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- 2026-04-15 22:52:05
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- Technology exports are active despite COVID-19 outbreak
- by An, Kyung-Jin Dec 28, 2020 06:14am
- The world is struggling with the surprise attack of COVID-19, but domestic pharmaceutical and bio companies' new drug technology export performance is very active. SK Biopharm received the most down payment for the second consecutive year as it transferred the copyright to the Japanese region for a new epilepsy drug developed with its own technology. Yuhan and JW Pharma have made the achievement of transferring new drug technology to overseas pharmaceutical companies for the third consecutive year since 2018. The share of technology exports from bio-ventures with platform technologies such as Alteogen and LegoChem Biosciences has increased significantly. ◆ Bio-venture activities and new drug technology exports are '4 out of 5' Number and scale of technology export contracts for major pharmaceutical bio companies in 2019-2020 (Unit: case, ₩100 million, Source: Financial Supervisory Service, each company) This year, 10 domestic pharmaceutical and bio companies have signed a total of 15 technology export contracts with foreign companies. Compared to last year, when 12 companies won 14 contracts, the number of contracting companies decreased by two, but the number of contracts increased by one. Technology exports are estimated to be ₩10 trillion, up 19.4% from last year. The driving force behind the breakthrough of ₩10.15 trillion in technology exports is bio-ventures, while the world is in a chaotic state due to COVID-19 outbreak. In April, LegoChem Biosciences signed a contract with Iksuda Therapeutics in the UK to transfer the original technology of antibody-drug complex (ADC) worth About ₩496.3 billion. ADC (Antibody-Drug Conjugates) is a technology that enhances therapeutic effect by accurately delivering drugs bound to antibodies to antigens. A total of five contracts signed by LegoChem Biosciences for a year using original technology. In May, the company passed an ADC-based anticancer drug to Iksuda and won an additional contract worth $227 million, and in October, it signed a technology export contract with CStone Pharmaceuticals in China for up to $363.5 million for ADC anticancer drugs. In December, it signed a technology export contract with Pyxis Oncology in the US and two pharmaceutical companies in Japan, respectively, related to ADC anticancer drugs. In the case of transferring the copyright of three ADC-based anticancer drugs to Takeda subsidiary Millennium Pharmaceuticals in March last year, it means that six contracts were signed with the same technology. In addition to LegoChem Biosciences, relatively small-scale bio-ventures showed outstanding technology export performance. 12 out of 15 new drug technology transfer contracts signed by domestic companies this year are achievements made by 7 bio companies including LegoChem, Futurechem, Alteogen, OliX, Voronoi, Genexin, and SK Biopharm. Alteogen received $16 million as a down payment when it passed the right to use the source technology for Hybrozyme to 10 global pharmaceutical companies in June. The technical fee for each stage according to clinical development, marketing authorization, and sales performance amounts to a total of $3.8 billion. Alteogen's original technology for Hyaluronidase is a technology that enables large amounts of subcutaneous administration of all biologics administered intravenously. By taking advantage of the scalability of the original technology that can be applied to various new drug development processes, it achieved an additional contract conclusion in 7 months following last November. Futurechem signed a contract for a total of €1.22 million with IASON GmbH in Austria in May for the diagnosis of prostate cancer, followed by a technology transfer contract worth about ₩650 billion with HTA in China in September. In addition, it is counted that OliX, Voronoi, and Genexine have been handed over. ◆SK Biopharmaceuticals No. 1 in contract payments, JW's outstanding global technology export for 3 consecutive years Among the technology transfer contracts signed this year, SK Biopharm's epilepsy treatment Xcopri (Cenobamate) received the largest down payment. SK Biopharm secured approximately ₩54.5 billion in deposit without obligation to return when it signed a technology transfer contract with Ono Pharm. The milestone according to the achievement of permission and commercialization is up to about ₩524.3 billion. After commercialization, sales royalties of 10% or more were guaranteed. SK Biopharm secured a down payment of ₩54.5 billion this year, the eighth largest of the domestic pharmaceutical industry. SK Biopharm also signed a total of $530 million worth of Xcopri contracts with Swiss Arvelle Therapeutics last year. The down payment secured at the time was $100 million, which is the third largest in history. It has maintained the No. 1 position in technology export contract payments for two years in a row by being recognized for the value of being approved by the US Food and Drug Administration (FDA) as first-in-class with a new mechanism. The size of the upfront of major pharmaceutical bio companies that signed a technology export contract in 2020 (Unit: ₩100 million, Source: Financial Supervisory Service) JW Holdings' nutrient solution technology export contract was the highest in the proportion of the total amount of technology exports. It has signed a technology export and supply contract for Winuf, a comprehensive nutrient solution, with Shandong Luoxin Pharmaceutical, a subsidiary of Luoxin Pharmaceutical in China. The total down payment is $39 million. The down payment without obligation to return is $5 million, which accounts for 12.8% of the total down payment. Winuf is a three-chamber comprehensive nutrient solution that can be easily mixed and used with three ingredients such as lipid, glucose and amino acids by dividing one container into three. It is composed of four lipid components, such as refined fish oil (20%), refined soybean oil (30%), olive oil (25%), and MCT (25%), as well as glucose and amino acids. It is known that it contains a higher content of refined fish oil than existing products, so it contains more omega 3 and omega 6 fatty acids that promote the improvement and recovery of patients' immunity. Previously, there was no case of commercialization of a third-generation comprehensive nutrient solution containing refined fish oil in China, and JW Life Science signed a high-purity contract with a high proportion of down payments as it was recognized for the distinction that JW Life Sciences is in charge of producing finished products after Winuf in China. It is an evaluation that it was possible. It has signed a global technology export contract for 3 consecutive years, starting with the technology transfer contract for atopic dermatitis new drug with Leo Pharma in 2018. ◆SK Biopharmaceuticals No. 1 in contract payments, JW Group's outstanding global technology export for 3 consecutive years The technology transfer contract between Hanmi and Yuhan is also a meaningful R&D achievement this year. Hanmi transferred the GLP-1-based dual agonist returned from Janssen back to MSD within one year. It is a dual-acting treatment that simultaneously activates GLP-1, which helps secretion of insulin and suppresses appetite, and glucagon, which increases energy metabolism, and the original technology of Hanmi Pharmaceutical's LAPSCOVERY, which increases the duration of the drug, was applied. The contract fee, which is not obligated to return, is $10 million, and the maximum contract size, including staged technical fees (milestone), is $870 million. It was positively evaluated for discovering new potential in the field of non-alcoholic steatohepatitis (NASH) instead of diabetes and obesity, which were the existing indications, leading to a new contract. Yuhan made a turning point by handing over gastrointestinal disease treatment candidates, which had been pending for nearly two years, to a small overseas bio-venture without obtaining satisfactory results in the domestic II clinical trial. Yuhan received $2 million of Procesa shares as a down payment by handing over the global copyright of the new functional gastrointestinal disease drug YH12852 to Processa Pharmaceuticals. The maximum contract size, including staged technology fee (milestone), is up to $410.5 million. After commercialization, it was agreed to receive a certain percentage of net sales as royalties. Processa Pharmaceuticals, a partner, will be listed on Nasdaq after the signing of the contract, and is looking forward to further development, saying that it will pursue a phase II clinical trial in the US early next year. Technology export status of major pharmaceutical bio companies in 2020 (Source: Financial Supervisory Service, each company) However, except for SK Biopharm and JW Pharma, the share of down payments in the total amount of technology exports was only 3%. While the overall contract size increased, the proportion of down payments decreased relatively as option contracts and comprehensive platform technology contracts for which the inflow of subsequent milestones was uncertain.
- Company
- Hanmi and SK win the final round of Xarelto patent dispute
- by Kim, Jin-Gu Dec 28, 2020 06:13am
- South Korean pharmaceutical companies won the patent dispute on Bayer’s non-Vitamin K antagonist oral anticoagulants (NOAC) Xarelto (rivaroxaban). As a result, Hanmi Pharmaceutical and SK Chemicals have overcome the last obstacle to prepare an early launch of rivaroxaban generic in next October. On Dec. 24, the Supreme Court ruled in favor of Hanmi Pharmaceutical and SK Chemicals for the third ruling on the negative confirmation scope in Xarelto’s composition patent. Besides the latest case, Hanmi has also won the patent nullification case as well. The patent dispute started from March 2015, when the two companies filed a negative scope confirmation on Bayer’s original tablet. The two Korean companies won the first ruling, and they earned the preferential sales rights after they received the item approval in 2016. However, Bayer disagreeing with the ruling filed an appeal to the Patent Court. But the second ruling remained unchanged from the first. The multinational company then filed the last appeal. The case initiated from November 2016 at the Supreme Court was concluded four years after, bringing good news to the generic companies. Bayer requested for trials for correction, while arguing the case, to lessen the claim but the company also lost the patent nullification case as well. The final ruling was the last step towards the early generic release for Hanmi and SK. The two companies’ generic may be marketed from October 2021 with preferential sales rights lasting until July 3, 2022. A pharmaceutical market research firm UBIST found Xarelto has generated total 50.8 billion won for the outpatient prescription. As of the third quarter this year, 37.6 billion won worth of the drug was prescribed. Now the industry’s interest is shifting towards Chong Kun Dang, who started taking legal action to evade Xarelto’s substance patent. If Chong Kun Dang succeeds in evading the substance patent to be expired in October 2021, the company would be able to launch its generic even before Hanmi and SK.
- Policy
- RSA-renewed Blincyto and PVA Xalkori pricing reduced
- by Kim, Jung-Ju Dec 28, 2020 06:13am
- Amgen Korea’s Blincyto 35 μg (blinatumomab) renewed the risk sharing agreement (RSA) with the National Health Insurance Service (NHIS) prior to its termination. As a result, the pricing was lowered by 11.4 percent, effective from next month. With surging sales, Pfizer Pharmaceutical Korea’s Xalkori (crizotinib) is now categorized as a subject for price-volume agreement (PVA) negotiation and has agreed to bring down the pricing of each dose by 2.3 percent. The pharmaceutical industry sources reported, the South Korean Ministry of Health and Welfare (MOHW) is working on the said revisions for the ‘List of Reimbursed Drugs and Upper Limit Pricing.’ The finalized revision would be enforced from Jan. 1. Apparently, Amgen Korea has negotiated with NHIS on the RSA renewal and settled on lowering the pricing by 11.4 percent. From next year, the existing price of 2,223,503 won per vial would be reduced to 1.97 million from next year. Newly categorized as a PVA Type Ga (가), Pfizer Pharmaceutical Korea’s Xalkori capsule has undergone pricing negotiation. A new drug listed through a pricing negotiation would be would be categorized as a Type Ga drug, if its total claim of the same product lineups exceeds over 30 percent of the projected claim decided during the pricing negotiation. And then, NHIS and the pharmaceutical company would negotiate and settle on a reduced pricing. The same product lineups mentioned above means a series of pharmaceutical items with identical supplier’s name, administration route, substance and form. The pricing of respective doses of the product would be lessened by 2.3 percent—previously 47,225 won to be 46,139 won for 200 mg, and previously 53,364 won to be 52,137 won for 250 mg. On the contrary, a company voluntarily chose to decrease the pricing as the drug has expanded its reimbursement scope, or the indication. Drug pricing reduction for expanded indication system preemptively reduces the pricing of a drug with new reimbursed indication by taking account of the projected increase or additional claim. Applying the change, Amgen Korea’s Xgeva injection’s (denosumab) existing price of 249,800 won would be brought down to 245,054 won by 1.9 percent.
- Policy
- The MFDS begins preliminary review of Janssen's vaccine
- by Lee, Tak-Sun Dec 28, 2020 06:12am
- Following AstraZeneca and Pfizer, Janssen also applied for a preliminary review to the MFDS for approval. The MFDS announced on the 22nd that Janssen (Johnson & Johnson) has applied for a preliminary review before applying for approval of COVID-19 Vaccine. This vaccine is one of the vaccines that the government has announced plans to introduce, and this time, it has requested a preliminary review of non-clinical and quality data. Accordingly, the MFDS said that virus-vector vaccine team will thoroughly review the toxicity, pharmacological and quality data of the vaccine in advance. The MFDS has formed and is operating two licensing teams for rapid evaluation in preparation for domestic applications for COVID-19 vaccines. The virus-vector vaccine team reviews vaccines developed by AstraZeneca and Janssen, and the nucleic acid vaccine team reviews vaccines by Pfizer and Moderna Vaccine developers can submit data such as quality, non-clinical, and clinical data to the MFDS as soon as they are prepared for preliminary review before applying for approval. The MFDS said it expects to secure time to sufficiently review the safety and effectiveness of the vaccine and shorten the period of review after application for approval. It plans to approve the product permission within 40 days after the application for permission. An official from the MFDS explained, "We will do our best to quickly supply safe and effective vaccines to our people."
- Company
- Multinational companies enjoy winter holidays up to 17 days
- by Eo, Yun-Ho Dec 24, 2020 06:10am
- Current status of winter holidays of 20 multinational companiesThis year, a number of multinational pharmaceutical companies' executives and staff members are entering long-term winter holidays. As a result of Dailypharm's survey of the year-end holidays of 20 major multinational companies on the 23rd, it was confirmed that more than 10 companies designated winter holidays for more than 10 days. In particular, as January 1, 2021 turns to Friday, two days of weekend holidays are added to January 2 and January 3, making the holiday season longer. The company with the longest holidays is GSK. The company will be closed for 17 days from the 18th to the 3rd of January 2021. AstraZeneca's employees are also given 14 days of vacation. The company was originally scheduled to start winter holidays from the 23rd, but with the addition of two days of special holidays from the global CEO, the company will enjoy the holidays from the 21st. In addition, Sanofi will be closed from the 22nd, Novartis, Viatris, Pfizer, and BMS will start on the 23rd, Daiichisankyo, Roche, and Boehringer Ingelheim will begin the holiday from the 24th, and Astellas will begin the holiday from the 25th. As of Christmas, a total of 11 pharmaceutical companies will be closed. The KRPIA and MSD start vacations from the late 28th. Most multinational pharmaceutical companies such as Galderma, Gilead, Lilly, Merck, Bayer, Amgen, Janssen, AbbVie, and Eisai have winter holidays using Voluntarily paid off. These multinational employees enjoy a minimum of 10 days off although voluntarily paid off. Even if it is not a designated holiday, many multinational employees are actually starting a break from this week. An official from a multinational company said, "Including the total holidays, there are many employees who take a break for more than 20 days. I am happy to have time to recharge because the industry as a whole has been busy in the aftermath of COVID-19."
- Policy
- Government TF to counteract pricing reduction litigations
- by Lee, Hye-Kyung Dec 24, 2020 06:10am
- The South Korean health authority is seeking for measure to keep their drug pricing reduction decision effective. Until recently, the Ministry of Health and Welfare (MOHW), the National Health Insurance Service (NHIS) and the Health Insurance Review and Assessment Service (HIRA) have been operating a taskforce for pricing reduction litigation and also completed a number of consigned researches. Based on the findings and knowledge gained so far, the authority plans to introduce relevant bills or revise regulations to counteract the pharmaceutical companies’ recklessly filing litigations to halt the drug pricing reduction. An ‘Analysis on Drug Pricing Reduction Litigation Related Administrative Order Suspension and Counteraction Strategies’ the NHIS entrusted Korea University’s industry-academy collaborative team with, and an ‘Analysis on Drug Pricing Reduction Litigation Cases and Seeking Response Plan’ the agency entrusted the Korean Government Legal Service (KGLS) with have been completed recently. On Dec. 17 and 21, NHIS posted the above mentioned details on the public agency management information disclosure system, ‘Alio.’ However, the in-depth information was decided to be kept confidential permanently as it could affect the ongoing litigation cases. The study was carried out while MOHW, NHIS and HIRA were operating the joint TF for months about the pricing reduction litigation. Since MOHW notified the new revision in drug pricing regulation, the court was swarming with large pharmaceutical companies trying to extend the reimbursement period by requesting the administrative notice suspension. Seeing the collective movement growing bigger, the health authority decided to take an action. The start of the government’s action was forming a taskforce for choline alfoscerate drugs currently in process of litigation after the authority announced its plan to reduce the reimbursement after it already enforced the order on single-use eye drops in 2018. The taskforce called for external consigned research and presented government legislation bills to seek measures to prevent pharmaceutical companies excessively requesting for administrative order suspension via pricing litigation. The confidential research report’s table of contents indicated the Korea University industry-academic collaborative team compared and analyzed foreign administrative order suspension system, addressed current status and issues in the existing administrative order suspension related to pricing reduction litigation and recommended prospective improvement. NHIS official explained the reason behind the confidentiality in the research and said, “The research report contains cases of administrative order suspension related to an ongoing litigation and short and long-term counteraction plan. Based on the research outcome, the government would consult with relevant organization to make decisions on the policy.” Highly likely the research report talks of the prospective plan on choline alfoscerate products. And the KGLS research recently turned confidential has compiled review on pricing reduction litigation status, analysis on the court decision regarding the first-in-class drug upper limit pricing adjustment, and pricing reduction notice on drug found providing rebate. NHIS official explained, “If the research result were to be disclosed now, the execution of the policy would be interfered greatly. It could harm the justification and objectivity of the pricing policy.”
- Policy
- TOC prevents the first approval of COVID-19 vaccine in Korea
- by Lee, Tak-Sun Dec 24, 2020 06:10am
- This is a response from the health authorities to concerns that the COVID-19 vaccine developed by AstraZeneca will be introduced in Korea in February-March next year, although approval by the US FDA is delayed. The MFDS is independently screened regardless of overseas institutions. However, Korea's licensing regulations require approval from other manufacturing and marketing countries, if FDA fails. The reason why the domestic authorities believe that the AstraZeneca vaccine can be introduced in February-March is that it is highly likely to be quickly approved by the UK MHRA or European EMA, not the FDA. According to Article 4 (1) 4 of the Regulation on Safety of Pharmaceuticals, etc., in the case of imported products, a manufacturing certificate certifying that they are properly manufactured according to laws and regulations by the government of the producing country or public institution, and the government or public institution of the country where the license is registered. A CPP must be submitted demonstrating that it is being marketed properly. In the pharmaceutical industry, this is called CPP (Certificate of Manufacturing Sales in Importing Country). It must already be used in another country to meet the CPP submission requirements. Therefore, the Ministry of Food and Drug Safety cannot approve the world's first overseas drug development. As AstraZeneca's COVID-19 vaccine is also the world's first overseas drug, the Ministry of Food and Drug Safety cannot approve it first. However, as it is a vaccine made in an urgent situation called Corona 19, there is a possibility of applying an exception. The MFDS has applied the CPP submission obligation only to imported new drugs. And at a briefing session on the 17th, the MFDS announced that it would completely abolish the submission of new drug CPP data. The MFDS said in a press release at the time, "Considering that The MFDS is conducting an independent review on safety, efficacy and quality, we will abolish the obligation to submit manufacturing and sales certificates, which are procedural regulations applied to imported new drugs." With the abolition of CPP, the MFDS was also able to license the world's first overseas drug development. The pharmaceutical industry also welcomes the complete abolition of CPP submissions. Although CPP has been abolished, documents proving data such as non-clinical trials or clinical trials submitted to the previous licensing countries must be submitted. An official in the industry explained, "It is called a TOC (Table of contents) certificate, and it is a document that proves that the same data was produced in the country where it was previously licensed. The country receiving this data should refer to the reference of the country prior to the license." Although the obligation to submit the CPP is abolished, the TOC certificate must be submitted as it is, so the first foreign drug can still be approved by the MFDS only after obtaining permission from another country. An official in the pharmaceutical industry said, "Korea has been classified as a CPP-dependent licensed country so far. It was backwards considering its status as a member of the ICH (International Drug Regulation and Harmonization Committee) or PIC/s (Pharmaceutical Initiative Mutual Cooperation Organization)." Explained. He said, "We expected the abolition of the CPP to lead to increased confidence in the domestic drug approval system. However, it is still difficult to approve the first overseas drug development because of the TOC certificate." He stressed, "To get out of the stigma of an underdeveloped country for permit screening as soon as possible, we must abolish the TOC certificate rather than request it." The MFDS aims to make an administrative notice within this year and complete the revision in the first half of next year on the regulations containing the abolition of the submission of imported CPP data. However, it is said that the content of the revocation of the TOC certificate has not been published.
- Policy
- References related to COVID-19 will not be present
- by Lee, Jeong-Hwan Dec 24, 2020 06:09am
- As the personnel hearing of candidate Kwon Deok-cheol of the MOHW took place in the morning of today (22), the adoption of references such as CEOs of Pfizer and AstraZeneca for inquiries related to COVID-19 vaccine was finally broken due to disagreement between the ruling party and the opposition party of the National Assembly Health and Welfare Committee. The opposition party requested the attendance of the CEO of the Korean subsidiary, a vaccine developer, for questions related to domestic supply and demand plans, vaccination timing, safety and effectiveness from the COVID-19 vaccine purchase contract, but the ruling party was reportedly rejected because it had no direct connection with the candidate personnel verification. According to the National Assembly's Health and Welfare Committee, Chairman Kim Min-seok, Sung-ju Kim, secretary of Democratic Party of Korea, and Ki-yoon Kang, secretary of People Power Party did not reach a mutual agreement on the adoption of witnesses and reference for candidate Kwon Deok-cheol's personnel hearing. As the agreement between the two parties has broken down, as a result, the hearing will be held without witnesses or reference members present. The hearing of the candidate for the MOHW is actually COVID-19 vaccine hearing. The People Power Party applied for CEO of Pfizer Korea/AZ Korea as reference at the personnel hearing. The intention is to inquire about the current issues such as the purchase contract process, domestic supply plan, supply and demand quantity, and actual vaccination timing to the CEO of the Korean subsidiary of COVID-19 vaccine developer with the candidate of the MOHW. The Democratic Party of Korea refused to adopt a reference by the opposition because it was not directly related to the candidate's hearing. Since the introduction of COVID-19 vaccine has already been confirmed and the government is facing additional contracts in addition to products that have completed a purchase contract, such as AstraZeneca, if unnecessary controversy arises at the personnel hearing hall, it may negatively affect additional purchase contracts and negotiations with global pharmaceutical companies. The People Power Party has consistently raised criticism that domestic supply and demand for COVID-19 vaccines is too late. Accordingly, the Democratic Party of Korea has announced its position that COVID-19 quarantine should not be contested. An official from the opposition party's office of the Welfare Committee said, "COVID-19 vaccine-related inquiries are a key issue for candidate Kwon Deok-cheol's personnel hearing. Many members of the opposition party applied for the CEO of Pfizer/AstraZeneca as a reference." "The Democratic Party of Korea unilaterally refused to adopt the reference, and it failed," he explained. An official from the ruling party's office of the Welfare Committee pointed out that "application for a reference person related to COVID-19 vaccine is not related to the personnel hearing of the Minister of Welfare or Candidate Deok-cheol Kwon. Since there are no witnesses or reference persons agreed between the ruling party and the opposition party, this hearing will proceed without interrogation."
- Company
- “Need to set up cold chain for COVID-19 vaccine ASAP”
- by Dec 24, 2020 06:09am
- Professor Lee Jae Hyun “Pfizer and Moderna both use mRNA type of COVID-19 vaccines and it is a highly unstable substance that requires exceptional level of cold chain management. Especially, the response plan on how to react on an emergency, for instance malfunctioning storage tool or power outage, is the most important part.” A Sungkyunkwan University College of Pharmacy professor, Dr. Lee Jae Hyun said as above on Dec. 21 at the Korea Pharmaceutical Distribution Association (KPDA) ‘Pharmaceutical Distribution Development Forum 2020’ that opened a discussion on the current pharmaceutical cold chain in South Korea and related solutions. As the number of biological drugs like vaccine is climbing, the drug distribution industry has to inevitably take account of cold chain. More specifically, Pfizer and Moderna have developed COVID-19 vaccine based on the novel technology using mRNA, which demands highly intricate control of the environment. However, only a handful of companies in the South Korean drug distribution industry has a cold chain for general biological medicine, not even suitable for the mRNA vaccine. Also at the forum, the chairman of KPDA Cho Sun-hye said, “Because the core of our industry is pharmaceutical distribution, we must achieve the hegemony in cold chain. And this forum was organized to swiftly and preemptively establish infrastructure for the cold chain market, and to prepare ourselves for the changes.” A cold chain is an environment with overall temperature control used to store and distribute biological drugs at its optimal state. The most integral part of cold chain is maintaining the optimal temperature for the entire process of distribution. Professor Lee Jae Hyun introduced a vaccine cold chain guideline and explained of the vaccine storing and distribution the industry is paying a close attention to these days. The professor elaborated, “The primary factor is to set a system that defines how to handle storing and shipping when using cold chain, what type of transportation cradle would be prepared and how to get to the destination. And also a validation system is needed to confirm the preparation of the system.” Dr. Lee stressed the cold chain has to be ready to handle emergency situation like malfunctioning and power outage. Moreover, a supply manager and quality control manager should be appointed to document the vaccine management criteria according the Good Distribution Practice (GDP). A wholesale manager can personally check the vaccine shipment, but a separate vaccine management staff should be designated with a proper training to react appropriately and timely to an emergency situation. A general prerequisite of a vaccine cold chain storage is a space that can maintain an adequate temperature and level of humidity. Refrigerated storage or a deep freezer has to use a biologic-specific fridge with an automatic thermostat. The professor highlighted, “Vaccine’s stock can vary depending on the season, but a distributor should have a sufficient space to manage all stock and more for the needed equipments.” The storage equipment has to be strictly maintained regularly, and it has to be kept clean all the time to ensure there is no dust on the heat conducting coil or motor. The storage equipment has to be validated for its adequate temperature via temperature mapping, which confirms well distributed target temperature in all spaces by using the temperature sensor and finding the maximum and minimum value. Professor Lee said, “Although an expert specialist can be hired to maintain the storage, especially for temperature and humidity, environmental hygiene and protection against pests and weather, the wholesale distributor would be held responsible so the company should visit and check the site regularly.” As soon as vaccines arrive, they would be moved to the storage immediately. And the staff in charge would have to record the arrival date and time, the name of acceptor and maintenance staff, the state of the vaccine with the corresponding solvent at the time of arrival, the name of vaccine accepting company, type and volume of the vaccines, and manufacturing serial number and expiration date. Professor Lee added, “For the thermostat in the vaccine cold chain, I recommend using a thermostat with tuning certification. And in case of temperature fluctuation issue caused by aged equipment, the temperature record should be archived for over two years at least.”
- Policy
- Korean clinical trial of MSD’s V114 is being conducted
- by Lee, Tak-Sun Dec 23, 2020 06:10am
- MSD's pneumococcal vaccine candidate is conducting phase III clinical trials for infants in Korea. It is noteworthy whether MSD will become a strong competitor in the Korean pneumococcal vaccine market dominated by Pfizer's Prevenar 13. On the 21st, the MFDS approved a phase III clinical trial plan for the pneumococcal vaccine candidate V114 Prefilled Syringe of MSD Korea. It is phase III clinical trial that evaluates the safety and immunogenicity of four doses of V114 in healthy infants. It is conducted for only 100 domestic infants at 18 medical institutions nationwide. V114 is a 15-valent vaccine that prevents 15 pneumococcal viruses. Clinical trials were conducted in adults and children. After the new pneumococcal vaccine, which has completed clinical trials overseas and is waiting for approval. In Korea, Pfizer's 13-valent pneumococcal vaccine, Prevenar 13, dominates the market. It recorded ₩40.4 billion in sales based on IQVIA last year, leading GSK's pneumococcal vaccine Synflorix pfs inj (₩6.1 billion) by a large gap. This year, sales volume increased further to prevent pneumonia due to COVID-19. SK Bioscience developed a generic for Prevenar 13 but withdrew the license because it could not pass the patent. SK Bioscience, together with Sanofi, is focusing on the next-generation pneumococcal vaccine. Pfizer is also committed to developing new vaccines to meet competitors' challenges. Already, a 20-valent vaccine is about to be approved by the US Food and Drug Administration (FDA). On the 10th, foreign media reported that the FDA will review the 20-valent pneumococcal vaccine '20vPnC', which Pfizer is developing, as the subject of priority evaluation. Accordingly, FDA approval is expected in the first half of next year. However, it was found that clinical trials for children have not yet been completed. In the case of pediatric vaccines, MSD's V114 is more imminent for commercialization, so it is expected that Korea will complete phase III and apply for approval. Interest is focused on whether the MSD V114 will compete with the Prevenar 13.
