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- 2026-05-18 18:57:16
- Company
- Hanmi’s Efpeglenatide reduces cardiovascular risk
- by Chon, Seung-Hyun Jul 01, 2021 05:55am
- Sanofi announced a study that reduces the risk of cardiovascular and kidney disease of new diabetes drugs that have returned rights to Hanmi. Hanmi plans to find new opportunities based on research results. According to Hanmi on the 29th, Sanofi held an independent session for Efpeglenatide at the American Diabetes Association (ADA) and announced the results of AMPLITUDE-O on eight subjects through eight researchers for two hours. Efpeglenatide is a GLP-1 family of diabetes drugs that Hanmi transferred technology to Sanofi in November 2015. It is a new bio-drug that extends daily injections from once a week to up to once a month. Sanofi conducts five clinical trials of Efpeglenatide. It finally gave back its rights to Hanmi in September last year. The findings released by Sanofi this time were conducted on more than 4,000 patients, the most among five clinical trials. AMPLITUDE-O Phase 3 clinical trials were given weekly Efpeglenatide or placebo to 4,076 patients with type 2 diabetes or cardiovascular disease in 344 regions in 28 countries. In type 2 diabetes patients, the risk of cardiovascular and kidney disease was significantly reduced when administered in two doses, Efpeglenatide 4mg and Efpeglenatide 6mg. The incidence of major cardiovascular diseases in the Efpeglenatide group compared to the placebo group decreased statistically to 27% and 32% in kidney disease. Professor Naveed Sattar of the University of Glasgow said, "The AMPLITUDE-O clinical trial safely reduced the incidence of major cardiovascular and kidney disease in low-risk and high-risk patients with type 2 diabetes." Major speakers and topics of the independent session for Efpeglenatide conducted by Sanofi (data: Hanmi) "Efpeglenatide has prepared a new opportunity to create another innovation," said Baek Seung-jae, executive vice president of Hanmi Pharmaceutical. "We are focusing our company's capabilities on expanding and materializing the potential of Efpeglenatide, which has been proven through large-scale global clinical trials," he expected. Another global clinical phase 3 (AMPLITUDE-M) result of Efpeglenatide, which was conducted on 406 type 2 diabetes patients whose blood sugar is not controlled by diet and exercise, was also introduced by Dr. Juan Frias, a leading researcher. The clinical trial, which was conducted with double blindness, divided Efpeglenatide into three dose groups (2mg, 4mg, and 6mg) for 56 weeks, compared Glycated hemoglobin with primary evaluation variables for 30 weeks, weight loss, and safety for 56 weeks. Studies have confirmed excellent blood sugar control and weight loss effects when Efpeglenatide is administered to type 2 diabetes patients. Treatment also remained stable for long periods of time. Glycated hemoglobin showed statistically superior improvements in all doses over placebo in Week 30 of treatment. Shortly after the announcement, the New England Journal of Medicine (NEJM) published a paper on Efpeglenatide. "Cardiovascular safety is an important factor that doubles the global competitiveness of drugs in large-scale clinical trials, allowing us to create other innovations and business opportunities," said Kwon Se-chang, CEO of Hanmi Pharmaceutical. Main screen of the New England Journal of Medicine (NEJM) introduced Efpeglenatide (reference: Hanmi)
- Policy
- Targets for PVA in third quarter include Darzalex & Alunbrig
- by Lee, Hye-Kyung Jul 01, 2021 05:55am
- Janssen Korea's (Daratumumab) and Takeda Korea’s Alunbrig (Brigatinib) were included in the Price-Volume Agreement (PVA). Otsuka Pharmaceutical Korea's "Iclusig" and AstraZeneca Korea's "Impinji" (Dubalumab) were also subject to negotiations on drug prices due to increased usage. The NHIS recently introduced "PVA (Type Ka/Na) Monitoring Drugs for 3rd Quarter of 2021" on its website. Targets for monitoring in third quarter of this year are 173 items from 90 pharmaceutical groups. PVA is a method shared by the NHIS and pharmaceutical companies to share the risk of health insurance finances, and the drug price will be reduced through negotiations with the NHIS. Type Ka of PVA corresponds to cases in which claims for the same product group with expected claims agreed with the NHIS have increased by more than 30% from expected claims. Type Na is subject to the same product group, which has been negotiated for type Ka or not negotiated for type Ka, where the previous type has increased by more than 60% or more than 10% or ₩5 billion every year from the end of the analysis period. Drugs with an annual claim of less than ₩1.5 billion, drugs with lower upper limit than the arithmetic average of the same ingredients, low-cost drugs, and drug shortage prevention programs are excluded from PVA. The pharmaceutical groups included Samoh's "Vimizim (Elosulfase Alpha)," Sanofi-Aventis Korea's "Mozobil (Plerixafor)," BL&H's Trisenox(Arsenic Trioxide) and SK Chemical's Migard(Frovatriptan Succinate Monohydrate). The pharmaceutical groups included Samo Pharmaceutical's "Vimizim (Elosulfase Alpha)," Sanofi-Aventis Korea's "Mozobil (Plerixapor)," BL&H's "Arsenic Trioxide" and SK Chemical's "Migard" (Frovat Monochlithinccate).
- Company
- Generics for Pradaxa, Xarelto & Brilinta will be released
- by Kim, Jin-Gu Jun 30, 2021 05:57am
- Material patents of Pradaxa and Xarelto expire in July and October this year, respectively. As a result, 8 generics for Pradaxa and 200 generic for Xarelto are expected to be released early in the second half of this year. In November, 25 generics for Brilinta will be released. Ahn-Gook's generic for Galvus is expected to be released within the year according to the Supreme Court ruling. ◆Generics for Pradaxa & Xarelto in July and October Xarelto and PradaxaAccording to the pharmaceutical industry on the 28th, a total of 82 pharmaceutical patents will expire in the second half of this year. What attracts the most attention is the expiration of the material patent for two NOAC products. Material patent of Pradaxa expires immediately on the 17th of next month. Four companies received generic for exclusivity with a total of eight items. Ajou Pharm's Davitran, Intropharm's Davican, Jinyang Pharmaceutical's Pradabi and Huons' Hubitran can get the exclusivity to sell generics for nine months from July 18 to April 17 next year. Material patent of Xarelto expires in October. 23 companies such as SK Chemical, Chong Kun Dang, and Hanmi have avoided follow-up patents. Two of them received generic for exclusivity. SK Chemical's SK Rivaroxaban 2.5mg and Hanmi Pharmaceutical's Riroxban 2.5mg will be sold exclusively from October 4th to July 3rd next year. 62 companies have been licensed for 195 items. More than 200 generics are expected to be released after October 4, when material patents expire. The early launch of generics for Pradaxa and Xarelto contrasts with the withdrawal of Eliquis' generic market. Earlier, six to seven companies, including Chong Kun Dang, won the first trial on material patent of Elyquis. Thus, it has released generic early since June 2019. They have accumulated more than ₩10 billion in prescription performance through the first quarter of this year. In April this year, however, the Supreme Court sided with the original company, BMS. Generics voluntarily withdrew their products from the market. The early launch of generis of Pradaxa and Xarelto is expected to lead to a reorganization of the NOAC market. In the case of the two items, judgment of the decision to avoid the follow-up patent has been confirmed. As of last year, Pradaxa had ₩14.3 billion and Xarelto had ₩50 billion in outpatient prescription performance. Considering that generic for Eliquis has previously increased its market share around Clinics, generics for Pradaxa and Xarelto are also expected to be in the market. ◆25 generics for Brillinta are expected to be launched simultaneously after November The patent for the anti-platelet drug Brilinta expires in November. It is predicted that 25 generics will be launched at the same time as the patent expires. 25 items, including Boryung Ticagrelor by Boryung from November 21 this year to August 20 next year have acquired generic for exclusivity. Attention is also focusing on whether Ahn-Gook will be able to release Novartis' GPP-4 inhibitor family of diabetes drugs early on. The generic for exclusivity for generic for Galvus is the sole acquisition of Ann-Gook. The period is from 30 August to 29 May next year. In 2019, Ahn-Gook succeeded in invalidating some of the extended periods of material patents for the first time in Korea. As a result, it succeeded in pushing forward the expiration of material patent of Galvus, which was originally scheduled to expire in March next year, by about six months (187 days). However, Novartis appealed, and the Patent Court ruled that 55 days were invalid, not 187 days. The release date of generic for Galvus will be pushed back to January next year. The case now awaits the Supreme Court's final ruling. The Supreme Court's decision determines the timing of Ahn-Gook's generic for Galvus. If it accepts the judgment of the Patent Tribunal, it can be released in August. If the patent court accepts the ruling, it is expected to be released in January next year. If it accepts Novartis' claim, it can only be released after March of next year.
- Policy
- 2 indications deleted for choline alfoscerate, changes label
- by Lee, Tak-Sun Jun 30, 2021 05:56am
- Authorities have ordered companies to delete the No.2 and No.3 indication of the brain function enhancer choline alfoscerate, for which the clinical re-evaluations have started recently. Accordingly, the indication must be removed from the label from the 28th of next month. Also, the Ministry of Food and Drug Safety requested doctors and pharmacists to review the need to prescribe and dispense substitute drugs for patients that use choline alfoscerate during the labeling change period. On the 28th, the MFDS ordered a label change for 144 choline alfoscerate products. After a review of the clinical trial protocols for the reevaluation of these products, the ministry determined that that trial will be unable to assess the efficacy of choline alfoscerate’s second and third indications and decided to remove the two indications. As a result, only the first and main indication, for ‘Secondary symptom caused by cerebrovascular defects or degenerative brain-organic psychiatric syndrome by cerebrovascular deficiency: reduced memory, derangement, disorientation by reduced willingness and spontaneity, reduced willingness and spontaneity, reduced concentration’ will be left approved for choline alfoscerate. The second indication, for ‘Emotional and behavioral change: emotional insecurity, sensitive to stimulation, indifferent to surrounding,’ and the third indication for’ Senile pseudodepression’ will be deleted. However, whether the first indicating will remain intact depends on the results of the domestic clinical reevaluation that will be conducted. The MFDS had ordered companies to submit clinical trial results for Alzheimer's patients by December 9th, 2025, and the same for patients with mild cognitive disorder by March 9th, 2025. 57 companies including Daewoong Pharmaceutical and Chong Kun Dang that will lead the clinical trial will be participating in the clinical reevaluation. With the order to change labels issued, choline alfoscerate products that will be produced a month from the indication change, from July 28th, must reflect the new efficacy and effect on the product box and label. Administrative sanctions will be imposed on the companies that do not comply with the order by the said date. In 2019, the prescription sales amount of choline alfoscerate for the deleted two indications (No.2, No.3) amounted to 39.3 billion won and accounted for 11.1% of total prescription sales for the drug. Therefore, pharmaceutical companies are not expected to suffer huge performance losses from the change of indications. The companies are more intently focused on negotiations with the government on the amount they may have to give back in case the reevaluations for the first indication fall through. The National Insurance Health Service had recently proposed a retrieval rate of 30% of the insurance claims amount to make progress in the fruitless negotiations.
- Opinion
- [Reporter’s view] Confusion by 1+3 bill must be minimized
- by Lee, Tak-Sun Jun 30, 2021 05:56am
- Sharing the results of the biological equivalence test with other companies and obtaining permission is restricted by the revision of the law. The National Assembly passed the pharmaceutical affairs law amendment on the 29th, which included 1+3 bill. Accordingly, a trustee who manufactures medical supplies may share permitted data and supply medical supplies only within three consignment companies. Therefore, it is expected that this will greatly reduce generic items that are easily licensed only by data sharing. Trustees are expected to suffer a setback in their projects due to a decrease in consignment production. Overall spending costs are also expected to increase as the number of medicines manufactured by pharmaceutical companies increases. The 1+3 bill was revised by the MFDS in 2019 by reflecting it in the screening regulations due to numerous generic drugs. However, the office for government policy coordination's Regulatory Reform Committee decided to withdraw the system, and the regulations were not amended. The National Assembly said that the number of generics should be limited when impurities were detected in preparations such as Ranitidine following Valsartan. As a result, it was re-promoted with the Pharmaceutical Affairs law, and despite opposition from small and medium-sized pharmaceutical companies, the MFDS, the KPBMA, and lawmakers from the ruling and opposition parties were generally in favor. Now, when the law is promulgated in July, it will be restricted from new medicines received from the future. Since the law takes effect immediately, pharmaceutical companies may suffer unfair damage due to the application of products prepared before that. Regulations can be avoided by proving joint development within one month of the enforcement date of the law. However, there may be complaints over the targets of exceptions, evidence, and procedures. Consequently, failure to make the exception correctly can be confusing. The MFDS should establish detailed rules after passing the law to minimize complaints from pharmaceutical companies and to ensure that the law is settled quickly. The 1+3 bill was effective and any debate became meaningless. The MFDS, which is in charge of ensuring that the law is applied fairly and quickly. It is up to the MFDS now.
- Company
- JW Pharma acquires domestic license for fostamatinib
- by Chon, Seung-Hyun Jun 30, 2021 05:56am
- On the 28th, JW Pharmaceutical Corporation announced that it has entered into a licensing agreement with Kissei Pharmaceutical Co., Ltd for the development and commercialization rights in Korea of fostamatinib, a thrombocytopenia treatment. Under the licensing agreement, JW Pharmaceutical may develop, obtain regulatory approval, and market fostamatinib in the domestic market. Fostamatinib was originally developed by Rigel Pharmaceuticals, Inc., and Kissei acquired exclusive development and commercialization rights for fostamatinib in Japan, China, Korea, and Taiwan from Rigel in 2018. Immune Thrombocytopenic Purpura (ITP) is a condition in which the body’s immune system attacks platelets, causing the platelet count to become lower than normal. Patients with ITP are easily bruised, bleed easily, and have difficulty stopping bleeding. In severe cases, it can lead to cerebral hemorrhage or upper gastrointestinal tract bleeding, and therefore is a rare blood condition with a high unmet need. Fostamatinib is an oral spleen tyrosine kinase (SYK) inhibitor that targets the underlying autoimmune cause of ITP in adult patients. Contrary to existing treatments that boost blood platelet production, this first-in-class drug suppresses the destruction of platelets by macrophages and suppresses platelet depletion. Fostamatinib was approved by the U.S. FDA in 2018 for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to previous treatment, and is sold under the name ‘Tavalisse.’ According to post hoc analysis results of Phase III clinical trial presented at the 2019 American Society of Hematology (ASH) Annual Meeting, the use of fostamatinib as second-line therapy after treatment with corticosteroid showed a high treatment response rate in patients who have been diagnosed within a year. Also, fostamatinib has less dietary interference and drug-drug interactions than other oral formulations and may be taken regardless of food intake or other medications. JW Pharmaceutical plans to receive the orphan drug designation for fostamatinib in Korea to expand treatment opportunities for adult patients with thrombocytopenia. An official from JW Pharmaceutical said, “The company was able to add a new drug for a rare disease in our lineup through the agreement. We will work to progress the domestic approval process without any delay to provide treatment for patients suffering from chronic ITP.”
- Policy
- Will Rosuvastatin OD be released?
- by Lee, Tak-Sun Jun 30, 2021 05:55am
- Crestor (Rosuvastatin)Attention is focusing on whether a treatment for hyperlipidemia, Rosuvastatin OD (Orally Disintegrated Tablet) will be released. Rosuvastatin OD was approved in Japan in 2016, but has not yet been released in Korea. According to industries on the 25th, BCWORLD Pharm recently applied for approval of Rosuvastatin OD to the MFDS. AstraZeneca's Crestor is the original for Rosuvastatin. Generics have been released in Korea since 2009, and 941 cases are currently approved. However, there is no formulation of ODT that is melted with the tongue without water. In Japan, AstraZeneca and Shionogi were approved for Crestor OD in 2016. It is said to have been developed by Shionogi. ODT is useful for patients who have difficulty swallowing tablets or who need to refrain from drinking water. However, since most patients are familiar with regular tablets, there will not be much demand for ODT formulation. Last year, Crestor recorded ₩85.5 billion in outpatient prescriptions in the country. Therefore, if ODT is released for the first time, it is enough to attract attention regardless of market size. However, it is too early to discuss the success of commercialization. When a new drug is applied for permission, the MFDS decides whether to approve the sale after safety and the review.
- Company
- Amitiza can be prescribed at general hospitals
- by Eo, Yun-Ho Jun 29, 2021 05:46am
- Amitiza, a chronic constipation drug, can be prescribed at general hospitals. According to related industries, Amitiza(Lubiprostone), which is conducting exclusive promotion activities in Korea through contracts with Takeda Pharmaceuticals, passed the drug committee (DC) of 42 medical institutions nationwide, including AMC and Severance Hospital. Amitiza is used to treat certain types of constipation (chronic idiopathic constipation, irritable bowel syndrome with constipation). Chronic idiopathic constipation has an unknown cause and is not due to diet, other diseases, or drugs. Lubiprostone is also used to treat constipation caused by opioid medications in people with ongoing pain due to medical conditions other than cancer. and was released in February last year. Amitiza, co-developed and marketed by Takeda with Sucampo Pharmacutics, obtained market approval from the U.S. FDA in 2006. Amitiza facilitates CIC-2 chloride channels to increase fluid secretion in the small intestine to relieve constipation symptoms. Clinical trials showed that 60% of constipation patients succeeded in natural bowel movements within 24 hours of taking Amitiza. Amitiza was sold about ₩688.2 billion last year alone in major countries including Japan, the United States and Europe. It is an oral bicyclic fatty acid that selectively activates type 2 chloride channels in the apical membrane of the gastrointestinal epithelium, resulting in increased fluid secretion Lee Kwang-jae, Professor of Gastroenterology at Ajou Medical School (chairman of the Korean Society of Neurogastroenterology and Motility), said, "As it is the first new mechanism in Korea, we expect it to be a primary treatment option for chronic constipation patients who experience daily discomfort."
- Company
- Select the right initial treatment for kidney cancer
- by Jun 29, 2021 05:46am
- Cancer immunotherapies are receiving the spotlight in the treatment of kidney cancer. Demonstrating superiority over existing therapies, these drugs are quickly gaining ground in the field of kidney cancer treatment. Recently, MSD’s cancer immunotherapy ‘Keytruda (pembrolizumab) received approval as first-line treatment in combination with Inlyta(axitinib). Afterward, the immuno+immunotherapy combo ‘Opdivo (nivolumab)+ Yervoy (ipilimumab)’ also received approval as a first-line treatment option. Dr. Chan Kim, Professor of Medical Oncology/Hematology at CHA Bundang Medical Center believes that the use of cancer immunotherapies will broaden in the field of kidney cancer. And there’s ample grounds to support Kim’s belief. Keytruda in combination with a different targeted therapy, ‘Lenvima (Lenvatinib)’ has recently produced even more superior data in a clinical trial. However, limitations do exist. Currently, cancer immunotherapies are approved only for the first-line indication. Therefore, if the patient had previously used other treatments, they may not be prescribed cancer immunotherapy drugs. Therefore, patients with Stage IV kidney cancer must carefully consider and select their first treatment. Dailypharm met with Professor Kim to seek his insight on the significance and prospect of cancer immunotherapy drugs in the field of kidney cancer. Professor Chan Kim-How has the kidney cancer treatment environment changed with the introduction of cancer immunotherapies? = Kidney cancer is a field known for its poor response to general chemotherapy or radiotherapy treatment. Due to this, cytokine-based immunotherapy has been used as an option for over 20-30 years in the field, but even this option has not been broadly used because its objective response rate is only around 10-20%, with serious side effects. This treatment paradigm for kidney cancer has completely changed with the introduction of cancer immunotherapy drugs (immune checkpoint inhibitors). Cancer immunotherapy drugs have fewer side effects than previous drugs and can be used safely even in elderly patients. Most of all, it showed a good therapeutic effect. However, immunotherapy drugs by themselves were not enough to produce satisfactory results as the objective treatment response rate of immunotherapy drugs alone was around 25-30%. As a result, attempts to use immunotherapies in combination with targeted therapies have been made, and clinical studies on this combination were released for kidney cancer in 2019. Results showed that the immuno+targeted therapy combination achieved a twice higher ORR than monotherapy, with an ORR of 55-60%. The uncrossed barrier of 30% was finally overcome. -Were many combination therapies implemented in practice after the data was presented on the immuno+targeted therapy combination? How effective is it in practice? =Use of the combination increased explosively after the presentation. In Korea, Keytruda in combination with the targeted therapy Inlyta is most commonly used. Much treatment data has been accumulated on the combination since its introduction in September 2019. Our hospital presented data on 42 kidney cancer patients who were treated with the Keytruda+Inlyta combination from September 2019 to March 2021 at the 47th Annual Meeting of the Korean Cancer Association that was held from the 17th to 18th this month. One key thing to note is that at the data cut-off point (June 3rd, 2021), the ORR was 54.3%, an excellent rate that is comparable to the clinical trial results. Also, among the patients, 2.9% achieved a complete response and 51.4% achieved a partial response. The median progression-free survival was 12.4 months, and the median OS was not reached in our study. In particular, tumor size in patients with aggressive tumors whose symptoms are difficult to control reduced significantly. 85% of the patients survived, and 63% are still continuing their treatment with the combination therapy. The 1-year survival rate is expected to be around the 90% range. In general, Real World Data (RWD) often does not produce as good a result as clinical trials that were conducted in controlled environments. In this context, the fact our results in the field showed a 90% survival rate that is similar to the clinical trial is encouraging news. -How would you interpret the 42 month long-term follow-up data on Keytruda+Inlyta that was recently presented in the 2021 ASCO Annual meeting? =The academic society had been unsure whether the combination would work in the long-term The data that was presented at the ASCO meeting holds significance as it demonstrated the long-term effect of Keytruda+Inlyta. More specifically, in the KEYNOTE-426 study, the overall survival of the combination therapy was 45.7 months, significantly longer than the 40.1 months when using the standard treatment, ‘Sutent (sunitinib).’ PFS also showed a significant difference of 14.7 months vs 11.1 months. OS at month 42 was 57.5% vs. 48.5%, respectively, and PFS at the same period was 25.1% vs. 10.6%, for the combination therapy group and Sutent group. ORR was 60.4% for the combination therapy and 39.6% for sunitinib. CR was also higher in the combination therapy group, being near 10%, compared to the 3.5% of sunitinib. -The Keytruda+Inlyta combination is currently approved only as a first-line treatment. Does this mean patients who already used other drugs do not have the chance to use the combination? =Yes. Patients often visit our hospital wanting to use Keytruda after using targeted therapies for a month or so. It is unfortunate, but these patients are not allowed to use Keytruda because it is only approved as first-line in Korea. This is why selecting the right initial treatment is ever so important for stage IV kidney cancer patients. If you hastily decide on using a treatment, it is highly likely that you may miss a good opportunity, so I ask the patients to make an informed decision after carefully collecting ample information in advance. -Recently, the Keytruda+Lenvima combination had also shown excellent, differentiated data results from previous kidney cancer treatments. =We have high expectations for the Keytruda+Lenvima combination. In the Phase III CLEAR study, the combination showed a median PFS of 23.9 months, which is over twice longer than the PFS shown in the Sutent group’s 9.2 months. The risk of mortality also decreased by 34% compared to the Sutent group. ORR of the combination therapy was 71%, and 16.1% of the patients reached complete response. The combination is expected to address all the limitations in effect and side effects that arose from previous treatments. If this combination is also approved in the future, 4 treatment options (targeted therapy, immuno+immuno combination therapy, Keytruda+Inlyta, Keytruda+Lenvima) will become the established options used to treat kidney cancer. Among these, the Keytruda + Lenvima combination is expected to be the most anticipated option in the field. -What role would cancer immunotherapies play in the field of kidney cancer in the future? =Cancer immunotherapies are already a well-established treatment option in kidney cancer, and its use will continue to expand in the future. I believe the new treatment trend would be for low-risk groups to first use targeted anticancer therapies and for mid-to high-risk groups to consider the use of immuno+targeted combination therapies. As the combination is yet non-reimbursed, not enough patients are benefiting from this effective treatment option. I hope the government will provide support as soon as possible in consideration of its excellent treatment effect.
- Policy
- Janssen Vaccine for 10,800 people has been approved
- by Lee, Tak-Sun Jun 29, 2021 05:46am
- The MFDS said it approved the nation lot release on the 25th (Friday) for 108,800 people of "Covid-19 Vaccine Janssen" applied by Janssen Korea. Nation lot release is a system in which the state checks the quality of the vaccine once again before it is distributed on the market by comprehensively evaluating the MFDS' test results of the vaccine. The MFDS explained that it has been thoroughly preparing for rapid national lot release of "Covid-19 Vaccine Janssen" by verifying its own test method since early this year and introducing equipment needed for testing such as enzyme analyzers. Test methods established by the MFDS include implantable gene expression, viral gene verification, viral protein verification, vector content, and purity. The effectiveness, safety, and quality were confirmed through the test and manufacturing and test data review of Covid-19 Vacine Janssen Inj and the lot release was decided because it met the national shipping approval criteria. This product was tested for the effectiveness of vaccines such as ▲ antigen protein expression, viral gene confirmation indicating effectiveness, and viral gene and transporter (vector) content by conducting a ▲ antigen test, verification test, etc. ▲It was confirmed that the product was not contaminated by conducting aseptic test, endotoxin test, and purity test. ▲ The MFDS explained that quality consistency was confirmed by conducting quality, pH, and practicality tests and reviewing quality test data issued by the manufacturer's quality assurance manager. Covid-19 Vaccine Janssen Inj is a virus vector vaccine manufactured by incorporating COVID-19 surface antigen gene into the adenovirus mold, the same platform as the country's first licensed AstraZeneca Korea Covid-19 Vaccine Inj. The MFDS stressed that it will do its best to thoroughly verify COVID, which will be introduced in Korea, by making the most of the related infrastructure necessary for the national lot release. Janssen vaccine, which was approved for lot release this time, is not a vaccine donated by the U.S. government, but an individual contract with Janssen.
