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- 2026-04-13 04:34:39
- Policy
- A clinical study on CAR-T tx at SNUH has been approved
- by Kim, Jung-Ju Dec 14, 2021 05:56am
- A clinical study at Seoul National University Hospital for CART-T (Chimeric Antigen Recepter-T cell) treatment for pediatric leukemia patients was first approved. This is the first approval since the enforcement of the "The Act on the “Safety and Support of Advanced Regenerative Medical and Advanced Biopharmaceuticals” (hereinafter Advanced Bio Act)" in September last year. The MOHW (Minister Kwon Deok-cheol) and the MFDS (Minister Kim Kang-rip) announced on the 8th that the clinical research plan applied by Seoul National University Hospital (Professor Kang Hyung-jin) was approved as the first high-risk high-tech regenerative medical clinical study since the implementation of the "Advanced Bio Act." CAR-T is the introduction of a gene that combines the receptor site of immune cells (T cells) and the characteristic antigen recognition site of the cancer cell surface into the patient's T cells, which has the function of specifically recognizing and attacking the surface antigen of cancer cells. The clinical study applied by Professor Kang Hyung-jin's team this time is a phase 1b clinical study of CD19 chimeric antigen receptor T cells (SNUH-CD19-CAR-T) produced by children and adolescents, which are recurrent or non-adaptive CD19-positive B cells acute lymphoid leukemia. This case is a "clinical study with uncertain or high risk of impact on human life and health (Article 2, Item 3 (a) of the Advanced Regenerative Bio Act), and high-risk clinical studies require detailed examination of safety and effectiveness as they can be treated in innovative ways different from previous treatments. In the case of high-risk clinical studies, clinical research plans can be conducted after being approved by the Minister of Food and Drug Safety after deliberation by the Advanced Regenerative Medicine and Advanced Biopharmaceutical Review Committee under the Advanced Regeneration Bio Act. Considering that this is the first high-risk clinical study, the deliberation committee and the MFDS thoroughly verified research capabilities, protection of research subjects, safety and effectiveness, and completed approval of the committee's results under the Advanced Regeneration Bio Act. The approved clinical study aims to treat patients with acute lymphocytic leukemia in children and adolescents using CAR-T. Patients with acute lymphocyte leukemia in children and adolescents have been treated with chemotherapy, but in the case of recurrent and non-adaptive patients, leukemia cells did not decrease with existing treatments, so there was a limit to leukemia treatment. It is the principle of attacking cells that proliferate at an excessively high rate, and it simultaneously attacks existing proliferating cells (bone marrow, mucous membrane, hair, etc.) as well as cancer cells that proliferate rapidly. Treatment using CAR-T is expected to minimize damage to normal cells in the body while accurately targeting only cancer cells, increasing the therapeutic effect, and minimizing the side effects of existing treatments. We will do our best to promote the regenerative medical field through related projects such as clinical research funding projects and pan-ministerial regenerative medical technology development projects, said Kim Young-hak, head of the regenerative medical policy department.
- Policy
- 241 items of the impurity detected Losartan were recovered
- by Lee, Tak-Sun Dec 14, 2021 05:56am
- Azido impurities are detected in Losartan, HTN treatment , and all 241 items are recovered, and only some manufacturing numbers of 54 items are recovered. However, 11 items are sold as they are because impurities are not detected excessively. The MFDS explained that the risk of harm to the human body is very low, but in the case of patients, it is possible to exchange products, be re-prescribed, and be re-dispensed. It has been decided that Hanmi Pharmaceutical products can be sold. The MFDS announced on the 7th that as a result of a safety survey on impurities in the middle of the drug containing Lozartan, which is a treatment for hypertension, the daily intake allowance (1.7~88.7㎍) was exceeded (1.5㎍/day), but concerns about human harm were very low. This impurity is an Azido impurity that occurs specifically in Losartan, and its mutagenicity (genetic mutation-causing property) has been confirmed and carcinogenicity has not been confirmed. It is explained that the impurities of the Losartan product are different from the impurities AZBT identified among Sartan products in September, and the safety survey was conducted according to the safety information of medicines such as overseas recovery. As a result of the safety survey, all or some lot number products of 295 items (98 companies) that are feared to exceed or exceed the daily intake allowance of Losartan impurities out of 306 items (99 companies) in circulation are voluntarily recovered by pharmaceutical companies. It is voluntarily being recovered from the pharmaceutical company. However, the MFDS confirmed that all or some of the 65 items (23 products) are within the daily intake allowance, and from December 1, only products with less than the allowable amount of Losartan impurities have been shipped. Patients taking Losartan should not stop taking it arbitrarily, but should decide whether to continue taking it after consulting with a doctor or pharmacist. It is explained that if necessary, it can be ▲exchanged for a different manufacturing number ▲ or re-prescribed and re-dispensed with another product. The MFDS consulted the Central Pharmaceutical Review Committee to set the daily intake of Azido impurities, and applied the International Guidelines (ICHM7) in the pharmaceutical sector to set it at 1.5//day. ICHM7 sets a "negligible level" as a daily intake allowance for mutagenic impurities that have not been confirmed to be carcinogenic when consumed daily for life (70 years). As a result of evaluating the health effects of most patients who took Losartan, which daily intake allowance of Losartan impurities was excessively detected, it was found that 0.54 out of 100,000 people had a very low possibility of developing additional cancer, which was negligible. It is explained that the human impact assessment of patients taking excess impurities detection products of Losartan was conducted according to ICHM7 by comprehensively considering ▲ the HIRA's prescription data for the past six years ▲ the maximum dose per day ▲ impurity test results. The MFDS stressed that patients prescribed the product should not arbitrarily stop taking drugs because taking Losartan, which exceeds the daily intake of impurities, has little impact on health. However, patients with health concerns visited the hospital where the drug was prescribed and asked the medical staff to consult whether they were taking the drug and the need to re-prescribe it. They can be exchanged for another lot number by visiting a pharmacy they previously prepared without visiting a medical institution, and patients wishing to re-prescribe can be re-prescribed and re-dispensed with other hypertension treatments. In the case of re-prescribing, re-dispensing, or exchanging medicines at hospitals, clinics, or pharmacies that have previously been prescribed or dispensed, patient compensation is exempted only once for the first time. It will support the use of the health insurance claim system for smooth cost settlement between nursing institutions and pharmaceutical companies. An official from the MFDS emphasized, "We will continue to strictly manage only Losartan, which is less than the daily intake allowance, to supply safe and effective high-quality medicines based on scientific knowledge and regulatory expertise."
- Policy
- Phase III for Amivantamab-Lazertinib was approved
- by Lee, Tak-Sun Dec 13, 2021 05:57am
- Leclaza (Lazertinib), a non-small cell lung cancer tx by YuhanLazertinib was exported to Janssen in 2018 worth 1.4 trillion won. Janssen is attempting to overcome existing treatments through the combination of its developed non-small cell lung cancer treatment "Amivantamab (Rybrevant)" and Lazertinib. The MFDS approved a phase 3 clinical trial plan for "JNJ-61186372" applied by Janssen Korea on the 10th. This clinical trial is the second phase 3 combination therapy of Amivantamab-Lazertinib in Korea. This test is a phase 3, label disclosure, and randomized clinical trial comparing platinum-based chemotherapy and combination therapy of Amivantamab and Lazertinib in clinical trial subjects with EGFR-mutagenic or metastatic non-small cell lung cancer that failed Tagrisso treatment. Tagrisso is a third-generation EGFR (Oral Epithelial Cell Growth Factor Acceptance)-TKI (Tyrrosine Inhibitor) such as Leclaza, and is the latest drug and widely used in the non-small cell lung cancer treatment market. Based on IQVIA, Tagrisso's 2020 sales alone amounted to 106.4 billion won. Janssen is developing combination therapy between Amivantamab and Lazertinib as a competitive drug for Tagrisso. In September last year, phase 3 comparative clinical trials with Osimertinib or Lazertinib were approved by the MFDS as the primary treatment for clinical trial subjects with EGFR mutant local progressive or metastatic non-small cell lung cancer. Leclaza, which was approved in Korea in January, was released by Yuhan in July. It recorded 1.5 billion won in sales in the third quarter of last year based on IQVIA. Janssen's Amivantamab is also known to be under review by the MFDS, and is expected to obtain domestic approval soon. This drug is attracting attention as a treatment for MET mutations in non-small cell carcinoma patients. In May, it was approved by the U.S. FDA as an indication to block EGFR and MET mutations at the same time. If the combination therapy of Amivantamab and Lazertinib is recognized for its efficacy and successfully commercialized, it is expected to lead to a rise in the global value of Lazertinib. Developer Yuhan Corporation can also expect royalties revenue.
- Company
- Boehringer loses another ‘Trajenta’ trademark dispute
- by Kim, Jin-Gu Dec 13, 2021 05:57am
- Boehringer Ingelheim once again tasted defeat in a trademark dispute over its DPP-4 inhibitor antidiabetic ‘Trajenta (linagliptin).' In addition to the trademark dispute against Kwangdong Pharmaceutical in 2019, the company recently lost once more in a suit against Daewoong Pharmaceutical. According to the industry on the 13th, the Intellectual Property Trial and Appeal Board dismissed the trademark invalidation trial field by Boehringer Ingelheim against Daewoong Pharmaceutical. Boehringer Ingelheim had filed a trademark invalidation trial against Daewoong Pharmaceutical claiming that Daewoong’s ‘Traceta’ is similar to Trajenta. Traceta is an Acetaminophen and Tramadol combination used to treat acute and chronic pain. The drug was approved in October 2019. In June 2019, four months before gaining approval, the company had filed a trademark application for the trade name Traceta and registered the trademark in October 2019, immediately after the drug approval. On Boehringer Ingelheim’s claim of trademark infringement, Daewoong Pharmaceutical rebutted that the antidiabetic Trajenta and the analgesic Traceta have very different uses, and therefore have little risk of causing misunderstanding or confusion among general consumers. As a result, the IPTAB ruled in favor of Daewoong Pharmaceutical. This was the second trademark dispute defeat for Boehringer Ingelheim in Korea. The company had filed a similar trademark invalidation suit against Kwangdong Pharmaceutical in July 2019 but lost. At the time, Boehringer Ingelheim claimed the trademark of Kwangdong’s ‘Diagenta’ invalid due to their similar name and class of goods. Diagenta is a generic of Trajenta made by Kwangdong Pharmaceutical that was approved in February 2019. 24 companies including Kwangdong Pharmaceutical had received approval for their generics by succeeding in invalidating the crystalline form patent of Trajenta at the time, but Boehringer Ingelheim had only requested an invalidation trial against Kwangdong Pharmaceutical. The IPTAB said, “Trajenta is a coined trademark with no special meaning. Diagenta’s name nor appearance is similar to Trajenta and the contrast is clear in concept. Although both names contain ‘genta’, the difference between the first two letters is large, leaving little room for consumers to misunderstand or confuse them.” Trajenta is Boehringer Ingelheim’s DPP-4 inhibitor used to treat diabetes. According to the market research institution UBIST, prescription sales of Trajenta amounted to 64.5 billion won last year. The drug was prescribed 47.2 billion won’s worth by Q3 this year. Trajenta Duo, a Trajenta+metformin combination of Boehringer Ingelheim, sold an accumulated amount of 49.9 billion won by Q3 this year. 19 companies including Sinil Pharmaceutical had received generic exclusivity for Trajenta’s generic through a crystalline form invalidation patent and passive trials to confirm the scope of composition patent in 2016. The companies may release their generics after September 2023 when Trajenta’s substance patent and use patent expires.
- Company
- Ildong Idience’s Venadaparib IND approved in China
- by Kim, Jin-Gu Dec 13, 2021 05:56am
- On the 10th, Ildong Holding’s new drug development subsidiary Idience announced that its IND(Investigational New Drug) application for ‘Venadaparib (IDX-1197)’ for gastric cancer patients was approved by China’s National Medical Products Administration. Venadaparib, a PARP (ADP-ribose polymerase) inhibitor, is a new targeted therapy candidate that is being developed to target breast cancer, ovarian cancer, gastric cancer, and PARP inhibitor-resistant cancers. Idience plans to evaluate the safety and efficacy of Venadaparib in combination with irinotecan, an established anticancer drug, on gastric cancer patients in China as soon as all the requirements are met. Idience is in clinical trials with Venadaparib in Korea and the US after receiving approval for its IND application from Korea’s Ministry of Food and Drug Safety and the US Food and Drug Administration. The company had presented results that demonstrate the efficacy of Venadaparib in PARP inhibitor-resistant cancer and BRCA mutation-negative cancer at academic conferences held this year by the American Association for Cancer Research (AACR), American Society of Clinical Oncology (ASCO), and the European Society for Medical Oncology (ESMO). An official from Idience said, “The high incidence of gastric cancer and relatively high number of patients in China make the country advantageous for clinical trials. The IND approval in China will allow us to speed up the development and commercialization of Venadaparib.” He added, “We will also continue research to confirm the effectiveness of Venadaparib and present our development progress, research results, and differentiated strengths of the drug at academic meetings and conferences overseas”
- Policy
- MFDS is considering changing the permission of Remdesivir
- by Lee, Tak-Sun Dec 13, 2021 05:56am
- Attention is focusing on whether COVID-19 treatment Veklury (Remdesivir) will be officially approved. In July last year, Veklury of Gilead Science Korea was conditionally licensed based on non-clinical test literature and interim clinical trial analysis results. At that time, the MFDS quickly approved the final results of clinical trials, some GMP data, and additional risk mitigation measures on the market. According to the industry on the 9th, Veklury submitted data that satisfies the conditions granted at the time of approval to the MFDS and applied for permission to change. On the 7th, an advisory meeting of the Central Pharmaceutical Affairs Council was also held. For now, there is a high possibility of Veklury's permission to change. The U.S. FDA officially approved Remdesivir in October last year. In a clinical trial conducted on 1,062 COVID-19 patients in the United States, the Remdesivir-treated group showed 10 days to recover, and the placebo-treated group showed 15 days, indicating that it was effective in shortening treatment time. However, the WHO announced that Remdesivir was not effective, sparking controversy. In October last year, the WHO reported that in a large-scale clinical trial, Remdesivir was found to have little or no effect in overall mortality, hospitalization period, and need for ventilation. In a small clinical trial released in July this year, Remdesivir drew attention by saying that it had no antiviral effect. In Korea, researchers at 20 university hospitals led by Professor Baek Kyung-ran of Infectious Diseases at Samsung Medical Center earlier this year announced the results of clinical effects. As a result of the analysis of 110 patients, 22.9% of the Remdesivir dosing group deteriorated enough to apply mechanical respiration as of the 28th day of hospitalization, lower than that of other treatment groups (44.7%). Based on this, some argued that Remdesivir should be administered early to severely ill COVID-19 patients. In Korea, Remdesivir and Dexamethasone, which controls immune response inflammation, are used in combination for severely ill patients who are hospitalized and treated. According to Central Disease Control Headquaters, Veklury was administered to 172 hospitals and 22,571 patients by the 3rd. Currently, only Remdesivir and Celltrion's Regkirona are approved treatments for COVID-19. Regkirona is being used to treat mildly high-risk COVID-19 and all secondary adult patients with permission to change. Currently, the MFDS is reviewing the EUA, Merck's oral treatment, and Pfizer's products are also being reviewed in advance before the approval review. Remdesivir is needed until a treatment that shows a definite effect is released. Attention is focusing on whether the controversy over the efficacy will disappear through this review of the change permit.
- Company
- GC Pharma, stopped discussing consignment of Janssen vaccine
- by Kim, Jin-Gu Dec 13, 2021 05:56am
- GC Pharma announced on the 9th that it will suspend discussions on Janssen's consignment production of the COVID-19 vaccine. GC Pharma said it has suspended discussions with Johnson & Johnson on consignment production of vaccines as of today (9th). It has been about four months since GC Pharma announced in August that it will produce Janssen's COVID-19 vaccine on consignment. At the time, a local media reported that GC Pharma was discussing consignment production of COVID-19 vaccines with Janssen. At that time, GC Pharma made an official position that "it has not been confirmed." The pharmaceutical bio industry expected that if GC Pharma signs a consignment production contract with Janssen, it will be the third case of domestic production of the global corona vaccine after SK Bioscience-AstraZeneca and Samsung Biologics-Moderna. Janssen's COVID-19 vaccine was approved in Korea in April. One vaccination has a preventive effect. The preventive effect is 66.9%. However, it is known that the preventive effect decreases sharply over time after inoculation.
- Company
- PH3s of Daewoong’s SGLT-2i antidiabetic near completion
- by Kim, Jin-Gu Dec 10, 2021 05:53am
- #1i Clinical trials for the new antidiabetic SGLT-2 inhibitor ‘Enavogliflozin’ in development by Daewoong Pharmaceutical are gaining speed. One of the three Phase III clinical trials is already complete, and the remaining two are also nearing their final stages after completing patient recruitment. With such progress, the industry expects the authorities to grant marketing authorization for Enavogliflozin within the first half of next year, then be released in 2023. ◆Phase III trial on two-drug combo complete… trials on monotherapy and three-drug combo also in final stages According to the industry on the 10th, Daewoong Pharmaceutical had recently completed the Phase III trial for its Enavogliflozin(DWP16001)+metformin combination therapy. Enavogliflozin, a new SGLT-2 inhibitor antidiabetic, is the first SGLTi developed by a domestic pharmaceutical company. Other antidiabetic SGLTi options available include AstraZeneca’s ‘Forxiga,’ Boehringer Ingelheim’s ‘Jardiance,’ Astellas’ ‘Suglat,’ MSD’s ‘Steglatro,’ among others. Last year, Daewoong Pharmaceutical had received approval to initiate a Phase III clinical trial on 190 patients with type 2 diabetes in 24 hospitals in Korea, including Seoul Saint Mary’s hospital, to assess the efficacy of its Enavogliflozin+metformin combination therapy. After registering the last patient in May this year, the company completed observations on the last patient in November and is currently analyzing clinical data. The company had initially expected to complete the trial by December 2023, but due to smooth progress, the end date was pulled forward by a year. Other clinical trials on Enavogliflozin are also in smooth progress. Daewoong Pharmaceutical is currently running 3 trials related to Enavogliflozin. In addition to its two-drug combination trial on Enavogliflozin+metformin, the company is also assessing Enavogliflozin as a monotherapy and a three-drug combination that uses metformin and DDP-4 inhibitor in addition to Enavogliflozin. Among these, the Phase III trial on the Enavogliflozin monotherapy has started in September last year on 140 patients in Korea. Patient recruitment is now complete and observation of the last patient is expected to be completed within this year at the earliest. The patient recruitment for the three-drug combo has also been completed. Daewoong Pharmaceuticals had received approval to initiate a Phase III trial to assess the efficacy of the Enavogliflozin+metformin+DPP-4 inhibitor combination on 256 patients last October. LG Chem’s gemigliptin was selected as the DPP-4 inhibitor for the three-drug combo, and patient recruitment was completed in August this year. With all three Phase III trials coming to an end, prospects on when the drug will be authorized have also been rising. The pharmaceutical industry believes that it is strongly likely that the company will apply for marketing authorization next year and release the drug in 2023. Daewoong Pharmaceutical had originally planned to release its drug in 2023. The pharmaceutical industry believes that there is a strong possibility that the company will apply for product approval in the first half of next year and release it in 2023. Daewoong Pharmaceutical had originally planned to release it in 2023. ◆ Extension studies for data acquisition also in smooth progress… started trials to enter global market For the Enavogliflozin monotherapy and the two-drug combination using metformin, an extension (long-term administration) trial is also underway in addition to the Phase III trial. Trials on long-term administration of drugs are usually conducted after the product is released, but Daewoong Pharmaceutical plans to release the drug after securing relevant data. The company’s move to first secure the long-term clinical data is interpreted as a strategic attempt to compete with existing SGLT-2 inhibitors. The extension trial for the Enavogliflozin monotherapy was approved in August this year. The clinical trial size is 70. The company started the trial in full by starting recruitment in September last year. The extension trial for the two-drug combination therapy using metformin was approved in March this year, and the company had succeeded in recruiting all 100 patients in November. The trial is expected to be completed by the first half of next year. With existing Enavogliflozin trials entering completion, the company has also been initiating new trials. The company had started a Phase I trial targeting Koreans, Westerners, and Latin American patients on December 1st. It is explained that the trial was prepared with global expansion in mind. The company is also actively seeking indication extensions. In August this year, the company had received approval to initiate a Phase I trial for DWP30600. DWP30600 is a combination of Enavogliflozin and an anorectic agent (DWC202010).
- Opinion
- [Reporter's view] Despite ↑reimbursed drugs for rare dz
- by Eo, Yun-Ho Dec 10, 2021 05:52am
- The need for improvement emerges every year, but patients with rare diseases are still struggling. In particular, even if there are drugs, the number of patients is so small that it is difficult to prove the cost effectiveness and predict financial consumption, making it difficult to register insurance benefits. There were many opinions this year. Kang Sun-woo, a member of the National Assembly Health and Welfare Committee, began holding a parliamentary debate in May to strengthen access to new drugs for rare genetic diseases, and in August, Kang Byeongwon, Kim Won-i, Seo Young-seok, and Shin Hyun-young held a public hearing to discuss ways to improve the treatment environment for rare diseases. But the HIRA reported that the average benefit rate for treatments for rare diseases was 85.3% (2016-2020) and 100% in 2020. At this rate, it is thought that the patient's access to the treatment for rare diseases was perfect. Then, why were there still many opinions on expanding benefits for treatments for rare diseases? The results announced by the HIRA differed from the benefit rate of drugs with rare diseases actually licensed as the benefit rate for drugs that went through the screening and evaluation process. Various factors such as dropout and voluntary withdrawal were excluded. According to data surveyed by the KRPIA and the KPBMA, only about 50% of the items designated as rare drugs over the past decade have been listed on the insurance benefit list for rare diseases. In order for the benefit rate of treatments for rare diseases to rise, the use of RSA and PE systems must eventually increase. Rare diseases are diseases in which the number of patients is less than 20,000 or difficult to diagnose, making it difficult to know the number of patients. In many cases, clinical trials themselves are difficult due to the small number of patients. Due to the small number of patients, it is difficult to actively develop new drugs because it is difficult to expect profitability in the market, and even if new drugs are developed with difficulty, it is difficult to prove cost effectiveness through PE. As a solution to this, the industry has insisted on expanding the PE exemption system. If there is no alternative drug, the PE exemption system should be applied even if it is approved for placebo control data, or the number of patients should be applied in accordance with the special calculation criteria. However, drug price adjustment for drugs subject to PE exemption has recently been predicted. The figure of 80% of the lowest A7 adjustment price has made the industry difficult for a while. In this regard, it is said that the HIRA and KRPIA meetings have recently clarified that they are at the "reference" level. The point is that PE exemption drugs increased and the government thought additional management measures were needed. The point is that PE exemption drugs increased and the government thought additional management measures were needed. If the government has reduced the risk factors, it should look at blind spots.This is because it is an area with few patients and no medicine.
- Policy
- Janssen Korea voluntarily withdrew Tylenol 500mg
- by Lee, Tak-Sun Dec 10, 2021 05:51am
- It is known that the item license for Janssen Korea's antipyretic analgesic "Tylenol 500mg" will be withdrawn soon. This was expected to some extent because the Hyangnam plant will be shut down at the end of this year. Janssen has already been approved for imported items with the same ingredients and the same dosage. According to the MFDS on the 9th, Janssen Korea expressed its intention to withdraw "Tylenol 500mg," which was approved in Korea in 2001. This product has been manufactured at Janssen Korea's domestic factory (Hyangnam). However, as Janssen announced that the Hyangnam plant will be shut down this year, related manufacturing items are also undergoing withdrawal procedures. Janssen's Hyangnam plant was acquired by Whanin Pharmaceutical for about 46 billion won in November last year, and it was decided to withdraw from Korea for the first time in 38 years. In preparation for the withdrawal of the item, Janssen has already been approved for imported items with the same ingredient (Acetaminophen) in August. The product name is Janssen Acetaminophen. This product is expected to replace 500 mg of Tylenol, which is suspended from manufacturing in Korea. Janssen is known to have put in a large number of inventory items this year as demand for "Tylenol 500mg" surged to ease the break from COVID-19 vaccination. Tylenol recorded cumulative sales of 50.1 billion won in the third quarter of this year based on IQVIA, showing a whopping 177% year-on-year growth. In particular, the demand for Tylenol is likely to increase as the number of COVID-19 confirmed cases has soared recently and new and additional vaccinations are expected to increase as vaccine passes are implemented. Janssen is expected to make the most of the inventory items manufactured at the Hyangnam plant, but to hurry to introduce imported items. Until now, it has been found that there is no shortage of Tylenol inventory on the market.
