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- 2026-04-11 21:14:16
- Policy
- “Bio-vaccine fund will be created within the year”
- by Lee, Jeong-Hwan Aug 22, 2022 05:53am
- President Yoon Suk-Yeol reconfirmed his new government’s plan to raise and create a K-Bio·Vaccine Fund that focuses investments on Phase III trials within the year. The government will induce investments with pan-ministerial support and also accumulate data on 1 million people to develop next-generation treatments such as advanced biopharmaceuticals and precision medicine. Also, a public policy-based fee system will be implemented to reinforce essential healthcare such as less-favored areas such as craniotomy for cerebral aneurysms and areas with reduced demand, such as pediatrics and childbirth. On the 19th, the Ministry of Health and Welfare reported the new government’s operation plan that contained the abovementioned plans to the president. ◆Making the leap to become a global biohealth hub=The MOHW announced plans for Korea to make the leap and become a global biohealth hub. It plans to strengthen pan-ministerial support to attract investment from companies in Korea and abroad and raise and create a K-Bio·Vaccine Fund that focuses on Phase III trial investments within the year to attract private investments. Also, the ministry will provide regulatory relief by reorganizing the innovative medical device designation system within and announcing step-by-step implementation plans to innovate the biohealth regulations within the year. In addition, a ‘National Integrated Bio Big Data’ system will be established to develop next-generation treatments such as advanced biopharmaceuticals and precision medicine. With the goal of accumulating data on 1 million people, the government will apply for a preliminary feasibility study within the year. Also, a ‘Health Information Expressway’ will be created to safely manage and relay personal health and medical data for customized use by HCPs. R&D investments to establish health security and resolve national challenges will also be expanded, with the goal of reaching ₩1 trillion in 2025. In particular, the investment will be concentrated on securing core technologies such as mRNA (messenger ribonucleic acid) platforms, antiviral drugs, and universal vaccines. ◆Advancing capabilities for infectious disease response= The government’s 3rd-year COVID-19 countermeasures were also presented in the report. The plan is to promote precise, targeted quarantine in infection-vulnerable areas while maintaining daily life. Therefore, targeted distancing measures such as restricting visits and prohibiting outdoor visits or stays will be implemented in vulnerable facilities that have a high frequency of confirmed COVID-19 cases. In order to prevent group infection and progression to severe disease in such infection-vulnerable facilities, preemptive tests for workers will be expanded, and confirmed patients will be promptly treated to prevent further infection or disease progression. Also, access to testing will be reinforced by extending weekend and nighttime operation hours of screening centers (602 centers) and temporary screening centers (6 centers). Also, progression to severe disease in high-risk groups such as the elderly will be prevented by utilizing one-stop medical institutions (currently 12 locations) that can test, treat, and prescribe COVID-19 treatments within one day. As of 00:00, the proportion of COVID-19 patients aged 60 years or older among patients with severe·critical disease and deaths were 86.8% (427 patients) and 91.6% (76 patients), respectively. Also, outpatient prescriptions of COVID-19 treatments will be made possible at the patient's regular hospitals with the allowance of outpatient prescriptions in such hospitals and an increased number of pharmacies that handle COVID-19 treatments. A system for intensive treatment of severely ill patients and rapid response to emergency patients will also be prepared. Communication will also be strengthened. Ki-Seok Jeong, Chairman of the National Infectious Disease Crisis Response Advisory Committee, will be appointed Director-General of Special Response Central Disaster and Safety Countermeasure Headquarters, and will be running and explaining COVID-19-related news to the public in easy terms through the YouTube channel, ‘COVID-19 TV.’ Also, communication with the medical community will be strengthened by operating a city-regional medical consultative body with doctors’ associations in cities and provinces. ◆Expanding essential healthcare through introduction of public policy-based fee system, etc. =Also, the government will work to expand essential healthcare through the introduction of a public policy-based fee system and reform of the national health insurance expenditures to prevent the recurrence of tragedies such as the recent death of the nurse at Asan Medical Center. Essential healthcare refers to services that pose a serious threat to the lives of the people if not urgently provided, or are inadequately provide due to reduced medical demand. A public policy-based fee system will be implemented to strengthen the grounds for essential healthcare, in less-favored areas such as craniotomy for cerebral aneurysms and areas with reduced demand such as pediatrics and childbirth. Compensation for high-risk high-difficulty operations and emergency operations that are less frequent but high-risk such as aortic dissection, heart, and brain surgery that are shunned will be strengthened by increasing the policy-based premium fee. Also, support for the recovery of infrastructure on childbirth will be reinforced through measures such as raising fees and support for vulnerable regions. Also, compensation will be reinforced and infrastructure expanded after evaluating essential healthcare to identify areas in deficit such as children's hospitals. The plan also contained measures to increase the listing of essential healthcare and high-priced drugs through a thorough re-evaluation of existing reimbursed items that cause excessive use such as ultrasound and MRI, the improvement of standards for foreign dependents, and preventing theft of health insurance qualifications.
- Company
- Strong performance of overseas subsidiaries of companies
- by Kim, Jin-Gu Aug 22, 2022 05:52am
- Starting from the left, "Beijing Hanmi", "YANGZHOU ILYANG PHARM", "GC China"Daewoong Pharmaceutical's Southeast Asian subsidiary doubled in a year. Major overseas subsidiaries of pharmaceutical bio companies showed strong sales in the first half of last year. Most of the local subsidiaries in China and Southeast Asia showed an increase in sales compared to the same period last year. Beijing Hanmi, Celltrion AP (Asia-Pacific), and Celltrion USA set new sales records based on half-year sales. ◆ Beijing Hanmi records half-year sales According to the Financial Supervisory Service on the 20th, the combined sales of 22 Chinese local subsidiaries of 10 Korean pharmaceutical companies in the first half of the year were 314.8 billion won. It increased 14% compared to 275.4 billion won during the same period last year. Net profit increased 28% from 38.5 billion won in the first half of last year to 49.1 billion won in the first half of this year. Beijing Hanmi broke the previous half-year sales record by making 173.3 billion won in sales in the first half of the year. It increased 30% compared to 132.9 billion won in sales in the first half of last year. Half-year sales of Beijing Hanmi recorded around 120 billion won before COVID-19. In the first half of 2020, when COVID-19 was rampant in China, it plunged to 92.8 billion won. However, after recovering to 110.7 billion won in the second half of 2020, 132.9 billion won in the first half of last year, 155.8 billion won in the second half of this year, and 173.3 billion won in the first half of this year. Beijing Hanmi expanded its syrup factory last year. The operation rate of this plant has been maintained at 100% this year. An official from the U.S. in Beijing explained, "As a result of timely expansion of facilities and supplying products in line with the rapid increase in demand for respiratory patients and cold medicines in China, we achieved solid performance until the first and second quarters." Most of the other Chinese subsidiaries have also grown by a large margin. In the case of Chong Kun Dang, sales at Chong Kun Dang Health in Qingdao more than tripled from 1.1 billion won to 6.7 billion won. Guangdong Pharmaceutical's total sales in the first half of the year were 20.1 billion won, up 24% from the same period last year. Daewoong Pharmaceutical has four subsidiaries in China, including Sacheon Daewoong Biotechnology Limited, Liaoning Daewoong Pharmaceutical Limited, and Beijing Daewoong Pharmaceutical and Technology Limited. The combined sales of the four corporations increased 39% from 8.8 billion won to 12.3 billion won in a year. YANGZHOU ILYANG PHARM·TONGHUA ILYANG HEALTH PRODUCTS of Ilyang Pharmaceutical recorded 71.2 billion won in sales in the first half of the year. It increased by 5% compared to 67.7 billion won in the first half of last year. Among major Chinese subsidiaries, sales of GC Pharma's subsidiaries declined. Total sales of GC China and GC China Pharm fell 34% year-on-year to 29.8 billion won. ◆ Celltrion and Takeda products in earnest in the Asia-Pacific region, Diagnostic kits are booming in the U.S Local subsidiaries in Southeast Asia also performed well in the first half of the year. Particularly noticeable is Celltrion's Celltrion Asia Pacific PTE located in Singapore. It recorded 75 billion won in sales in the first half of this year. It nearly tripled from 25.2 billion won in the first half of last year. Net profit also shifted from a deficit of 6.8 billion won to a surplus of 9.7 billion won. Analysts say that the sale of 18 products acquired from Takeda Pharmaceutical has begun in earnest. Celltrion Pharmaceutical is in charge of sales in Korea, and Celltrion Asia Pacific PTE is in charge of sales in the remaining eight countries, including Thailand, Taiwan, Hong Kong, Macau, the Philippines, Singapore, Malaysia, and Australia. In the case of Daewoong Pharmaceutical, the total sales of five local subsidiaries located in Thailand, Indonesia, and the Philippines more than doubled from 8.4 billion won to 17.2 billion won. In the case of Chong Kun Dang, sales of local subsidiaries in Indonesia increased 2.2 times from 2.1 billion won to 4.7 billion won in a year. In addition, in the North American market, Celltrion USA made strides by increasing its sales nearly 16 times in a year. Celltrion USA's sales in the first half of this year increased from 9.4 billion won last year to 150.4 billion won in the first half of this year. Celltrion USA's sales expansion is attributed to strong sales of COVID-19 diagnostic kits. Celltrion is jointly developing and selling antibody diagnostic kits, antigen rapid diagnostic kits, antigen home test diagnostic kits, and neutralization antibody diagnostic kits with Humasis. Among them, antigen rapid diagnostic kits and antigen home test diagnostic kits have been supplied to the U.S. in earnest since late last year through Celltrion USA.
- Company
- Avastin biosimilar Vegzelma has obtained a European license
- by Kim, Jin-Gu Aug 22, 2022 05:52am
- Celltrion announced on the 19th that Vegzelma (CT-P16) developed with Avastin biosimilar has obtained a sales license from EC on the 18th (local time). According to Celltrion, Vegzelma received an EMA approval recommendation in June. Within two months after that, it received permission to sell full labels approved by Avastin, including metastatic direct bowel cancer and non-small cell lung cancer. Celltrion's strategy is to quickly settle Vegzelma in the market with cost competitiveness by mobilizing all of its own drug development and production capabilities. Celltrion has also completed a global patent agreement with the original drug developer before obtaining Vegzelma's permission, and plans to release it in Europe through Celltrion Healthcare within this year. Vegzelma is the third anticancer antibody biosimilar developed by Celltrion after blood cancer treatment Truxima and breast cancer and stomach cancer treatment Herzuma. Celltrion expects Vegzelma's sales license in Europe to further strengthen its anti-cancer drug portfolio. Celltrion is revealing the possibility of Vegzelma's permission in the U.S. and Korean markets following Europe. Celltrion also applied for Vegzelma's sales license to the Ministry of Food and Drug Safety and the U.S. Food and Drug Administration (FDA) at the end of last year, and expects approval within the year. According to IQVIA, a global pharmaceutical market research firm, the global Bevacizumab market in 2021 is $6.413 billion, of which the European market accounts for $1.614 billion and the U.S. market accounts for $2.62 billion. A Celltrion official said, "With Vegzelma's permission to sell in Europe, Celltrion has secured its third anticancer antibody biosimilar." He said, "We will do our best to help Vegzelma settle in the European biosimilar market early and proceed with the remaining global licensing process without a hitch."
- Policy
- The PVA exception to COVID-19 cold drug is actively applied
- by Lee, Tak-Sun Aug 22, 2022 05:52am
- Pharmaceutical Industry Says "Response After Gathering Internal Opinions" The Ministry of Health and Welfare said it would actively apply the correction method to the pharmaceutical industry's request to exclude cold drugs used in COVID-19 from PVA. Although it is not excluded from the negotiation, the policy is to actively apply exception rules to prevent damage to drug price cuts. First, the pharmaceutical industry plans to collect opinions on the proposal and respond through a public-private consultative body. However, as the Ministry of Health and Welfare's official position has been reported, the pharmaceutical industry is also expected to consider using the correction method in a more advantageous way. According to the industry on the 18th, the Ministry of Health and Welfare sent an official letter to pharmaceutical organizations such as KPBMA, saying that if the COVID-19 drug is selected for negotiations, it will be actively applied. The KPBMA suggested that COVID-19 drugs be excluded from PVA to actively support the production of COVID-19 symptom treatments. Prime Minister Han Duck-soo said at a meeting of the COVID-19 Central Disaster and Safety Countermeasures Headquarters on the 12th, "As the number of COVID-19 confirmed patients increases, we will encourage and support the expansion of supply and demand of cold medicines such as antipyretics. He said, "We will ease PVA, which cuts prices when the use of drugs increases, so that manufacturers can increase production." The pharmaceutical industry also had some expectations for Prime Minister Han's remarks. The plan proposed by the Ministry of Health and Welfare is interpreted as an extension. The Ministry of Health and Welfare and the NHIS also conveyed their intention to correct the COVID-19 cold medicine in accordance with related regulations through a public-private consultative body, so not all demands from the pharmaceutical industry to be excluded from the negotiation were accepted this time. According to the provisions of Article 10 (2) of the PVA Negotiation Detailed Operation Guidelines, exceptions are made when applying PVA in the case of drugs used to support the treatment of infectious diseases. The Ministry of Health and Welfare explained that if the cold medicine that the Ministry of Food and Drug Safety encourages production for the treatment of COVID-19 is selected as a PVA target, the relevant regulations will be actively applied. When calculating the negotiation reference price, the amount of use prescribed for COVID-19 treatment is excluded, or the amount of use at a specific time (e.g., February to August) is excluded. However, the correction method will be decided after sufficient discussion with related associations through a public-private consultative body. The pharmaceutical industry plans to seek countermeasures after internal discussions. An official from the Pharmaceutical Association said, "We would like to hear the opinions of pharmaceutical companies on the proposal of the Ministry of Health and Welfare and communicate with the government through a public-private consultative body at the end of the month." As the government's policy has become official, the industry is expected to discuss countermeasures accordingly. This is because the demand to continue to be excluded from the negotiation target may work against the discussion process.
- Company
- Ibrance safety is OK even in male breast cancer patients
- by Eo, Yun-Ho Aug 19, 2022 05:53am
- Breast cancer treatment Ibrance has added safety-related product information in male patients. The Ministry of Food and Drug Safety recently added a phrase that male patients also showed consistent safety profiles with women in post-marketing experience through updating the permits of CDK4/6 inhibitor Ibrance of Pfizer Korea. The measure was based on the results of post-marketing surveys and electronic health records in the United States, and the U.S. FDA expanded its indication to prescribe Ibrance to male patients based on the data in 2019. Male breast cancer is a rare disease that accounts for about 1% of all breast cancers, and most of the patients' mammary tumors are expressed in hormone receptors and are generally treated with endocrine therapy, and Ibrance combined therapy is possible for progressive cancer. But, Ibrance has not secured an indication for male breast cancer in Korea. Meanwhile, Ibrance recently reaffirmed its effectiveness, including the Overall Survival, through a large-scale Real World study. The study, published in the European Society for Medical Oncology Breast Caner 2022, retrospectively analyzed the data of 2888 actual patients prescribed Ibrance combination therapy and Aromatase inhibitor monotherapy. As a result, OS median of Ibrance was 53.4 months, and Aromatase inhibitor alone was 40.4 months. The risk of death in Ibrance combination therapy was 33% lower.
- Policy
- Manufacturing for development allowed during suspensions
- by Lee, Hye-Kyung Aug 19, 2022 05:53am
- An interpretation that manufacturing activities for the purpose of product development, not for commercial sale, is possible during the manufacturing business suspension disposition period. According to industry sources on the 18th, the Ministry of Food and Safety announced that not-for-sale manufacturing activities, such as those for product development or to prepare data for approval changes, are allowed during the manufacturing suspension period. This interpretation was provided after a number of queries on 'whether manufacturing for the purpose of product development is allowed during the suspension of manufacturing business period, and whether such manufactured units can be sold,’ were submitted on the national e-petition website, e-People. According to Article 76 of the Pharmaceutical Affairs Act, if a manufacturer of drugs or its importer violates the Pharmaceutical Affairs Act or any order issued under the Pharmaceutical Affairs Act, the Minister of Food and Drug Safety may revoke permission, approval, or registration held by the manufacturer of drugs, issue an order to prohibit manufacturing or importing products, or issue an order to fully or partially suspend his or her business for a period of up to one year. Also, according to Article 95, Annex 8-10 of the ‘Regulation on Safety of Medicinal Products,’ if companies perform the suspended business during the suspended period, their license or registration may be revoked. Regarding the provisions, the industry posted an inquiry on the e-People website on whether companies subject to manufacturing suspension dispositions may conduct manufacturing activities for the purpose of preparing submission data for the product’s approval change (change of consignee) or product development (and if allowed, whether the manufactured lot may be sold). After review, the MFDS said, “acts of manufacturing for non-sale, product development purposes (to prepare data for approval changes, etc.) are allowed during the manufacturing suspension period. However, the sale of the lot manufactured for approval changes, etc. or product development during the manufacturing suspension period is not allowed."
- Company
- US FDA approves Samsung Bioepis' high conc Humira biosimilar
- by Kim, Jin-Gu Aug 19, 2022 05:53am
- On the 18th, Samsung Bioepis announced that the U.S. Food and Drug Administration (FDA) approved the high-concentration formulation of its Humira biosimilar, ‘Hadlima 100mg/mL’ on the 15th (local time). The company plans to market the high-concentration Hadlima in the US market in July next year through its US marketing partner, Organon. Hadlima is used for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, and plaque psoriasis. To improve patient convenience, the formulation will be offered to patients in a prefilled syringe (PFS) or autoinjector. The approval of the citrate-free, high-concentration Hadlima was based on clinical data from a clinical study that compared the pharmacokinetics, safety, tolerability, and immunogenicity of two formulations of Hadlima (100 mg/mL vs 50 mg/mL) in healthy volunteers. The low-concentration formulation (50 mg/mL) of Hadlima was previously approved by the FDA in July 2019. More than 5 million prescriptions of Hadlima had been made under various brand names since 2018. Byoungin Jung, VP and Team Leader of Regulatory Affairs at Samsung Bioepis, said, “With the FDA approval, we are now able to expand our treatment options to both the low- and high-concentration versions of Hadlima in the US. By leveraging our R&D expertise, manufacture, and supply chain management capabilities, we will continue our efforts to provide quality drugs to patients around the globe.”
- Policy
- We need to increase the rate of PO tx for COVID-19 crisis
- by Lee, Jeong-Hwan Aug 19, 2022 05:53am
- In order to respond to the increase in the number of patients with COVID-19, it was pointed out that the prescription rate of treatments such as Paxlovid should be raised more than now, while continuing to maintain an environment where prescriptions are quickly prescribed. It was also suggested that the fast track of the COVID-19 high-risk oral drug prescription currently prepared by the government should be repeatedly checked, and the fast track system should not be predicted to continue to be sustainable. On the 17th, Jeong Ki-seok, chairman of the National Advisory Committee on Infectious Disease Crisis Response, made this announcement at a regular briefing on COVID-19. Chairman Chung Ki-seok positively assessed that the prescription rate of oral treatments, which stood at only 4% earlier this year, has now risen to 20%. Chung's assessment is that the prescription rate of PO drugs must rise steadily to be effective in responding to critical patients. He stressed that it is very important to secure a system that can prescribe PO drugs quickly and continue to check. Chairman Chung said, "The government is preparing a lot of PO drugs, but the medicine does not solve it." He said, "The system that can be prescribed the fastest in the right time is important. This is why experts strongly recommended fast-track operation to the government," he explained. Chairman Chung added, "We are operating a fast track, but the government should check for other system that allows high-risk groups to receive treatment first and receive treatment first," adding, "We should not predict that this will continue to be sustainable just because we have it in place." The Ministry of Health and Welfare announced that it will do its best to secure additional medical institutions and pharmacies handling oral drugs. Currently, there are only 274 places that prescribe treatments taken at or above the general hospital level and only 7 upper-level general hospitals. Park Hyang, head of the central disaster management headquarters, said, "There are about 10,000 one-stop hospitals, but it is true that the number of high-level general hospitals or general hospitals that can be opened at night is small." There will be more medication in the future," she said. "I heard opinions on why the drug progress is slow at the medical field, and there were problems with pharmacy issues and outpatient prescriptions," Park Hyang said. "In the case of Paxlovid, it seems still difficult to combine them." "Although 2,000 pharmacies have been previously secured, we are preparing to designate additional pharmacies at any time if there is an additional on-site request," she said. She added, "We will continue to listen to opinions from the medical field and supplement them."
- Company
- Indication of Norvatis Beovu's DME was expanded
- by Aug 19, 2022 05:52am
- Novartis Korea announced on the 17th that Beovu, an Age-related macular degeneration treatment, has added diabetic macular edema (DME). Beovu is a treatment that inhibits neonatal vascular expression and retinal effusion leakage in combination with VEGF-A. The Beovu dose for DME treatment is administered once every 6 weeks, 6 mg (0.05 mL) for the first 5 times, and once every 12 weeks thereafter. Patients with disease activity can be administered once every eight weeks. The administration interval is determined based on disease activity evaluated on vision and/or anatomical criteria. This permission was based on the results of 2 phase 3 clinical trials, KESTREL and KITE, which directly compared the efficacy and safety of the existing treatment, Aflibercept. The clinical trial was conducted on 926 patients with type 1 or type 2 diabetes (566 KESTREL and 360 KITE) aged 18 or older with impaired vision due to diabetic macular edema. In the Beovu medication group, loading dose was administered 5 times every 6 weeks, then administered every 12 weeks, and patients with confirmed disease activity were administered every 8 weeks. The control group was administered 5 times every 4 weeks with loading dos according to the drug's permission and then administered every 8 weeks. At the first year (52 weeks), the median was administered 7 times in the Beovu medication group and 9 times in the control group. The researchers said that existing anti-VEGF treatments that treat DME were usually administered monthly when administering loading dose, making it difficult to improve the patient's treatment burden and resulting symptoms, and based on the results of this study, Blucizumab-dbll will be a new treatment option to reduce the treatment burden for diabetic macular edema. DME is a disease that causes swelling in the macula by increasing vascular endothelial growth factors and proliferating new blood vessels as exudates flow from damaged microvascular vessels due to the inability to control high blood sugar. According to a paper published in 2011, DME is a major disease that causes blindness in adults in developed countries, with 12% of type 1 diabetes patients and 28% of type 2 diabetes patients being affected. Cho Yeon-jin, executive director of Novartis Korea's ophthalmology division, said, "We are pleased to expand treatment options to patients suffering from vision damage following Lucentis with the expansion of indications for the treatment of diabetic macular edema." Executive Director Cho Yeon-jin explained, "Novatis will continue to have leadership in the field of eye disease treatments and make efforts to introduce treatments with efficacy and safety to clinical sites."
- Company
- Why is the exp. date of the Sanofi flu vaccine short?
- by Aug 18, 2022 01:06pm
- With domestic and foreign pharmaceutical companies starting to distribute flu (influenza) vaccines, the expiration date of the Sanofi vaccine is about three months shorter than that of other products. This means that the Sanofi vaccine must be discarded in April, when Korea is still considered to be a flu epidemic period, so it cannot be used. Sanofi explained that it is the best way to speed up the introduction of Korean products. According to the pharmaceutical industry on the 17th, domestic and foreign pharmaceutical companies such as Sanofi, GC Pharma, Boryung Biopharma, Ilyang Pharmaceutical, and Korea Vaccine have started supplying vaccines in preparation for the 2022-2023 seasonal flu epidemic. According to the current status of the seasonal flu vaccine lot release for domestic use released by the Ministry of Food and Drug Safety, a total of 9.32 million people were approved for shipment from July 18 to the 12th of this month. Among them, the expiration date of Sanofi's flu vaccine Vaxigrip is about seven months later, until March 31, 2023, which is particularly shorter than other vaccines. Sanofi received Lot releases for each lot of Vaxigrip on August 1, 2, 4, and 9, which were valid for the same period as March 31 next year. The flu vaccine is usually valid for one year. The validity period of other flu vaccines approved for shipment at the same time is around June-July next year, about a year later. For example, GC Pharma's GC FLU , which received a Lot release on August 1, has an expiration date of June 12, 2023, and Korea Vacine's Kovax-Flu validity period, which was approved on the same day, is June 23, 2023. On August 10, Boryung Bio Pharma's Boryung Flu, which was released on August 10, is specified to expire on July 5, 2023. Ilyang Pharmaceutical Terrestrial Pfs, which received a lot release on July 19, ahead of Sanofi, also has an expiration date of June 14, 2023. This means that the expiration date of Vaxigrip is about three months shorter than that of other flu vaccines, so Vaxigrip must be discarded in April next year, when the flu vaccine is in vogue. In Korea, the flu epidemic is expected from October to April of the following year. The government's national flu vaccination project is also in line with this. The expiration date is not a problem when receiving national shipping approval, but vaccine manufacturers generally distribute vaccines that can be received until the end of the business period. This is because if the expiration date ends within the epidemic period, products that need to be discarded can be inoculated to consumers, and common sense believes that it is inappropriate to supply products that need to be discarded within the business period. Some raise suspicions that the reason why Sanofi supplied the flu vaccine so early is because of the expiration date. Originally, Sanofi distributed the flu vaccine in Korea from September to October every year with GSK. In the case of imported finished products, unlike domestic manufactured vaccines, it takes longer to finish production at foreign factories and enter Korea through a certification process. However, this year, Sanofi began supplying vaccines at the same time as domestic manufacturers. Previously, the expiration date was longer than this, so there was no big difficulty in supplying from September to October, but this year, the expiration date had to be advanced as the expiration date was less than eight months away. An official from a vaccine manufacturer said, "As Sanofi distributes vaccines with a short distribution period in Korea, confusion is expected in the vaccine market," adding, "Some analysts say that Sanofi is accelerating the introduction as it has to quickly exhaust its products this year." Sanofi explained that it brought in products produced relatively early so that domestic consumers could receive vaccines quickly. Unlike previous years, influenza strains that will be prevalent in the southern and northern hemispheres this year were consistent, so there was no need for a technical process to change the strain, which allowed the production of vaccines for the northern hemisphere to be accelerated. Imported finished products have more testing processes and are more difficult than domestic companies, so no matter how fast they speed up, the remaining validity period is bound to be shorter than other domestic vaccines that have been released at the same time. An official from Sanofi said, "Korean corporations have tried to advance the timing due to the late introduction schedule of imported products in Korea, and we have secured vaccines as soon as possible as we can produce Northern Hemisphere products early this year due to the same strain." "The introduction process may be complicated and the expiration date may be relatively short, but we did our best to supply the product at a similar time to other vaccines. Also Vaxigrip Tetra whose expiration date is from May to July 2023 is going to be supplied sequentially in Korea," he said.
