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- 2026-04-11 06:00:35
- Company
- Announcement of commercialization of oral insulin
- by Eo, Yun-Ho Nov 17, 2022 05:54am
- Expectations are rising for PO use for injectable insulin. Medicox recently signed an exclusive distribution contract with Israeli pharmaceutical company Oramed Pharmaceuticals following the introduction of oral insulin technology. As a result, Medicox will be able to distribute Oramed's oral insulin candidate "ORMD-0801" for 10 years in Korea after approval by the Ministry of Food and Drug Safety. Oramed is said to be innovating the diabetes treatment market through the development of ORMD-0801, which is undergoing phase 3. Topline results of Phase 3 will be released in January 2023, and ORMD-0801 is expected to be the world's first commercial oral insulin capsule for diabetes treatment in the future. SCD Pharmaceutical, a domestic pharmaceutical company, is also developing oral insulin. The company is currently preparing an IND application for oral insulin SCD-0503. This clinical review period takes at least six months, but the clinical review period can be shortened through the submission of data from previous studies. It will be possible to consult with the Ministry of Food and Drug Safety in major countries to simplify the clinical trial period and conditions. In addition, based on the results of previous studies, it is possible to advantageously adjust the contract terms with partners. SCD conducted prior research for the purpose of final verification of global clinical, registration, and commercialization at the request of partners in the United States, Europe, China, and Japan. The company explained that SCD-0503 showed faster drug expression time and higher absorption rate than Israel Oramed at Human Pilot Study. Insulin PO is delivered to the liver through the intestinal absorption process. It is evaluated that insulin can prevent hypoglycemia and help control weight with a principle similar to that of going from the pancreas to the liver.
- Company
- The aftermath of stricter generic regulations?
- by Kim, Jin-Gu Nov 16, 2022 06:11am
- It was found that the number of applications for generic for exclusivity decreased sharply. Experts agree that the implementation of the 1+3 system has affected the decrease in the number of generic for exclusivity applications. Lee Myung-hee, a senior researcher at KIIP, introduced the number of generic for exclusivity applications in 2020 and 2021 at the 2022 Pharmaceutical Intellectual Property Policy Forum held on the 15th. According to him, the number of generic for exclusivity, which reached 272 in 2020, plunged to 26 in 2021. The implementation of the 1+3 system is likely to be the reason for the sharp drop in the number of applications for generic for exclusivity. Lee Myung-hee said, "The 1+3 system has been in effect since July 2021. The number of generic for exclusivity applications has decreased significantly compared to the previous year, he said. "We need to accumulate more data to see if it is the result of the implementation of the system, but we believe that the implementation of the system has affected the decline in a number of generic for exclusion applications." Until now, the pharmaceutical industry has consistently pointed out that the effectiveness of the system is poor due to the acquisition of generic for exclusivity. It was criticized that it did not fit the purpose of introducing the system to induce patent challenges by granting exclusive sales rights. In the case of Jardiance Duo, 99 generics obtained generic for exclusivity. 45 generics for Amosartan, and 33 generics for Janumet won generics. Lawyer Lee & Ko, an example, pointed out, "As many generics acquire generic for exclusivity at the same time, pharmaceutical companies have repeatedly challenged patents due to economic losses due to non-acquisition rather than economic benefits from acquiring generic for exclusivity." A lawyer said, "Since the 1+3 system was implemented in July 2021, BA test data have not been available indefinitely," adding, "As a result, the number of applications for generic for exclusivity seems to have decreased sharply. "In 2022, the acquisition of generic for exclusivity is expected to decrease further," he said. "However, as the effectiveness of the generic for exclusivity increases, it is necessary to examine whether the 1+3 system hinders generic development or hinders generic companies' patent challenges," a lawyer stressed. Attorney Kim Ji-hee said, "A close analysis is needed to see if the implementation of the 1+3 system has actually affected the reduction of generic for exclusivity."
- Company
- Gavreto applies for reimbursement following Retevmo
- by Eo, Yun-Ho Nov 16, 2022 06:10am
- In line with the progress made in Retevmo’s reimbursement review process, its competitor Gavreto was also found to have started its reimbursement process in Korea. According to industry sources, Roche Korea submitted an application for the reimbursement of its RET (Rearranged during transfection) gene fusion targeted therapy Gavreto (pralsetinib). With the reimbursement agenda for Lilly Korea’s Retevmo (selpercatinib) passing the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee (CDDC) meeting earlier this month, the industry’s eyes are on the reimbursement progress of the two drugs. At the meeting, the CDDC set reimbursement standards for Retevmo as a treatment for patients with metastatic RET fusion-positive non-small-cell lung cancer, thyroid cancer who require systemic therapy with prior sorafenib and/or lenvatinib treatment history, etc. Although Gavreto was slightly behind in applying for reimbursement, as both are advanced new drugs that target a very small number of patients, there lies the possibility that the government will discuss the reimbursement listing of the two drugs together. The two RET-targeted anticancer drugs may also benefit from HIRA’s plan to reduce the reimbursement listing period of drugs by 30 days used for life-threatening diseases, depending on the specific timing of its implementation. Meanwhile, Retevmo and Gavreto were both granted marketing authorization by the Ministry of Food and Drug Safety in March this year. As the two drugs not only inhibit primary RET fusions and mutations but also secondary RET mutations that cause resistance to anticancer treatment, the drugs are expected to address the unmet needs that remain in various types of cancers. In terms of the approval period, Retevmo became the first to receive global approval by a few months. Retevmo received marketing authorization from the US FDA in May last year, and Gavreto in September. Retevmo was approved for NSCLC and thyroid cancer indications, whereas Gavreto was first approved as a lung cancer treatment and then approved for thyroid cancer in December of the same year.
- Policy
- Use of Evusheld extended to the severely immunocompromised
- by Kim, Jung-Ju Nov 16, 2022 06:10am
- The COVID-19 Vaccination Response Promotion Team (Head: KDCA Commissioner Kyung-Ran Baek) announced that it had expanded the eligibility of Evusheld as of the 14th to protect the severely immunocompromised from the next wave of COVID-19 outbreak that may arise in the winter season. With the expansion, blood cancer patients, transplant recipients, and people with congenital immunodeficiency who are severely immunocompromised; those with solid cancer, HIV, or rheumatism following deliberation by the Infectious Disease Control Committee; and patients who are receiving serious immunosuppressive treatment such as chemotherapy or B-cell depletion treatment regardless of disease are eligible for Evusheld. Also, the treatment period for patients to apply for the treatment has been extended from the previous 2-4 months to 6-12 months. The dose, which had previously been 300mg, was also increased to 600mg based on MFDS’ Emergency Use Authorization which allows ‘patents to recieve 600mg in the event variants arise,’ cases in the US where the authorities granted increasing the dosage to 600mg to respond to the Omicron variant, and committee deliberation, etc. Those who already received the 300 mg dose within 3 months may receive an additional dose of 300mg, and those who received Evusheld over 3 months ago may receive an additional dose of 600mg. The COVID-19 Vaccination Response Promotion Team said, “As we have expanded the target and increased the administered dose of Evusheld in preparation for the next wave of COVID-19 that may arise in the winter season, we ask the severely immunocompromised that receive serious immunosuppressive treatments to receive Evusheld for further protection. Healthcare professionals at medical institutions that administer Evusheld should actively explain the changes to eligible patients and encourage prompt administration and apply for Evusheld.”
- Company
- Impinzi's indication of biliary tract cancer
- by Nov 16, 2022 06:10am
- AstraZeneca Korea announced on the 14th that its immune anticancer drug "Imfinzi" has received additional approval from the Ministry of Food and Drug Safety for biliary tract cancer. Imfinzi can be used as a combination therapy with Gemcitabine and Cisplatin in the primary treatment of patients with locally advanced or metastatic biliary tract cancer. It is the first indication of the first treatment of biliary tract cancer. The approval of this additional indication was based on a phase 3 TOPAZ-1 study that evaluated the effectiveness of lymphoid combination therapy compared to existing chemotherapy (Gemcitabine and Cisplatin) in 685 patients with local progressive or metastatic biliary tract cancer who have no treatment experience and cannot be resected through surgery. The first evaluation variable is the overall survival rate (OS), and the second evaluation variable is the progression-free survival rate (PFS), the objective response rate (ORR), the response duration (DoR), and the patient report results. As a result of the study, Imfinzi group improved the overall survival rate by 20% compared to the placebo group. At the time of two years, the survival rate of the impingement group was 24.9%, and the placebo group was 10.4%. The median PFS value was 7.2 months for Impinzi, which was 25% better than 5.7 months for the placebo group. The ORR of Imfinzi group was 26.7% (91 cases), of which 2.1% (7 cases) was confirmed to be complete, and partial reactions were observed in 24.6% (84 cases). The most common abnormalities were anemia (48.2%), zone (40.22%), constipation (32%), and neutrophil reduction (31.7%), and the Impinzi group (75.7%) and the placebo group (77.8%) were similar. In a recently confirmed additional analysis, Imfinzi group confirmed the overall survival rate, which improved to 24% compared to the placebo group. The total survival rate at the time of two years was also consistently 23.6% and 11.5% in the impingement group and the placebo group, respectively. Based on these findings, the NCCN recommends Imfinzi as the standard treatment (Category 1) in the primary treatment for local progressive or metastatic biliary tract cancer. "Biliary cancer is cancer with a poor prognosis, with no clear symptoms and a recurrence rate of 60-70%, and Korea has a relatively high incidence of biliary tract cancer in the world," said Oh Do-yeon, a general researcher at TOPAZ-1 at Seoul National University Hospital.
- Opinion
- [Reporter's view] APAP price increase should be quick
- by Lee, Tak-Sun Nov 16, 2022 06:10am
- The government is rushing to raise the upper limit of Acetaminophen which supply and demand are unstable due to COVID-19. The government's plan is to end the review and negotiations as early as this month to reflect the increase plan next month. As the supply and demand of cold medicine continue throughout the year and a large-scale COVID-19 epidemic is expected at the end of the year, we should hurry to raise the price of medicine to expand supply. If the existing procedure is followed, the weak price increase will not be realized until February next year at the earliest, but it is likely to be too late then. It is worrisome that a hasty agreement will be reached in accordance with the unreasonable rapid processing policy. The upper limit of Acetaminophen 650mg is listed at 43 won to 51 won. Some say that it should be more than 100 won, twice as much as this price. First of all, it is necessary to analyze the cost data of individual pharmaceutical companies and come up with a suitable increase plan. We can't just keep up with the position of pharmaceutical companies. Safety measures are also needed so that an increase in weak prices can lead to supply expansion. Therefore, as the price has risen, it is necessary to expand the supply in proportion to it. If the government emphasizes only expedited processing, the government will not be able to avoid criticism that it only raised prices without practical benefits. It is bound to be a burden for the HIRA and the NHIS, which hold the key to analysis and negotiation. As the increase in the weak price is for the people exposed to COVID-19, a wide agreement is urgently needed. If it is difficult to reach an agreement with only mutual interests, it seems that there is no need to stick to swift action. This is because, although this issue is special, equity for other drugs must also be considered.
- Policy
- Negotiations on Strepto, concluded in the early 20% range
- by Lee, Tak-Sun Nov 15, 2022 05:39am
- Major pharmaceutical companies of the anti-inflammatory enzyme Streptokinase and Streptodornase have reportedly reached an agreement with the NHIS in redemption negotiations. The recovery rate, which has been an issue, is said to be in the early 20% range. It is interpreted as the result of the two sides' concessions to each other. According to the industry, major pharmaceutical companies such as the NHIS, Hanmi Pharmaceutical, and SK Chemicals, which held negotiations for the return with a deadline of the 14th, succeeded in reaching an agreement on the last day. Hanmi Pharmaceutical and SK Chemicals are ranked first and second in sales in related markets and are currently leading clinical re-evaluations. The recovery rate agreed by the two sides is said to be in the early 20% range, which is higher than that of the Choline alfoscerate sanctions that previously negotiated the recovery. Until now, pharmaceutical companies have stuck to less than 20% and the NHIS has stuck to more than 20%. The shorter recovery period than the Choline alfoscerate formulation seems to have affected it. As negotiations with major pharmaceutical companies have been concluded, the results of the negotiations are expected to be reported to the Committee this month without renegotiation. There are many opinions within the government that there is an extension of the negotiations on the premise of a settlement this month, but there is no renegotiation. The HIRA conducted sanctions evaluations on Streptokinase and Streptodornase and concluded that the evaluation would be suspended for one year only for items agreed to be recovered negotiations based on the results of clinical re-evaluation. In order to avoid the deletion of benefits, pharmaceutical companies had to agree on redemption negotiations with the NHIS. It is interpreted that the negotiations have been concluded without taking time, given that the final clinical re-evaluation results will be released next year. The analysis also reflected that class action lawsuits, such as choline alfoscerate pharmaceutical companies, will not have much profit. This is because the annual prescription is only 20 billion won, and when the clinical re-evaluation result report is released next year, the salary status will be sorted out. Major pharmaceutical companies have reached an agreement this time, but some consignment production pharmaceutical companies are said to have decided to accept the deletion of benefits without any intention of negotiation. A total of 37 pharmaceutical companies are subject to negotiation, and it is not known exactly how many companies agreed.
- Opinion
- [Reporter’s View] Advanced new drugs, reimb, and patients
- by Eo, Yun-Ho Nov 15, 2022 05:39am
- Some drugs can be prescribed regardless of mutation or receptor status at certain stages of a disease. Other drugs can be prescribed regardless of disease if a certain gene mutation is identified in the patient. As such, the field of pharmaceuticals is evolving at a rapid pace. New drugs that are no longer attached to a specific disease are emerging, introduced as all-comers or disease-agnostic drugs. And the emergence of these drugs is heralding a paradigm shift. However, the new drugs are not easily granted reimbursement in Korea. Due to the broad application of the drugs, the government has to consider how their increased use volume may raise financial concern. For all-comer drugs, further concerns remain. Some raise doubts about their efficacy, on how they can be effective regardless of the gene targeted by their mechanism of action. However, although the efficacy may vary, these drugs have proven their effect as all-comer drugs and obtained approval from the Ministry of Food and Drug Safety. The case is not so different for disease-agnostic drugs that target gene mutations either. And the development of precision medicine is heralding the shift in the prescriptions from ‘disease’ to ‘gene,’ announcing the arrival of the era of personalized medicine. Existing targeted therapies, immunotherapies, as well as tumor-agnostic therapies that were listed this year have also suffered much in the course of expanding their scope of reimbursement. Not only because the drugs are expensive but because each drug needs to reconduct value assessments and estimate their increase in usage volume. This is the main framework that supports Korea's health insurance system. While prudence in financial spending is important, the government also needs to consider the demand of the patients and make some compromises. Times have changed. Patients and their families no longer solely depend on their doctors to make decisions. They search papers for new drugs in clinical trial databases like clinicaltrial.gov. Therefore the question remains, how should Korea embrace these advanced new drugs in the future?
- Company
- Tecentriq approved as adjuvant treatment for NSCLC
- by Nov 15, 2022 05:38am
- On the 14th, Roche Korea announced that its anti-PD-L1 immuno-oncology drug Tecentriq (atezolizumab) was approved as adjuvant therapy following resection in patients with early-stage non-small-cell-lung cancer, and became the first immunotherapy to receive approval for the indication. Tecentriq may now be used as an adjuvant treatment following complete resection and platinum-based chemotherapy in adult patients with stage II to IIIA NSCLC with PD-L1 expression of 50% or higher on tumor cells (TC). With this approval, Tecentriq became the first cancer immunotherapy to be approved as adjuvant therapy in early-stage NSCLC in Korea. The indication extension was approved based on findings from an interim analysis of Phase 3 IMpower010 trial. Tecentriq was found to result in a 57% reduction in the risk of disease recurrence or death compared with best supportive care (BSC) in patients with stage II to IIIA NSCLC with PD-L1 expression of 50% or higher Also, the disease-free survival (DFS) benefit derived with adjuvant Tecentriq over BSC was consistently observed across most of the subgroups analyzed on the trial, including histology and disease stage. The overall survival (OS) data remain immature for this population, but a trend toward improved survival with atezolizumab over BSC was observed with a stratified HR of 0.43. The median OS and subgroup analysis results at 46 months showed that Tecentriq reduced the risk of disease recurrence or death 57% compared with best supportive care (BSC) in subject patients. The safety profile of Tecentriq was consistent with what has previously been observed with the Tecentriq monotherapy, and no new safety signals were observed. Grade 3-4 adverse effects (AEs) that were most frequently reported in the Tecentriq arm were increased ALT (2%), pneumonia (1%), and increased AST. Based on the data, the U.S. National Comprehensive Cancer Network (NCCN) guideline recommends Tecentriq as adjuvant therapy (Category 2), and the American Society of Clinical Oncology (ASCO) also recommends Tecentriq as adjuvant therapy in its guideline for adjuvant therapy in early-stage lung cancer patients. Sang-We Kim, Professor of Oncology at Asan Medical Center, said, “Around half of NSCLC patients experience recurrence after surgery, some of which at an untreatable state. With immuno-oncology drugs that had been mainly prescribed in metastatic NSCLC now available for use in the early stages of the disease, NSCLC patients in Korea that have a high rate of PD-L1 expression can have the opportunity to reduce their chance of recurrence after surgery and chemotherapy.”
- Company
- CR of AML new drug candidates is identified in Phase 1/2
- by Kim, Jin-Gu Nov 15, 2022 05:38am
- Hanmi Pharmaceutical announced on the 14th that it has confirmed cases of complete response (CR) in various dose groups as a result of phase 1/2 clinical trials of Tuspetinib (HM43239), which is being developed as an AML treatment. Aptose was recently introduced at the KOL webinar, "As a result of the global phase 1/2 for patients with recurrent or refractory acute myeloid leukemia, we confirmed CR cases in all of the various doses (80 mg, 120 mg, 160 mg) of HM43239." Aptose will present details of the study at the 64th ASH in New Orleans, the U.S., from the 10th to the 13th of next month. HM43239 is an oral MKI administered once a day that targets major kinases acting in myelogenous malignant tumors. It was designated as a fast-track development drug by the FDA in May. In 2018, it was also designated as a rare drug. According to the successful results of this clinical trial, Aptose plans to expand clinical trials with single-administration therapy and combination-administration therapy in the future. In the extended clinical trial of single administration therapy, the efficacy of HM43239 120mg will be confirmed in the AML patient group, including patients with FLT3 mutations who do not respond to existing FLT3 inhibitors. In addition, it plans to conduct a combined clinical trial with HM4323980mg and Venetoclax, an existing AML treatment.
