could be interpreted as a result of Korean society’s effort to flexibly expand accessibility to drugs in recognition of the social importance of each drug. The government estimates around 104,849 patients will be benefiting from the new drugs. By fiscal scale, this will roughly translate to ₩177.9 billion’s worth of coverage reinforcement every year. First, 20 new drugs were newly listed on the reimbursement list or were already listed but their reimbursement standards (indication, administration criteria) were enhanced (based on the drug’s representative strength, etc.) from January to September this year. Newly listed drugs as of the 1st this month were Somavert (acromegaly), Atctrua and Enerzair Breezhaler capsules(asthma), and Yervoy inj (renal cell carcinoma). The expected number of patients using new drugs that were listed or expanded reimbursement is also diverse. For example, the number of patients expected to be applied reimbursement was 90, however, those for ), Atctrua and Enerzair Breezhaler capsules were 13,000 and 12,000, respectively. For Yervoy, the number is expected to be around 300. The two items that are newly expanded reimbursement are the cancer immunotherapy Opdivo inj. and the breast cancer treatment Kisquali tab. Reimbursement for Opdivo will be applied to 490 new patients, increasing finances invested by ₩14.5 billion, and for Kisquali, ₩5.1 billion will be invested to benefit 270 new patients. Such a large difference in the expected number of patients is interpreted as the result of the government’s policy to flexibly expand coverage for high-priced drugs that are used for a small number of rare diseases, and social maturity that can accommodate such policies. For the new listings and expanded reimbursement standards, the government and payer will spend around ₩177.9 billion annually to provide access to new drugs to around 104,849 patients.
- Company
- The cumulative sales of Biktarvy amounted to ￦60 billion
- by Sep 30, 2021 05:56am
- Gilead Science's Biktarvy dominated the AIDS tx market around the world, including Korea, two years after its launch. Biktarvy consists of Bictegravir Sodium, Emtricitabine, and Tenofovir Alafenamide Fumarate as Gilead's HIV treatment. Compared to conventional treatments, the effectiveness and safety are improved, the expression rate of resistance is low, the pill size is small, and it can be administered regardless of meal. After obtaining approval from the MFDS in January 2019, Biktarvy entered the market in earnest by applying benefit in July of the same year. According to IQVIA, a pharmaceutical market research firm, Biktarvy's sales increased to 4.6 billion won in the first quarter of its launch. In 2020, quarterly sales increased to 6.6 billion won, 7.9 billion won, and 9.8 billion won, respectively. It recorded 10.5 billion won in the first quarter of this year. Until the second quarter of this year, cumulative 24-month sales amounted to 59 billion won. In June 2019, just before the launch of Biktarvy, the HIV market had Genvoya and GSK's Triumeq. Genvoya and Triumeq accounted for 44.3% of cumulative market share over the year. Biktarvy recorded a cumulative market share of 19.4% over a year in June 2020, one year after its launch. In June this year, the market share was 38.3%, surpassing both Triumeq and Genvoya. As a result, Biktarvy topped the domestic HIV treatment market in the shortest time. This is because at the time of introduction in Korea, the time required from permission to notification was reduced to one-fifth, and permission and insurance benefit registration were completed in about 100 days. Gilead successfully made a replacement from Genvoya to Biktarvy. Biktarvy has already been a blockbuster in the global HIV treatment market. It posted about 8 trillion won in global sales last year, up 53.1% from about 5 trillion won a year earlier. Biktarvy ranked ninth in the world's most sold medicine last year. This is the first and only HIV treatment to be ranked in the top 10 in sales. Leading global HIV trends is analyzed as a factor in sales. Even in the COVID-19 pandemic, Biktarvy is recommended as a primary treatment. The BHIVA issued guidelines for ART to be applied to HIV-infected people in August last year, recommending Biktarvy as the only initial treatment drug among HIV treatments. It emphasized, "HIV infected people have a higher risk of COVID-19 death than the general population, so they should receive ART treatment, and it is important to use drugs that can effectively control the virus." Another HIV treatment trend is RapIT (Rapid Initation of Treatment). RapIT recommends major guidelines such as the WHO and IAS that treatment begins quickly within up to seven days of HIV diagnosis. Unlike other treatments, Biktarvy is considered a drug that meets the rapid treatment trend because it does not contain ABC and does not limit the virus level or CD4+ level of infected people. The DHHS recommends that acute and new HIV-infected people can start treatment through Biktarvy before confirming the results of genetic drug resistance tests. Biktarvy is the first and only HIV treatment to contain symptoms and emotional conditions that patients feel in their daily lives. In the PRO, patients evaluated that Biktarvy improved nausea, vomiting, sleep disorders, and fatigue compared to existing treatments, so patients' satisfaction was high. An official from Gilead Science Korea said, "Biktarvy has become the world's most prescribed HIV treatment, proving its strong and long-lasting virus suppression effect and long-term safety through the combination of upgraded integrated enzyme inhibitors and proven effective TAF drugs." He also said, "We will provide a good treatment experience for patients in need of drug switching and strengthen patient-centered marketing activities."
- Company
- SK C&C-GC Pharma, establish a big data platform for healthca
- by Chon, Seung-Hyun Sep 30, 2021 05:56am
- SK C&C announced on the 27th that it will carry out a project with GC Pharma Holdings to build a comprehensive healthcare big data analysis platform based on artificial functions (AI). During the project period, the two companies analyze and map various standard medical data based on the "cloud-type digital platform" and conduct AI convergence analysis activities based on domestic and foreign medical big data. "Cloud-type digital platform" is an all-in-one package platform that allows field practitioners to easily and quickly create necessary AI big data analysis models using AI, big data, cloud, and blockchain platforms and solutions without establishing a separate development environment. The company explains that cloud-type digital platforms allow users to freely develop various digital systems and services. The agreement was promoted with the aim of discovering new businesses related to digital healthcare through integration and analysis of data distributed to affiliates under GC. Starting with this agreement, the two companies will consider digital transformation for all affiliates under GC in the future. It plans to integrate distributed data from each company and collaborate closely in research and service solution development in the field of digital healthcare. Lee Jin-cheon, executive director of GC's Digital Transformation Office, said, "We will actively utilize domestic and foreign medical big data and DT technologies to strengthen our business capabilities in the digital sector and focus our capabilities on securing future competitiveness." Lee Ki-yeol, general manager of SK C&C's Digital Platform, said, "We will faithfully play a role as a digital transformation partner for GC Group, which plays a pivotal role not only in vaccine and new drug development but also in digital healthcare."
- Company
- Generic for Xarelto is about to be released.
- by Kim, Jin-Gu Sep 30, 2021 05:56am
- Bayer's new oral anticoagulant (NOAC) Xarelto (Rivaroxaban)' generic is imminent to be released. In particular, Hanmi, which received generic exclusivity, plans to release Xarelto 2.5mg exclusively, and Hanmi has a patent dispute with Bayer, drawing keen attention to the future response of the two companies. According to the pharmaceutical industry on the 24th, the Xarelto material patent will expire on the 3rd of next month. Generic for Xarelto will be released after the 4th of next month. In the case of the rest of the patents, Generic companies have succeeded through a Supreme Court ruling late last year. 133 generics for Xarelto are expected to be listed as starting next month. A total of 66 generic companies are expected to release generics for Xarelto 10mg and 15mg products, respectively. Hanmi's Riroxban 2.5mg was the only one to succeed in registering benefit. Hanmi is expected to release Riroxban 2.5 mg at the same time along with Riroxban 10mg and Riroxban 15mg. ◆ Bayer and Hanmi have registered their patents for use after obtaining generic for exclusivity In the case of Riroxban 2.5mg products, patent disputes still remain. This is because Bayer belatedly registered a patent for use in Riroxban 2.5mg after acquiring Hanmi's generic exclusivity. Hanmi and SK Chemicals challenged patent for Xarelto 2.5mg in March 2015. In November of that year, the two companies won the first trial. Then, as the two companies applied for permission for the first time, in July 2016, the two companies succeeded in obtaining generic for exclusivity. However, in September 2019, Bayer Xarelto 2.5 mg newly registered a patent for use. The patent expires in June next year, more than two years after acquiring generic for exclusivity. Since the new registration of the patent for use, the indication of Xarelto 2.5mg has also changed. Initially, Xarelto monotherapy was approved for the purpose of "reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation."However, after the registration of the patent for use, the combination therapy with Aspirin changed to "reduction of the incidence of atherosclerotic events such as myocardial infarction and stroke." ◆Will legal disputes continue? Riroxban's sales impact will be minimal The pharmaceutical industry predicts that it will lead to legal disputes between Bayer and Hanmi. Some predict that even if the two companies have legal disputes, sales of Riroxban 2.5mg will not be significantly disrupted. An official from the pharmaceutical industry said, "There was no problem with the approval of Riroxban 2.5mg after patent avoidance." However, if it is actually sold, there is a possibility that Bayer will raise the issue in the future, he said. ◆After the 4th of next month, it is predicted that generics for Xarelto such as Riloxvan will be released
- Policy
- Will a treatment for resistant hypertension be released?
- by Lee, Tak-Sun Sep 29, 2021 05:54am
- Attention is focused on whether a treatment for resistant hypertension that cannot be controlled with existing drugs, that is in the final stages of its clinical trial, will succeed in commercialization. The drug is firibastat, that is developed by Quantum Genomics. Dong Wha Pharmaceuticals owns exclusive commercialization rights to supply the drug in Korea. The Ministry of Food and Drug Safety approved the multinational Phase III trial for firibastat on the 24th. The clinical trial will verify the efficacy and long-term safety of once-daily oral administration of firibastat for a maximum of 48 weeks in difficult-to-treat resistant hypertension patients. A total of 750 patients will participate in the clinical trial, among which 75 are from Korea. The clinical trial will be conducted in 12 large hospitals in Korea including the Seoul National University Hospital. Resistant hypertension is high blood pressure that is not well controlled even with the use of three or more blood pressure medications. It accounts for 10% to 20% of all hypertension patients Such patients usually also have other accompanying diseases and take over 4 types of hypertension drugs or are considered for surgical options such as renal denervation. Firibastat is a promising new treatment option for resistant hypertension. It is a Brain Aminopeptidase A inhibitor (BAPA) that blocks the generation of angiotensin III in the brain’s RAS (Renin Angiotensin System) to bring a triple action of lowering blood pressure, diuretic effect, and heart rate control. In the clinical trial, the drug’s efficacy will be verified through the systolic blood pressure after 12 weeks of treatment. It seems that the company will immediately apply for marketing authorization if the drug’s efficacy is verified in the Phase III trial, In April, Dong Wha Pharmaceuticals has signed an exclusive license to supply firibastat in Korea with Quantum Genomics in France. Under the agreement, Dong Wha Pharmaceuticals owns an exclusive license to develop and sell the drug in Korea. Dong Wha Pharmaceuticals sees the commercialization of firibastat as an opportunity to rise to a new leader in the 1.4 trillion won hypertension market. The drug is currently under global Phase II trial in patients with heart failure.
- Policy
- DUR check for more than 28 days of Zolpidem combined Rx
- by Lee, Hye-Kyung Sep 29, 2021 05:54am
- In the future, 49 drug ingredients, such as "Zolpidem," that should be careful during the administration period, will also be checked for drugs that exceed the maximum administration period by adding up the number of prescription days. The HIRA announced that it will apply "improvement of DUR inspection standards" to 345 items (213 reimubrsed drugs and 132 non reimbursed drugs) of 49 medicines that need to be careful of the administration period from November. Currently, DUR inspections on drugs that are subject to the period of administration are conducted only on drugs that exceed the maximum administration period per Rx. If 20 days' worth of Zolpidem-based drug A and 20 days' worth of B-based drug are prescribed in one prescription, the maximum administration period of 28 days. However, if a patient visits two medical institutions and receives 20 days' worth of prescriptions for Zolpidem-based drug at medical institution A and 20 days' worth of Zolpidem-based B drug at medical institution B, it is excluded from the DUR inspection as a separate prescription. As a result, out of the 102 million outpatient DUR information provided by the HIRA last year, 1.6 million cases, or 1.6%, were provided with medication information for the period of administration. Therefore, it was decided to check all prescriptions prescribed, induce proper use of medicines, and strengthen patient safety.
- Policy
- Delstrigo listed at ₩19,491 … Zejula’s price cut 6%
- by Kim, Jung-Ju Sep 29, 2021 05:53am
- MSD Korea’s fixed-dose combination product Delstrigo (doravirine·lamivudine·tenofovir disoproxil fumarate) will be listed with insurance benefit next month, at ₩19,491. Also, reimbursement for Takeda Korea’s Zejula cap. 100mg (niraparib) has been extended to cover monotherapy for ovarian cancer, upon which the price was cut by 6% and will be reimbursed at the price. The Ministry of Food and Drug Safety held a Health Insurance Policy Deliberation Committee (HIPDC) meeting today and passed the ‘proposed amendment to the drug benefit list and price ceiling table.’ The amended list and table will be effective from October 1st. ◆Pifeltro·Delstrigo tab.= MSD Korea’s Pifeltro tab(doravirine) and Delstrigo tab(doravirine·lamivudine·tenofovir) are oral HIV medications that are taken as one tablet, once daily. One year after receiving approval from the MFDS on November 22nd, 2019, the company applied for insurance listing of the two products in December last year and received deliberation for the insurance benefit by HIRA’s Pharmaceutical Benefit Assessment Committee in early June. Delstrigo tab(doravirine·lamivudine·tenofovir disoproxil fumarate르). At the time, the PBAC determined the drugs to be cost-effective, as they are recommended for the treatment of HIV infections in textbooks and clinical practice guidelines and accepted the price of less than 90% of the weighted average price of its alternatives. The alternatives to Pifeltro are the non-nucleoside reverse transcriptase inhibitors Stocrin and Edurant tablets. And alternatives to Delstrigo are 2 NRTI + NNRTI combo therapies such as Triumeq and ‘Troubadour+stocrin, ‘Descovy+Edurant’. Pifeltro is listed in all A7 countries abroad, and its weighted average price is ₩24,099 per tablet. Delstrigo is listed in the U.S, France, Germany, Italy, U.K, Switzerland among the A7 countries, and is its weighted average price is ₩36,483 per tablet. In the same month, the company had made negotiations with the National Health Insurance Service on the amount of expected claims of each drug. The NHIS expected no additional funds The final listed insurance price of each drug was set at ₩7,975/ tablet for Pifeltro and ₩19,491/tablet for Delstrigo. ◆Lynparza 100mg and 150mg = AstraZeneca Korea’s Lynparza tab(olaparib) is a treatment for ovarian cancer including fallopian tube cancer or primary peritoneal cancer. The drug was listed through the risk-sharing agreement scheme (RSA) in October 2017, using the pharmacoevaluation exemption system. However, its reimbursement was first only allowed for up to 15 months as maintenance therapy after chemotherapy, and then the restriction was lifted in May 2019 after discussions between the government and the company to extend reimbursement. After then, the company received MFDS approval on October 29th 2019 and applied for insurance benefits in January 2020. In June of the same year, the agenda was deliberated by HIRA’s Cancer Drug Review Committee, but the company had to reapply for reimbursement in October of the same year. The drug was finally put on the agenda for deliberation by HIRA’s PBAC in April this year. In April, the PBAC confirmed that the drug prolonged PFS compared to placebo from a clinical trial. Also, the committee decided that the ICER is at an acceptable level for use as first-line maintenance therapy and that the drug was cost-effective as second-line maintenance therapy as it cost less than its alternatives, Lynparza cap, and Zejula cap. The adjusted price of Lynparza tab that is listed in all A7 countries is ₩62,062 for the 100mg tab and ₩67,911 for the 150mg tab. Based on the calculated price, the company had been negotiating with the NHIS on the drug’s price and expected claims amount. During the pricing negotiations, both parties agreed on incorporating two types of reimbursement where the company pays back to NHIS a specific portion of the claims amount and a specific portion of the amount of claims that exceed the expected cap. The final price was set at ₩38,842 for 100mg and ₩48,553 for the 150mg dose. Zejula cap. 100mg (niraparib).◆Zejula cap. 100mg = Like Lynparza, Takeda Korea’s Zejula cap 100mg(niraparib) is also a treatment for ovarian cancer including fallopian tube cancer or primary peritoneal cancer that is already receiving reimbursement for the indication. 200mg of the targeted therapy is taken orally twice a day and has been reimbursed as second-line maintenance therapy for ovarian cancer since December 2019, and the reimbursement has been extended to treat patients with recurrent ovarian cancer who have received 3rd-line or higher chemotherapy since February this year. This time, discussions had been held to extend reimbursement to maintenance monotherapy in ovarian cancer for patients who have responded to first-line platinum-based chemotherapy. The company succeeded in adding the indication by MFDS on August 3rd last year and has requested an extension of reimbursement in the same month. In January, the drug has passed CDRC deliberations and was deliberated by the PBAC in June. At the time, HIRA had determined for reimbursement is appropriate as the drug is recommended as maintenance therapy in ovarian cancer patients who have responded to first-line platinum-based chemotherapy and is cost-effective as it is cheaper than alternative drugs. Also, it is listed in the U.S, France, Japan, Italy, U.K, Switzerland among A7 countries and its weighted average price is set at ₩129,886 per tablet Since then to earlier this month, the company had negotiated with the NHIS on the drug’s price and expected claims amount. Both parties had agreed that the company should pay back a specific portion of the amount of claims that exceed the expected cap, and the price to be set at 6% lower than the current cap of ₩74,184 and at ₩69,733.
- Company
- ST Pharm’s new cash cow ‘oligonucleotide’
- by Kim, Jin-Gu Sep 28, 2021 05:54am
- The oligonucleotide API business has become a major business of ST Pharm. The company has signed many deals over the past three years and the expansion and expectations for contract extensions have also greatly contributed to improving the company’s performance. Experts expect the oligonucleotide API business to stay as a cash cow for ST Pharm for a decade to come, with the global surge in demand for oligonucleotide API and the fact that most contracts signed by ST Pharm are long-term contracts. On the 27th, ST Pharm publicly announced that its oligonucleotide API supply contract with a biotech firm A in the U.S. has been expanded. In November 2019, ST Pharm had signed a contract with the company to supply 5 batches (150kg) of raw materials for clinical trials. The contract at the time was signed for ₩13.6 billion. Company A had requested to add 1 batch to its contract. With the request, the ST Pharm will be supplying a total of 6 batches (180kg) of its API to Company A. The contract amount also increased to ₩18.1 billion with the added ₩4.5 billion. With the addition, ST Pharm’s total contract for oligonucleotide has increased to ₩270 billion, which is more than twofold the sales made by the company last year. Since November 2017, the company had made a total of 14 deals to supply oligonucleotide API to companies, with most of the deals made in the past 3 years since 2019. ST Pharm had jumped into the oligonucleotide API business in 2018 after completing its Banwol plant in 2018. With its API business on track, the company’s performance has significantly improved. ST Pharm had recorded an operating loss for 9 consecutive quarters from Q2 2018 to 3Q 2020, then marked a turnaround in Q4 last year. The company e explained that its oligonucleotide API business was the cause of the turnaround. ST Pharm’s turnaround is drawing greater expectations as most of ST Pharm’s oligonucleotide API deals being long-term contracts. Industry experts foresee that its oligonucleotide business will contribute as a stable cash cow for 10 years at the most. The company has completed delivery of ₩80 billion’s worth of APIs from the ₩270 billion contracts. This means that the company still has around ₩190 billion left to be reflected in its performance from 2H this year to 2023. Also, expectations for additional sales being made from contract extensions exist. Most of the company’s contracts are for the supply of raw materials for clinical trials or initial commercialization. Therefore, if the drug succeeds in commercialization and enters full-scale production, this may lead to further requests for more supply of oligonucleotides.
- Policy
- Domestic venture introduces new imported breast cancer drug
- by Lee, Tak-Sun Sep 28, 2021 05:54am
- As domestic startup is imminent to introduce new breast cancer drug from overseas, Geo-Young is in charge of third-party logistics of the drug, drawing attention. This is because it is different from the existing anticancer drug distribution method that foreign pharmaceutical companies and large domestic pharmaceutical companies used to supply. According to the MFDS on the 27th, the screening of Nerlynx (Neratinib), a treatment for adult patients with early breast cancer positive for HER2, will be completed, and the final approval will be decided soon. It is introduced by Bixink, a subsidiary of KOSDAQ-listed company KPS, which focuses on OLED business, from Puma Biotech, Inc. in the U.S. Neratinib was approved by the U.S. FDA in July 2017 as an auxiliary treatment for HER2 positive early breast cancer adult patients under Trastuzumab-based therapy. Last year, it was additionally approved as a tertiary treatment for HER2 positive progressive and metastatic breast cancer patients through combination therapy with Capecitabine. The company explains that unlike conventional HER2 targeted anticancer drugs, it has been developed with a small molecular weight to penetrate blood vessel-brain barriers and overcome limitations in treating and preventing brain metastasis. If Nerlynx is approved, it is the first drug sold by Bixink. In addition to Nerlynx, Bixink also secured Asian copyrights for Mucosamin PO liquid, which helps prevent and treat oral mucosal inflammation caused by chemotherapy such as radiation and chemotherapy, from PDI, an Italian amino acid pharmaceutical company in December last year. Founded in 2016, the company is focusing on developing digital treatments in addition to the project to introduce anticancer and anti-cancer aids. KPS is looking forward to the synergy between IT and bio-business units. Bixink, which has no domestic distribution network as a new venture, will supply products through Geo-Young, the No. 1 pharmaceutical distribution company.
