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- 2026-05-17 11:18:11
- Policy
- Moderna Korea has obtained permission for sales
- by Lee, Tak-Sun Dec 15, 2021 05:52am
- On the 13th, Moderna Korea, which was approved for Spikevax, an mRNA-based COVID-19 vaccine commissioned by Samsung Biologics, was approved for the ninth time in Korea as a "medical consignment manufacturing and sales business." According to the MFDS on the 14th, Moderna Korea acquired a drug consignment manufacturing and sales business at the same time as the Spikevax product license. The CEO is Son Ji-young, who worked for a global pharmaceutical company for more than 20 years and served as president of CSL Behring Korea until just before. CEO Son is known to have graduated from Ewha Womans University College of Pharmacy and completed an MBA at Korea University Graduate School of Business. Since then, he has worked at Pfizer Korea, Roche Korea, and Roche Switzerland headquarters. Moderna Korea's sales office is located in Saemunan-ro, Jongno-gu, Seoul. The pharmaceutical consignment manufacturing and sales business was newly established in 2007. At that time, the MFDS established a new industry so that companies without factories in Korea can obtain permission for pharmaceutical items. In 2008, GL Pharm Tech was licensed as the No. 1 industry, and since then, MSD Korea, Corepharmbio, Crystalgenomics, Abbott, Gunkang Pharmaceuticals, AstraZeneca Korea, Woosung Pharma, and Moderna Korea have acquired consignment manufacturing and sales. In particular, AstraZeneca Korea Covid-19 Vaccin, a COVID-19 vaccine that entrusts production to SK Bioscience, has also obtained additional approval for new industries following the import industry. Only two companies have acquired consignment manufacturing and sales businesses only with the COVID-19 vaccine. As domestic companies' production capacity is receiving favorable reviews with the COVID-19 vaccine, more and more companies are expected to acquire the drug consignment manufacturing and sales business. Spikevax of Moderna Korea is the first domestic consignment production in the mRNA method among the approved COVID-19 vaccines in Korea. Samsung Biologics is receiving raw material drugs and producing them as finished drugs through various processes. In response, CEO Stéphane Bancel Moderna said, "The Moderna COVID-19 vaccine production partnership with Samsung Biologics is helping Moderna improve its production capacity outside the United States. Moderna will take the lead in ending the COVID-19 pandemic." John Lim, CEO of Samsung Biologics, also said, "Through rapid response and close cooperation between the national government and Moderna, the first product produced by Samsung Biologics to obtain permission for mRNA vaccine items in Korea has set another meaningful milestone."
- Policy
- The project to expand the age of NIP will be implemented
- by Lee, Jeong-Hwan Dec 14, 2021 05:58am
- The project to expand the age of free vaccination (NIP) against human papillomavirus (HPV) promised by President Moon Jae In will be implemented within the first quarter of next year. The KDCA plans to implement it immediately as soon as the notification revision process necessary for expanding the subject of HPV vaccine NIP is completed between January and March next year. In this case, free HPV vaccinations, which are currently applied only to girls aged 12, will be expanded to those aged 12 to 17, and low-income women aged 18 to 26 will also be able to benefit from free vaccinations. An official from the vaccination management department explained in a phone interview with Dailypharm on the 13th, "We are currently collecting expert opinions on the HPV vaccine NIP age expansion project and will proceed with the administrative notice process for the new year." President Moon Jae In promised to expand the free HPV vaccine, called cervical cancer prevention vaccine, to under the age of 17, in the process of directly responding to the public to mark the fourth anniversary of the national petition on August 19. President Moon said that women aged 18 to 26 would be vaccinated free of charge from low-income families and gradually expand the scope. The KDCA, the ministry in charge of vaccination, has taken follow-up measures after President Moon's promise to expand the HPV vaccine NIP. The KDCA succeeded in winning 21.5 billion won as a regular budget for next year by starting to secure the budget needed immediately to expand NIP. The KDCA is in the midst of establishing related guidelines and promotional materials and establishing a vaccination system with the aim of implementing the project in the first quarter of next year. All procedures were carried out after collecting opinions from experts, and the revision of the notice to expand the NIP was intended to be completed within January to March of the new year. From the time the revision of the notification is completed, the age of free HPV vaccination will be expanded, and free vaccination will not be retroactively applied if vaccinated before the revision of the notification. Vaccines included in the NIP are expected to be GSK Cervarix and tetravalent MSD Gardasil. MSD Gardasil 9, a 9-valent vaccine, has also obtained domestic approval, but has not yet been applied to the NIP program. The cervical cancer prevention vaccine has excellent preventive effects in adolescence without sexual contact and is known to maintain antibodies for about 30 years. Cervical cancer is evaluated as a 100% preventable carcinoma among currently known cancers. When the KDCA completes the revised notification of the expansion of HPV vaccine NIP targets early next year, the free vaccination age range will be significantly expanded from 12-year-old girls, but the number of additional vaccinations will not increase significantly immediately. The HPV vaccine has been applied with NIP since 2016, and girls born between 2003 and 2004 were the first subjects, as children in the age group to be expanded this time are eligible. In other words, among female teenagers aged 13 to 17, those who missed the past NIP vaccination period will be able to benefit. According to KDCA, the first vaccination rate for those born in 2003 in the first year of HPV vaccine NIP application was 61.5%, which allows female adolescents who have not been vaccinated so far to benefit. 72.6% of those born in 2004 and 87.2% of those born in 2018 have already received vaccines. A KDCA official said, "The expansion of the NIP age can be implemented only by revising the notice without revising the law." He said, "We will soon promote the expansion of the target age and implement it as a revision of the notification early next year."
- Policy
- Promotion of legislation to expand HPV vaccine NIP to boys
- by Lee, Jeong-Hwan Dec 14, 2021 05:57am
- Following the ruling party, the opposition party will also push for a bill to expand the NIP range of HPV (human papilloma virus) vaccines from girls to boys. Currently, the target of HPV vaccine NIP is 12-year-old girls, and the legislative goal is to prevent diseases caused by HPV such as cervical cancer by expanding them to "11-year-old and 12-year-old children" regardless of gender. On the 13th, Rep. Baek Jong-heon of the People Power Party announced that he had proposed a "partial amendment to the Infectious Disease Prevention and Management Act." Rep. Baek submitted the bill on the 8th. HPV is the main cause of cervical cancer, and the most effective way to prevent cervical cancer is HPV vaccination. Currently, the target of HPV vaccine NIP is limited to 12-year-old girls. However, it is pointed out that HPV infection can be infected by both men and women through sexual contact, so not only girls but also boys should be included in the vaccination list. Twenty out of 37 OECD countries, including the United States, Canada, and the United Kingdom, already include boys in the HPV vaccination list. Men's HPV vaccination is effective in preventing cervical cancer in women, and HPV causes male anal cancer, penis cancer, and mouth pharyngeal cancer in addition to cervical cancer in women, so men also need to be vaccinated. Rep. Baek Jong-heon proposed a bill to expand the HPV vaccine NIP to children aged 11 and 12 regardless of gender. It also included a clause that complements the limitations in responding to infectious diseases that are prevalent at certain times as mandatory vaccination infectious diseases are set every five years. Rep. Baek said, "Cervical cancer is the only preventable cancer because it spreads to the virus, and if it is completely prevented, it can be eradicated. I hope that Korea will become a country that has eradicated cervical cancer with the passage of the bill." The ruling party also proposed a bill similar to Baek's bill. Rep. Choi Hye-young of Democratic Party of Korea proposed a bill in November last year to expand the target of HPV vaccine NIP to "all children and adolescents under the age of 18." President Moon Jae In also promised to expand the age range of HPV vaccine NIP to female adolescents under the age of 17 to mark the fourth anniversary of the national petition.
- Company
- Pfizer’s NSCLC drug Vizimpro to be prescribed at GHs
- by Eo, Yun-Ho Dec 14, 2021 05:57am
- Pfizer’s EGFR TKI Vizimpro may now be prescribed at general hospitals. According to industry sources, Pfizer Korea’s Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor (TKI) Vizimpro (dacomitinib) passed the Drug Committees (DCs) of four of the Big-5s - Samsung Medical Center (SMC), Seoul National University Hospital (SNUH), Seoul St. Mary’s Hospital, Asan Medical Center (AMC) – and many other major medical institutions including the National Cancer Center, Seoul National University Bundang Hospital, Pusan National University Hospital, Chungbuk National University Hospital, and Chungnam National University Hospital, etc. Vizimpro, which was listed for reimbursement in Korea in December last year, was granted priority review by the US FDA in January 2018 and approved in September of the same year. The drug is currently approved in the US, EU, and Japan among other countries. In Korea, Vizimpro was approved as a first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC). The drug is indicated to treat EGFR-positive advanced NSCLC patients diagnosed with exon 19 deletion or exon 21 L858R substitution mutations. Currently, 1st generation EGFR TKIs AstraZeneca’s Iressa (gefitinib) and AstraZeneca’s Iressa (gefitinib); 2nd generation EGFR TKI Giotrif (afatinib); and 3rd generation EGFR TKI AstraZeneca’s Tagrisso (osimertinib) are being prescribed in Korea. Among these drugs, competition between Vizimpro and the other 2nd generation EGFR TKI Giotrif for prescriptions is expected to intensify. Vizimpro’s efficacy was demonstrated through the Phase III ARCHER 1050 study. The study directly compared Vizimpro with Iressa (gefitinib) and registered a total of 452 NSCLC patients. Results showed that by progression-free survival, (PFS) Vizimpro reduced the hazard ratio by 41% compared to Iressa, and the median PFS of Vizimpro was 14.7 months, an improvement to the 9.2 months in the Gefitinib group.
- Company
- Sang Wook Kang, CEO of GSK consumer healthcare, resigned
- by Eo, Yun-Ho Dec 14, 2021 05:57am
- The CEO of GSK and Novartis' OTC joint venture "GSK Consumer Healthcare" is expected to be replaced. According to related industries, Kang Sang-wook (45) CEO of GSK Consumer Healthcare Korea recently resigned. As a result, CEO Kang will leave the company about three years after taking office in January 2019. He entered the pharmaceutical industry through BAT Korea and L'Oreal Korea. The exact reason for resignation is unknown, and it has been confirmed that Kang's successor has not yet. For the time being, GSK Consumer Healthcare will be operated as a temporary representative system. Meanwhile, GSK Consumer Healthcare was launched in 2015 as a Novartis joint venture as a company that sells items such as GSK's OTC and consumer goods. Since then, it has maintained its corporation so far after integrating the US pharmaceutical company Pfizer and Consumer Healthcare business in 2018. The company is selling more than 50 products in Korea, including oral care brands such as Sensodyne, Parodontax, and Polydent, as well as OTC and medical device brands such as Theraflu and Otrivin.
- Opinion
- [Reporter’s View] Moderna needs to learn the Korean way
- by Dec 14, 2021 05:57am
- “We expect the establishment of the Korean subsidiary will aid the smooth supply of mRNA vaccines and allow for a more active engagement and communication with the Korean government, media, and academia.” This was what Moderna had said on the 2nd to the invited media at a press conference. Moderna’s establishment of the Korean subsidiary had been the focus of all interest, that a US biotech that had gained nationwide fame in the COVID-19 pandemic will be establishing a subsidiary in Korea. Their establishment of a branch indicates that their plans do not end at selling COVID-19 vaccines in the area. It had also signed CMO agreements with Samsung Biologics for the fill&finish manufacturing of its vaccine. In addition, there were rumors that the company may also CMO the drug substance as well or build a plant of its own to manufacture the drug substance. It was the same day that the company announced the appointment of Ji-Young Sohn as the new general manager of Moderna Korea. This official announcement was seen as the start of the company’s official activity in Korea and was why many had anticipated the press conference that was held that day. There were many questions to be asked on how the Korean subsidiary will be organized, its activities, the company’s plans in Korea, and collaboration with local companies, among others. However, the active engagement in communication that the company had signified was not up to par or two-way. The press conference that day was rather disappointing. Only two Moderna officials – the VP of Global Medical Affairs at Moderna HQ and the VP of Medical Affairs from the Korean subsidiary had attended the conference. The newly appointed GM was also not at the meeting, and the attendees refrained from answering any questions related to the company’s business activities as they are medical officials. The reporters were only able to get little insight into how the company’s workforce will be organized. The only response provided to questions unrelated to vaccines, such as those regarding the company, was that we should refer to the company’s PR agency for answers. Moderna only provided detailed information on its ‘plans to develop booster shots,’ and the ‘myocarditis side effect’ of vaccines that it had planned to deliver at the conference. Of course, such vaccine-related news is important information. But the company should have also been more open in sharing information about the activities and collaborations that will be made by the Korean branch that the media and the public were also curious about. From Moderna’s point of view, the actives of its Korean branch may not be such a big issue. But still, true communication entails the faithful exchange of questions and answers on both sides. The response and non-participation of relevant personnel required to answer questions are more of a non-communication. The miscommunications on Moderna's part this time left much to be desired.
- 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.
