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- 2026-06-29 02:32:16
- Policy
- CDDC sets reimb standards for Inrebic Capsule
- by Lee, Tak-Sun Feb 03, 2023 05:54am
- A green light has been turned on for the reimbursement of the myelofibrosis treatment Inrebic Cap. (fedratinib, BMS Pharmaceutical Korea) with the Cancer Disease Deliberation Committee setting reimbursement standards for the drug. Also, the reimbursement standards for the ovarian cancer treatment Zejula Cap (niraparib, Takeda Pharmaceutical) have been extended. The drugs will be approved and listed for reimbursement after passing review by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee and drug pricing negotiations with the National Health Insurance Service. HIRA announced that it had held the 1st Cancer Disease Deliberation Committee (CDDC) meeting in 2023 on the 1st and announced it had deliberated as such. Inrebic is indicated as a treatment for enlarged spleen or other symptoms related to ▲ primary myelofibrosis ▲ post-polycythemia vera myelofibrosis, and ▲ post-essential thrombocythaemia myelofibrosis in adult patients that have been previously treated with ruxolitinib. The CDDC determined that setting the salary standard in line with the indication was appropriate. The 1st CDDC deliberation results in 2023 Also, the CDDC determined it appropriate to extend reimbursement and set additional reimbursement standards for Zejula Cap as ‘maintenance monotherapy in adult patients with HRD-positive ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) who have shown response to first-line platinum-based chemotherapy (partial or complete response).’ On the other hand, no reimbursement standard had been set for the MET exon 14 skipping mutation treatments Tabrecta and Tepmetko. At the same meeting, the CDDC declined Kyowa Kirin Korea’s application to set reimbursement standards for ‘Poteligeo Inj’ to treat adult patients with mycosis fungoides (MF) or Sézary syndrome (SS).
- Company
- Enhertu quickly lands at general hospitals in Korea
- by Eo, Yun-Ho Feb 03, 2023 05:53am
- Prescription of the next-generation new antibody-drug conjugate 'Enhertu' has started in earnest. According to industry sources, Enhertu (trastuzumab deruxtecan), AstraZeneca and Daiichi Sankyo Korea’s new antibody-drug conjugate drug for HER2-positive breast cancer have passed the drug committees (DCs) of 20 medical institutions in Korea, including Samsung Medical Center, Seoul National University Hospital, Sinchon Severance Hospital, Kangbuk Samsung Medical Center, and Chonnam National University Hwasun Hospital. Most hospitals held an emergency DC meeting to generate a prescription code for Enhertu, suggesting the healthcare professional’s high interest in the drug. The drug was approved by the Ministry of Food and Drug Safety in September last year based on the DESTINY-Breast01 and DESTINY-Gastric01 trials. In Korea, Enhertu is indicated to treat ▲ unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting’ and ▲ locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen. Also, in December, based on the DESTINY-Breast03 trial, the drug’s indication was expanded to treat patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens. Enhertu is an ADC that combines ‘trastuzumab,’ a monoclonal antibody that binds to specific target proteins, and ‘deruxtecan,’ a strong cytotoxic agent, by a linker. ADCs act selectivity on antibody targets and apoptosis of target tumor cells allows the drug to work selectively only on the tumor cells, increasing its therapeutic effect and minimizing side effects. However, Enhertu has not been reimbursed yet in Korea. AstraZeneca and Daiichi Sankyo applied for reimbursement listing in December last year and are awaiting review by the Health Insurance Review and Assessment Service. If listed, the drug’s prescriptions are expected to increase rapidly. Sun-Young Rha, Professor of Medical Oncology at Yonsei Cancer Center, said, “Enhertu is the first and only HER2-targeted therapy that demonstrated a survival period of over one year as a treatment for advanced gastric cancer after treatment with a trastuzumab-based regimen. We hope reimbursement will be applied as soon as possible in consideration of the small number of patients.” Enhertu demonstrated a significant improvement in progression-free survival (PFS) in the head-to-head DESTINY-Breast03 trial that compared Enhertu with trastuzumab emtansine (T-DM1) in patients in patients with HER2-positive unresectable or metastatic breast cancer previously treated with one or more anti-HER2 therapy. The interim analysis results that were updated in 2022 showed that Enhertu also continued to demonstrate a clinically meaningful improvement in progression-free survival (PFS) with a 22-month improvement in median PFS over T-DM1. The median PFS for patients in the Enhertu arm was 28.8 months compared to 6.8 months for T-DM1. Also, in terms of OS, the key secondary endpoint in the trial, Enhertu demonstrated a statistically significant 36% reduction in risk of death versus T-DM1. Also, in the DESTINY-Breast01 trial, Enhertu demonstrated continued anticancer effect in patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens that include T-DM1, trastuzumab, and pertuzumab. Results showed that Enhertu met its main efficacy outcome with an objective response rate (ORR) of 60.9%. The median duration of response (DoR) was 14.8 months, and the drug showed a continued anticancer effect in severe patients with a median of 6 previous lines of treatment (range 2-27).
- Company
- Generic for Forxiga competition in the 90 Billion market
- by Kim, Jin-Gu Feb 03, 2023 05:53am
- Forxiga The patent for "Forxiga," a large diabetes treatment that produces more than 90 billion won a year, was completely lifted by the Supreme Court ruling. It is expected that patent challengers will release Forxiga generic in two months. Competition for generics is expected to intensify when the sales ban period ends in January next year due to the permission for priority sales items. ◆14 Generics are expected to be released in April this year, expanding to 90 in January next year On the 2nd, the Supreme Court ruled against 17 companies, including international drugs, in an appeal filed by AstraZeneca to side with generic companies. As a result, patent challengers will be able to release generics after Forxiga's first substance patent expires on April 7 this year. Patent challengers were qualified to release generics because they won the first and second trials. However, AstraZeneca's appeal did not rule out the possibility of a reversal decision by the Supreme Court, putting a lot of pressure on the release of Generic. The Supreme Court finally ruled in favor of patent challengers, and Generics succeeded in relieving the burden of patent infringement completely. It is expected that 14 companies that have acquired generic for exclusivity will release the product in April. Forxiga received generic for exclusivity use as 39 items of single and composite products. Generic for Exclusivity is until January 7 next year, when Forxiga's second substance patent expires. After that, more pharmaceutical companies are expected to enter the market. According to the Ministry of Food and Drug Safety, 89 pharmaceutical companies have been approved for 285 items as a single Forxiga drug and complex. This means that when the effect of generic for exclusive expires in January next year, more than 90 pharmaceutical companies will compete with the same ingredient. ◆Forxiga·Xigduo Last year's prescription amount of 91.4 billion won Drug price cuts are inevitable when General Electric is released. The reason why generics are paying keen attention to the market is that Forxiga is producing more than 90 billion won in prescriptions. According to UBIST, a pharmaceutical market research firm, Forxiga's outpatient prescription performance last year was 48.5 billion won. It increased by 14% from 42.6 billion won in 2021. Xigduo, a compound of dapaglyfluazine and metformin, recorded 42.9 billion won last year. It increased 16 percent from 36.9 billion won a year ago. Forxiga and Xigduo repeated rapid growth every year. The combined prescription amount, which was 33.3 billion won in 2017, increased 2.7 times to 91.4 billion won in five years. ▲ Forxiga and Xigduo prescription performance by year (unit: 100 million won, data UBIST) However, it is widely expected that the existing growth will be dampened if the generic is released after April this year. This is because a 30% reduction in drug prices is applied to the release of drugs with the same ingredient. Then, one year after the release of the Generic, the drug price will be further lowered to 53.55% of the existing upper limit. On top of that, AstraZeneca cannot avoid competition with Generic, which is newly entering the market. Dong-A ST released Dapflo in December last year with the same ingredients as Poshiga. Dapflo is a prodrug product with the same main ingredients but a different chemical structure from the original. When absorbed into the body, the structure changes and has the same effect as Forxiga. Dong-A ST alone challenged Forxiga's first substance patent for early release of generic. After succeeding in avoiding the first trial, Dong-A ST pushed ahead with the sale of Dapflo based on the victory of the first trial at a time when a patent dispute with AstraZeneca was underway. As a result, it released generic products about four months ahead of other companies that have acquired generic exclusivity. Dong-A ST believes that it will take risks and preoccupy the generic market, given that Forxiga generic competition is expected to be very fierce in the future. The key is how much Dong-A ST maximizes the effect of preoccupying the market for four months. Dong-A ST has its own developed Suganon as a DPP-4 inhibitor-based diabetes treatment. Dong-A ST plans to increase Dapflo's influence by linking with Suganon for the remaining two months until April when Forxiga generic is released. In this extension, Dong-A ST plans to maintain the sale of Dapflo regardless of the Supreme Court ruling. On the 2nd, the Supreme Court ruled in favor of AstraZeneca in an appeal filed by Dong-A ST against AstraZeneca on the avoidance of Forxiga's first substance patent. In response, an official from Dong-A ST said, "The first trial, which was the basis for the release of Tapflo, has nothing to do with the Supreme Court's ruling, and the second trial is currently underway due to AstraZeneca's appeal."
- Policy
- Introduction of online electronic sign-off from February
- by Lee, Tak-Sun Feb 02, 2023 05:48am
- NHIS Pharmaceutical Price Negotiation Introduces Online Electronic Signing from February Simplify operations to shorten the end of negotiations. The online electronic signing method will be introduced in next month's drug price negotiations. It is expected to simplify work and shorten the negotiation period by compensating for the shortcomings of the existing written agreement. The NHIS plans to introduce drugs subject to calculation and adjustment first, and next year, it plans to introduce an electronic signing method to negotiate new drugs and usage. NHIS (Chairman Kang Kyung-tae, hereinafter referred to as the Public Corporation) announced on the 30th that it will sign online electronic contracts for drugs subject to calculation and adjustment starting with drugs ordered by the Ministry of Health and Welfare. Since the electronic signing method is a method of signing in the form of an electronic (PDF file) through an authentication service company, it is evaluated that it has compensated for the shortcomings of the existing written agreement. The NHIS expects that related tasks will be greatly simplified, such as issuing and submitting seal certificates and eliminating the process of sending seal seals and mail in written agreements, which have been repeated every negotiation, and the end of the negotiations will be shortened by at least six days. In order to consider the preparation period of pharmaceutical companies and prevent confusion, the company will first apply it to the existing written agreement method and actively promote it by sending detailed notices to individual pharmaceutical companies and pharmaceutical associations and holding online briefing sessions for pharmaceutical companies. An NHIS official said, "We plan to expand the electronic contract method to new drug and usage negotiations next year and unify the agreement method to electronic signing method in the second half of this year. NHIS will continue to contribute to stabilizing the supply and quality of medicines and protecting public health by actively communicating and cooperating with pharmaceutical companies."
- Policy
- A year after Abilify 1mg was released,
- by Lee, Tak-Sun Feb 02, 2023 05:48am
- Competition is expected to intensify as generic companies gradually for Aripiprazole 1mg used for childhood autism hypersensitivity. The original product of this preparation is Otsuka's Aripiprazole 1mg. The drug was approved on December 3, 2021, and even generics appeared in more than a year. According to the industry on the 31st, 1mg of Aripiprazole from Whanin will be listed at 170 won per tab from the 1st of next month. This is the third time as an Aripiprazole 1 mg preparation. As for generic companies, Repizole was the first to register 1mg of Aripiprazole The first drug listed was the original Aripiprazole 1mg, which was listed at 595 won per tab in March last year. Myungin Repizole 1mg was then listed in November last year, becoming the first generic to enter the market. The upper limit of Myungin and Whanin is the same at 170 per tablet. It is about 71% cheaper than the original. Aripiprazole, which is used for schizophrenia and depression, had various doses such as 2 mg, 5 mg, 10 mg, and 15 mg, but there was no use for 1 mg until the 1 mg product was approved. The demand for 1mg was not small while prescribing first doses or combinations. However, as the 1mg product was approved, a new indication was created. 1 mg was recommended with 2 mg as the recommended initial dose of hypersensitivity related to autism disorder in children (6-17 years old). Previously, Otsuka was also licensed in Japan for 1 mg as an initial dose of childhood autism disorder hypersensitivity. As new products came out like this, generic companies responded quickly. Eight months after the original's salary was registered, a master entered the market, and Hwanin also joined the ranks this time. The two pharmaceutical companies also succeeded in paying 30mg of Aripiprazole, which is not even in the original. Last year, the original Aripiprazole was 31.9 billion won in outpatient prescriptions. Myungin Repizole and Whanin Aripizole are 400 million won and 1.2 billion won, respectively, which are wide apart from the original, but latecomers are expected to gradually increase their market share as they are strengthening sales and marketing activities. Accordingly, the movement of the two CNS-specialized pharmaceutical companies, including Myungin and Whanin which have received the 1mg market, is also expected to become active.
- Company
- Hanmi’s Rolontis makes USD 10 million in 3 mths
- by Kim, Jin-Gu Feb 02, 2023 05:48am
- Pic of Rolvedon Hanmi Pharmaceutical’s partner Spectrum Pharmaceuticals issued a press release announcing that “’Rovedon (Korean brand name: Rolontis)’ that the company had launched in October last year made an estimated sales of KRW 10 million in 3 months.” Spectrum plans to release details of the results on Rolvedon in its Fiscal Year 2022 Earnings Call that is scheduled for March. Spectrum received marketing authorization for Rolvedon from the US Food and Drug Administration in September last year, then released Rolvedon in the US in October last year. Rolontis is a new biodrug that Hanmi Pharmaceutical licensed out to Spectrum Pharmaceuticals in 2012. The drug is indicated for the treatment or prevention of neutropenia in cancer patients that receive myelosuppressive chemotherapy. As a granulocyte colony-stimulating factor (G-CSF) class that stimulates the granulocyte to increase neutrophil production, the drug has a similar mechanism of action with Amgen’s blockbuster drug ‘Neulasta (pegfilgrastim).’ In Korea, Rolontis was approved in March as the 33rd homegrown new drug.
- InterView
- Takeda will lead industry with focus on Oncology
- by Eo, Yun-Ho Feb 02, 2023 05:47am
- A company has achieved evolution through aggressive investment in line with the current trend. Through such evolution, Takeda Pharmaceuticals has become renowned as a 'Big Pharma' rather than a 'Japanese company' from some point. The company had previously focused on OTCs and chronic diseases such as diabetes and hypertension. However, through various small and large M&As, the company quickly secured pipelines for anticancer drugs and rare diseases. Until now, the company conducted four M&As, starting with Millennium Pharmaceutical in 2008, Nycomed in 2012, ARIAD Pharmaceuticals in 2017, then Shire in 2018. As a result, the company has been actively releasing advanced anticancer drugs in the oncology market, including the PARP inhibitor ‘Zejula and the’ EGFR Exon 20 insertion mutation targeting ‘Exkivity.’ Also, the company has made constant progress in treating hematologic cancers with products such as ‘Ninlaro,’ and ‘Adcetris.’ Dailypharm met with Sun Jin Lee, Head of the Oncology Business Unit at Takeda Pharmaceuticals Korea to seek insight into the company’s vision and future. Sun Jin Lee, Head of Oncology BU at Takeda Pharmaceuticals Korea-Could you give us a brief introduction of yourself? I first started my career in the industry as a peritoneal dialysis Product Manager at Baxter. Since then, I also was in charge of high blood pressure treatment products for 3 years and then served as a marketing manager for the circulatory system division for 3 years at Boehringer Ingelheim. After joining Takeda Pharmaceuticals in 2017, I first worked for over 3 years in the hemophilia BU and was involved in the domestic launch of ‘Adynovate,’ etc. After that, I was assigned to Takeda’s Asia-Pacific office and worked in Singapore for 1 year. Last year, I returned to Korea after being appointed the head of Oncology BU at Takeda Pharmaceuticals Korea. In other words, I have worked in marketing throughout my entire career in the pharmaceutical industry. - Takeda has been known to have undergone many changes. In the Oncology BU, the role of its head would have increased significantly with the reimbursement listing and prescriptions of the company’s oncology products. What area did you focus most greatly on last year? I have been with the Oncology BU for about 7 months now. As the head of the BU, I feel the greatest responsibility in performance delivery. This is the basic goal for all business units. Takeda’s fiscal year begins in April, therefore we are in our last quarter right now. Currently, we are focusing on achieving the performance target we set for the last year. My next area of focus was in strengthening the organization. After being assigned to the unit, I had a certain observation period, then focused on strengthening the internal capability of our unit. So I am focusing externally on performance, and internally on our human resources. In particular, only one manager had been assigned to manage all our oncology products despite our increasing portfolio. So we appointed additional managers and divided the work by disease area to increase efficiency. - What do you think is the most important competency required to be a marketer in the Oncology BU? Brand managers (BMs) in each unit have their own strengths and weaknesses as well as various abilities. Having experienced Primary Care and rare diseases firsthand, I believe anticancer drug brand managers should basically have an underlying respect for the patients and their life. In the Oncology BU, we consider various activities such as patient programs and directions to improve access to treatments. Many of these programs cannot be carried out if we are profit-focused or sales-focused. Therefore, I thought it would be difficult for our managers to understand how we carry out our activities if they do not have experience and patient-centricity at heart. Also, our managers need to have the ability to quickly acquire, examine widely, and draw out the essence of the flood of information. There is always a lot of up-to-date data on anticancer drugs. So you have to be able to read out the trend of the entire therapeutic area, including those about competing drugs. Otherwise, you will not be able to communicate with healthcare professionals. sb-The word all-comer is mentioned often during discussions on the reimbursement of anticancer drugs in Korea. Zejula was one representative example of such a drug last year, and more are expected to come this year. However, Korea has been conservative in reviewing these drugs for being less effective and having lower-level results. That is a very difficult issue. Our primary consideration is what will benefit the patient the most. This is also true on the doctors’ part. Pharmaceutical companies obtain permission based on clinical data and then promote drugs based on approved indications. And this will continue to be the same in the future. Doctors as clinicians will use the drug when they feel that the drug is beneficial and needed by the patient. The decision is entirely at the discretion of the doctor. - Exkivity was released this month and is receiving much attention from academic societies. The company would also have rising expectations for the product. Exkivity was approved in Korea last July and released on the 1st of this month. One significant aspect of the release is that we released the drug for the first time in Asia in Korea. Also, Korea is the 5th country in the world to obtain marketing authorization for Exkivity. Being the first oral anticancer drug that targets the EGFR exon 20 insertion mutation, we expect eligible patients to benefit greatly from our release.
- Company
- Takeda's Exkivity launches as non-reimbursement
- by Eo, Yun-Ho Feb 01, 2023 05:52pm
- EGFR Exxon 20 insertion mutation target anticancer drug Exkivity, which is eaten by Takeda Pharmaceutical Korea, will be released as non-reimbursement in February. EGFR Exxon20 insertion mutation Non-small Cell Lung Cancer treatment Exkivity targets biomarkers such as Rybrevant of Janssen Korea, but there is a difference in that it is an oral drug. The EGFR Exon 20 insertion mutation is a biomarker that has recently attracted new attention in the field of non-small cell lung cancer. Currently, prescribed anticancer drugs are suitable for Exon19 deficiency or Exon21 L858R substitution mutation, which is commonly found in EGFR mutations, but EGFR Exon20 was still a blind spot. The benefit is still unknown. As Rybrevant failed to pass the HIRA, it remains to be seen whether Exkivity can succeed in registering. Takeda has yet to submit an application for Exkivity's benefit. Exkivity proved its effectiveness through phase 1/2 of 114 patients with EGFR Exxon20-inserted mutated non-small cell lung cancer who had previously undergone platinum-based chemotherapy. Clinical results showed that the ORR evaluated by IRC was 28% and the mDOR was 17.5 months in the group of patients taking Exkivity 160 mg. In particular, the median reaction time after administration of Exkivity was 1.9 months, and it was confirmed that the drug effect appeared rapidly from the beginning of treatment. The mPFS was 7.3 months and the mOS was 24.0 months. The safety profile was also shown to be good. The most common adverse reactions were diarrhea, rash, and fatigue, which can be managed by adjusting the dosage.
- Company
- JW Pharma develops new drugs with Merck Life Science
- by Lee, Seok-Jun Feb 01, 2023 05:55am
- JW Pharma is expanding AI technology from new drugs to raw drug research fields to increase R&D efficiency. JW Pharma announced on the 30th that it recently signed a business agreement with Merck Life Science in Germany to research and develop raw materials for new drugs using AI. Merck offers its AI software Synthia to JW Pharma. Synthia is a program that quickly analyzes and provides the synthesis route of raw drugs in the new drug development stage. Merck's Custom Synthesis Lab's know-how in synthesizing new materials is also consulted with JW Pharma. JW Pharma's raw material research center plans to actively utilize Synthia for research on the synthesis of its new drug candidates. It is expected to reduce research time and cost on the method of preparing compounds to be used in non-clinical and clinical trials. Based on the synthesis conditions proposed by Synthia, it also plans to establish an unmanned automated laboratory environment in which robots synthesize raw materials 24 hours a day on behalf of researchers. Lee Nam-gu, CEO of Merck Science and Lab Solutions Business, emphasized, "Synthia can derive solutions with more than 100,000 rules and sophisticated algorithms and use them for patent applications and papers as well as developing new drugs." Shin Young-seop, CEO of JW Pharma, said, "The company is conducting various open innovation activities with bio companies with innovative AI technologies to strengthen the pipeline of new drugs discovered through its own R&D platform. "The cooperation with Merck in automated synthetic research will serve as a cornerstone for efficiently conducting JW's various new drug studies," he said.
- Policy
- South Korea will maintain its EU whitelist
- by Lee, Hye-Kyung Feb 01, 2023 05:54am
- Korea will continue its status as an exempt country from submitting GMP written confirmation while maintaining its EU whitelist. The Ministry of Food and Drug Safety (Director Oh Yoo-kyung) announced on the 30th that Korea has maintained its status as a registered country in its first regular re-evaluation since it was listed on the EU Whitelist (GMP written confirmation exemption country) for the 7th time in the world in 2019. It is interpreted that maintaining the status of a registered country is once again recognized that the domestic drug manufacturing and quality control standards (GMP), the Ministry of Food and Drug Safety's GMP-related regulatory system, and domestic raw drug manufacturers that comply with it are world-class. South Korean pharmaceutical companies expect to reduce the time required by more than four months by exempting the submission of GMP written confirmation when exporting raw materials to the European Union and to help the domestic pharmaceutical industry grow. As of 2021, EU countries' exports ($468,170,000) accounted for 23.7% of Korea's total exports ($1,971,426,000). EU whitelist refers to a list of countries that are exempt from submitting GMP written confirmations if they are recognized as equivalent to the EU by evaluating the manufacturing and GMP of non-EU countries that want to export raw drugs to Europe. Korea, which was listed in 2019, received regular re-evaluation in December last year as it was evaluated based on 10 areas (78 indicators) and re-evaluation to maintain the listing was conducted every three to five years. "The maintenance of the status of the EU whitelist is internationally and objectively recognized for Korea's regulatory capabilities and industrial excellence," said Oh Yoo-kyung, head of the Ministry of Food and Drug Safety. "Our government will boldly change regulations that hinder domestic companies from entering overseas and competing to global standards." The Ministry of Food and Drug Safety expects that maintaining the status of a registered country will also help the government realize a global central country, and will continue to push for regulatory innovation leading international standards to promote and expand its entry into the global market based on regulatory and quality competitiveness in the domestic pharmaceutical sector.
