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- 2026-05-17 05:43:52
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- First PIK3CA-targeting ‘Piqray’ lands in general hospitals
- by Eo, Yun-Ho Jan 17, 2022 05:51am
- ‘Piqray,’ the first targeted anticancer drug that targets the PIK3CA gene, may now be prescribed at general hospitals. According to industry sources, Novartis Korea’s ‘Piqray (alpelisib)’ passed the drug committee (DC) reviews of 2 of the ‘Big 5’ hospitals in Korea - the Seoul Samsung Medical Center, and Seoul Asan Medical Center. Piqray, which was approved in Korea in May last year, is a PIK3Caα inhibitor that blocks the overactivation of the PI3K pathway by inhibiting the overactivation of PI3K-α that is caused by PIK3CA mutation. This targeted therapy is prescribed in combination with ‘Faslodex (fulvestrant)’ for patients with HR-positive/ HER2 negative metastatic or advanced breast cancer who have progressed on or after prior therapies. However, as the drug is yet to be reimbursed, it is expected that some time would be needed for its active prescription even after it lands in hospitals. The efficacy of Piqray was demonstrated in the SOLAR-1 trial that studied 572 men and postmenopausal women with HR-positive, HER2-negative, advanced, or metastatic breast cancer whose cancer had progressed while on or after receiving an aromatase inhibitor. Study results showed that the median progression-free survival improved to 11 months in patients with a PIK3CA mutation who used Piqray in combination with Faslodex, compared with the median PFPS of 5.7 months in those who used Faslodex alone. The objective response rate (ORR) that shows the proportion of patients whose tumor size had reduced by 30% or more was 35.7% in the combination therapy (Piqray+Faslodex) group, which was over a twofold increase compared to the 16.2% in the Faslodex monotherapy group. The secondary endpoint, overall survival (OS) in the PIK3CA-mutated cancer group, was 39.3 months in the combination therapy group. Although this was 8 months longer than that of 31.4 months in the monotherapy group, the results were not statistically significant. Joo-Hyuk Sohn, professor of Medical Oncology at Sinchon Severance Hospital, said, “Piqray in combination with fulvestrant is recommended as Category 1 in the NCCN guidelines for breast cancer patients with a PIK3CA mutation. The introduction of this treatment option is raising hope of overcoming resistance to endocrine therapy”
- Policy
- A plan to expand patient access to Kymriah should be passed
- by Kim, Jung-Ju Jan 17, 2022 05:51am
- While the agenda for the health insurance registration of the ultra-high-priced innovative drug Kymriah and the expansion of immuno-cancer drug Keytruda benefits have been in full swing since the afternoon of today (13th), patient groups gathered in front of the Kukje Electronic Center's Smart Work Center. Patient maximum co-payment of 1 million won Of the patients' Union including patient maximum co-payment of 1 million won told the Drug Reimbursement Evaluation Committee, that the committee should pass the Kymriah insurance registration agenda and the expansion of Keytruda benefit standards, and presidential candidates insisted on the introduction of a "fast new drug health insurance system" and "Patient maximum co-payment of 1 million won." Acute lymphoblastic leukemia, lymphoma - car kymriah t treatment is Novartis Korea by taking advantage of the 'drug approval - patent linkage system' for listing on March 3, health insurance last year and on October 13, nearly seven months after conditionally cancer drugs benefit appraisal committee through. Kymriah, an acute lymphocytic leukemia and lymphoma CAR-T treatment, applied for health insurance registration on March 3 last year using the "Drug Approval-Patent Linkage System" and passed the Cancer Drugs Benefit Appeal Committee on October 13, about seven months later. No longer there is no cure, recurrence or refractory acute lymphocytic leukemia and lymphoma patients about 200 new cases annually. Kymriah's treatment effect was a one-time treatment, with 8 out of 10 patients with end-stage acute lymphocytic leukemia and 4 out of 10 patients surviving for a long time, which is a "one-shot treatment" with only one dose, but the disadvantage was about 460 million won. In addition, Keytruda, a non-small cell lung cancer immuno-cancer drug among lung cancer, has to be used from the first treatment to obtain better treatment effects, and thousands of patients are required to pay from 70 million won to 100 million won per year. Therefore, Kymriah has been delayed in health insurance registration for 11 months, and Keytruda has not been able to expand its health insurance standards to primary treatments for 4 years and 4 months. Patient groups appealed, "Thousands or tens of thousands of terminal acute lymphocytic leukemia and lymphoma patients and stage 4 non-small cell lung cancer patients, who had been eagerly waiting for the coverage of Kymriah and Keytruda health insurance, eventually died because they could not afford the drug price." These groups also argued in connection with the recent pledge of the ruling party's presidential candidate to apply health insurance to hair loss drugs. Patient groups said, "Whether hair loss drugs are covered is a matter of comprehensive judgment considering the priority of financial use, Korea's health insurance situation, patient burden of drug prices, and cost-to-treatment effects, but if Presidential candidate Lee Jae-myung actively reviews life-related health insurance coverage, he should soon." In particular, these groups pressured the National Human Rights Commission of Korea's review of the petition filed against the Minister of Health and Welfare in October last year by some patient guardians preparing for leukemia patients and Kymriah treatment. Finally, they urged the government ▲to push for patient maximum co-payment of 1 million won system to ensure rapid access to Kymriah and Keytruda to about 200 terminal acute lymphocytic leukemia and lymphoma patients and thousands of stage 4 non-small cell lung cancer patients, ▲ to be held today, drug reimbursement evaluation committee the agenda through, and ▲the government should introduce a quick registration system for new drug health insurance directly related to life.
- Company
- Shortening the completion of Samsung Biologics plant 4
- by Kim, Jin-Gu Jan 17, 2022 05:51am
- Samsung Biologics announced that it will start partial operation within this year in connection with its fourth plant currently under construction. It also introduced that it has already won orders for consignment production from three global pharmaceutical companies. John Lim, CEO of Samsung BioLogics, made the remarks at a press conference at the JPMorgan Healthcare Conference held online on the 13th. He explained that the completion schedule of the four plants currently under construction has been moved up by about six months. Samsung Biologics announced its plan to establish a 256,000-liter plant in 2020. The fourth plant, which is under construction with a total floor area of 240,000 square meters in Songdo, Incheon, is originally expected to be completed by 2023. CEO John Lim predicted that plant 4 will be able to operate partially within this year as the construction schedule is shorter than the previous plan. "We will start partial operation after October this year," he said adding, "60,000 liters are expected to be operated first." He added, "The rest will be in operation in the second quarter of next year as originally planned," adding, "It will be possible to obtain cGMP in the second quarter of next year." In particular, he said, "We are winning orders for existing clients or potential clients before the full operation of the fourth plant," stressing, "We have already won five projects from three global top tier pharmaceutical companies and are continuing discussions with 20 pharmaceutical companies about 30 projects." Samsung Biologics will secure a total of 620,000 liters of plants 1 to 4 when it enters full operation next year following partial operation of plant 4 within this year. It will be reborn as the world's largest producer of biopharmaceuticals. On top of that, CEO John Lim explained that the establishment of new plant 5 & 6 with a size of 326,400 square meters (100,000 pyeong) is also speeding up. We are talking to Incheon City about the site of BioCampus 2 for the construction of plant 5 & 6, he said. "We will sign a contract to secure the site within the 2nd quarter of this year." In addition, it also proposed strategies for the development of cell gene therapy. Samsung Biologics denied rumors of the acquisition of Biogen, a U.S. bio company that developed Aduhelm (Aducanumab), an Alzheimer's dementia treatment, late last year. CEO John Lim said, "We are considering various measures, including M&A, regarding cell gene therapy." He said, "It could be a new business or an M&A. "It's not that we're not doing M&A, but we're continuing to push for it," he said.
- Company
- Korean companies' progress in developing COVID-19 treatment
- by Moon, sung-ho Jan 17, 2022 05:51am
- News of the decision to introduce Pfizer’s oral COVID-19 treatment ‘Paxlovid’ in Korea from earlier this year has increased interest in the progress made in the development of oral COVID-19 treatments at Korean pharmaceutical companies. The interest in when the homegrown oral COVID-19 treatments will be commercialized was triggered by the earlier-than-expected introduction of oral COVID-19 treatments from multinational pharmaceutical companies. # According to the Ministry of Food and Drug Safety and industry sources on December 29th, Shin Poong Poong Pharmaceutical, Daewoong Pharmaceutical, Ildong Pharmaceutical, and Genencell are developing oral COVID-19 treatments. The MFDS comprehensively had previously granted emergency use approval (EUA) of ‘Paxlovid (nirmatrelvir·ritonavir)' based on a comprehensive review of the results of the expert advisory meeting among others. Paxlovid is indicated for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older, at least 40kg) who have positive COVID-19 results from PCR tests and are at high risk for progression to severe COVID-19. In addition, the government purchased the oral treatment ‘molnupiravir’ from the US company MSD (Merck & Co.) in advance, confirming the introduction of COVID-19 treatments in Korea earlier this year. Meanwhile, the oral COVID-19 treatment being developed by the domestic companies is in clinical stages. The well-known Shin Poong Pharmaceutical’s ‘ Pyramax (pyronaridine-artesunate combination),’ the repositioned COVID-19 treatment in development, has entered Phase III trials after registering its first patient at the end of October. # Daewoong Pharmaceutical has repositioned its Foistar tablet and is in clinical trials to develop the drug under the name ‘Coviblock’ for the ‘treatment of patients with mild-to-moderate COVID-19’ and ‘treatment of patients with severe COVID-19.’ Also, Ildong Pharmaceutical and Genencell have received MFDS approval for Phase II and III trials respectively for their oral COVID-19 treatments in development. Dailypharm found that Ildong is planning to conduct a clinical trial and aims to register more than 200 patients with asymptomatic, mild, or moderate COVID-19 symptoms in Korea, and is currently recruiting participants from medical institutions, centered around Inha University Hospital. An Ildong Pharmaceutical official said, “The Inha University Hospital is the lead clinic for our trial. We are recruiting participants at 23 medical institutions including Inha and is also conducting a global clinical trial with the goal of receiving approval in the first half of this year.” The issue is that it is difficult to recruit participants in the course of clinical development for domestic oral treatments, which raises concerns over the disruption it may cause. This issue has been repeatedly raised since the start of the development of homegrown COVID-19 treatments, and the pharmaceutical companies have set out to resolve the issue by conducting global clinical trials rather than domestic trials. However, some expect that these latecomers will have sufficient competitiveness if they are sold at a lower price than that of Pfizer's or Merck's. Price-wise, 30 tablets of Paxlovid are classified as a single course, and the US government has made an agreement for 10 million treatment courses of Paxlovid at 530 dollars (approximately 630,000 won) per course. The US government has also signed for Merck’s molnupiravir at 700 dollars (approximately 830,000 won) per course.
- Company
- ₩200 bil schizophrenia treatment market is changing
- by Kim, Jin-Gu Jan 14, 2022 05:50am
- Change is in the air in the schizophrenia treatment market that was once led by global pharmaceutical companies such as Otsuka Pharmaceutical and Janssen. Domestic companies are acquiring rights of originals and introducing new products to chase the multinational leaders in the market. In response to the change, the global pharmaceutical companies are also preparing strategies such as adding a new dose to their product line for the first time in 6 years. ◆ Boryung rises to the rank as No.3 after securing ‘Zyprexa’ According to industry sources on the 13th, the schizophrenia treatment market in Korea is estimated to be around ₩200 billion. The market had been led primarily by multinational pharmaceutical companies, with Korea Otsuka Pharmaceutical, Janssen Korea, and Lilly Korea owning the top 3 items in the market. Pic of Zyprexa. Boryung acquired the rights, including sales and licensing for Zyprexa from Lilly in October last yearHowever, a change has been forewarned in the market with Boryung’s acquisition of ‘Zyprexa (olanzapine).’ Boryung Pharmaceutical had acquired all sales and licensing rights for Zyprexa in Korea from Lilly in October last year. At the same time, the company announced its plans to reinforce its CNS (central nervous system) treatment portfolio around Zyprexa. The company’s goal is to raise its CNS sales, which are currently around ₩30 billion to ₩50 billion by 2025. Boryung’s confidence in setting such an aggressive sales goal lies in its securement of an original drug. Preference for originals is very high in the CNS treatment market that includes schizophrenia treatments. In the case of olanzapine, Whanin Pharm, Myung In, Hanlim Pharm own generic versions of olanzapine, but the companies had earned very little. In 2020, Whanin’s ‘Zyrepin’ earned ₩5.9 billion, Myung In’s ‘Neurozapine’ ₩3.1 billion, and Hanlim’s ‘Zyzapine’ ₩2.7 billion. In other words, the original drug that has been in the country for 25 years since its approval in 1997 holds an overwhelming influence over the market. This is why Boryung Pharmaceutical also made the decision to acquire the license of Zyprexa rather than release a generic version. ◆ Whanin plans to introduce ‘Cariprazine’…first new drug to be introduced in 11 years After acquiring original schizophrenia drugs, Boryung and Whanin are preparing to chase its leaders in the market This is why other Korean companies are also intent on securing their own originals. In this sense, Whanin Pharm set a strategy to introduce a new drug for schizophrenia to Korea. For the past decade, no new drugs had been introduced in the schizophrenia treatment market. ‘Abilify(aripiprazole),’ the No.1 leader in the market, was approved in 2002, and the No.2 ‘Invega (paliperidone) was also first approved in 2010. Whanin’s new drug ‘Cariprazine’ therefore is the first new drug to be introduced to the Korean market in a decade. Cariprazine is an atypical antipsychotic developed by the Hungarian company Gedeon Richter. The drug is being sold under the brand names Vraylar in the United States and Reagila in the European Union Whanin Pharm received approval to conduct a bridging study for the introduction of the drug to Korea in April last year. The trial is being conducted on 342 patients who have acute-phase schizophrenia at 30 institutions including the Seoul National University Hospital. Considering that it takes around a year for a bridging study to be complete, it is expected that the company will be completing the study within the year and receive marketing authorization for the drug. Samil Pharm has also jumped into the schizophrenia treatment market with an original of its own. In December last year, Samil Pharm had entered into a co-promotion agreement with Viatris Korea for the sale of three drugs - schizophrenia treatment ‘Zeldox (ziprasidone),’ antidepressant ‘Zoloft,’ and anxiolytic ‘Xanax’- to expand its CNS business. Dong Wha Pharmaceutical had previously been selling and distributing the drugs for the past 6 years. Samil is known to have set up a team dedicated to CNS to increase the influence of the three drugs. ◆MNCs in defense…Otsuka receives approval for a new dosage for the first time in 6 years With the entry of such new contestants companies that are already in the lead are preparing measures to defend their ranks in the market. Korea Otsuka Pharmaceutical newly received approval for its ‘Abilify 1mg’ in December last year. Previously, the company had 2mg, 5mg, 10mg, 15mg dosages of Abilify in the market. This is the first change made to the pipeline in 6 years since ‘Abilify Maintena Inj.’ was introduced in 2015. When limiting the product to the table formulations, it is the first new dosage to be introduced in 13 years, since the company received approval for the 2mg product in 2008. The industry believes this move was made conscious of the competition with domestic pharmaceutical companies that entered with original drugs at their forefront. Otsuka expects the ultra-low-dose product to play a positive role in securing their lead in the market as prescriptions of low-dose products are increasing in practice. No.1 and 2 in the schizophrenia treatment market, Abilify(left), Invega(right) According to the market research institution IQVIA, Korea Otsuka Pharmaceutical’s Abilify series makes the most sales among all domestic schizophrenia treatments. It recorded sales of ₩50.9 billion in 2020 with its three products -Abilify Tab, Abilify OD Tab, and Abilify Maintena Inj. Last year, in the first half year alone, the company had made ₩27.4 billion with the product line. The runner-up in the ranks is Janssen Korea’s Invega series. Janssen Korea recorded sales of ₩25.3 billion with Invega ER Tab, Invega Sustenna Inj, and Invega Trinza Inj in 2020. The company had sold ₩13.1 billion in the first half of last year. The third-most sold is Zyprexa, which sold ₩14.2 billion in 2020.
- Policy
- The ultra-high-priced new drug Kymriah passed the Committee
- by Lee, Hye-Kyung Jan 14, 2022 05:50am
- Kymriah(Tisagenlecleucel) of Novartis Korea, dubbed an ultra-high-priced "one-shot treatment" with a cost of 500 million won per dose, passed the committee. The HIRA (Director Kim Sun-min) held the first Drug Reimbursement Evaluation Committee in 2021 on the afternoon of the 13th and conducted a review on the appropriateness of medical care benefits for five items such as Nasa Care Realtris Nasal Spray 18mL or 31mL. At that time, the deliberation committee was slightly delayed until the agenda was presented. ▲ Higher levels of risk sharing by pharmaceutical companies considering the level of overseas drug prices, ▲ In the case of diffuse giant B-cell lymphoma, which has insufficient clinical performance compared to acute lymphoid leukemia, the risk-sharing system of the performance-based payment model according to treatment performance is added on a patient-by-patient basis, and ▲ Kymriah While attaching clues such as setting the total amount of expenditure. While the committee decided on the adequacy of Kymriah benefits, it attached conditions for applying DLBCL and Expenditure Cap. Until now, the NHIS has been holding continuous meetings with the MOHW regarding financial sharing ahead of the Kymriah price negotiations, and will use RSA/Expension Cap for 60 days to come up with financial sharing plans between the government and pharmaceutical companies. In addition, five items, including lesinowon, which were reviewed, were also recognized for their appropriateness of benefits, but NASA Care Realtris Nasal Spray can take the stage of listing salaries if they are accepted below the committee's evaluation amount.
- Policy
- MOHW·MOTIE accelerates Global COVID-19 Vaccine Hub project
- by Kim, Jung-Ju Jan 14, 2022 05:50am
- The Ministry of Health and Welfare (MOHW) and the Ministry of Trade, Industry, and Energy (MOTIE) joined forces to come up with a plan to accelerate the government’s goal of Korea becoming a ‘Global Vaccine Hub’ that was set last year. On the morning of the 13th, Minister of Health and Welfare Kwon Deok-Chul and First Vice Minister of Trade, Industry, and Energy Park Jin-kyu co-hosted the ‘Meeting to promote investment in companies for vaccine and raw materials, followed by a ‘Cooperative meeting of the heads of Top 10 relevant agencies.' The events were held in the light of the new year for the government, companies, and related agencies to share their achievements and progress that were made to turn Korea into a global vaccine hub in 2021, as well as discuss policy vision and direction for this year. Officials from relevant ministries such as the Korea Disease Control and Prevention Agency (KDCA), Korean Intellectual Property Office (KIPO), MOTIE, Ministry of Food and Drug Safety and Korea Customs Service, as well as 10 heads of relevant institutions, and presidents from KoreaBio, Korea Pharmaceutical and Bio-Pharma Manufacturers Association, Korea Biomedicine Industry Association, as well as CEOs from 14 vaccine and raw material companies, attended the meeting. In the first part of the event, the 'Meeting to promote investment in companies for vaccine and raw materials,’ ▲Presentation on the investment performance of 13 vaccine and raw material companies ▲Import/export trend of vaccines and measures to strengthen support for export ▲Business roundtable were held sequentially. Using the government’s ₩18 billion (last year's supplementary budget) to prime investment and ₩50.4 billion of their own investment fund, the 14 vaccine and raw material companies plan to complete their facility investments worth ₩68.4 billion by July this year. The 10 vaccine companies participating are ST Pharm (mRNA), Quratis (mRNA), BMI Korea (mRNA), Hanmi Pharmaceutical (mRNA/DNA), HK Bio Innovation (synthetic antigen), CdmoGen (mRNA), Humedix (vector type), Jetema (vector type), Boran Pharma (vector type), and CELLID (vector type), and 4 raw material companies are Hanmi Fine Chemical (mRNA), Amicogen (synthetic antigen/vector type), LMS (mRNA), and Ecell (mRNA) The investments are expected to expand the manufacturing capability of various vaccine platforms for mRNA, virus vector, and synthetic antigen vaccines in Korea's progress to becoming a global vaccine manufacturing hub. Also, 847 new employees will be hired in the vaccine and raw material manufacturing sector to help ease the youth unemployment issue and contribute to fostering high-quality personnel. In addition, over 34%, ₩23.8 billion of the ₩68.4 billion of the fund for purchasing facilities and equipment will be used to first purchase domestic equipment and provide market support for domestic equipment manufactures, and improve business conditions. In terms of vaccine import and exports, vaccine export last year reached a record-high amount of $520 million powered by the export of contracted COVID-19 vaccine products among others. This is a threefold increase from the previous year. In terms of vaccine API and raw materials, exports of ▲vaccine carriers and low-temperature storage boxes, ▲Sterol (raw material that makes up mRNA vaccines and LNP), and ▲syringes also increased with the expanded global vaccine market. Export of carriers and cold boxes also reached a record-high of $1.35 billion. The increase in manufacturing of mRNA vaccinees (Pfizer/Moderna) had increased the export of sterols by 72% to reach a record of $4.74 million this year. For syringes, the increased vaccination rate had made the largest ever exports, with a record-high growth rate of 87.9%. Meanwhile, the government announced it will be strengthening the corporate support services to expand exports of vaccines and raw materials, including corporate matching and marketing support. In the case of the corporate matching service, the government will actively support matching between domestic and global pharmaceutical companies and the companies’ market pioneering through the ‘Global Partnering (GP)’ business in linkage with the 3 major B2B export platforms in Korea, as well as through Bio Korea. For marketing support, the government will hold a global vaccine business forum tour in Korea and abroad and support customized overseas expansion services (local market research, roadshows, etc.) for individual companies. In the case of financing, the government will increase the trade insurance cap of vaccine exporters to twice the current amount, provide insurance premium discounts, and loan funds for building domestic facilities for vaccine export purposes. Also, the government will significantly strengthen export support using its trade networks such as the WTO and FTA to establish global vaccine partnerships that encompass advanced and developing countries alike. In particular, based on the Korea-US and Korea-EU partnerships, the government will specifically support the procurement of vaccines and raw materials, investment attraction, and mutual market entry with advanced countries. With the developing countries, the government will explore the possibility of cooperation, such as discovering domestic vaccine exporters and joint manufacturing of vaccines and raw materials, at various occasions of bilateral talks. In addition, the government held a business roundtable at the meeting in four separate sessions, ▲ clinical-related support ▲ R&D/patent/testing support ▲ raw material supply/demand support ▲ production/export/customs clearance support, to hold an ear out to the difficulties experienced by companies and derive results. For clinical-related support, the government will provide all-out support at the government level through various diplomatic channels to contact foreign governments and utilize international conferences such as WHO and CEPI in addition to reaching out to individual companies to secure comparator vaccines for the Phase III trials that are essential for the development of domestic vaccines. The licensing and authorization process will also be simplified. The MFDS will accelerate the review of clinical trial protocols and marketing authorization for COVID-19 vaccines and treatments through a rolling review that allows for prior review of company data (non-clinical, GMP, quality, clinical trial protocol, etc) upon their preparation before applications are filed. In the case of R&D/patent/testing support, the MOHW plans to organically link and support R&D projects distributed to each Ministry as the national vaccine R&D control tower while establishing an industry-academia-research-hospital cooperative model to secure domestic technology for mRNA platform development in Korea. Support measures for patent response were also prepared. KIPO plans to address the lack of patent information and actively support domestic vaccine and raw material companies' response to patents that may hinder the production of undiluted vaccine solutions and raw materials. KIPO will also expand its patent-R&D strategies to provide patent evasion and licensing strategies to the vaccine and raw material companies in the R&D stage and provide early diagnosis and support dispute response strategies for small-and-mid-sized companies in the product production and export stage. Also, measures to secure raw materials were prepared. MOTIE will request cooperation from major suppliers for the stable procurement of raw materials to resolve the difficulties in supply and demand of such materials and work with diplomatic offices overseas and KOTRA to support the discovery of alternative supply lines. In addition, the authorities will expand R&D support to secure technology for raw materials in Korea to prepare a basis for a stable supply of raw materials domestically. Also, MOTIE will regularly hold a ‘consultative body to seek cooperative co-growth for vaccines, raw materials, and equipment’ and devise diverse support measures such as an exchange between demand and supplier companies and promotion of best practices. MOTIE will encourage cooperation between the companies supplying and demanding the products to increase acceptance of domestic products. Furthermore, a measure will be prepared for developers to borrow raw materials from one other. MOTIE and MOHW plan to prepare a forum where the general measures for cooperation may be discussed from sharing inventory status among major vaccine companies, mutual rental of raw materials, and the possibility of joint purchases between major vaccine companies in Korea through the ‘consultative body to seek cooperative co-growth for vaccine, raw materials, and equipment.' Currently, Samsung Biologics, Celltrion, LG Chem, SK Bioscience, Hanmi Pharmaceutical, GC Pharma, ST Pharm, Ecell, Dongsin Tube Glass, Junghyun Plant, Wiatek are members of the consultative body, and the authorities are planning to increase participating companies in the coming future. The government will also support the localization of raw materials and equipment for vaccines. MOTIE plans to accelerate the technological development of key items by newly establishing a technology development project specializing in the production of raw materials for vaccines this year (₩30 billion by 2025). In particular, MOTIE plans to intensively support the development of raw materials for mRNA COVID-19 vaccines (core enzymes, resins, etc.), and the development of the mRNA vaccine manufacturing process and core equipment technology. Measures to support the production, export, and customs were also prepared. The MOHW is seeking measures to improve the system from various angles, such as sending an official letter to local governments to shorten the time required for the review of 'prior approval for research and production facility installation, which is required before registering plans within registration in the high-tech medical complex.’ MOTIE plans to also prepare a performance evaluation system for raw materials of vaccines at a global level this year, including various test and evaluation support measures necessary needed by companies, including leachable tests. In addition, the government plans to significantly strengthen export support for companies that produce vaccines, raw materials, and equipment. For this, the Korea SMEs and Startups Agency (KOSME) will award up to 5 additional points for vaccine and raw material companies that wish to participate in the export voucher business. Also, it will prioritize entrance of the companies’ vaccine and raw material products in the Top 3 B2B export platforms in Korea - BuyKOREA (KOTRA), GoBizKorea (KOSME), and TradeKorea (Korea International Trade Association) - and BioKorea (Korea Health Industry Development Institute), and expand the provision of customized support for the vaccine industry, such as support for major overseas market research, buyer matching, and certification support. MOTIE had previously only supported booth installation cost for overseas exhibitions, but will now support booth installations in academic conferences and forums in the future. In the second part of the event, ‘Cooperative meeting of the heads of Top 10 related organizations,’ ▲ Korea’s achievements in becoming a global vaccine hub and its future tasks, ▲ achievements and strategies for attracting foreign investment in vaccines and raw materials ▲ top 10 related organizations’ visions and focus plans for this year, were discussed. Looking at Korea’s achievements in becoming a global vaccine hub and its future tasks, SK Bioscience conducted Phase III clinical trials after receiving approval for its trial protocol (August last year) and plans to commercialize ‘the first homegrown COVID-19 vaccine’ in the first half of this year. In addition, the company plans to expand the domestic CMO production of COVID-19 vaccines (Moderna, Novavax, etc.) this year as well. On December 13th last year, Samsung Biologics had obtained marketing authorization for the Moderna vaccine it manufactured under a CMO agreement with Moderna. This is the first domestically manufactured mRNA vaccine approved for marketing authorization in Korea. Under the companies’ agreement, hundreds of million doses of Moderna vaccine will be produced and distributed within Korea and exported abroad. This marketing authorization obtained by Moderna Korea officially allows Moderna’s COVID-19 vaccine manufactured at Samsung Biologics’ local pharmaceutical production facilities to be distributed within Korea and exported to other countries. SK Bioscience had signed a CMO agreement to produce AstraZeneca’s vaccine from February of last year, however, the CMO agreement expired on December 31st of the same year. On the other hand, Novartis received marketing authorization for its vaccine from the MFDS on the 12th of this month and is expected to start manufacturing in earnest this year. The MOHW plans to raise a "K-Global Vaccine Fund" worth ₩500 billion this year for clinical support in the biopharmaceutical sector In terms of achievements and strategies for attracting foreign investment in vaccines and raw materials, foreign direct investment in vaccines and raw materials last year reached $1,007 million, up 58.7% from the $635 million in 2020. In particular, Sartorius plans to invest $300 million, around ₩350 billion in Korean won to build a manufacturing plant to produce various raw materials and manufacturing facilities for cell culture media, pharmaceutical filters, and membranes until 2025 in Songdo. The company completed reporting the investment in December last year and will start construction after the City of Incheon confirms its location within the Songdo Biocluster by June this year. Also, Cytiva will invest $52.5 million, around ₩62.8 billion in Korean won from this year to 2026 to build manufacturing facilities for its raw materials including its disposable cell culture bags. The City of Incheon confirmed its location in Songdo in December last year, and construction is scheduled to start in the second quarter of this year. The government will continue to look for global raw material and equipment companies to attract to Korea and promote the project in consideration of the export scale, the demand of domestic companies, the possibility of foreign-invested companies entering the country, and project progress. Due to heated efforts to attract vaccine and raw material companies globally, the government plan to strengthen activities to attract such by each stage of investment rather than employ short-term events. The government will expand cash support and prioritize the designation of high-tech investment districts. In line with the expansion of investment tax deductions for national strategic technologies that are implemented this month, the government will also promote expanding cash support under the Foreign Investment Promotion Act. Each of the top 10 related organizations also set up visions and focus plans for this year. The top 10 relevant agencies will provide concentrated support for vaccines, raw materials, and equipment companies by linking them with support programs needed in the field, from technology development, financial loans, industrial support, export support, export insurance, and guarantees.
- Policy
- COVID-19 vaccine by NovaVax is approved in Korea
- by Lee, Tak-Sun Jan 14, 2022 05:50am
- COVID-19 vaccine by NovaVax was approved for domestic items on the 12th. At the final inspection committee held on the same day, experts judged that the Novavax vaccine had a sufficient effect on preventing COVID-19. The MFDS announced on the 12th that SK Bioscience has decided to approve the product on the condition that it submits a final report on the clinical trial results for the COVID-19 vaccine Nuvaxovid PFS, which has applied for approval for manufacturing and sales items. Nuvaxovid PFS is a gene recombinant COVID-19 vaccine developed by Novavax in the U.S. and manufactured by SK Bioscience in Korea from undiluted to complete. The main active ingredient is the same as a vaccine (10 vials packed with doses) conditionally licensed in EUA by 30 countries including Europe and WHO. The newly approved vaccine can be immediately inoculated with a single dose PFS injection that contains one dose per vaccine without dilution. Storage conditions are 5 months in refrigeration (2-8°C). The MFDS evaluated that the vaccine is meaningful in that it was manufactured in a gene recombination method with existing national vaccination experience, that it is convenient to store, transport, and inject, and that the types of vaccines that can be selected in the medical field have expanded. The MFDS began reviewing in advance from April 29 last year. A total of four data were submitted, including clinical trials conducted in Australia, the United States (clinical phase 1/2), South Africa (clinical phase 2), the United Kingdom (clinical phase 3), and the United States (clinical phase 3). As a result of analyzing the people who were confirmed with COVID-19 after 7 days of the second vaccination in clinical trials, about 89.7% of the preventive effect was found in British clinical trials, 10 in the vaccine group and 96 in the control group. In clinical trials in the United States, 14 vaccine groups and 63 control groups showed a preventive effect of about 90.4%. In addition, according to the evaluation of neutralizing antibodies that induce preventive effects by binding to the surface of the COVID-19 virus to neutralize the infectivity of the virus, compared to before vaccination, antibodies more than quadrupled from two weeks after vaccination. The final inspection committee for Novavax vaccine held on the 12th Abnormal cases predicted after vaccination (local, systemic) include tenderness, injection site pain, erythema, and swelling, most of which are mild to moderate, and were lost within one to three days of occurrence. The MFDS went through a triple advisory process consisting of experts to enhance the expertise and objectivity of the licensing process. Starting with the verification advisory group on the 29th of last month, the Central Pharmaceutical Review Committee on the 6th and the final inspection committee on the morning of the 12th were held. The final inspection committee judged that most of the reported abnormalities were generally good as predicted abnormalities related to vaccination. In addition, the review based on the submitted clinical trial data concluded that the preventive effect of the vaccine was sufficient.
- Company
- One clinical trial of NeoImuneTech's new immuno-cancer drug
- by Ji Yong Jun Jan 14, 2022 05:50am
- NeoImuneTech has suspended one clinical trial for the treatment of COVID-19 of NT-I7 (efineptakin alfa), which is being developed as a new immuno-cancer drug. According to ClinicalTrials.gov operated by NIH in the U.S. on the 12th, it was confirmed that NeoImuneTech withdrew one phase 1 clinical trial related to NT-I7 in the second half of last year. Earlier, NeoImuneTech was approved by the U.S. Food and Drug Administration (FDA) in June 2020 for two clinical trials related to COVID-19. The withdrawn clinical trial corresponds to a pilot study. Pilot research is a small-scale study conducted to minimize errors before entering large-scale clinical trials of new drugs. Regarding the reason for the suspension of clinical trials, the company explained, "We withdrew it because the situation in the United States changed rapidly due to the emergence of vaccinations and treatments because it did not match the planned clinical design in the early stages of the COVID-19 incident." NeoImuneTech attempted to develop NT-I7 treatments as the number of patients increased rapidly due to the COVID-19 pandemic. From June 2020, 30 adult patients with mild COVID-19 were recruited and NT-I7 was administered as muscle injection to conduct clinical trials for treatment effectiveness and safety evaluation by dose with the NIH. A month later, an additional phase 1 clinical trial of NT-I7 was approved to obtain more detailed data than the existing clinical trial. The study was conducted by Jian Campian of Washington University in St. Louis. This clinical trial planned to confirm the immune effect of COVID-19 due to an increase in lymphocytes in the blood after NT-I7 administration. However, the additional clinical trial was withdrawn due to Professor Jian Campian's resignation without registering a single subject for more than a year since it was approved. In addition, the clinical trial conducted with NIH is in the process of recruiting patients. NT-I7 is a hyleukin-7 T cell amplifier developed by NeoImuneTech as a new immuno-cancer drug. NT-I7 has a mechanism to remove cancer cells and infected cells by increasing the number of T cells in the body. According to NeoImuneTech, NT-I7 was clinically confirmed to amplify and activate T cells in cancer patients and patients with lymphocytopenia. Currently, NeoImuneTech is examining clinical effects with a combination of immuno-cancer drugs such as Merck's Keytruda, Roche's Tecentriq, and BMS' Opdivo and NT-I7. There are only 10 global clinical trials aimed at securing indications for various carcinomas such as gastric cancer, breast cancer, and non-small cell lung cancer.
- Policy
- The timing of approval for Novavax vaccine is unpredictable
- by Lee, Tak-Sun Jan 13, 2022 02:54pm
- The MFDS, which was active in disclosing information on COVID-19 vaccine screening, is suddenly not disclosing any information on the Novavax vaccine. There was no news of the expert advisory group, and 40 days have already passed the promised screening period. Some analysts say that this is because it is difficult for the MFDS to predict the timing of approval with "quality" data different from overseas. The Novavax vaccine was reviewed by the MFDS in November. It is the fifth COVID-19 vaccine to be officially reviewed. The previously approved vaccines of AstraZeneca, Pfizer, Janssen, and Moderna were approved 40 days after the screening. Considering the urgency of infectious diseases, the MFDS has established a policy to grant permission within 40 days by advancing the screening period for the COVID-19 vaccine as much as possible. However, the Novavax vaccine has not been approved for more than 60 days since the screening, let alone expert advice. The MFDS has set up a triple advisory group to speed up the screening of the COVID-19 vaccine as much as possible, but has finally approved it so that the public does not worry about safety and effectiveness. After the first COVID-19 vaccine safety and effectiveness verification advisory group, the second Central Pharmaceutical Review Committee and finally, the final inspection committee decided on the same day's approval. Whenever experts consulted, the MFDS distributed media data and held briefings. It was part of an attempt to increase transparency in public interest in screening. However, the Novavax vaccine seems to be an exception. According to some media reports, the first verification advisory group meeting among the triple advisory groups was passed. Now, the verification of the Central Pharmaceutical Review Committee and the Final Inspection Committee remains. However, unlike the previous vaccines, the MFDS has not actively disclosed information. Analysts say this is because there are other variables. The Novavax vaccine is a recombinant protein vaccine made by gene recombination technology that injects COVID-19 virus antigen proteins into the body to produce antibodies. Vaccines currently being reviewed by the MFDS are produced at SK Bioscience's Andong plant. However, the vaccines produced by SK Bioscience are different from those approved by the WHO and the EMA. Vaccines approved by the WHO and the EMA are multi-use vials, while domestic license applications are single-use PFS. Accordingly, the quality data submitted to the review authorities are also different. The MFDS is known to be cautious about this quality data. It is said that one or two supplementary orders have also been issued. The safety and effectiveness verification seen by the triple advisory group is not too unreasonable as it has been recognized overseas, but it seems that the MFDS is checking quality data that has never been verified abroad more meticulously as it is a sole review. Therefore, it is analyzed that the MFDS has been cautious about disclosing information so far because it is possible to predict the time of final approval when quality data are fully prepared than the triple advisory group. However, some insiders say that the Novavax vaccine is likely to be approved within this month. Analysts say that the expert verification plan will be disclosed and the final approval will be decided when the data submission is properly prepared. An official from the MFDS said, "Not only safety and effectiveness, but also quality data will be approved at the end of the review. We plan to proceed with expert advisory procedures soon."
