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- 2026-03-18 17:36:35
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- Korean-made novel drug Kanarb keeps on evolving
- by Kim, Jin-Gu Jan 08, 2021 06:20am
- Product image of Kanarb Boryung Pharmaceutical’s star Kanarb (fimasartan) has added a new indication after a decade. Now the drug is indicated to reduce proteinuria in a hypertensive diabetic patient. In the highly saturated market for angiotensin II receptor blocker (ARB) for hypertension, Kanarb has found a new weapon to break through the stagnated growth. Besides the indication expansion, Boryung Pharmaceutical is also seeking for Kanarb combination drug, adding a variety of doses and expanding user age group to drive the prescription growth even after a ten-year anniversary. ◆A third ARB to be indicated to reduce proteinuria confirming superior effect than losartan On Jan. 6, Boryung Pharmaceutical announced the Ministry of Food and Drug Safety (MFDS) newly approved another indication for Kanarb last year. The new indication is to lessen proteinuria in hypertensive type 2 diabetic chronic kidney disease (CKD) patient as an antihypertensive treatment. Now a patient with diabetic CKD can be prescribed with Kanarb. The Korean Society of Hypertension reported 9.02 million patients in South Korea are being treated for their hypertension as of 2018. Among the total patient size, 26 percent, or 2.35 million patients, has a diabetic complication. CKD is the most common complication for a diabetic patient, as two out of ten are suffering from CKD. Because of the medical situation, the healthcare providers primarily prescribe an angiotensin converting enzyme inhibitors (ACE inhibitors) or ARBs to a diabetic CKD patient with hypertension. Prior to Kanarb’s indication expansion, losartan and irbesartan were the only ARB indicated to treat a diabetic CKD. But the new indication has opened a new door for Boryung Pharmaceutical to tap on the potential market of 500,000 patients. The base of the indication expansion, the FANTASTIC study confirmed Kanarb’s effect of reducing proteinuria is significantly better than that of losartan. The Korean company is apparently working on marketing strategy focusing on the indication. ◆Ten years in the market, Kanarb keeps developing doses and combination treatments After ten years, Kanarb was able to add another indication. The drug was first approved by MFDS in September 2010 as a first antihypertensive new drug developed by a Korean company and was released to the market in March 2011. Boryung Pharmaceutical also expanded Kanarb’s doses ranging from 30 mg to 60 mg and 120 mg. Moreover, the company released combination drugs like Lacor (fimasartan plus hydrochlorothiazide) in 2013, and Dukarb (fimasartan plus amlodipine) and Tuvero (fimasartan plus rosuvastatin) in 2016. And in February and September last year, the company also launched Dukaro (fimasartan plus rosuvastatin plus amlodipine) and Akarb (fimasartan plus atorvastatin), respectively, to further diversify the Kanarb line-up. In this year, the company is planning to launch a three-substance combination treatment including fimasartan, amlodipine and hydrochlorothiazide. The drug is now also available for a wider range of age groups as well. The initially stated caution on the label, ‘no record of administering the drug to a patient aged over 70,’ was removed to provide access of the drug to elderly patients aged 71 and over. The constant expansion of the drug use is the source of prescription volume increase. A pharmaceutical market research firm UBIST reported the Kanarb family has generated 94.3 billion won as of November last year. Combining the December prescription volume, it would have exceeded 100 billion won mark. Kanarb single drug alone has generated 45.1 billion won as of last November, showing a 5-percent growth compared to the previous year same time. Although the drug has been in the market for over a decade, its market presence is still growing. Boryung Pharmaceutical could also shoot for the patent term extension with the new indication. Kanarb’s product patent is to expire in February 2023. If the company adds an indication patent, Kanarb’s patent term would be extended by 15 years to 2038. However, the Korean company official mentioned “The term extension is still under review.”
- Company
- SK Bioscience and GSK signed a joint sale of 5 vaccines
- by Kim, Jin-Gu Jan 08, 2021 06:19am
- Product photos of 5 vaccines that SK Bioscience and GSK signed a joint sales contract. Cervarix, Menveo, Boostrix, Havrix, and Priorix clockwise from top left SK Bioscience has signed a joint sales contract with GSK for five vaccines. SK Bioscience announced on the 6th that it has signed a co-promotion contract for major vaccines with GSK to expand the domestic vaccine market. This is the content that SK Biosciences jointly sells and distributes vaccines developed by GSK in Korea. These products are ▲Tdap (tetanus, diphtheria, pertussis) vaccine Boostrix ▲ meningococcal vaccine Menveo ▲ hepatitis A vaccine Havrix1440 ▲ (measles, parotitis, rubella) vaccine Priorix ▲ cervical cancer vaccine Cervarix. Based on its domestic sales network, SK Bioscience is in charge of sales of Boostrix, Menveo, Havrix1440, and Priorix in the adult market, and sales of Cervarix in the entire market including infants and children. The domestic market size of the five vaccines that SK Bioscience and GSK signed a joint sales contract was about ₩128 billion last year. Boostrix is vaccinated in adolescents and adults over the age of 10 and is the only vaccine in Korea that can be vaccinated to seniors over 65 years of age. Menveo is the only meningococcal vaccine available to the widest range of age groups and can be administered from 2 months of age. Havrix, the world's first hepatitis A vaccine, is sold in more than 100 countries. Cervarix can prevent cervical cancer as well as anal cancer and is sold in more than 130 countries. An-joon Choi, head of the marketing division of SK Bioscience, said, "Through this agreement, we have secured a new growth engine in the vaccine market. In the future, we will expand the market and strengthen our position as a leading company by securing a variety of self-developed vaccines and co-sale vaccines."
- Company
- Cyramza·Tarceva therapy is expected to be proposed
- by Eo, Yun-Ho Jan 08, 2021 06:19am
- It is noteworthy whether the first combination option of targeted anticancer drugs to enter insurance coverage in the first-line lung cancer therapy will be possible. According to related industries, first-line therapy for non-small cell lung cancer (NSCLC) VEGF receptor 2 antagonist Cyramza (Ramucirumab) and epithelial cell growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tarceva (Erlotinib), It is expected that the combination therapy of Tarceva (Erlotinib) will be presented to the Review Committee for Cancer Diseases of the HIRA this year, which will be held next week. The combination therapy of the two drugs was approved by the EMA in January and the FDA in June. The new combination targeting VEGF and EGFR is attracting attention because it has shown efficacy in mutant patients such as EGFR exon 19 deletion and exon 21 (L858R), which have been relatively weak so far. Cyramza-Tarceva combination therapy confirmed the possibility of a through phase 3 RELAY trial. In the study, the combined use of Cyramza and Tarceva reduced the risk of mortality by 40% compared to Tarceva alone, and progression free survival (PFS) was also 19.4 months, which was more than 7 months different from the control group. Overall Survival (OS) has not yet been derived. The median follow-up was 20.7 months, and the objective response rate was similar to Cyramza (76.3% in the combination group and 74.7% in the Erlotinib alone group, but the median duration of response was 18 months and 11.1 months.) It is also encouraging that about 70% of them included East Asians. Lee Ki-hyung, professor of hematology and oncology at Chungbuk National University, said, "The EGFR-TKI target therapy, which was used for the treatment of non-small cell lung cancer of existing EGFR mutations, had a relatively low clinical effect in the exon 21 substitution group compared to the exon 19 defect group, so improvement was needed. He added, "The dual inhibition mechanism of Cyramza-Tarceva combination therapy is expected to more effectively inhibit the growth of cancer cells compared to inhibiting one mechanism. It is a remarkable treatment option in terms of overall treatment." Meanwhile, Cyramza was listed as refund type of risk sharing agreement (RSA) in second-line gastric cancer therapy in May 2018. It is domestically approved to ▲second line therapy for advanced/metastatic gastric cancer or ▲metastatic colorectal cancer patients with advanced disease during or after treatment including Bevacizumab, Oxaliplatin, and Fluoropyrimidine, and combination therapy with FOLFIRI (Irinotecan, Folinic acid, 5-FU) ▲patients with metastatic non-small cell lung cancer whose disease progresses during or after chemotherapy including platinum as a combination therapy with Docetaxel. Lilly (a developer of Cyramza ) is also in the process of insurance benefits about Cyramza monotherapy for patients with advanced or unresectable hepatocellular carcinoma that has a serum alpha fetal protein (AFP) of 400 ng/mL or more and patients not tolerated after Nexavar (Sorafenib) administration previously.
- Company
- Mitsubishi Tanabe licensed to market narcolepsy drug Wakix
- by Jan 08, 2021 06:18am
- On Jan. 4, Mitsubishi Tanabe Pharma Korea (CEO : Yomogida Osamu) announced the Ministry of Food and Drug Safety (MFDS) has green lit a narcolepsy treatment Wakix Film Coated Tablet (pitolisant hydrochloride) on Dec. 30, 2020, for marketing in the South Korean market. Wakix is indicated to treat cataplexy in adult patients with narcolepsy. The marketing approval would allow Wakix to be the only treatment option for cataplexy in narcolepsy. A rare chronic disease narcolepsy has limited treatment option in South Korea. In the U.S. and EU, modafinil, sodium oxybate, solriamfetol and pitolisant are used as a narcolepsy treatment, but only modafinil and an isomer armodafinil are approved in South Korea. Narcolepsy is a sleep disorder causing difficulty in regulating sleep-wake cycles due to loss of the neurons creating hypocretin in brain. Major symptoms include excessive daytime sleepiness (EDS) and catalepsy that can enter REM sleep directly from a waking state. Catalepsy is known to be expressed in 70 percent of narcolepsy patients. Wakix is the first treatment approved in South Korea with confirmed clinical efficacy and safety in treating catalepsy. Wakix, a first-in-class medication, is a selective histamine 3 (H₃) receptor antagonist/inverse agonist. Its efficacy could be mediated through its activity at H₃ receptors, thereby increasing the synthesis and release of histamine, a wake promoting neurotransmitter. CEO Yomogida Osamu of Mitsubishi Tanabe Pharma Korea stated, “We are exhilarated to provide an innovative treatment option to South Korean patients with narcolepsy through the health authority’s approval. Wakix is the only narcolepsy treatment in South Korea that has proved safety and efficacy in treating both EDS and catalepsy, the most common symptoms of narcolepsy. The company would do its best to bring practical medical benefit to South Korean patients and healthcare providers.” Wakix was designed and developed by a French-based pharmaceutical company Bioprojet. After the drug was first approved as an orphan drug by the European Medicines Agency (EMA) in March 2016, Wakix has been prescribed to patients with narcolepsy in the U.K., France, Germany and other European countries. In August 2019, the drug also earned the U.S. Food and Drug Administration’s (FDA) approval as well.
- Company
- SK Chemical's Ongentys can be prescribed at BIG 5
- by Eo, Yun-Ho Jan 06, 2021 06:20am
- SK Chemicals' Ongentys can be prescribed in general hospitals. According to related industries, the 3rd generation COMT inhibitor Ongentys (Opicapone) has passed the drug commitee (DC) of Big 5 hospitals such as SNUH, AMC, and Shinchon Severance Hospital. Ongentys, which was listed at a drug price of ₩2,515 last October after domestic approval in November 2019, was introduced by SK from the Portuguese pharmaceutical company BIAL, and was launched with the convenience of taking once a day. Unlike the second-generation COMT inhibitor, there were no side effects associated with severe diarrhea and urine discoloration, and no special safety issues appeared even when long-term administration for more than 1 year. Parkinson's disease, which has the second highest prevalence along with dementia among degenerative neurological diseases, has not yet been developed, so symptomatic management with drug therapy is the only general treatment. Levodopa, a basic drug for Parkinson's disease treatment, has been pointed out as a problem with motor fluctuation, which changes the duration of the drug when administered for a long time. In order to solve this problem, COMT inhibitors are being administered in combination. However, Entacapone, a second-generation COMT inhibitor, had a short duration of drug effect, so it was necessary to take the drug more than 5 to 8 times a day. In addition, side effects such as diarrhea and urine discoloration were also a problem. Meanwhile, it obtained US FDA approval in April of last year after EMA approval in 2016. In Asia, it was released for the second time in Korea after Japan.
- Company
- SK Bioscience loses MSD vaccines but nabs GSK vaccines?
- by Kim, Jin-Gu Jan 06, 2021 06:19am
- SK Bioscience is reportedly sealing the deal on commercializing four types of GSK vaccines in South Korea. When the deal is finalized, SK Bioscience would be able to fill the gap of four types of MSD vaccinea taken over by HK inno.N last year. According to a pharmaceutical industry source on Jan. 5, SK Bioscience and GSK Korea are in discussion for co-promotion contracts on a cervical cancer vaccine Cervarix, a hepatitis A virus vaccine Havrix, a meningococcal vaccine Menveo, and a Tdap vaccine Boostrix. SK Bioscience and GSK Korea left no official comments, but the industry seems to be aware that the two companies are close to inking the co-promotion deal. Since late last year, the local sales licenses for the global pharmaceutical companies’ vaccines have been shuffled around. In last November, seven MSD vaccines’ sales licenses, previously owned by GC Pharma and SK Bioscience, have been handed over to HK inno.N. Apparently, the Korean company started taking actions from the break of the new year. The seven MSD vaccines included cervical cancer vaccine Gardasil 4 and 9, a shingles vaccine Zostavax, a rotavirus vaccine RataTeq, a hepatitis A virus vaccine Vaqta, a measles, mumps, and rubella vaccine MMR2, and a pneumococcal vaccine Prodiax. The popular vaccines like Zostavax and Gardasil were handled by GC Pharma, and the rest of the vaccines—RotaTeq, Vaqta, MMR2 and Prodiax—were sold by SK Bioscience. Zostavax and Gardasil raised 120 billion won a year, whereas RotaTeq, Vaqta, MMR2 and Prodiax generated approximately 24 billion won a year. In just two months, SK Bioscience is getting its hands on GSK vaccines. Currently, four GSK vaccines are sold by Yuhan Corporation and Kwangdong Pharmaceutical, each focused on sales in children and adolescents, and in the rest of the target, respectively. The industry experts expect SK Bioscience would nab the vaccines sold by Yuhan. GSK has reportedly suspended the supply of vaccine to Yuhan as of Dec. 31, 2020. If SK Bioscience successfully signs the co-promotion deal on the four vaccines by GSK, the company would be able to compensate the loss from losing MSD’s Cervarix, Havrix, Menveo, and Boostrix, which used to generated 28 billion won annually. A pharmaceutical industry insider commented, “GSK has cut the ties with Yuhan for the new contract. Highly likely that SK Bioscience would take over all the vaccine sales and marketing, except for the pediatric market. However, both SK Bioscience and GSK are reserving any definite answer. SK Bioscience official explained, “We have no comment to make on the domestic sales licenses on GSK vaccines.” GSK official also stated, “There is nothing to confirm except that the talk is in progress.”
- Company
- Patient copayment on Dupixent drops from 60% to 10%
- by Jan 06, 2021 06:18am
- From the break of the new year, the copayment burden on the patients prescribed with an atopic dermatitis treatment Dupixent would be reduced significantly. Sanofi Aventis Korea’s Dupixent would be applied with a special case reimbursement from Jan. 1, 2021 for the patients with severe case of atopic dermatitis. Accordingly, their copayment rate for administering 300 mg of Dupixent would be decreased from 60 percent to 10 percent. The Health Insurance Policy Deliberation Committee (HIPDC) has made the decision at the 22nd meeting convened by the Ministry of Health and Welfare (MOHW) on Nov. 27 last year. A special case reimbursement benefit is provided to patients with rare or severe chronic diseases to cut their copayment rate for the healthcare reimbursement down to 10 percent. To this date, atopic dermatitis was ruled out of the special case benefit as there was no distinction between mild and severe cases. But the relevant legal basis has changed since last July, when a new disease code was designated to a ‘severe case of atopic dermatitis.’ The government also rapidly processed the changes. Now the patients prescribed with Dupixent can only pay 71,000 won, the 10 percent of the listed price 710,000 won per shot. The annual cost of the treatment is estimated to be around 2 million won. Compared to last year, the cost would be maximum 5.82 million won less or about the half. However, the special case reimbursement is only granted to patients who meet the requirements; treating adult patient over the age of 18 with severe atopic dermatitis apparent for over three years, who has uncontrolled condition after four-week topical treatment as first-line treatment, and not showing more than 50 percent improvement in Eczema Area Severity Index (EASI) score after three-month systemic immunosuppressant therapy; has EASI score over 23 before administrating the treatment; and has a record of receiving topical treatment and systemic immunosuppressant therapy within past six months. The Dupixent sales are also expected to surge even more this year as the copayment rate dropped drastically from the New Year’s Day. A pharmaceutical market research firm IQVIA reported Dupixent’s sales income has skyrocketed since last year’s January, when the healthcare reimbursement was granted. The initial quarterly sales making approximately 1 billion won to 2 billion won leaped to 3.3 billion won in last year’s first quarter, and also it soared to 5.2 billion won and 7.1 billion won in the second and third quarters, respectively. As the injection sales accumulated 15.6 billion won as of last year third quarter, Dupixent would likely to break through the 20 billion won record in the first year of reimbursement. Meanwhile, the special case benefit and reimbursement are not applicable on Dupixent 200 mg. The lower dose is currently approved only for adolescents with atopic dermatitis and asthma cases. Sanofi Aventis informed of the detail and explained, “The healthcare reimbursement is not granted for Dupixent 200 mg, so the patients would have to wholly cover the cost of administration.”
- Company
- Industry busy with M&A and investment for new opportunity
- by Chon, Seung-Hyun Dec 31, 2020 06:21am
- In the year 2020, many of South Korean pharmaceutical companies turned their eyes on new potential businesses. They reported major M&A news more than before. Some of them also took a bold step into bio company investment to find new opportunities. ◆GC and Celltrion ink notable M&A deals in hopes of finding new lucrative businesses The industry paid a close attention on GC as it delivered the news of finalizing two big M&A deals. GC Healthcare paid 208.8 billion won in last February to acquire an IT company UB Care. GC Healthcare is a subsidiary of GC that provides customized healthcare service based on IT. UB Care is South Korea’s number one electronic medical record (EMR) solution company, which developed EMR system for the first time in the country. It owns Korea’s biggest medical network and IT-based business platform consisting of 23,900 hospitals and clinics nationwide. Green Cross Holdings anticipates the existing business sectors covering traditional pharmaceutical business, genetic testing, diagnostic testing, medical checkup and many more would maximize the synergy effect in various healthcare sectors after it merges with UB Care. Moreover, bio companies have also joined the colossal M&A market. In last June, Celltrion signed a deal to take over the rights to Takeda’s Primary Care product assets from the Asia-Pacific markets for a total of USD 278 million (approximately 330 billion won). The deal would grant the company all rights over the 18 products available in nine markets including South Korea, Thailand, Taiwan, Hong Kong, Macao, the Philippines, Singapore, Malaysia and Australia. The list of the product assets ranges from prescription drugs like antidiabetic drug ‘Nesina’ and ‘Actos,’ antihypertensive drug ‘Edarbi,’ to OTC drugs like cold drug ‘Whituben’ and stomatitis drug ‘Albothyl.’ In last September, HLB Group acquired Mediforum (previously C-Tri). HLB, HLB Life Science and top shareholders of HLB invested total 16.6 billion won. A biopharmaceutical company Vivozon used its subsidiary to merge with Inist Bio Pharmaceutical. Lumimicro inked a contract to obtain 89.57 percent of Inist Bio Pharmaceutical shares for 60.9 billion won. After merging with the company, Lumimicro re-launched itself as Vivozon Healthcare. Lumimicro manufactures and sells compound semiconductor. Ultimately, Vivozon is merging with Inist Bio Pharmaceutical and taking over the company’s management. Established in 2008, Vivozon is a biopharmaceutical company developing new drugs. Currently, the company is conducting a clinical trial to develop non-narcotic painkiller ‘VVZ-149’ administering to manage post-surgery pain and neuropathic pain. Regardless of the failed attempt to merge, Genexine successfully acquired Toolgen. Genexine secured 16.64 percent of Toolgen’s share and became the biggest shareholder of the company. .Genexine is currently developing immunotherapy and gene vaccine .At the moment, the company is working on global clinical trials in immunotherapy ‘hyleukin-7’ and gene vaccine against cervical cancer .Toolgen owns source technology on third generation CRISPR/Cas9 genome editing, which the company uses it to develop gene therapy .◆Yuhan, Boryung and Huons actively invest externally The pharmaceutical companies were particularly active this year in investing on biopharmaceutical companies .By shaking hands with bio companies for R&D partnership, the pharmaceutical companies aim to seek the next big opportunity .Yuhan Corporation has been fruitful with lazertinib the company took over from Oscotec and licensed out to Janssen .Yuhan spent 38 billion won on four companies as equity investment .In April, the South Korean company invested in Mediogen for 23 billion won .Specializing in probiotics, Mediogen is the biggest shareholder of GI Innovation with 20.79 percent of the share .With Mediogen’s 19.82 percent share gained, Yuhan is now the second biggest shareholder of the company .The company invested quadruple of its last year operating income at 12.5 billion won in an external company for emerging opportunity .Early this year, Yuhan also invested total 15 billion won, or 5 billion won each on Huinno, Amyloid Solution and GI-Biome .Boryung Pharmaceutical reported its nine outward investments took place this year spending total 29.1 billion won .In last July, Boryung Pharmaceutical had decided to invest 24 billion won on a U.S.-based global healthcare investment fund Hayan1 L.P, an investment fund company operated by Boryung’s U.S .branch Hayan Health Network, established for the purpose of healthcare sector investment .Hayan1 fund would seek and invest on promising global bio venture based on 24 billion won Boryung paid out .
- Company
- Celltrion has applied for approval of COVID-19 treatment
- by Chon, Seung-Hyun Dec 31, 2020 06:20am
- Celltrion applied for accelerated approval of an antibody treatment COVID-19, the MFDS initiated a review. Celltrion announced on the 29th that it has applied to the MFDS for accelerated approval of CT-P59 (Regdanvimab), COVID-19 antibody treatment. An application for authorization was filed based on the recently ended global phase II clinical trial. CelltrionBased on the clinical results, Celltrion is also starting a procedure for obtaining EUA in the US and Europe. This global clinical phase II was designed through prior consultation with the MFDS the US Food and Drug Administration (FDA), and the European Medicines Agency (EMA). A total of 327 patients from South Korea, Romania, Spain and the United States participated and completed the final medication on November 25th. Celltrion explained, “We have completed the analysis of the detailed data of this clinical trial through domestic and foreign experts and self-evaluation, and have immediately submitted an application for approval because we have determined that we have secured sufficient grounds for applying for accelerated approval from the Ministry of Food and Drug Safety for CT-P59. The MFDS requested that detailed clinical data related to the safety and efficacy of CT-P59 be not disclosed until there is a separate guideline, in view of the recent focus of the public on COVID-19 treatment. Celltrion plans to present the results of this phase II clinical trial in detail at an international conference soon. In addition, based on the results, it plans to quickly enter phase III clinical trials in 10 countries around the world to further verify the safety and efficacy of CT-P59 through a broader patient group. Celltrion is also promoting the overseas Emergency Use Authorization (EUA) procedure of CT-P59. While sharing the data on the results of this phase II clinical trial in detail with the FDA and EMA, consultations on the submission of applications for approval will be initiated, and They will be submitted to most of these countries in January of next year. When responding to inquiries about orders from overseas government agencies, it plans to induce pre-orders while explaining the results of this phase II clinical trial in detail so that domestic supply is possible as soon as possible as soon as EUA is available. An official from Celltrion said, “We are grateful to domestic and foreign health authorities, medical institutions, and participating patients who have actively supported this clinical trial to be completed smoothly as planned. Special thanks are also to the dozens of our employees who have been dedicated to working in the US and Europe.” The MFDS has initiated the CT-P59 permit review process. The MFDS explained, "As Celltrion submitted the application for permission and related data, the approval review began." The submitted data is preliminary reviewed by the high-tech product licensing officer, and then a pre-configured “COVID-19 Vaccine/Therapeutic License Review Team” examines the data necessary for approval, such as non-clinical, clinical, and quality. After that, the review opinions are synthesized to determine the validity of the permit, and the final approval is obtained after consulting the Central Pharmaceutical Affairs Review Committee composed of external experts. The MFDS aims to shorten the existing processing period (180 days or more) and process it within 40 days for the rapid approval and review of COVID-19 vaccine and treatment, including the product for this approval. An official from the MFDS explained, "We will thoroughly verify the safety and effectiveness by using experts in each field and external experts of COVID-19 Vaccine and Treatment License Examination Team so that safe and effective COVID-19 treatment can be used by the public."
- Company
- Who would manufacture Moderna vaccine in South Korea?
- by Kim, Jin-Gu Dec 31, 2020 06:20am
- President Moon Jae-in and Moderna CEO Stephane Bancel reportedly had a conference call over supplying COVID-19 vaccines for 20 million people in South Korea. Now the question is who would sign the consignment production contract for the vaccine in South Korea. The pharmaceutical industry is mentioning four names of potential candidates, including GC Pharma, Hanmi Pharmaceutical, Samsung Biologics and ST Pharm. ◆Cheong Wa Dae “Strengthening collaboration with Korean CMO for the vaccine” On Dec. 29, Cheong Wa Dae stated the South Korean government plans to reach a purchasing agreement over COVID-19 vaccine for 20 million people with Moderna by the end of the year. Compared to the original plan, the number of doses was increased to vaccinate 10 million more people, and the supply schedule was push up from the third quarter to the second quarter. Also the presidential office disclosed the plan to secure Moderna vaccine through consignment production. Cheong Wa Dae spokesperson Kang Min-seok said, “We have agreed to strengthen the cooperation with Moderna by having South Korean company to manufacture the vaccine under consignment contract.” If the government finalizes the supply contract with Moderna, it would resemble that of the AstraZeneca’s vaccine contract. In last July, the government has inked a three-way contract with AstraZeneca and SK Bioscience for the vaccine supply. The pharmaceutical industry predicts GC Pharma, Hanmi Pharmaceutical, Samsung Biologics and ST Pharm would have a chance at it. ◆Top candidates: GC Pharma, Hanmi Pharmaceutical, Samsung Biologics and ST Pharm GC Pharma has been mentioned as a candidate backed by the company’s Ochang manufacturing facility opened in October. The facility has integrated each vaccine facility previously located in Hwasun and Ochang, Jellanam-do. GC Pharma has also signed a facility utilization contract with Coalition for Epidemic Preparedness Innovations (CEPI) in last October. Basically, the Korean company has agreed to manufacture 500 million doses, if a vaccine developer (including Moderna) successfully develops a vaccine supported by CEPI. According to the agreement, the company plans to manufacture COVID-19 vaccine assigned by CEPI from March 2021 to May 2022. CEPI is part of COVAX Facility along with WHO and GAVI. South Korea has signed to receive vaccines for 10 million people through COVAX Facility, but the said doses are not part of the deal the government and Moderna is lately discussing of. Hanmi Pharmaceutical is also on the list of the Moderna vaccine CMO candidates. The company’s Peongtaek Bio Plant can manufacture maximum 1 billion doses of vaccines per year. Two years ago, Hanmi Pharmaceutical has completed constructing a Bio Plant equipped with 20,000 liter of microbial fermentation and biochemical conjugation reaction processors. Apparently, the plant can manufacture 20 million doses of mRNA vaccine in a week. Along with GC Pharma and Hanmi Pharmaceutical, ST Pharm is mentioned as a manufacturer candidate as the company has been consistently preparing for mass production of mRNA vaccine. Since three years ago, the South Korean company forecasted an anticancer vaccine using mRNA mechanism would be promising and started expanding relevant facilities. On Dec. 2, the company opened mRNA Business Development Department directly under the CEO’s command as an expansion of emerging business, and recruited a gene therapy expert Dr. Yang Joo-sung as the department head. Also the company is reinforcing the related facility as well. However, ST Pharm is backed up with other consignment contracts, and it still lacks the capacity to mass produce mRNA vaccine. Another candidate Samsung Biologics has the world’s biggest biopharmaceutical production capacity. The company has already signed consignment production deals with various global pharmaceutical companies for COVID-19 treatments. Regardless of the colossal facility, the company would have to newly establish facility to mass produce mRNA vaccine. A pharmaceutical CMO industry insider noted, “Moderna would likely to license out the technology for the consignment production as the vaccine is already quite close to commercialization. Due to the government’s settlement with Moderna, a multiple companies may handle the production in South Korea.”
