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- 2025-12-26 12:27:07
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- 8th meeting for Keytruda’s 3+ yrs pending reimb. to be held
- by Eo, Yun-Ho May 21, 2021 05:27am
- The cancer immunotherapy drug Keytruda will be up for its 8th deliberation by the Cancer Drug Review Committee. According to industry sources, MSD Korea’s application to expand the reimbursement of ‘Keytruda (pembrolizumab)’ to cover first-line treatment of non-small cell lung cancer (NSCLC) is expected to be put on the agenda for deliberation by the Cancer Drug Review Committee on the 26th. In March, MSD Korea had once again revised and submitted a final cost-sharing proposal to the Health Insurance Review & Assessment Service (HIRA). The reimbursement expansion for Keytruda had been discussed since September 2017, and over 3 years had already passed with no result. The biggest barrier to the reimbursement was the condition that the government set for the reimbursement expansion to companies of immunotherapy drugs, for 'the pharmaceutical companies' to bear the administration cost of the initial 3 cycles.' Roche, which owned ‘Tecentriq(atezolizumab),’ a latecomer to the market, was the only company to accept the government’s condition, and 2 types of PD-1 inhibitors – Keytruda and ‘Opdivo(nivolumab)’ did not accept the condition. Since then, MSD had repeatedly submitted and revised its proposal. The last discussion was held in August last year, during which the decision for the drug was put on hold as the committee believed that MSD Korea’s proposal lacked compromise on the company’s part. In September of the same year, HIRA handed the proposal back to MSD Korea and requested a re-revision. A month later, MSD Korea submitted a re-revised proposal, which was discussed by the reimbursement standard sub-committee meeting but to no avail. The agenda of Keytruda’s reimbursement was not deliberated by the Cancer Drug Review Committee. So, once again, MSD Korea submitted a cost-sharing plan to HIRA. The proposal submitted by MSD this time contains an offer equivalent to the company ‘covering the initial 3 cycles’ worth of administration cost’ by measures including adjusting the reimbursement rate. If this proposal is again deliberated and rejected by the Cancer Drug Review Committee, the possibility of expanding reimbursement of Keytruda may virtually be difficult. An MSD official said, “Although we cannot share details as discussions with the government are still ongoing, we will do our best so that our patients in Korea can promptly receive the global standard-of-care treatment.”
- Company
- ASCO 2021 preview: News drugs from Yuhan, Genexin, and Hanmi
- by An, Kyung-Jin May 21, 2021 05:27am
- ASCO 2019 학회 전경(자료: ASCO) The organizers of the 2021 ASCO Annual Meeting (ASCO 2021) released the accepted abstracts on the 19th (local time), two weeks ahead of the virtual event that will be held next month, from June 4-8. The ASCO meeting is considered one of the most important events for biopharmaceutical companies around the world in introducing the latest clinical data on anticancer drugs. Due to the COVID-19 pandemic, all schedules in the 5-day event, including its keynote lectures, poster sessions, and exhibitions will be held virtually, non-face-to-face, for the second consecutive year. The abstracts of Korean biopharmaceutical companies including Yuhan Corporation, Hanmi Pharmaceutical, MedPacto, and Genexin that have been developing new anticancer drugs have also been unveiled with the pre-release. Whether the long-awaited international event will be able to rekindle investors’ interest in the biopharmaceutical industry is drawing attention. At the event, the multinational pharmaceutical company Janssen will be presenting 2 studies on the combination of its EGFR/cMET dual antibody ‘amivantamab’ and Yuhan Corporation’s new drug ‘Leclaza (lasertinib).’ The abstracts are an update from the Phase 1b CHRYSALIS study that received much attention at the ESMO 2020 Meeting last year. The abstract focuses on the potential of the combination in overcoming the resistance issue of its competitor ‘Tagrisso (osimertinib).’ The study focused on delaying cancer progression through treatment with amivantamab in combination with Leclaza in patients with non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) exon 19 deletion or L858R mutations who have acquired resistance to Tagrisso. The study focused on analyzing the biomarkers while conducting genetic testing through next-generation sequencing (NGS) in circulating tumor DNA (ctDNA) to profile each patient’s tumor. If each patient’s response rate could be predicted in advance, this could maximize the response rate of the amivantamab and Leclaza combination therapy. Results showed that among the 45 patients whose disease had progressed on osimertinib that were administered 240mg of Leclaza and 1050mg or 1400mg of the amivantamab and Leclaza combination, the ORR(objective response rate) was 36% (95% CI, 22–51), with 1 patient showing complete response and 15 showing partial responses. Up to this, the data presented were similar to those presented at the ESMO 2020 last year. However, the investigators additionally presented an analysis of potential biomarkers of response. According to the analysis, 8 out of the 17 patients with EGFR and/or MET-based mutations – which is known to be the cause of resistance to Tagrisso – showed a confirmed tumor response. The median progression-free survival (PFS) of these patients was 6.7 months (3.4months- not reached). However, as some (8 patients) of the 18 patients who had unknown mechanisms of Tagrisso-resistance also showed a partial response to the regimen, grounds for its use as a biomarker was seen to be insufficient. 9 out of 10 Immunohistochemistry (IHC) high patients (90%) showed a high response rate to treatment, but the abstract determined that further investigation is warranted. More progressed data on the study will be shared at the oral abstract session for metastatic non-small cell lung cancer on the 5th, the second day of the meeting. The principal investigator of the Phase III LASER301 trial, Professor Byoung Chul Cho (Director of the Lung cancer center, Yonsei Cancer Center), will be presenting the session. Genexin released an abstract on the interim results of its Phase 2 clinical trial that evaluated the combination of its cervical cancer DNA vaccine 'GX-188E' with Merck(MSD)’s immunotherapy ‘Keytruda(pembrolizumab).’ The abstract contained results of the efficacy group of patients with late-stage recurrent or advanced HPV-positive (HPV-16 or HPV-18) cervical cancer. 5 of the 48 patients had a complete response (CR) where the target lesion completely disappeared, and 10 had a partial response (PR) where the target lesion was reduced by 30% or more. The objective response rate (ORR) was 31.3%. Subanalysis results showed that the ORR of patients with PD-L1 positive, HPV-16, and squamous cell carcinoma was highest, being 48%. The combination therapy showed an improved median PFS of 4.1 months, and OS of 16.7 months compared to Keytruda monotherapy. Most of the patients who experienced adverse events showed grade 1 or 2 adverse events, demonstrating that there were no safety issues concerning to the combination therapy. The details of the GX-188E and Keytruda combination will be introduced at the oral abstract session on the first day of the ASCO meeting, on the 4th (local time). MedPacto released the Phase 1b/2a trial results of ‘vactosertib’ (capecitabine)’ combined with ‘Keytruda’ in microsatellite stable (MSS) metastatic colorectal cancer (mCRC) patients. According to the abstract, 5 of the 33 patients enrolled in the trial reached PR, and the ORR was 15.2%. 7 patients had stable disease where the tumor did not grow further. Industry has seen that the study fully demonstrated the potential of vactosertib as a combination option in MSS mCRC as the response rate of Keytruda monotherapy is near 0% for the disease. Further clinical data on more patients and the OS data and doses will also be released in the final poster that will be released on the 4th (local time). Hanmi Pharmaceutical has released the latest update on ‘belvarafenib,’ which was licensed to Genentech. The results are from a Phase I trial of belvarafenib in combination with cobimetinib in patients with BRAF- and NRAS-mutant melanoma. The abstract shows further progress that had been made since the last presentation at the 2019 ASCO meeting. According to the abstract, 5 of the 13 NRAS-mutant melanoma patients reached PR, giving an ORR of 38.5%. Currently, no approved standard of care exists for NRAS-mutant melanoma. According to clinicaltrials.gov, a clinical trial registration website operated by the U.S. National Institute of Health (NIH), Genentech had recently registered a new global Phase I clinical trial on belvarafenib. The Phase 1b study will evaluate the safety, pharmacokinetics, and activity of belvarafenib as a single agent and in combination with either ‘Cotelic (cobimetinib) or Cotelic plus ‘Tecentriq (atezolizumab)’ in patients with NRAS-mutant advanced melanoma who have previously received anti-PD-1/PD-L1 therapy. As this is the first clinical trial initiated for a belvarfenib combination therapy by Genetech in 5 years since singing the technology transfer deal with Hanmi Pharmaceutical, concerns over the deal cancellation have been said to be resolved. Analysts predict that if the three-dug combo including belvarafenib shows a superior response rate over ‘Zelboraf,’ the new drug’s value may increase additionally.
- Company
- Tylenol is in short supply for a long time
- by Kim, Jin-Gu May 21, 2021 05:26am
- Along with the issue of side effects of COVID-19 vaccines in pharmacies, the shortage of Tylenol is intensifying. Domestic companies with generic products are expecting reflective profits. Several companies are said to have started marketing related to Tylenol shortages so that they can lead to increased sales of other generics of acetaminophen. Tylenol According to the pharmaceutical industry on the 14th, Tylenol has become more scarce in outpatient pharmacies over the past month. In the case of Tylenol and Tylenol 8-hour ER, it is confirmed that they are completely out of stock at online malls exclusively for major pharmacies. Analysts say that the issue of side effects of COVID-19 vaccine and the government's guidance have caused a shortage. As the number of people vaccinated against COVID-19 increased, the side effects of fever and muscle pain increased, and more people wanted to buy Tylenol. In addition, the quarantine authorities guided, "If fever occurs after vaccination, it is recommended to take fever reducer such as Tylenol," and most pharmacies are now unable to find Tylenol. Pharmacists are recommending generic products instead of original Tylenol. A pharmacist who runs a pharmacy in Seoul said, "The number of people looking for Tylenol has more than doubled than usual," adding, "We recommend generics because Tylenol is not available." "If the number of people vaccinated against COVID-19 increases in the future, sales of generic products will increase." Another pharmacist in Daejeon said, "We're barely getting Tylenol. I think it's been about a month. Wholesale stores offer limited supplies to each pharmacy. If generics are recommended, one to two out of 10 people buy the drug." As the shortage of Tylenol intensifies, its effects are gradually expanding to other generics. Sales of Samjin's Geworin, Jong Kun Dang's PENZAL-Q, Dong-A's Panpyrin, and Daewoong's EZN6 Ace, which include the same ingredients as Tylenol, are reportedly increasing little by little. Geworin Cooldown Korean companies are also starting related marketing in line with this trend. Emphasizing that it is the generics for those who have not obtained Tylenol, it is necessary to prepare for the possibility of side effects after vaccination. In the case of Geworin, sales volume is said to have increased slightly last month due to the issue of side effects of vaccines. "We are pushing for Geworin Cooldown as a product to prepare for side effects of the vaccine," said a representative for Samjin. "It is true that sales have increased compared to the past." "In the case of Geworin Cooldown, the number of new businesses is increasing just after its release. "We understand the impact of this, the issue of side effects of vaccines, and the result of marketing." An official from Dong-A said, "Panpyrin's sales have increased a little compared to last year," adding, "However, it is too much to blame only the issue of side effects of vaccines." "It's Acetaminophen, but it's more widely known as a cold medicine than a pain reliever. "In case of PENZAL, there is little change in sales compared to the past," said a representative for Chong Kun Dang. "There is a possibility that sales will increase as the number of people vaccinated against COVID-19 increases."
- Company
- Zopista for insomnia to be prescribed at general hospitals
- by Eo, Yun-Ho May 20, 2021 05:56am
- The insomnia treatment ‘Zopista,’ which can be prescribed long-term, is now cleared for prescription at general hospitals. According to industry officials, Huons’ Zopista(eszopiclone) passed the Drug Committees (DCs) of the Big-5s - Seoul National University Hospital (SNUH), Asan Medical Center (AMC), Seoul St. Mary’s Hospital, Samsung Medical Center (SMC), and Severance Hospital – and many other major medical institutions in the nation. Zopista was first introduced in Korea along with its reimbursement approval in November 2019. However, as the drug has been prescribed in the U.S. since 2004, its generics have also soon entered the Korean market, expanding the competition. With no domestic patent or Post Market Surveillance (PMS) period set for the drug, there was no way for the company to deter or block the entrance of its generics. However, with Huons successfully landing its product in general hospitals, whether Zolpidem can maintain its share in the market as the leading product remains to be seen. Contrary to other existing insomnia treatments like ‘Zolpidem,’ Zopista can be used long-term. In case of Zolpidem, its long-term use is not recommended, and the treatment period is regulated to not exceed 4 weeks. However, according to a survey by the Health Insurance Review and Assessment Service, insomnia is a common condition that 1 out of 3 adults in Korea experience, with its market rapidly growing as the number of insomnia patients rose 48.3% from 2013 to 2017. Considering that a relatively small number of patients currently receive treatment for insomnia due to low recognition of the disease, the potential for growth in the market is high.
- Company
- Piqray has been released in Korea
- by May 20, 2021 05:56am
- The first new drug targeting the PIK3 gene in breast cancer has been released in Korea. The MFDS approved Piqray (Alpelisib/50·150·200 mg' by Novartis on the 13th. Piqray is HR- (+)/HER2 (-) and may be combined with the endocrine treatment Faslodex (Fulvestrant) in postmenopausal women and men with progressive or metastatic breast cancer. PIK3CA positive diagnostic tests are evaluated using in vitro diagnostic medical devices licensed by the MFDS. It is the first domestic PIK3 inhibitor. It also obtained permission from the U.S. and Europe in May 2019 and July 2020, respectively. PIK3CA genetic variation is known to be a common pattern in about 40% of patients with HR+/HER2- breast cancer. Sporadic genetic mutations can mutate independently of family history. If PIK3CA mutations are latent, they can lead to cancer proliferation as well as resistance to endocrine therapy and poor prognosis. In a three-phase SOLAR-1 study conducted by Novartis, Piqray and Fulvestrant combined therapy approximately doubled the primary evaluation variable, Progressive Survival Period (PFS). The median survival period for the combined therapy group was 11.0 months and 5.7 months for the sole therapy group. Overall response rate (ORR), an indicator of the proportion of patients who experience at least a 30% reduction in overall tumor size (in patients with measurable disease), was more than doubled when Piqray was added to Fulvestrant in patients with a PIK3CA mutation, (ORR= 35.7% vs 16.2% for fulvestrant alone, p=0.0002). There was a clinically relevant improvement in OS of eight months for patients with a PIK3CA mutation taking Piqray plus Fulvestrant compared to Fulvestrant alone (median OS 39.3 months vs. 31.4 months). This difference did not reach the prespecified threshold of statistical significance set for the secondary objective of OS in patients with PIK3CA-mutated breast cancer. In terms of safety, most of them were mildly reactive, which can be managed by dose control, and the rate that led to discontinuation of medication was similar to that of the sole therapy group. However, during the administration period, patients may experience severe skin irritation due to drugs, which requires management. The MFDS recommended that Piqray be stopped if the skin is more than 30% toxic to the body surface. As the first PIK3CA-targeted treatment that can meet unmet demand has crossed the licensing threshold, attention is expected to be focused on whether to be reimbursed for combined therapy.
- Company
- IQVIA acquires Korean healthcare marketing firm MMK
- by Eo, Yun-Ho May 18, 2021 05:52am
- The healthcare big data company IQVIA has acquired MMK Communications. Industry sources said that IQVIA Korea had completed the merger and acquisition of MMK communications, expanding its business area to digital consulting services. MMK Communications is a company that provides digital detailing services including webinars and call center medication counseling services with nurses. It has been providing customized services in the COVID-19 pandemic during which the need for non-face-to-face communication had been rising. Through the M&A, IQVIA plans to transform into a comprehensive healthcare service provider that offers a wide range of services from Contract Research Organization (CRO) to healthcare data analytics. In 2019, the company had acquired CoreZetta, a firm that analyzes big data provided by the Health Insurance Review and Assessment Service (HIRA). After a merger between IMS Health and Quintiles, the company adopted the new name of IQVIA in 2017. Powered by IQVIA CORE, IQVIA provides customized solutions for its clients leveraging the world’s largest curated healthcare information source, advanced analytics, leading technologies, and extensive industry knowledge across diseases, geographies, and scientific methods.
- Company
- 11 companies join the use patent for Entresto
- by Kim, Jin-Gu May 18, 2021 05:51am
- EntrestoWhile Hanmi filed an invalidation trial with Entresto's use patent and composition patent, 11 companies, including Daewoong and Chong Kun Dang, filed for the same judgment. According to the pharmaceutical industry on the 13th, 10 companies including Chong Kun Dang, Yooyoung, Hanlim, Hana, Ahn-gook, Boryung, Yuyu, Genuonesciences, Kolmar, and Samjin filed an invitation trial for Novartis' heart failure drug Entresto patent on the 12th. Daewoong filed a request for the same judgment on the 30th of last month. As a result, a total of 12 companies are challenging Entresto's use patent and composition patent. Analysts say that the fact that Korean companies filed for the validation trial on the same day is related to generic exclusivity. It is intended to meet 'request of first trial', one of the requirements for obtaining generic exclusivity. Under the current regulations, if a particular company claims the same judgment within 14 days of the first trial, it is considered to have achieved the request of first trial requirement. Hanmi filed an invitation trial with generic exclusivity on the 29th of last month. This patent is known to be the most difficult to overcome among the four patents registered as generic exclusivity. Patents registered as generic exclusivity include ▲ use patent and composition patent, which expires in July 2027, ▲ composition patent, which expires in September 2027, ▲composition patent, which expires in November 2028, ▲ and composition patent, which expires in January 2029 etc. Entresto is a heart failure treatment with Valsartan, an ARB-based hypertension treatment, and Sacubitril, another NEP inhibitor. With each patent expired, Novartis conducted a clinical trial by combining the two ingredients and was approved as a treatment for heart failure. 20 companies, including Elyson, filed a passive trial to confirm the scope of their rights on a crystalline patent that expires in September 2027. This includes 12 companies that challenged use patent and composition patent, including Hanmi. If 12 additional companies, including Hanmi, overcome the patent, they can receive generic exclusivity on the assumption that they meet the requirements for applying for the initial item permit and enjoy generic exclusivity for nine months regardless of Elyson's success. The remaining three patents need to be overcome, but they are relatively easy to overcome and are expected to be less burdensome. Since its launch in Korea in October 2017, Entresto's prescription sales have been increasing rapidly. According to UBIST, a pharmaceutical market research firm, Entresto's prescription sales were ₩6.3 billion in 2018, the first year of its release. Last year's sales more than tripled to ₩20.3 billion in two years. Prescription sales in the first quarter of this year are ₩5.8 billion, the highest quarterly prescription amount ever.
- Company
- Negotiations on the drug price of Onivyde have begun
- by Eo, Yun-Ho May 14, 2021 05:50am
- The new pancreatic cancer drug "Onivyde" is in the final stages of listing insurance benefits. According to related industries, Servier Korea has recently entered pharmaceutical negotiations with the NHIS for the registration of Onivyde (Irinotecan HCl) under the order of the MOHW. As a result, attention is being paid to whether a new insurance benefit application drug can be created in the area of pancreatic cancer, which does not have many treatments. Onivyde's application for benefits, which passed the HIRA's Pharmaceutical Benefits Advisory Committee on the 8th of last month, was approved. It is a combination of 5-FU/LV and secondary treatment in patients who fail Gemcitabine based primary care. Through a global multi-organ three-phase clinical NAPOLI-1 study, Onivyde significantly improved treatment performance in combination with the existing secondary treatment option 5-FU/LV in patients who failed to receive Gemcitabine-based primary care. Yoo Chang-hoon, a professor of oncology at Asan Medical Center in Seoul, said, "We currently talk a lot about secondary and tertiary drugs with a considerable number of pancreatic cancer patients. Since benefits are not applied, we will also examine whether there is an Indemnity Health Insurance Plan. "Onivyde has global phase 3, Asian data, and Korean RWE, but it's a pity that benefits are not yet applied." Leclaza (Lazertinib), the third-generation epithelial cell growth factor receptor (EGFR) of Yuhan, which passed the Pharmaceutical Benefits Advisory Committee with Onivyde, is also under drug negotiation. Considering the negotiation deadline, it is expected that the registration of both drugs will be decided between June and July.
- Company
- Will Lipitor Plus be able to continue Lipitor’s legacy?
- by Eo, Yun-Ho May 13, 2021 05:57am
- Whether Viatris Korea, which owns the original atorvastatin ‘Lipitor,’ will be able to perform as well in the ‘ezetimibe’ combination therapy market, is drawing attention. Recently, the use of combination therapy in dyslipidemia patients has become more than a strategic treatment option - it has become a main trend in the market. In line with the trend, Viatris Korea, which has been leading the dyslipidemia treatment market with its ‘Lipitor(atorvastatin), and Jeil Pharmaceutical have jointly launched ‘Lipitor Plus,' a combination drug that contains atorvastatin and ezetimibe. With many combination therapies containing the same substances already in the market, whether Lipitor Plus will be able to continue on the original Lipitor’s legacy remains to be seen. The combination market, which is represented by MSD’s ‘Atozet,' is expected to have over 100 competitors fighting for a share of the pie. Viatris Korea’s strategy is to penetrate the market with the brand power of its Lipitor and by highlighting their use of the original API. In the case of Atozet, the drug is a combination of original ezetimibe and generic atorvastatin. As Lipitor Plus on the other hand uses Lipitor’s original API atorvastatin, these differences will be actively used in the promotion of Lipitor Plus. In addition, Lipitor Plus was approved at a lower price than Atozet under the new tiered pricing system. As a result, Lipitor Plus has a lower price than other therapies despite its use of the original API. An official from Viatris Korea said, “We also improved drug compliance of our patients by reducing the tablet size. For patients with chronic diseases who have to take multiple drugs, this can also work as an edge over other drugs.” An official from the company added, “The release of the combination drug Lipitor Plus in addition to our Lipitor hold significance as it completes our Lipitor lineup that covers both first-line statin therapy and second-line statin+ezetimibe therapy options recommended by major dyslipidemia treatment guidelines in Korea and around the globe.” Viatris Korea is the Korean subsidiary of the Viatris Group that was launched in November 2020 through a merger between Global Pfizer’s business division Upjohn and the global healthcare company Mylan. The company changed its name to Viatris Korea in February.
- Company
- Which company signed the CMO deal? Rumors rampant
- by Kim, Jin-Gu May 13, 2021 05:57am
- Rumors on CMO production of COVID-19 vaccines by domestic companies continue. Rumors are rife on which company would be producing which vaccine. Repeatedly, a specific company is mentioned by some, then the rumor is denied by that company. On the 12th, Samsung Biologics publically announced that the reports that it will produce Pfizer’s COVID-19 vaccine through a CMO deal are “not true.” Earlier that day, a media had quoted a high-level government official to report that Samsung Biologics will be producing Pfizer’s COVID-19 vaccine from coming August under a CMO deal. According to the report, Samsung Biologics was revamping production lines at its Incheon Songdo plant to produce up to 1 billion doses of the vaccine per year. Samsung Biologics immediately drew the line. Through a public announcement on clarification of the rumors and reports, the company said that the reports were “not true.” Despite the company’s denial, the rumors have not ceased to exist. After Samsung Biologics publicly denied the report, another media reported that ‘Samsung Biologics is in discussions about producing Pfizer’s vaccine under a CMO deal.’ Only the wording had changed, from ‘signed a CMO deal,’ to ‘discussing a CMO deal,' with its context still intact. Regarding the issue, Pfizer Korea’s position is the same as Samsung Biologic’s. An official from Pfizer Korea said that “(The CMO deal) is not true.” ◆Rumors rife after the government’s announcement of a “domestic CMO producing vaccines in August” The unceasing rumors about COVID-19 vaccine production by domestic companies have been on the increase since the government made the remark of a ‘Korean CMO’s production of COVID-19 vaccines from August.” On the 15th of last month, Young-Ha Baek, head of vaccine procurement at the pan-government vaccine procurement task force, said that “A Korean pharmaceutical company is currently working on a contract manufacturing organization (CMO) deal to produce a COVID-19 vaccine that has been developed abroad. The vaccine will be manufactured in Korea from August.” The remark had aroused a great amount of interest. The report also coincided with Moderna’s announcement of its plan to establish a Korean subsidiary. This immediately brought up several companies as potential candidates. Among the companies, ST Pharm received the most attention. The rumor gained strength as the company had been working to develop an mRNA technology of its own since last year. ST Pharm denied the rumors, however still, this led to an incident where the stock prices of ST Pharm and other mRNA R&D companies surged. The next day, speculations on whether the company and vaccine mentioned by the government were Huons and the Russian vaccine Sputnik V rose as Huons Global announced that it had formed a consortium with Prestige Biopharma, Humedix, etc. and signed a technology transfer deal to produce the global supply of the Sputnik V vaccine. As the rumor spread as if it was an established fact, the government stepped up to correct the rumor. Young-rae Son, director of the Central Disaster Management Headquarters (CDMH) strategy and planning team said, “We cannot disclose which vaccine was commissioned for production, but it is not Sputnik V.” On April 16th, Young-rae Son, director of the Central Disaster Management Headquarters (CDMH) strategy and planning team, is explaining that the commissioned vaccine to be developed in August is not Sputnik V. And earlier this month, Moderna’s progress in establishing its Korean subsidiary once again stirred up rumors on the CMO production of vaccines in August. Officials from Moderna had visited a Korean pharmaceutical company prior to the establishment of its subsidiary, which gave leeway for speculations on which companies may be candidates of the CMO deal. More recently, not Moerna’s or Pfizer’s, but another vaccine also entered the discussion. This new vaccine was jointly produced by GSK and CureVac. CureVac had submitted an application for the authorization of its mRNA vaccine to the European Medicine Agency (EMA) after completing the Phase III trial. With the approval of a third mRNA vaccine imminent in Europe, some had raised the prospect that this vaccine is the one that will be produced under a CMO deal in Korea. However, whether speculations on CureVac’s production in Korea is true or not has not been determined yet. An industry official said, “You hear rumors about the CMO deal all day. Investors are immensely interested in which company will be producing the COVID-19 vaccines. As the rumors started due to the government’s announcement, I believe the government needs to sort out its position to some extent, to reduce confusion."
