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- 2026-04-15 18:24:23
- Company
- Daewoong & Boryung challenged the patent for Sprycel
- by Kim, Jin-Gu Jan 21, 2021 06:13am
- Daewoong challenged the patent for BMS' chronic myelogenous leukemia treatment Sprycel (Dasatinib). As other domestic companies have failed to overcome the patents one after another, attention is focused on Daewoong's challenge. According to the pharmaceutical industry on the 19th, Daewoong recently requested an invalidation trial against use patent of Sprycel. At the end of last year, Boryung filed an invalidation trial on the patent. Sprycel is registered for product patent, crystalline patent, and use patent. Among them, the product patent expired in April of last year. Generics can release early if they overcome the use patent expiring in March 2024 and the crystalline patent expiring in February 2025. However, no pharmaceutical company has yet overcome the patent. In 2015, Hanmi, JW Pharma, Boryung, Ahn-gook, Huons, Yuhan, and Navipharm challenged Sprycel's patents, but were withdrawn. Sprycel's annual sales are ₩30 billion, which is growing every year. According to IQVIA, Sprycel's sales in 2019 were ₩29.7 billion, up 25% from ₩23.7 billion in 2019. Last year, it posted ₩26 billion in sales until the third quarter. With the expiration of the product patent last year, attention is focused on whether generic companies, including Boryung and Daewoong, will try to overcome the use patent and crystalline patent with a new strategy in the future.
- Policy
- Paclitaxel + Carboplatin + RT will be reimbursed
- by Lee, Hye-Kyung Jan 21, 2021 06:13am
- Paclitaxel+Carboplatin+RTprior chemotherapy, which required prior approval from the Director of the HIRA, will be reimbursed for anticancer therapy The HIRA announced that it plans to announce an amendment to the announcement of drugs prescribed/administered to cancer patients containing the above contents, and that opinion inquiry will be conducted by the 26th. In the case of resectable esophageal and marginal cancer, in order to receive Paclitaxel+Carboplatin+RT, a prior chemotherapy regimen, the medical institution had to submit an application for exceeding the scope of product approval to the HIRA. However, as a result of side effects evaluation for patients who used the same therapy as exceeding the scope of product approval, safety and clinical usefulness are recognized, so it is decided to recognize the same benefits as the alternative therapy Capecitabine + Cisplatin + CCRT. It was set to 5 cycles according to the clinical practice guidelines. The standards for reimbursement of anticancer drugs used for ovarian cancer have also been partially changed. for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy and for the treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either: a deleterious or suspected deleterious BRCA mutation, or Genomic instability and who have progressed more than six months after response to the last platinum-based chemotherapy, Zejula, among monotherapy, changed the target of maintenance therapy and added therapy. Regarding maintenance therapy, there was a significant difference in progression-free survival in the clinical trial (NOVA) non-gBRCA patient group, but the NCCN guidelines prioritize the same therapy for BRCA mutant patients, and the sBRCA mutant group among non-gBRCA patients decided to recognize the benefit only for somatic BRCA patients, considering the clinical characteristics and effects similar to those of the gBRCA mutant group. It is recognized only for patients with BRCA mutation in consideration of the high demand for unmet medical care for new drugs that show sufficient effects in indications as a result of review of textbooks and guidelines regarding treatment regimens, and histological classification of patients subject to clinical trials. It was limited to highly serous ovarian cancer for reference.
- Company
- “Yuhan’s change is just warming up with Leclaza”
- by An, Kyung-Jin Jan 21, 2021 06:13am
- CEO Lee Jung-hee “We believed the path for Yuhan Corporation taking the step forward to another century ahead would be through new drug pipeline. We are exhilarated to see the world acknowledging the company’s first proud outcome of the open innovation strategy, Leclaza (lazertinib).” During an interview with Daily Pharm on Jan. 18, Yuhan Corporation CEO Lee Jung-hee seemed exceptionally composed, regardless of the news that the South Korean health authority approving Leclaza. He almost seemed unburdened by the news as if his whole maneuver in last six years was finally paid off. On the day, the Ministry of Food and Drug Safety (MFDS) authorized the marketing of a 31st Korean-made new drug and Yuhan Corporation’s next-generation novel drug for lung cancer, Leclaza. The drug is the South Korean company’s brand new novel drug to be developed since an ulcer treatment Revanex in 2005. CEO Lee reminisced and noted, “Year 2026 would mark a centennial anniversary of Yuhan Corporation. And I became the CEO at the pivotal point in time, just before the centennial anniversary. I kept thinking about how to change the public’s evaluation that the company’s new drug pipeline is weak compared to the revenue.” After a thorough contemplation, CEO Lee apparently made a first command; ‘Invest bold.’ This is how the company took a groundbreaking shift in the external investment strategy for last few years. “The answer was clear, once I put myself in the shoes of the late founder Dr. New Ilhan. Based on the abundant cash flow, I decided it was time to explore a future growth driver. And I came to a conclusion that the open innovation is the only way to push up the new drug R&D capacity the company was falling short of,” the CEO elaborated. It matched with the CEO’s philosophy that even a pharmaceutical company with a long history of 100 years should learn from a venture company’s speed and passion to not fall behind. Since his appointment in March 2015, CEO Lee immediately endeavored to reform the company to develop new drug. A vast number of R&D staffs were recruited, and the R&D investment ratio kept at 5 percent was doubled to 10 percent. Last year, the company spent 200 billion won in R&D. The South Korean company also boldly invested on promising venture companies financially hindered to develop new drug. Starting from Oscotec that originally found Leclaza, the company invested hundreds of billion wons in Genexin, Bioneer, Abclon, Pharmabcine, and NeoImmuneTech. The company was on to secure source technology that would leverage the future for the company. Yuhan Corporation is currently leading Phase III global clinical trials on Leclaza monotherapy in 17 different countries around the world. The company is speeding up the Leclaza commercialization to level with Janssen’s investigational drug amivantamab as a combination therapy. Although the clinical trials are still in progress, the anticipation on Leclaza is heightening. A global market research firm Global Data projected the value of lazertinib as both monotherapy and combination therapy would be valued at USD 569 million a year. The value of the pipeline soared as the company’s two-track strategy to develop both the monotherapy and combination therapy worked. The investigational drug Leclaza is already the company’s biggest cash cow. Besides the 50 million dollars paid upfront for the license-out deal, the drug generated over 100 million dollars of technology payment in last year only. Leclaza is the only Korean-made new drug that made over 100 billion won additional to the license-out upfront payment. CEO Lee said, “The company could have missed out on both the pipeline and profit, if it was only fixated on the short-term performance. But by ceaselessly seeking the external investment opportunity for the future growth driver, the public perception on the company was changed naturally.” “Yuhan’s change is just warming up. Watch how Yuhan Corporation takes the new leap as a global pharmaceutical company,” the CEO urged.
- Company
- Tumor-agnostic Rozlytrek applies for NHI coverage
- by Eo, Yun-Ho Jan 20, 2021 06:04am
- A tumor-agnostic anticancer medicine Rozlytrek is shooting for the National Health Insurance (NHI) reimbursement listing. A pharmaceutical industry source reported Roche Korea submitted a reimbursement listing application for a neurotrophic tyrosine receptor kinase (NTRK) targeted therapy Rozlytrek (entrectinib) to a South Korean health authority last year. Approved as an orphan drug in South Korea in last August, Rozlytrek is indicated to treat adult and pediatric patients 12 years of age and older with solid tumors that have a NTRK gene fusion without a known acquired resistance mutation, are locally advanced ROS1-positive or metastatic NSCLC. Technically, the treatment can be prescribed to any cancer patients confirmed to have NTRK gene. The treatment’s approval was based on results from the Phase I/II STARTRK-NG study targeting pediatric patients and the pivotal Phase II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA-372-001 trials. In STARTRK-2, Rozlytrek achieved an objective response rate (ORR) of 56.9 percent in patients with NTRK-positive solid tumors. The patients had ten types of different solid tumor and their median duration of response (DoR) was 10.4 months. And at the European Society for Medical Oncology (ESMO) Asia 2020 convened late last year, Rozlytrek unveiled its Asian subgroup analysis result. The subgroup analysis result found NTRK fusion-positive patients treated with Rozlytrek had ORR of 69.2 percent, the median DoR of 10.4 months, and median progression-free survival (PFS) of 14.9 months. The overall survival (OS) was unable to measure. Among ROS1-positive patient with NSCLC, the researchers confirmed ORR of 69.9 percent and median DOR of 14.9 months, when median OS and median PFS were 28.3 months and 13.6 months, respectively. And a second endpoint, the intracranial ORR (IC ORR) was 100 percent in patients with solid tumors that have a NTRK gene fusion, whereas ROS1-positive patient with NSCLC marked 36.4 percent. The central nervous system (CNS) metastasis progression confirmed with a scan was generally very low. Professor Ahn Myung Ju at the Samsung Medical Center Department of Hematology and Oncology said, “Based on the confirmed clinical evidence of Rozlytrek treatment efficiency in Asian patients and the introduction of the tumor-agnostic treatment to the South Korean market, we can expect to expand the rare cancer patients’ access to treatments customized to personal gene characteristic, and to create a positive cycle of precise medicine, which would feed the patients’ treatment information back to R&D.”
- Opinion
- [Reporter's View] Yuhan's Open Innovation Success Model
- by Kim, Jin-Gu Jan 20, 2021 06:02am
- Until only five years ago, Yuhan was the No. 1 pharmaceutical company in Korea, but it was criticized for being a company that sells foreign drugs and only acts as a wholesaler. The company had very few pipelines. However, since President Lee Jung-hee took office in 2015, Yuhan's new drug pipeline has increased to 29 as of the end of last year. The sales share of R&D expenses also increased from 5.7% to 10.8%. This year, Yuhan plans to invest more than ₩130 billion in R&D. Yuhan's Leclaza (Lazertinib mesylate) received conditional marketing authorization on the 18th. Leclaza's rival drug is Tagrisso (Osimertinib), which generates about ₩4 trillion in sales globally. Considering that Tagrisso enjoys a dominant position in the third-generation non-small cell lung cancer treatment market, Leclaza's competitiveness in the global market is highly evaluated. According to the published data so far, it is said that the efficacy is similar to that of Tagrisso, while the safety is more superior. Global Data, a global pharmaceutical market research firm, predicts that Leclaza will generate annual sales of about ₩600 billion. Leclaza's approval is noteworthy in that it has established a relationship between bio-ventures, Yuhan and global pharmaceutical companies. It is evaluated that it has established a business model that licenses a promising candidate substance from a bio-venture and then licenses it out to a global pharmaceutical company. Many biopharmaceutical companies are actively involved in open Innovation. However, there were no successful commercialization cases until receiving Leclaza's CMA. There were also many opinions that were unsure about the Korean open innovation model. Leclaza's approval is an evaluation that gave substance to Korean open innovation. The Korean open innovation model proposed by Yuhan is expected to instill confidence in the direction of new drug development to other pharmaceutical bio companies targeting another Leclaza.
- Policy
- Conditional approval on Celltrion COVID-19 treatment advised
- by Lee, Tak-Sun Jan 20, 2021 06:02am
- The South Korean health authority’s panel of experts verified the clinical results and advised an approval of Celltrion’s COVID-19 monoclonal antibody treatment candidate Rekirona with a condition to conduct Phase III trial. The panel recommended the drug to be used to alleviate the mild to moderate COVID-19 symptoms in adult patients. The Ministry of Food and Drug Safety (MFDS) stated a meeting for the advisory panel to verify the safety and efficacy in COVID-19 treatment and vaccine candidate was convened on Jan. 17 to discuss about the clinical results of Celltrion’s antibody treatment Rekirona. Prior to the consultation with the Central Pharmaceutical Affairs Deliberation Committee, the advisory panel was gathered to provide advice on clinical and non-clinical drugs and quality. The panel meeting consisted of eight external experts including infectious disease specialist, virologist, clinical statistic expert and other clinical trial experts, and four members from the Review Team and Clinical Trial Evaluation Team under MFDS COVID-19 Treatment Approval Evaluation Team. The advisory panel provided their assessment on the Rekirona injection’s clinical trial outcome to confirm the treatment’s efficacy and safety. The clinical efficacy was evaluated by how fast a patient recovers from seven COVID-19 symptoms (fever, coughing, shortness of breath, sore throat, muscle ache, fatigue and headache) after receiving the candidate treatment. The pharmaceutical mechanism was evaluated by timing how fast a patient’s viral test result change from positive to negative. Advisory panel “Shortened symptom alleviation time clinically meaningful" The trial participants either took the drug or a placebo twice-daily, when they expressed any one of the COVID-19 symptoms at a high or medium level. The researchers measured the time to alleviate or weaken all of their symptoms, after monitoring them until Day 14. As a result, the patients administered with the investigational drug took 5.34 days to recover from the COVID-19 symptoms, when the patients administered with a placebo took 8.77 days. The drug was confirmed to reduce the time to alleviate the COVID-19 symptoms by approximately 3.43 days. The panel judged the clinical outcome is meaningful as it statistically proved the drug could lessen the time to improve the COVID-19 symptoms. The trial also tested the participants who have received the treatment for the change in the viral load to verify the mechanism of preventing the viral infection in a human body by letting the drug to bind with the novel virus instead of a human body cell. The virus test confirmed there is no significant difference between the drug-administered group and the control group with the duration of time the test result change from positive to negative. Although the shortened duration was not statistically meaningful, the panel claimed the administration of the drug seemed to show a tendency to decrease the viral load. Recommends conditional approval, but needs sufficient Phase III evidence To confirm the safety of the drug, the researchers monitored the administered participants until Day 28 to observe adverse reaction and any internal infusion related reaction for its frequency, type and severity. In the end, the type of adverse reactions like hypertriglyceridemia and hypercalcemia were predictable as they were reported from Phase I trial already. The majority of the cases were mild or moderate, and the rate was similar to that of the control group. None of life-threatening case was reported. Overall, the advisory panel recommended approving Rekirona, with a condition to conduct a Phase III trial, but also they laid down a few advices on the product’s efficacy and effect; the treatment clinically demonstrated alleviating mild to moderate COVID-19 symptoms in adult patients aged 18 and over, who does not require supplementary oxygenation, but showed the symptoms within seven days of the injection. The advisory panel demanded the South Korean company to conduct a Phase III to verify meaningful decrease in the disease progression from mild-to-moderate to severe in sufficient number of patients, and to set a detailed guideline for the use in the clinical scene by discussing it with the government separately. Also, the panel advised the company to conduct another trial to verify the combination of the treatment candidate and other severe symptom treatment or an immunomodulator to be used on patients who needs supplementary oxygenation. MFDS plans to utilize the panel’s advices, recommended efficacy and effect and indication and outstanding evidence material to review the investigation drug, and to seek for advices on safety, efficacy and pre-approval consideration from the Central Pharmaceutical Affairs Deliberation Committee, a legal advisory panel under MFDS.
- Policy
- Yuhan's Lazertinib was approved
- by Lee, Tak-Sun Jan 20, 2021 06:02am
- The new drug Lazertinib developed by Yuhan for the treatment of non-small cell lung cancer has obtained approval from the MFDS. The technology was transferred to the global pharmaceutical company Janssen and is currently undergoing licensing procedures in other countries such as the United States. It is the first country in the world to obtain approval from the FDA. The MFDS announced on the 18th that it has approved Yuhan's non-small cell lung cancer treatment Leclaza (Lazertinib mesylate) as the 31st new drug developed in Korea. Leclaza is used in patients with advanced lung cancer with specific gene mutations who have previously been treated for lung cancer. It is a target anticancer drug that inhibits the proliferation and growth of lung cancer cells by interfering with the signal transmission involved in lung cancer cell growth, and is less toxic to normal cells. The drug treats patients with EGFR T790M mutation-positive locally advanced or metastatic non-small cell lung cancer who have previously been treated with EGFR-TKI. It selectively inhibits the epithelial cell growth factor receptor Tyrosine Kinase, which is involved in the growth, differentiation, and survival of cancer cells, and prevents cancer cell survival, proliferation and metastasis. Yuhan applied to conduct a phase III clinical trial after marketing based on the results of a phase II clinical trial conducted in Korea. The MFDS explained that the quality, safety and effectiveness, and post-marketing safety management plans were scientifically reviewed and evaluated according to the review criteria of the Pharmaceutical Affairs Law. The Central Pharmaceutical Affairs Review Committee, which includes experts treating lung cancer in the medical field, gave the final approval after consulting on the completion of the license and conformity to the system. The MFDS said that the approval of the new drug is expected to expand the range of drug options for the treatment of patients with recurrent non-small cell lung cancer. It emphasized that it will continue to provide scientific and thorough approvals and reviews, and by securing objectivity and transparency through expert advice, to ensure that the safety and effectiveness of treatments are sufficiently verified.
- Policy
- COVID-19 vaccination to start in February
- by Lee, Jeong-Hwan Jan 20, 2021 06:01am
- “COVID-19 vaccination begins at the end of February and early March, and will form herd immunity in November at the latest. If side effects occur only after the vaccination, the government will be fully responsible. I am urged to inoculate, and if the national anxiety increases and the need to take an initiative, as the president, I will not avoid it.” President Moon Jae-in said that COVID-19 vaccination will begin in late next month (February) and early March, and that he will form Herd immunity by November at the latest. He promised that the government will take all responsibility from mild to severe side effects that can occur after free vaccinations for all citizens, and said that he would be the first to get the vaccine as a president to alleviate public anxiety. On that day, BBC Bureau chief Laura Bicker asked President Moon, "If Korea had secured the vaccine a little faster, wouldn't the point of returning to daily life have been accelerated?" President Moon said that the domestic COVID-19 vaccine introduction and vaccination plan were systematically established. He especially hoped that he could succeed in forming herd immunity faster than any other country. The vaccination will be from late February to early March, and herd immunity is expected to be formed in November at the latest. President Moon said, "COVID-19 vaccine is the first vaccine developed in the world. We evenly purchased various vaccines to distribute the risks and secured sufficient quantities. Because vaccination takes time and the expiration date is short, herd immunity will be formed by starting the vaccination in February and the end of the vaccination management of the people by September." President Moon said, "If the vaccination is completed in the fourth quarter, the formation of Herd immunity is expected in November at the latest. It will be rather faster compared to other countries." He said, "The start of vaccination is at the end of February or early March, and there is a possibility that the quantity of COVAX facility will be introduced first, and the possibility that the time of introduction will be accelerated is being reported." The authorities will report it to the public in detail.“ President Moon said not to worry about the public being anxious about the side effects of COVID-19 vaccine. He said that if it helps relieve anxiety, he will be the first to receive vaccination as the president. The government will take full responsibility for any personal damage. President Moon said, "The quarantine authorities were very cautious in the process of signing a vaccine introduction contract, including side effects. As a vaccine that took more than 10 years was developed in one year with a fast track, we carefully observed the results of phase II/III clinical trials. "The MFDS approves global vaccines according to domestic standards. We analyze enough side effects. The public can trust the safety of vaccinations in Korea." President Moon said, "However, all vaccines have some side effects. From mild pain to more serious side effects. In this case, the government will take full responsibility for the side effects. So please do not worry about personal damage without government protection." He said, “Today (18th), the number of confirmed cases is about 300. It is clear that the third COVID-19 epidemic is over. If less than 400 people are confirmed during this week, the level of quarantine can be lowered. Because vaccination and treatment will be available soon, we will be able to succeed in quarantine ahead of any other country in the world and return to our daily routine after overcoming the crisis.”
- Policy
- NMO drugs ready for Korean market release within this year
- by Lee, Tak-Sun Jan 19, 2021 06:02am
- Roche’s NMO treatment Enspryng with satralizumab. A group of rare disease neuromyelitis optica (NMO) treatments are preparing for the South Korean market. NMO is a chronic disease with a no specific treatment. Recently, however, a number of treatments for the disease have passed the U.S. Food and Drug Administration (FDA) and they are now readying for the South Korean health authority’s approval as well. According to the pharmaceutical industry on Jan. 18, Mitsubishi Tanabe Pharma’s inebilizumab and Roche’s satralizumab have reportedly submitted application to the Ministry of Food and Drug Safety (MFDS) for the approval review. Inebilizumab received the U.S. FDA approval in last June. The U.S. health authority also granted an approval on satralizumab in last August as well. The first NMO treatment is Alexion’s Soliris. Initially, the drug was cleared by the FDA in 2007, indicated to treat patients with paroxysmal nocturnal hemoglobinuria (PNH). The additional indication to treat neuromyelitis optica spectrum disorder (NMOSD) was approved in June 2019, making it the first drug to treat the disease. Regardless of the title, the additional indication is not yet expanded in South Korea. The industry expects that Soliris would also follow through with the MFDS indication expansion procedure. NMO is an extremely rare disease, also characterized as an inflammatory demyelination that attacks the eye nerves and the spinal cord. The symptoms include numbness, weakening muscles and rapid loss of vision. Apparently, the disease is more likely to be expressed in Asian females, and the symptoms tend to stay permanently, while it could result in death due to shortness of breath. As all three drugs have applied for the approval, the patients may expect to get access to the first NMO treatment in South Korea. But the last hurdle is the pricing. Administering satralizumab costs over 200 million won per year. Soliris is famous in South Korea as ultra expensive drug. The financial impact on the National Health Insurance would be inevitable. The key to South Korean market release would be the successful pricing negotiation. The industry is closely following the relevant news to see who would become the first NMO treatment in the country and for how much with the reimbursement.
- Company
- Mavenclad can be prescribed at general hospitals
- by Eo, Yun-Ho Jan 19, 2021 06:02am
- New multiple sclerosis drug Mavenclad can be prescribed in general hospitals According to related industries, highly active recurrent multiple sclerosis treatment Mavenclad (Cladribine) by Merck has now passed the drug commitee (DC) of SMC, AMC, Shinchon Severance Hospital, and NCC. Mavenclad is the first short-term oral treatment that has shown a significant overall effect in terms of the degree of physical disability progression, annual recurrence rate, number of active lesions shown on MRI, and major disease activity indicators in patients with recurrent multiple sclerosis. Mavenclad's clinical trial program included long-term follow-up data from the 8-year prospective observational registry PREMIERE study, along with the CLARITY Phase 3 study and CLARITY EXTENSION, ORACLE MS, and ONWARD Phase 2 study corresponding to the CLARITY expanded clinical trial. As a result of post-hoc analysis of patients with high disease activity in the CLARITY 2,3 study conducted for two years, the annual recurrence rate of patients receiving Mavenclad decreased by 67%, and the Extended Disability Status Scale (EDSS), which indicates the degree of disability progression. Also, Mavenclad administration group showed a 82% decrease compared to the control group. However, Mavenclad’s significant adverse reactions are lymphopenia and shingles. The lymphocyte count of patients must be measured before and during Mavenclad administration to patients with multiple sclerosis. It is contraindicated in certain populations, including patients with impaired immune function and pregnant women. Seongmin Kim, Professor of Neurology, SNUH said, "Multiple sclerosis is a chronic inflammatory demyelinating disease that occurs in the central nervous system such as the brain and spinal cord. If not treated, symptoms may worsen and sequelae such as severe disorders may remain, so a new treatment option with high convenience is available. It was a necessary situation. Mavenclad can be taken orally and can help improve the quality of life for patients in that it provides lasting effects for 4 years with only short-term treatment of up to 20 days."
