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- 2026-05-18 11:04:05
- Company
- Bayer’s ‘Nubeqa’ can be prescribed at general hospitals
- by Eo, Yun-Ho Oct 28, 2021 05:59am
- The new prostate cancer drug ‘Nubeqa’’ can now be prescribed at general hospitals in Korea. According to industry sources, Bayer’s oral androgen receptor inhibitor for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC), ‘Nubeqa (larotrectinib)’ has recently passed the review of drug committees (DC) in three major hospitals - the Samsung Medical Center, Asan Medical Center, and Gangnam Severance Hospital. Nubeqa is an androgen receptor inhibitor with a distinct chemical structure that binds to the receptor and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells. The drug was approved based on the Phase III ARAMIS study that assessed the safety and efficacy of Nubeqa in combination with androgen deprivation therapy (ADT) compared to ADT alone. Study results demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS) in Nubeqa +ADT, with a median of 40.4 months, compared to the 18.4 months for placebo+ADT. Also, Nubeqa+ADT reduced the risk of death by 31%. Also, the full overall survival (OS) results from the pre-specified final OS analysis of the Phase III ARAMIS trial were published in the New England Journal of Medicine (NEJM) on the 9th. Results showed that Nubeqa+ADT showed a statistically significant improvement in OS compared to placebo plus ADT, with a 31% reduction in risk of death. The results hold significance as the OS improvement was achieved despite 55% of patients that taking placebo received subsequent Nubeqa or other life-prolonging therapy after the trial was unblinded at data cut-off for final analysis (November 15, 2019). Meanwhile, Nubeqa has not been added to the insurance benefit list yet. The drug has been determined inappropriate for reimbursement by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee in February, and the company has supplemented the data and is again undergoing the listing process.
- InterView
- Patients with severe diseases don't really like Mooncare
- by Lee, Jeong-Hwan Oct 28, 2021 05:59am
- Health insurance authorities should recognize that as universal health and welfare increases the coverage of mild diseases, the access to drugs for severely rare and intractable diseases is greatly reduced. It is nonsense that policies to strengthen coverage such as herbal medicine benefits are implemented without economic evaluation today, when there are many serious drugs that cannot be reimbursed due to the adequacy of benefits." This year's parliamentary audit of the National Assembly's Health and Welfare Committee also dealt with the issue of accessibility to patients with ultra-high-priced one-shot treatments, which cost hundreds of millions of won per dose. Technologies for treating severe rare and intractable diseases such as cancer and autoimmune diseases are rapidly developing, but health insurance finances for benefit-applied drugs are not keeping up. On the 27th, Dailypharm met Professor Lee Hyung-ki (57), a professor of clinical pharmacology at Seoul National University Hospital, and asked about the direction of Korea's health insurance benefit system for expensive drugs. Professor Lee Hyung-ki said the so-called "Moon Jae In Care" implemented by the current government is not welcome at all to patients with severe rare and incurable diseases. While it is strict for drugs developed by global pharmaceutical companies or domestic pharmaceutical companies, it is unreasonable to enter the insurance right without any problems. Professor Lee said the government should adopt a selective differential welfare method. The basic direction for the government is to focus on expanding the benefits of ultra-high-priced treatments that are inaccessible even with average or high benefits, leaving treatments or diagnoses for mild diseases that can be spent on average annual income. According to a survey of 787 domestic companies by Job Korea, the annual salary of new college graduates this year is 41.21 million won for large companies and 27.93 million won for small and medium-sized companies. According to the analysis of business reports by each company of the top 100 companies in market capitalization, the average annual salary of employees of large companies is 83.22 million won. In addition, this year's average annual salary for small and medium-sized workers is 28 million won for employees and 57 million won for managers. Professor Lee points out that it takes about two years for one new drug to enter the benefit range, although the government claims to be completing the benefits evaluation about 300 days. Professor Lee said, "In the case of anticancer drugs, it takes about two years to receive health insurance benefits. In this case, pharmaceutical companies that have developed treatments and patients waiting for insurance will suffer from double regulations, he explained. Professor Lee added, "Since we mainly focus on price control, it becomes difficult to be reimbursed and patient difficulties increase." Asked by a reporter if it would be difficult to apply new drug insurance benefits that did not take into account health insurance finances at all, Professor Lee said, "There are too many policies such as herbal medicine benefits to put health insurance finances as a justification." Professor Lee criticizes that health insurance benefits are often made without standards or principles in areas that are difficult to accept from the perspective of new drug development pharmaceutical companies and severely ill patients. Professor Lee said, "The ultra-high-priced drug itself is, in the end, an innovative drug. Patients who have been confirmed to be effective will have an experience of changing their lives and not losing their lives. "Kymriah treatment costs hundreds of millions of won. It is a level that individual patients cannot bear, he pointed out. Professor Lee said, "The national health insurance funding alone will inevitably reach the limit of the medical insurance drug cost support system." Professor Lee said, "It is necessary to consider raising a third fund and financial source. The government should show leadership to expand fiscal sources, he said. Professor Lee also criticized the lack of economic evaluation tools for ultra-high-priced one-shot treatments. There is no additional system other than RSA, and ICER are too low. Professor Lee said, "I understand that the benefit evaluation tool has become more flexible than before. The problem is that health insurance authorities rely only on ICER. In particular, if the standard treatment is already expensive, no matter how innovative the new drug is, accessibility will not increase, he stressed.
- Company
- “Prolia·Evenity drives the osteoporosis treatment market”
- by Oct 28, 2021 05:59am
- Amgen has long been considered the company that has changed the osteoporosis treatment paradigm with potent new drugs. After sweeping over the osteoporosis treatment market with ‘Prolia (denosumab),’ a bone resorption inhibitor, the company then presented a new treatment strategy with ‘Evenity (romosozumab),’ a bone builder with a dual mechanism of action that increases bone formation and inhibits bone resorption. The sequential therapy strategy of using Evenity then Prolia is regarded as the top-priority treatment option in patients at very high risk of fractures. Prolia recorded 75 billion won (based on IQVIA) in domestic sales in just 4 years after its release, and Evenity, which has been rapidly approved for reimbursement, is also settling well in the market. Behind such great success are the hidden efforts of three Amgen Korea’s three PMs in charge of marketing Amgen’s osteoporosis treatments. The PMs Yoochae Park, Ga-eul Lee, and Saim Shin, who have an average of 10 years of experience in the industry, work to make known the importance of treatment to those at high risk of osteoporosis that were left unattended while introducing the effect and treatment strategy of Prolia and Evenity to HCPs. Dailypharm met with the three Amgen Korea PMs that have been driving the growth of Prolia and Evenity to hear about the marketing strategies of the two products and the changing paradigm in osteoporosis treatment. (From the left) PMs Yoochae Park, Ga-eul Lee, Saim Shin in charge of Amgen’s osteoporosis treatments -Could you tell us about your roles in marketing Amgen’s osteoporosis treatments? PM Yoochae Park (hereinafter “Park”)= I joined the marketing team as a PM for Prolia in Januarya last year. My main tasks include strategy establishment, planning, and material production to strengthen Prolia's position as a market leader in osteoporosis treatment. PM Saim Shin (hereinafter “Shin”)= I joined Amgen ahead of Prolia’s launch in 2016 and worked at its sales team until 2019 when I started to work as a PM for Prolia. I am mainly responsible for overall branding activities such as the development of Prolia messages as well as HCP support activities such as symposiums and webinars. PM Ga-eul Lee (Hereinafter “Lee”)=I am a PM for Evenity. I joined Amgen in March last year and prepared for and executed the non-reimbursed launch of Evenity. My marketing activities are similar to those done by the Prolia team, but more focused on branding activities such as message development and market positioning to promote Evenity, as Evenity is still in the early stages of its launch. -Prolia holds a solid position in the osteoporosis treatment market, recording an annual sales of 75 billion won in Korea. What factors do you believe contributed to Prolia's rapid growth? Shin=In the past, an unmet need among HCPs had existed as there had been insufficient clinical grounds to support the need for long-term treatment in osteoporosis. In other words, treatment efficacy, such as the continued reduction in risk of fractures and continuous increase in bone density from long-term treatment, were not established for the long-term treatment. The long-term data of Prolia in the 10-year FREEDOM clinical study demonstrated the drug’s effect in improving bone density and reducing the risk of fractures. The longer-term between treatments, with a single shot every 6 months, had also improved convenience in administration in patients, allowing them to more realistically receive long-term treatments. Such characteristics that differentiated Prolia from other existing treatments for HCPs and patients were the biggest factor that pushed the growth of Prolia. Park=We were able to directly see the patients’ bone health and density improve after being prescribed Prolia. The HCPs prescription experience and trust in our product has allowed for the continuous growth of Prolia. -With Evenity recently approved for reimbursement, there must be a lot on your plate. What are you most focused on for Evenity? There must be some regrets due to the somewhat limited conditions for Evenity’s reimbursement. Lee=The most important activity for us now is to position Evenity to be used as a first-line treatment after fractures. In this regard, we are focusing more on expanding the market for anabolic agents so that patients who have already experienced fractures can prevent additional fractures. Our focus is on delivering the personalized treatment message to more very-high-risk patients so that they can receive the appropriate treatment to prevent osteoporosis fractures, rather than is limited reimbursement -How have HCPs in the field responded to Prolia-Evenity? Shin=The most difficult issue that the HCPs had faced was that patients were unable to receive continuous treatment despite the HCP’s strong will for their treatment. However, the doctors have acknowledged that continued osteoporosis treatment became a lot easier with the introduction of the once-every-6-months injection, Prolia. According to research, the reduction in fracture risk is lessened if the patients miss 1 of the 2 osteoporosis treatments. In this sense, the high medication adherence in Prolia is a great advantage Lee=With expectations also high for Evenity overseas, HCPs in Korea have shown much interest in the therapeutic benefits of Evenity. In this sense, the most feedback I receive is about how much the HCPs expect a good effect. In addition, the continuous treatment rate of Evenity in HCPs who have previous prescription experience has been maintained high. Also, we were able to confirm successful treatment cases where patients were able to act and return to daily life without protective gear only 3-4 months after receiving surgery for their fractures. -Were there any difficulties in switching the previous face-to-face marketing methods to online due to COVId-19? Shin=At first, digitalizing all marketing directions came as a great burden. All the pharmaceutical companies had launched similar online marketing activities in the same period, and we paid special attention to the online materials that we prepare to increase the mail check rate and the number of webinar viewers. As a result, we have hosted the 24th webcast symposium for osteoporosis experts this year, which has been running for 4 years now. An average of 500 HCPs accessed the symposium live in real-time. It was a difficult but rewarding year in which our symposium was recognized for its quality lectures that address the questions made by HCPs on Prolia and Evenity. Park=Switching all our work to online had increased our load, and also brought concern whether the messages that need to be effectively delivered to the HCPs are being sent one-way. In the field, many HCPs seem to have a positive view of online marketing activities. The HCPs immediately check the material online and request additional material, if necessary. We have been better utilizing the advantages of online communication than our initial concerns, and our message and the advantages of our product are being well delivered online. Lee=Evenity was approved for reimbursement after the COVID-19 pandemic, and the launch symposium for the drug was held as a hybrid event, increasing the need for marketing activities in the online environment. Therefore we considered various measures to organically utilize the brochures, emails, and iPad contents on and offline. Due to our continued efforts, we saw high viewer numbers and e-mail checks from HCPs from the start of the launch.
- Company
- Samsung BioLogics' sales surpassed ₩1 trillion
- by Chon, Seung-Hyun Oct 28, 2021 05:58am
- View of Samsung BioLogics Plant 3Samsung BioLogics surpassed 1 trillion won in sales in three quarters. Sales exceeded 1 trillion won in nine years after its establishment last year, and it showed a steeper rise this year. Samsung Biologics announced on the 26th that its operating profit as of the third quarter was 167.4 billion won, up 196.12% from a year earlier. Sales amounted to 408.5 billion won, up 104.02% from the previous year. Both sales and operating profit are the largest ever. It broke new records of sales (412.2 billion won) and operating profit (166.8 billion won) set in the second quarter again in one quarter. Samsung Biologics' cumulative sales in the third quarter amounted to 1.1237 trillion won, up 42.34% from the previous year. Founded in 2010, Samsung Biologics recorded sales of 1.1648 trillion won last year, exceeding 1 trillion won for the first time in nine years. This year, it surpassed 1 trillion won for the second consecutive year in three quarters. The company's cumulative operating profit in the third quarter was 408.5 billion won, up 104.02% from a year earlier. The operating profit ratio to sales reached 36.4%. The company explained, "In the third quarter, sales increased 64% year-on-year due to the rise in the utilization rate of the third plant due to the performance of new product orders, and operating profit increased significantly due to the operating leverage effect of the third plant operation rate." Samsung Biologics is currently operating three biopharmaceutical plants. As the world's largest (180,000 liters) three plants as a single factory were in full operation in October 2018, the volume of consignment contracts is also soaring. Samsung Biologics signed consignment production contracts with global pharmaceutical companies such as Roche and MSD in the third quarter of this year alone, surpassing $7.1 billion in cumulative orders. Samsung Biologics is building its fourth plant with the aim of operating it in 2023. The fourth plant is the largest ever with 256,000 liters of production. When the fourth plant is in operation, Samsung Biologics will secure a total of 618,000 liters of production facilities along with its third plant (3,000 liters of first plant, 152,000 liters of second plant, and 180,000 liters of third plant).
- Policy
- Multinational companies have more drugs for PVA
- by Lee, Hye-Kyung Oct 28, 2021 05:58am
- The NHIS made an official position that it cannot accept the criticism that new domestic drugs are being reversely discriminated within the PVA. After the parliamentary audit of the National Assembly's Health and Welfare Committee on the 15th, The NHIS replied, "It cannot be regarded as reverse discrimination in domestic new drugs," when asked about reverse discrimination by People Power Party lawmaker Lee Jong-sung. For this reason, as a result of analyzing drugs applied more than three times in a row since the reorganization of the PVA system in 2014, seven drugs were included in the case of "Type Ka and Na" and six drugs in the case of "Type Da." However, among them, only six types of drugs (type Da) were domestic, and all of the other drugs (type Da) and seven drugs (type Ka and type Na) were from multinational companies. Eight multinational companies had PV negotiations more than three times in a row. In addition, in the case of items that have been cut more than three times, the price has changed due to drug prices and changes in the alternative drug market. The NHIS selected 14,888 drugs as targets for monitoring drug analysis for negotiations on type Da in April this year. Among them, 14,097 drugs from domestic pharmaceutical companies and 791 drugs from multinational pharmaceutical companies were applied, and the final number of drugs subject to negotiation was 55 (0.39%) from domestic pharmaceutical companies and 4 (0.51%) from multinational pharmaceutical companies. Although domestic new drugs seem to be overwhelmingly subject to PVA negotiations, multinational companies are higher when calculating the ratio selected for negotiation. The NHIS explained, "PVA is a system that cuts the upper limit through drug price negotiations between the NHIS and pharmaceutical companies when drug costs increase to a certain level, and the rate of increase in claims affects insurance finances." The NHIS emphasized, "Drugs subject to continuous drug price cuts through PVA continue to affect finances." Rep. Lee Jong-sung also said in the data, "In the case of multinational history, most of them go through PVA in Type Ka and Na, and most of the domestic pharmaceutical companies in Type Da are applied, so it is understood that there is no reverse discrimination overall." Rep. Lee said, "New drugs developed by multinational pharmaceutical companies and entering the domestic market are also subject to PVA measures, but domestic new drugs seem to have been repeatedly cut by PVA." "The government is creating a structure that cuts prices when sales of drugs that have a positive impact on health insurance finances," he said, urging the promotion of motivation for the development of new domestic drugs. The NHIS said, "There was a preferential policy for new domestic drugs, but the related system was changed due to the Korea-U.S. FTA trade dispute," adding, "As soon as the MOHW comes up with research services on preferential measures for domestic pharmaceutical companies, we will review them."
- Company
- 'Vyndamax' fails reimbursement listing once again
- by Eo, Yun-Ho Oct 27, 2021 05:49am
- The new transthyretin amyloid cardiomyopathy (ATTR-CM) drug, 'Vyndamax,’ is suffering hardships in its process of being listed for insurance benefit. According to industry sources, the application Pfizer Korea submitted for the reimbursement of its new ATTR-CM drug, Vyndamax (tafamidis 61mg), was unable to pass the insurance benefit standard subcommittee. After the company failed to receive designation as an essential drug earlier this year, the company had applied for reimbursement once again through the Risk Sharing Agreement (RSA) scheme. Being deemed inappropriate after submitting data for PE evaluation, reimbursement of Vyndamax is facing difficulties. The problem is that this delay in reimbursement is affecting the patients. ATTR-CM is a fatal condition with a poor treatment outcome due to a lack of specific treatment and is often mistaken for simple heart failure. If not treated properly, patients with ATTR-CM have a survival period of only 2 to 3.5 years. Vyndamax is the only drug that demonstrated its survival benefit in ATTR-CM (ATTR amyloidosis with cardiomyopathy) and is virtually the only drug available as there are no alternatives. The subcommittee’s decision left much room for disappointment as experts have submitted a consistent opinion on the clinical benefit of Vyndamax at the government’s inquiry on the need to apply reimbursement to Vyndamax. Usually, another reason would have to exist for a drug that demonstrated clinical efficacy, has no alternative, and received a positive opinion from the academic society to not pass the insurance benefit standard subcommittee, and for Vyndamax, the reason is assumed to be its fiscal impact. However, separate subcommittees such as the economic evaluation subcommittee and the fiscal impact subcommittee do exist to assess the economic feasibility and fiscal impact of a drug. Therefore, the industry has been voicing complaints about the redundancy of the subcommittee reviews, by the insurance benefit standard subcommittee that is in charge of reviewing the insurance benefit standards conducting assessments on a drug’s fiscal impact. Jungwoo Son, Professor of Cardiology at Wonju Severance Christian Hospital said, “Early diagnosis and continued treatment is important for patients with the progressive ATTR-CM disease. Last year, the domestic ATTR-CM treatment environment has made rapid progress with the approval of Vyndamax, the only drug that provides practical survival benefit to ATTR-CM patients, however, the continued non-reimbursement of the drug has brought on the unfortunate situation where patients cannot start treatment even after being diagnosed.” Son stressed, “The insurance reimbursement system needs to be operated in a flexible manner for drugs like Vyndamax that has clear clinical benefit and no alternatives in consideration of the characteristics of rare diseases so that the patients’ right to treatment is not obscured by economic logic.”
- Policy
- Development of generics for DPP4+SGLT2 has begun
- by Lee, Tak-Sun Oct 27, 2021 05:49am
- The development of generics that combines "DPP-4 Inhibitors" and "SGLT-2 Inhibitors," which are not covered so far, is underway. This is because there are less than two years left until the end of the PMS, which can be approved for generics. Until now, the domestic market for DPP4+SGLT2 complex has not been formed due to benefit issues, but generic companies are also paying attention as benefit issues are recently being discussed. GC Pharma received approval from the MFDS on the 25th for the biological equivalence test plan of GC2123A. The active ingredients are known as Empagliflozin+Linagliptin. Empagliflozin+Linaglipin are the active ingredients of Esglito, which was approved by Beringer Ingelheim Korea in March 2017. Four years have passed since Esglito was granted permission, but it has not yet reimbursed. There are only two years left before the PMS period, when generic license applications are blocked. The PMS period ends in March 2023. Generic development began after March 2023. Currently, the DPP4+SGLT2 complex licensed in Korea is three items, including Esglito, AstraZeneca's Qtern (Dapagliflozin+Saxagliptin) and MSD's Stegluzan (Ertugliflozin+Sitagliptin), all of which are unreimbursed. Qtern also ends PMS in March 2023, and Stegluzan ends in August 2024. They need to solve the benefit issue before the launch of generics to expect market preoccupation. Until now, insurance authorities were conservative about the prescription benefits for diabetes, so only some item combinations were recognized. However, as discussions are underway recently, it is expected that the benefit issue will be solved soon. The MFDS is also improving and applying it so that it can be used in combination between affiliates. DongKoo Bio applied for permission for the Sitagliptin+Dapagliflozin in March. LG Chem is conducting commercial clinical trials for DPP-4 inhibitors Gemigliptin and SGLT-2 inhibitors Dapagliflozin, while Aju is conducting commercialization clinical trials for Linagliptin and Dapagliflozin. Patents for originals are also expected to expire by 2023, so generic development in Korea is expected to become more active.
- Company
- The supply of 8 GSK vaccines will be suspended until Feb
- by Oct 27, 2021 05:49am
- The supply of eight GSK vaccines, including Rotarix, is temporarily suspended, which is expected to disrupt the inoculation schedule. According to the pharmaceutical industry on the 26th, GSK announced a temporary suspension of supply of its vaccines to clinics and hospitals. Discontinued vaccines are ▲Rotarix (Human Rotavirus Live Attenuated), ▲Synflorix (Pneumococcal Vaccine), ▲Menveo, ▲Havrix, ▲Priorix (MMR Vaccine), ▲Boostrix (Tdap Vaccine), and▲Infanrix-IPV, IPV/Hib(DTaP vaccine). GSK said, "Some errors were found in the process of checking the registration details of its vaccines supplied to Korea, so we stopped importing and shipping additional products altogether." And GSK added, "This is a documentary error that does not affect product safety, quality, characteristics, purity, and efficacy, but this measure is expected to disrupt supply." Vaccines suspended from shipment are expected to be released by February next year. All products except Rotarix are included in the NIP. Most alternative generics exist, but some are multiple doses vaccinations and cross-vaccination with other products is not recommended, which is expected to disrupt the inoculation schedule.
- Policy
- Samsung Bio’s Moderna vaccine receives GMP certification
- by Lee, Tak-Sun Oct 27, 2021 05:49am
- The Ministry of Food and Drug Safety issued a Certificate of GMP Compliance for Samsung Biologics manufacturing facility that will be producing Moderna’s COVID-19 vaccine after signing a contract manufacturing agreement with Moderna. With the GMP certification, discussions on the domestic supply of the vaccine are also expected to gain momentum. According to industry officials on the 26th, the Gyeongin Regional Office of Food and Drug Safety issued a Certificate of GMP Compliance of a Manufacturer to Samsung Biologics’ Moderna vaccine manufacturing facility on the previous day. This was in line with what Gang-lip Kim, Minister of Food and Drug Safety, said at the National Assembly audit on the 8th, that “the GMP review will be completed within the month.” However, the GMP certification does not mean that the vaccine will immediately be supplied to the domestic market. A separate marketing authorization needs to be obtained to supply to the domestic market, but Samsung Biologics has not yet applied for the authorization. Still, the vaccine can be released in Korea through the Emergency Use Authorization scheme. Therefore, authorities including the Korea Disease Control and Prevention Agency are expected to discuss granting emergency use authorization to the said vaccine. The MFDS’ GMP certificate provides an advantage in exporting drugs and medical supplies to other countries that joined the Pharmaceutical Inspection Co-operation Scheme (PIC/S), which will speed up overseas registration of the Moderna vaccines manufactured by Samsung Biologics.
- Company
- Celltrion's self-test kit has been approved for EUA
- by Chon, Seung-Hyun Oct 27, 2021 05:49am
- Celltrion announced on the 25th that the COVID-19 antigen rapid self-test kit DiaTrust COVID-19 Ag Home Test, jointly developed with Humasis recently acquired Emergency Use Authorization from the U.S. Food and Drug Administration (FDA). Celltrion received the EUA of Celltrion DiaTrust™ COVID-19 Ag Rapid Test for Professionals from the FDA in April, and the rapid self-test kit was also approved this time. The DiaTrust Home Test conducted clinical trials on 490 patients with COVID-19 symptoms in the United States from March to July, and showed 86.7% and 99.8% accuracy in sensitivity and specificity, respectively. Third-party products that have already been approved by the FDA and are in circulation in the U.S. require consecutive tests that require at least two tests regardless of symptoms. The company explains that this product requires the same continuous itest for asymptomatic patients, but for symptomatic patients, it is possible to check for infection with just one test. This product is available for those aged 14 or older and can be purchased online or offline without a separate prescription. Celltrion is planning to supply DiaTrust Home Test in the U.S. through its subsidiary Celltrion USA. For rapid supply, last-minute consultations are underway with local governments, online distributors, and offline distributors. The home test kits are handled by Humasis, a co-developer. Celltrion won a contract from DLA in the U.S. last month to supply DiaTrust for experts worth up to 738.2 billion won. An official from Celltrion said, "This EUA is based on the high reliability of Celltrion diagnostic kit products, and we will make efforts to prevent the spread of COVID-19 through early supply of products."
