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- 2025-12-26 14:02:31
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- Tagrisso expands benefits as a first-line treatment
- by Mar 24, 2021 05:45am
- Tagrisso, a targeted treatment for EGFR mutant non-small cell lung cancer, is not receiving benefits from the first-line treatment in Korea. The medical staff emphasized the need for Tagrisso's benefit. On the 19th, AstraZeneca Korea held an online press conference to commemorate the 5th anniversary of Tagrisso's postoperative adjuvant therapy acquisition and its launch in Korea. National Cancer Center’s Chief Researcher Ji-Yeon Han and Professor Min-hee Hong, Department of Oncology, Yonsei University Medical School, presented as speakers. Tagrisso, a third-generation EGFR TKI agent, started as a second-line treatment for EGFR mutant patients and acquired indications for the first-line treatment. Recently, it was used as an adjuvant therapy after surgery for patients with early stage (1B~3A) lung cancer among the first EGFR target treatments. Tagrisso is currently being used as a second-line treatment in Korea. This is because the most important insurance benefits are applied only to secondary treatment. This is in contrast to the insurance benefits applied to primary treatments in major countries around the world, such as the UK, the US, Japan, Germany, France, Italy and Switzerland. In recent years, in Canada, Russia, Australia, and Taiwan, benefits have also been expanded through primary treatment. The National Comprehensive Cancer Network (NCCN) also recommends Tagrisso the most (category 1) for the first-line treatment of EFGR mutant non-small cell cancer patients. In Korea, the results of sub-analysis on the Asian subgroup during the clinical trial of Tagrisso's FLAURA were controversial. Although the overall survival benefit was demonstrated in the entire global FLAURA patient population, the risk ratio (HR) of the Asian sub-analysis was 0.995. In fact, there was no difference from the control group, so there were opinions that there was no OS benefit for Asians. Accordingly, Chief Researcher Han Ji-yeon said, "One-third of the Asian subgroups were Japanese patients, which may have been due to different types of treatment than global ones." She explained, "In Japan, patients with recurrence after surgery, not general stage 4 lung cancer patients, were especially enrolled in the control group. Patients with recurrence after surgery are known to have a better prognosis than general stage 4 patients." Here, in the case of Japan, if there is any possibility of progressing to pneumonia, the drug is stopped immediately and there is a characteristic of switching to another drug. AstraZeneca admitted to the cross-over prescription of patients with confirmed T790M mutations in the first-generation drug from an ethical perspective, and taking this into account, it is encouraging to improve OS. Tagrisso is an EGFR TKI drug that has proven OS for more than 3 years in clinical practice. In a recent FLAURA China study of Chinese, OS showed a similar pattern to global clinical trials. Korea, which follows global treatment standards, will be similar. In particular, among other EGFR TKI agents, Tagrisso has the best BBB permeability, reducing the risk of disease progression or death due to central nervous system metastasis by 52%. One Chief Researcher explained, "The first principle in cancer treatment is to administer the most effective treatment to everyone first." "If Tagrisso resistance develops, there is no follow-up treatment option, so if it is used as a second-line drug, more than half of the patients who can actually be treated with Tagrisso will not have a chance. It is correct to use the best treatment for the first time." Professor Hong Min-hee also said, "From the point of view of the medical staff, the OS may be considered the most important part, but it is also very important for patients to live long and healthy. So, the primary evaluation indicators were disease-free survival (DFS) and progression-free survival (PFS)." Jin MYEONG, Managing Director of Korea AstraZeneca's anticancer drug business division, said, "We are sincerely discussing with the health authorities about the expansion of the primary benefits." We hope to make good progress." It is the first among EGFR TKIs, and it is very encouraging considering the cross-over prescription of a patient whose T790M mutation was confirmed in the first-generation drug for research ethics.
- Company
- Domestic approval of Ajovy is imminent
- by Eo, Yun-Ho Mar 23, 2021 06:24am
- The second anti-CGRP mechanism following Emgality is expected to be approved in Korea. According to related industries, Teva Handok is in discussions for domestic approval of Ajovy(Fremanezumab), a migraine treatment targeting Calcitonin gene-related peptide (CGRP). Approval is possible within the first half of the year. The effectiveness of Ajovy in preventing migraine headaches was evaluated through two phase 3 placebo-controlled clinical studies in migraine patients who had difficulty in daily life, and proved the efficacy of reducing the number of migraine incidence days compared to the placebo group. As a result, Ajovy competes with Emgality (Galcanezumab) in the reimbursement and non-reimbursement market. Both drugs are humanized monoclonal antibody drugs that block binding to receptors by binding to the CGRP molecule, which plays a major role in triggering migraine symptoms in the brain. In the case of Ajovy, in addition to the once-monthly dosage form, it has a quarterly dosage form to improve medication compliance. It was approved by the European Commission (EC) in six months following the acquisition of marketing approval from the US FDA in September 2018. Emgality was launched in Korea in December 2019. Since no drugs have been registered, the process of insurance benefits is expected to be fierce. However, since CGRP is a relatively expensive drug, it is highly likely to be limited to at least tertiary therapy. However, since there are not many treatment options for migraine patients, the non-reimbursment market is also expected to be active. Shinchon Severance Hospital Neurology Professor Joo Min-kyung said, "Migraines are a pain that is more than expected and impair the quality of life of patients. Patients who experience migraine headaches more than 4-5 days a month can expect improvement in their quality of life through preventive treatment. CGRP drugs will be an encouraging option in situations where high blood pressure and epilepsy drugs have been recommended for preventive treatment." Last year, Emgality’s indications for reduction of headache attacks during cluster headache in adult patients suffering from cluster headache were expanded It occurs mainly in men in their 20s to 40s, and when the pain begins, it lasts for 15 to 180 minutes, and this pain occurs up to 8 times a day. Among them, patients who experience cluster headaches from 7 days to 1 year but experience painless periods for more than 3 months are classified as intermittent cluster headaches.
- Company
- Who’ll be the 2nd Korean-made COVID-19 drug?
- by Kim, Jin-Gu Mar 23, 2021 06:23am
- Product image of Nafabeltan Chong Kun Dang’s candidate COVID-19 treatment Nafabeltan has failed to get the South Korean health authority’s conditional approval. As the Ministry of Food and Drug Safety (MFDS) shut the first door of conditional approval to highly anticipated candidate Nafabeltan, the public is now curious of who would be the next second South Korean-made COVID-19 treatment. Currently, the public highly anticipates of GC Pharma’s investigative plasma treatment. Also the anticipation on Bukwang Pharm, Daewoong Pharmaceutical and Shin Poong Pharm are heightening as well. ◆MFDS “Needs additional clinical trial,” Chong Kun Dang “Phase III clinical trial planned” On Mar. 17, MFDS announced the result of the COVID-19 Treatment Advisory Panel’s discussion on the candidate’s efficacy and safety. The Advisory Panel stated approving Chong Kun Dang’s Nafabeltan as a COVID-19 treatment, only based on the Phase II trial outcome would be inappropriate. They added it would need further clinical trial to be approved as a COVID-19 treatment. On Mar. 18, Chong Kun Dang announced its official position through an official statement. The statement explained, "The company has not received any official notification of the conditional approval rejection from MFDS. The related news would be officially announced immediately after the company receives an official notification." To this date in South Korea, Celltrion’s Regkirona (regdanvimab) was authorized as the first domestic COVID-19 treatment on last Feb. 5. After Celltrion snatched the honorable title first, the public started talking about Chong Kun Dang, GC Pharma, and Daewoong Pharmaceutical as the second domestically developed treatment. Among them, Chong Kun Dang was evaluated to be closest. In fact, Chong Kun Dang was the first of the three companies to apply for conditional approval to MFDS on Mar. 8. ◆GC Pharma “Approval application to be submitted in April,” while Bukwang, Daewoong and Shin Poong clinical trials well in process As the conditional approval on Chong Kun Dang’s Nafabeltan fell through for now, the interest of the pharmaceutical industry is again focused on the GC Pharma. Among all candidates of the second South Korean-made COVID-19 treatment, GC Pharma’s is considered to show the fastest progress. GC Pharma is developing a plasma treatment named, ’GC5131A'. On last Dec. 31, the company completed the administration of the drug on the Phase II participating patients. Currently, related data is being analyzed and organized. GC Pharma official said, "After completing data analysis within the first quarter, we plan to apply for approval to MFDS in April." The increasing cases of treatment-purpose use approval are also heightening the anticipation. According to MFDS, GC5131A has received approval for a total of 41 therapeutic uses since October last year. The public’s interest on Bukwang Pharm, Daewoong Pharmaceutical and Shin Poong Pharm is rising as well. Similar to Chong Kun Dang, the three companies are in process of repurposing an existing drug. Bukwang Pharm says that it is in the final stage of Phase II clinical trial. Bukwang Pharm is developing its own hepatitis B virus treatment, Levovir as a COVID-19 treatment. The Phase 2 clinical trial has completed administering 60 participants. Currently, the company is analyzing the gathered data for MFDS submission. Daewoong Pharmaceutical is repurposing a camostat-based chronic pancreatitis treatment Foistar as a COVID-19 treatment. The outcome of Phase IIa trial announced last year concluded the drug has statistically failed to meet the primary endpoint (cessation of viral shedding). However, the drug confirmed a meaningful improvement in symptom, which was a secondary end point. Based on the findings, Daewoong Pharmaceutical is currently conducting three cases of Phase IIb and Phase III trials—Phase II/III to evaluate Foistar’s efficacy and safety, Phase III to evaluate the candidate in combination with remdesivir and Phase III to evaluate the preventive effect against COVID-19. The specific plan for the approval application has not been disclosed. The company’s clinical trial protocol submitted to MFDS stated the trials would be done by coming December, but they could conclude earlier depending on the circumstances. Apparently, the company has not decided to apply for the full authorization after the Phase III trial is done, or for conditional authorization before completing the trial. Shin Poong Pharm plans to complete the Phase 2 clinical trial next month. Shin Poong Pharm’s trial is investigating the company’s malaria treatment, Pyramax, as a repurposed drug. The company announced that 76 out of 110 target patient size have been administered for Phase II trial as of Mar. 5. In order to expedite the progress of the remaining clinical trials, the company has added three clinical trial institutions to the existing 13.
- Company
- Big 5 to prescribe a novel antifungal drug Cresemba
- by Eo, Yun-Ho Mar 22, 2021 06:17am
- The Big Five South Korean general hospitals have registered a novel antifungal drug Cresemba for prescription. Pharmaceutical industry sources reported the Drug Committee (DC) at all of the Big Five general hospitals in South Korea, including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital and Severance Hospital, have recently passed Cresemba (isavuconazonium). However, the drug faces an issue with the healthcare reimbursement. In last year, the Health Insurance Review and Assessment Service (HIRA) internally revised the regulation on the pharmaceutical reimbursement subject evaluation standard and procedure. HIRA narrowed the scope of prospective subject for pharmacoeconomic (PE) analysis exemption, initially suggested as ‘antibiotics,’ to ‘antibacterials.’ Both the industry and academic scholars supported the government’s plan to expand the subject scope of the PE analysis exemption. But their definition of antibiotics was controversial. Medically speaking, an antibiotic means antimicrobial medicines that cover antibacterial, antifungal and antiviral. And the constant increase of antimicrobial resistance (AMR) is considered as the most critical public health risk around the world. Due to the major public health risk, some were disputing over unifying the definition of the new PE exemption subject—antibiotics—as ‘antibacterial’ based on the variant definitions of antibiotics. And the government sealed the deal by ‘limiting the exemption to ‘antibacterial’.’ Cresemba, categorized as an antifungal, is in shock of the government’s decision. Including South Korea, the number of fungal infection cases around the world has been surging as more than one million people are reportedly dying annually from fungal infection. However, the number of developed antifungal is limited. Among all fungal infection, the invasive aspergillosis is considered as one of three most deadliest invasive fungus to the human race. Even in Korea, the infection is counted as one of most frequent causes of death in patients with immune deficiency, due to increased number of patients receiving anticancer therapy and fighting against AIDS. President Choi Jung-hyun (Catholic University of Korea Eunpyeong St. Mary's Hospital) of Korean Society for Antimicrobial Therapy (KSAT) said, “The risk of secondary nosocomial infection increases higher, when a patient with COVID-19-like severe disease is hospitalized for a long term or uses respirator for a long term. While the demand for securing sufficient amount of infectious disease drug is becoming ever more important to respond against novel infectious disease and secondary nosocomial infection, it is regretful that the government had to neglect the academic society’s advice and narrow down the definition of antibiotics.” In January last year, the Ministry of Food and Drug Safety (MFDS) has approved Cresemba, indicated to treat adult patients in age of 18 and older with invasive aspergillosis, and adult patients in age of 18 and older with mucormycosis for whom amphotericin B is inappropriate. With a wide variety targeted antifungal spectrum, Cresemba can treat both invasive aspergillosis and invasive mucormycosis. The drug is currently the only azole antifungal in South Korea indicated for invasive mucormycosis.
- Company
- Keytruda is expected to expand its indications
- by Eo, Yun-Ho Mar 19, 2021 06:29am
- Keytruda, an immune anticancer drug, is expected to expand its indications for the first-line therapy for colon cancer and esophageal cancer. According to industry sources, MSD Korea recently submitted an application for additional indications about PD-1 inhibitor Keytruda's (Pembrolizumab) ▲MSI-H, microsatellite instability high or dMMR, first-line therapy in patients with advanced colorectal cancer with mismatch repair deficient and ▲ combination therapy of first-line platinum-based chemotherapy drugs for unresectable, locally advanced or metastatic esophageal cancer and gastroesophageal junction cancer (GEJ). The study was conducted in 307 patients with advanced colorectal cancer with MSI-H/dMMR with poor prognosis. Keytruda alone and conventional chemotherapy (5-FU-based therapy ± Bevacizumab or Cetuximab) was compared and evaluated. As a result of the interim analysis, the median follow-up period was 32.4 months, the median progression-free survival (mPFS) of the Keytruda-treated group was 16.5 months, and more than twice that of 8.2 months of the chemotherapy group, and reduced the risk of disease progression and death by 40%. The objective response rate (ORR) was 43.8% in the Keytruda-treated group and 33.1% in the chemotherapy group. In these patients, 83% of the Keytruda-treated group and 35% of the chemotherapy group maintained a response even in the second year. In the case of stomach cancer, the efficacy was proven through the KEYNOTE-590 study. As a result of interim analysis, the combination of Keytruda and platinum-based chemotherapy improved both overall survival (OS) and PFS compared to standard therapy, and passed safety indicators such as duration of response (DOR) and ORR. Keytruda is also in the process of approving indications for first-line therapy for metastatic triple-negative breast cancer (TNBC) in Korea. The effectiveness of Keytruda in triple-negative breast cancer was proven through the KEYNOTE-355 study. In this study, Keytruda improved progression free survival (PFS) and an objective response rate of 53% (17% for complete, 36% for partial) in the entire patient group including patients with poor prognosis who recurred rapidly for more than 6 months.), with a high rate of complete relevance, suggesting the possibility of cure in metastatic triple-negative breast cancer.
- Company
- The outpatient Rx market is shrinking in this winter
- by Chon, Seung-Hyun Mar 18, 2021 06:22am
- With the winter flu season, the outpatient prescription drug market is shrinking. In January and February of this year, the prescription size decreased by 6% from last year. The outpatient prescription drug market has been sluggish since the end of last year. It is analyzed that the prescription drug market has also been affected by a sharp decline due to the prolonged COVID-19. According to the drug research institute UBIST on the 17th, the cumulative outpatient prescription amount in January and February was ₩2,315 billion, a 6.3% decrease from the same period last year. The prescription amount in January was down 7.0% from the previous year, followed by a 5.6% decline in February. Monthly outpatient Rx amount trend (Unit: ₩100 million, Source: UBIST) In last December, the amount of outpatient prescriptions dropped by more than 5% for three consecutive months after falling 6.0% from the previous year to ₩1,235 billion. Last month's prescription amount was the lowest in two years since February 2019. Compared to previous years, sales in the prescription market in January and February are unusual. In last January and February, prescriptions amounted to ₩2.47 trillion, an increase of 3.4% from the same period last year, and the amount of prescriptions in January and February of 2019 increased by 6.3% from the previous year. Despite COVID-19 variable last year, the prescription drug market generally made good progress, but it has been sluggish since winter. Last year, the total outpatient prescription amount was ₩14,855.9 billion, an increase of 0.2% from the previous year. Until November of last year, the cumulative prescription amount was ₩12,385 billion, an increase of 0.8% from the same period last year, but it has declined since December. 지난해 전체 원외 처방금액은 14조8559억원으로 전년보다 0.2% 증가했다. 지난해 11월까지 누적 처방금액은 12조3850억원으로 작년 같은 기간보다 0.8% 늘었지만 12월부터 하락세로 돌아섰다. Monthly outpatient Rx amount increase/decrease from the previous year (Unit: %, Source: UBIST) Since the spread of COVID-19, it is highly likely that the incidence of infectious diseases has greatly decreased due to reinforced personal hygiene management such as hand washing and wearing a mask, leading to a decrease in visits to medical institutions. Since the end of last year, no flu pandemic warning has been issued this winter. According to The KCDA, the number of suspected flu patients per 1,000 outpatients from week 1 to 8 this year is 2.4, 2.4, 2.6, 2.3, 1.9, 1,9, 1.9, 2.0, etc., half of the epidemic standard of 5.8. Compared to 49.1, 47.8, 42.4, 40.9, 28.0, 16.4, 11.6, and 8.5 outpatients per 1,000 outpatients during the 1st to 10th week of last year., there have been few cases of flu recently. Number of suspected flu patients per 1,000 outpatients (Unit: # of patient, Source: The KCDA) It is also possible that visits to medical institutions have further decreased as the social distancing stage has been elevated due to the rapid increase in the number of COVID-19 confirmed patients since the end of last year. As more than 300 confirmed cases occurred from November 18 last year, the government raised the social distancing from November 24 to level 2 from the previous level 1.5. From then on, only packaging and delivery were allowed from cafes regardless of business hours, and only packaging and delivery were allowed after 9 o'clock from restaurants. As the number of COVID-19 confirmed rapidly increased, the government raised the social distance in the metropolitan area to level 2.5 from December 8 last year. Accordingly, in the metropolitan area, operations such as singing rooms and indoor sports facilities in addition to the existing five types of entertainment facilities such as entertainment bars were additionally suspended. Shops, marts, department stores, movie theaters, PC cafes, and other facilities that are closely related to daily life must also close after 9 p.m. Despite social distancing campaign, the number of COVID-19 confirmed cases surpassed 1,000 and the Seoul Metropolitan Government implemented a super-precipitation measure that banned ``private gatherings with more than 5 people'' from December 23 last year, and the same measures have been applied across the country afterwards. In this month, social distancing in the metropolitan area was eased to level 2, but Strengthened distancing measures are being implemented, such as “private gatherings for more than 5 people” are still banned.
- Company
- Industry to yet again drive for flexible use of ICER
- by Eo, Yun-Ho Mar 18, 2021 06:20am
- The pharmaceutical industry is to push for the versatile use of incremental cost-effectiveness ratio (ICER). Related industry sources reported, a third meeting for the public-private consultative council to improve the drug pricing would be held on Mar. 19. Director Yang Yoon Seok and Deputy Director Choi Kyung-Ho of Pharmaceutical Benefits Division at Ministry of Health and Welfare (MOHW), representatives from National Health Insurance Service (NHIS), Health Insurance Review and Assessment Service (HIRA), Korean Research-based Pharmaceutical Industry Association (KRPIA), Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) and Korea Biomedicine Industry Association (KoBIA) would participate in the meeting. And KRPIA, representing the multinational pharmaceutical companies in South Korea, is to reiterate the needs to flexibly apply ICER, as the organization has been pursuing the change for a long time. While the healthcare coverage enhancement initiative on pharmaceuticals tends to focus on severe and disease and anticancer treatments, the public is demanding for the expansion of ICER range, which decides the reimbursed pricing (upper limit pricing with healthcare coverage) of increasingly expensive new drugs. Particularly, the ICER in South Korea is quoting GDP in 2013, and the industry is pointing out the value does not reflect the latest trend. Even before the Moon Jae-in Care, ICER on new drug treating severe and rare diseases was double the general new drug, or flexibly applied up to GDP 50 million won (2 ICER). And the industry insists more versatile approach is needed. As of 2019, the industry urges the actual value would be over 2 ICER, or 50 million won. An industry insider noted, “We do not mean the ICER used on adjusting the upper limit pricing should be used for all. Literally, using the ICER ‘flexibly’ would make it feasible. The ICER should be lowered for a mild disease treatment, whereas the value for absolutely necessary treatment should be raised.” But the government and the industry would have to see if they can settle on a middle ground. Although the issue of ICER has been addressed at the National Assembly audit, the government has been maintaining conservative stance. In fact, at the National Assembly audit session for NHIS and HIRA last year, HIRA Kim Sun-min answered, “The accessibility problem with the expensive anticancer treatment is regrettable, but it is socially challenging to make the change.” At the time, he said, “Regarding the ICER, we need to predict the effect of the additional cost. Anticancer treatments recently listed would cost about average of 1 billion won for extending one year of life expectancy. Considering patients other diseases, we need further social consensus and discussions.”
- Company
- Chinese regulator cracks down on illegal Botox distribution
- by Nho, Byung Chul Mar 18, 2021 06:19am
- Chinese regulators are expected to strengthen crackdowns on unauthorized procedures in the local medical and beauty market, effectively blocking exports of illegal botulinum toxins to China. According to the Chinese media, Xinhua, etc. on the 15th, the public security authorities said they would strictly crack down on illegal activities related to unauthorized procedures in the Chinese medical and beauty market. It is understood that in China, the treatment of illegally distributed drugs causes fatal side effects to patients, as well as frequent medical disputes. It is known that the National Medical Products Administration (NMPA), Ministry of Culture of the People's Republic of China, and the Cyber Investigation Unit are working together to block the distribution of unauthorized and illegal drugs. The Chinese medicine, medical device, and beauty product market is divided into institutional products that have been approved by the NMPA and the gray market distributed by Daigong. According to Article 418 of the Drug Administration Act of the People's Republic of China, all drugs used in China must be approved in accordance with the laws of the Chinese government, and it is illegal if they are sold without obtaining permission for production or import. The Yanzhi economy in China is attracting attention as a new consumption trend. It refers to consumption activities related to appearance, such as plastic surgery, surgery, and cosmetics. With the spread of the trend, the establishment of illegal medical institutions and the distribution of illegal drugs are also increasing. Korea's botulinum toxin is the number one target for such regulation and management, and more attention and attention are being paid to it. A domestic industry official predicted that "Letybo is the only botulinum toxin product that has been officially licensed by the NMPA. Some companies that are estimated to have distributed the product to China through Daigong will suffer much damage." In October 2019, China's national broadcaster CCTV2 reported that the MFDS issued an order to forcibly collect and dispose of many of the botulinum toxin products exported to China by domestic parent companies. At the time, CCTV2 said, "The test report data of this company's product was manipulated, and the lot number that was discarded due to defects was changed to the normal lot number. Products with unstable medicinal effects were distributed." It is sold without a registration permit from the China Pharmaceutical Supervisory Service and requires a lot of attention from consumers." Another industry insider said, “Unauthorized distribution of Korean botulinum toxin products in China is an offense that undermines market order and destroys the status of K-Toxin and K-Bio. Exporting to China through illegal distribution channels is prohibited. It's time to find a solution to eradicate it."
- Company
- Repurposed drugs for COVID-19 unveil clinical trial findings
- by Moon, sung-ho Mar 18, 2021 06:19am
- A series of clinical trial results in repurposing already-commercialized drugs for COVID-19 treatment is unveiling one by one, and the outcome seems to be contrasting among the pharmaceutical companies. For some pharmaceutical companies, their highly anticipated clinical trials have failed and the results are affecting different drugs by other companies. The companies without an outcome, yet, are busy covering up the market’s anxiety and concern by presenting interim status report or requesting for authorization. # According to pharmaceutical industry sources on Mar. 9, Il-yang Pharmaceutical broke the news that it became the first South Korean company to have failed the clinical trial for repurposing the drug for COVID-19 treatment. The company initiated a Phase III trial on a leukemia treatment Supect (radotinib) to repurpose the drug, but it was unable to confirm the expected effect. With the announcement, the pharmaceutical industry was instantly thrown into turmoil with the stress of uncertainty in a successful drug repurposing trial. To resolve the concern, pharmaceutical companies conducting the clinical trials are reporting their current status with the trial, requesting for conditional approval to the Ministry of Food and Drug Safety (MFDS) and unveiling plans to execute a large-scale Phase III trials with 600 participants. For instance, Shin Poong Pharm unveiled the current progress in the locally conducted Phase II clinical trial on Pyramax (artesunate plus pyronaridine phosphatein) to confirm its effect to treat COVID-19, and explained the company has expanded the number of clinical institutes to accelerate to outstanding process. On top of the 10 healthcare institutes initially conducting the trial, the company added three more institutes including Eunpyeong St. Mary Hospital. But as the plan was finalized under the tight confidentiality, the associated hospitals apparently got the news from the company’s official statement. For the Phase II trial, Pyramax has been administered to 76 patients and Shin Poong Pharm aims to call for another 110 patients. According to the company’s plan, the trial should be completed in April. Moreover, Chong Kun Dang has submitted an application to MFDS of requesting conditional item approval and Phase III trial on Nafabelltan (nafamostat) as a COVID-19 treatment. For the Phase III, the South Korean company also submitted a clinical trial protocol involving 600 participants. Chong Kun Dang official explained, “The Phase III trial targeting about 600 patients in South Korea with severe level of high health risks would be conducted in 10 healthcare institutes including the Seoul National University Hospital. As we are aware of the challenges in calling for patients, the company plans to push global clinical trial to promptly register clinical trial participating patients.” On the other hand, Bukwang Pharm is currently working on repurposing its own hepatitis B virus treatment Levovir (clevudine) as a COVID-19 treatment. Recently, 60 patients participating in a Phase II trial have been administered with the drug, which their data is currently being analyzed. Daewoong Pharmaceutical has also started a Phase III trial on Foistar (camostat mesilate) to confirm its effect to treat COVID-19. The company struggled to get statistically meaningful data during the Phase II trial, but the company is to confirm the drug’s efficacy with a Phase III trial. While the South Korean pharmaceutical companies are dealing with different outcomes of repurposing existing drug and developing COVID-19 treatment, the pharmaceutical industry expects to see the outcomes within this year. A pharmaceutical company employee, who requested to be anonymous, commented, “Many of South Korean pharmaceutical companies are seeking for COVID-19 treatment by repurposing their existing drugs. And we are expecting to see the results within this year. But the companies seem to be heavily burdened by the exceptionally heightened interest from the industry and investors.”
- Company
- Lynparza, to be approved for prostate & pancreatic cancer
- by Eo, Yun-Ho Mar 17, 2021 06:10am
- Lynparza, a PARP inhibitor, is expected to be approved as a treatment for prostate and pancreatic cancer in Korea. According to related industries, AstraZeneca is currently expanding the license to Lynparza (Olaparib) for two indications of maintenance therapy for patients with metastatic castration-resistant prostate cancer with a homologous recombination recovery (HRR) mutation and patients with metastatic pancreatic cancer with a BRCA mutation (gBRCAm). Approval is expected in July. Lynparza's indication for prostate cancer was approved by the U.S. FDA in May of last year and in December of 2019 for pancreatic cancer. The efficacy of this drug in prostate cancer has been demonstrated in PROfound study. In this study, Lynparza showed a risk ratio (HR) of 0.34 in patients with mCRPC with BRCA or ATM mutant genes compared to hormone therapy based on Abiraterone acetate or Enzalutamide, reducing the risk of death, a key efficacy evaluation index, by 66%. In general, when the risk ratio is less than 1, it indicates that the risk of the experimental group decreases. Lynparza recorded an HR value of 0.49 compared to the group administered with Abiraterone or Enzalutamide even in the patient group with the total HRR mutant mCRPC, reducing the risk of death by 51%. The patient group with the HRR mutation included patients with 11 other gene mutations, including the BRCA 1/2, ATM, or CDK12 gene mutations. Lynparza also showed statistically and clinically significant improvement in radiographic progression-free survival (rPFS). In the cohort group with BRCA or ATM mutations, the median rPFS was 7.39 months for Lynparza and 3.55 months for the hormone drug-treated group. In the case of pancreatic cancer, the efficacy was confirmed through the phase III POLO trial. As a result of the study, the median progression-free survival (PFS) of the Lynparza first-line maintenance therapy group was 7.4 months, which reduced the risk of disease exacerbation and death by 47% compared to 3.8 months in the placebo group. At both 1 year (Lynparza 34% vs. placebo group 15%) and 2 years (Lynparza 22% vs. placebo group 10%), progression-free survival was confirmed in patients treated with Lynparza more than twice the placebo group. Lynparza was first approved for treatment of ovarian cancer. The indications are for▲adult patients with ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) who have responded (partial or complete) to primary and secondary platinum-based chemotherapy and ▲ patients who have received more than 3 lines of chemotherapy.
