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- 2026-03-16 23:45:11
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- Moderna to soon release bivalent COVID-19 vaccine
- by Jul 20, 2022 05:49am
- Moderna is determined to promptly commercialize its new bivalent COVID-19 vaccine “mRNA-1273.214 (214)” in Korea. On the morning of the 19th, Moderna held a “Moderna’s mRNA technology and strategy in the endemic era” press conference at JW Mariott Hotel. At the conference, the company stated that it can “supply the 214 globally by the end of August, and plans to submit data for its approval in a few days.” (From the left) Hee Soo Kim, Medical Director at Moderna Korea; Paul Burton, Chief Medical Officer at Moderna Global ; Ji-Young Sohn, General Manager of Moderna Korea; Francesca Ceddia, Senior Vice President of Respiratory Vaccines at Moderna Global The 214 that was developed by Moderna combines a vaccine that targets the original strain and the Omicron variant BA.1. The vaccine achieved superior neutralizing geometric mean titer ratio (GMR) over the current vaccine against the original virus as well as Omicron subvariants BA.4/5. Specifically, GMR of the 214 was 1.24 against the original virus, and 1.78 against BA.1. The GMR against BA 4/5 was relatively lower at 1.68. Even so, Moderna explained that this demonstrates a superior protective effect compared to the current vaccine. Francesca Ceddia, Senior Vice President of Respiratory Vaccines at Moderna Global, said, “ A GMR of 1 or higher means it has a superior effect over its comparator. In this sense, the 214 has demonstrated a superior effect against BA.4/5. We plan to submit data for its approval to the Ministry of Food and Drug Safety, and will work closely with the regulatory authorities to supply our vaccine by end of August.” However, one obstacle that remains to its use is the FDA’s position. The US FDA had recently requested vaccine manufacturers Moderna and Pfizer to add omicron BA.4/5 spike protein component to the current vaccine composition in the development of their vaccine combos. In consideration of the additional time required for clinical trials, the FDA also emphasized that it will accept animal testing data for approval. Moderna’s position is that its bivalent vaccine, the 214, also shows superior effect against Omicron compared to the current vaccine and should be first administered. The company referred to how other countries and the World Health Organization requested the company to add a BA.1 component to the company’s bivalent vaccine. SVP Ceddia explained, “Moderna is working to take into account the different requests made by each country. The important matter is that our bivalent vaccine is an effective solution. If supplied, the 214 will also provide protection against the BA.4/5 subvariants." Ji-Young Sohn, General Manager of Moderna Korea, said, “The MFDS is also known to be positively reviewing 214. I believe it is important to receive vaccination with a certain vaccine at a certain period according to virus variants. Therefore, rather than waiting several more months for the release of a vaccine against BA.4/5, it would be more beneficial to use a readily available vaccine and protect public health.”
- Company
- Big Pharma are making all efforts to preoccupy orphan drugs
- by Jul 20, 2022 05:49am
- New drugs are emerging one after another for rare diseases such as multiple Castleman's disease, beta thalassemia, Fabri's disease, and spinal muscular dystrophy, which were not well known and had no medicine. Global pharmaceutical companies such as Johnson & Johnson, AstraZeneca, and Roche are leading new drugs for rare diseases. It was suggested that Korea should also provide institutional support and active development in the rare disease market dominated by global companies. ◆ Global company focused on rare drugs. 26% of total sales in 2026 According to the "Global Rare Disease Market Research Report" published by KIMCo, the global orphan drugs market is expected to grow by 12% annually, and sales of orphan drugs are expected to account for 20% of the total prescription drug market by 2026. Global Big Pharma is aggressively dominating the market through active technology transfer and mergers and acquisitions. In fact, the M&A case of a global pharmaceutical bio company in the first half of this year also reveals the high interest of Big Pharma in rare diseases. Pfizer acquired Biohaven, a developer specializing in treatments for rare nervous system diseases, for $11.6 billion. It is the largest deal in the first half of this year. GSK and UCB also spent $1.9 billion each to buy biotechs that developed treatments for rare cancers and rare epilepsy. Last year, AstraZeneca spent $39 billion to acquire Biotech Alexion, which specializes in treating rare diseases. It is predicted that 79% of the global new drug pipeline currently being developed is rare drugs, and the trend of global new drug development in the future will focus on more rare drugs. It is predicted that sales of rare drugs will reach an average of 26% of Big Pharma's total sales in 2026. ◆"Korea Has Less Development and Poor Support. Development strategies for orphan drugs" Behind the global big Pharma's rush to turn to rare diseases is the policies of major countries that give strong benefits to the development of orphan drugs. The U.S. Food and Drug Administration (FDA) provides up to 50% of tax benefits for R&D costs for new drugs designated as orphan drugs. It also advises on the design of subsidies and protocols for clinical development and exempts for orphan drugs for application for examination. If a new drug is commercialized, the exclusive right period will also be given seven years, two years longer than five years of general new drugs. This year, it also established a priority review for orphan drugs. Europe also has tax benefits for orphan drugs, exemption from examination application fees, and priority review systems. Monopoly rights can be granted up to 10 years from the date of marketing authorization, and the monopoly period is set through re-evaluation five years after marketing. Tax benefits are given from the development stage and various incentives such as priority review, post-marketing monopoly rights, and extension of item permits can help pharmaceutical companies secure growth engines in the long run. Global Big Pharma is taking a strategy to maximize drug sales by continuously expanding the indication of non-rare diseases after entering the market after phase 2 with an orphan drug designation and rapid screening program. Korea has implemented the Rare Disease Control Act since 2017, relatively late, and has prepared a legal basis for incentives for orphan drugs. Under this law, orphan drugs are given a 10-year validity period. In addition, the priority review system can be applied to orphan drugs, and fees will be reduced. The exclusive right shall be granted for four years from the date of marketing authorization. Some point out that the domestic benefit policy for orphan drugs, which are relatively expensive, is still insufficient. At the "policy debate to improve the environment of pediatric rare diseases" held at the National Assembly on the 13th, Professor Lee Bum-hee of AMC argued that orphan drugs designated by the Ministry of Food and Drug Safety and rare disease treatments are separated. Professor Lee Bum-hee pointed out that even if a new drug is developed successfully, the market will not be able to be activated unless an environment that can be used properly is supported.
- Company
- Maximizing JW Pharma's platform technology
- by Chon, Seung-Hyun Jul 20, 2022 05:48am
- JW Group is implementing an active open innovation strategy to maximize R&D capabilities. In order to boost the potential of two core platform technologies developed by themselves, they are mobilizing all resources that can be utilized from domestic bio ventures to overseas investment institutions. According to industries on the 13th, JW Group signed a business agreement with ARCH Venture Partners, a U.S. venture capital (VC). ARCH Venture Partners is the largest venture capital in the United States that invests in companies with early innovative technologies in the healthcare field. It is recognized for commercializing technologies developed by academic institutions, corporate research institutes, and national research institutes, and is investing in companies jointly established by major scientists and entrepreneurs to showcase innovations in life and physical science to the market. JW Group will be provided with the ARCH technical service program under this business agreement. ATS provides promising biotech and technical information selected by ARCH Venture Partners to strategic investors interested in business cooperation with venture companies around the world. This is the first time for a domestic pharmaceutical company to work together with a VC specializing in bio and healthcare in the U.S. for open innovation in the field of discovery stage. The reason why JW Group joined hands with ARCH Venture Partners is to maximize its own platform technology. JW Group is currently operating a new drug development program using two platform technologies, JWELRY and CLOVER. Its goal is to discover new targets that can increase the utilization of these platform technologies by utilizing ARCH Venture Partners' ATS program. Both JWELRY and CLOVER are big data platforms based on chemical and bioinformatics built by JW Pharmaceutical. JWELRY is a platform that distinguishes between activity and inhibition of Wnt signals. Wnt signaling pathways are preserved across all species, from nematodes and fruit flies to mammals, and play an essential role in cell proliferation or differentiation, animal organ development, and morphogenesis. Although the Wnt signaling pathway is involved in many diseases, there are no new drugs involved in this pathway so far. It is developing a treatment for hair loss (JW0061). The blood cancer and stomach cancer treatment (CWP291), developed based on the Wnt platform, is undergoing phase 1 clinical trials worldwide. New drugs are also being developed in the field of immune disease and tissue regeneration. CLOVER is a big data platform that accumulates cancer cell lines, tissues, genetic information and compounds, as well as pharmacological efficacy prediction data. CLOVER, which is capable of deriving low-molecular substances that inhibit or activate STAT signals, is evaluated as a platform capable of overall performance of mechanical and biomarker studies. STAT is an essential signaling system that regulates cell growth, mutation, proliferation, differentiation, and apoptosis. Abnormal STAT signals can cause various diseases affecting the skin, cancer, and immune system. JW Pharma has discovered more than 10 species through CLOVER so far. Among them, atopic dermatitis treatment (JW1601), gout treatment (URC102), and solid cancer treatment (JW2286) have entered the clinical stage. In addition, atopic dermatitis treatment and gout treatment were exported to global companies, respectively. JW Pharma signed a technology export contract with Leo Pharma in August 2018 for JW1601, an atopic dermatitis treatment. The total amount of contracts, including 17 million dollars in down payment, is 402 million dollars. In August 2019, Nanjing Simcere Dongyuan Pharmaceutical signed a technology export contract for the gout treatment URC102. The down payment is $5 million and the total down payment is $70 million. JW Pharma is expanding joint research with domestic bio companies to maximize the potential of its own new drug development technology. JW Pharma signed a joint research contract with bio-venture ILIAS Biologics last month. It is about developing a target type exosome treatment equipped with a low-molecular anticancer drug. The contract aims to develop a global innovative new drug that applies ILIAS's own exosome platform technology to low-molecular anticancer new drug candidates secured by JW Pharmaceutical. Earlier, JW Pharmaceutical also signed a joint research cooperation contract with Voronoi, SyntekaBio, Oncocross, and Organoidscience. The study with Voronoi is a method of applying Voronoi's (PROTAC; Proteolysis-targeting chimera) technology to JW Pharm's STAT3 target low-molecular anticancer drug candidates. PROTAC is a new drug development platform that removes target proteins using the in vivo proteolysis system. During the development process, Voronoi is in charge of designing compounds, synthesizing them, and deriving clinical candidate materials, while JW Pharm is in charge of intermediate clinical research including candidate material evaluation. SyntekaBio and Oncocross are pushing to develop new drugs using AI. JW Pharma has been discovering candidate materials for innovative new drugs for SyntekaBio and specific protein targets since last year. It is jointly planning innovative new drug tasks that work on specific proteins and speeding up the discovery of innovative new drug candidates with DeepMatcher, an AI platform owned by SyntekaBio, and drug 3D simulation technology. Since March, JW Pharma has been exploring new indications of new drug candidates and existing drugs with Oncocross and verifying the possibility of development. Oncocross has a RAPTOR AI platform. RAPTOR AI is an R&D platform that screens for optimal indications for new drug candidates or previously developed drugs, increasing the probability of clinical success and shortening the development period. In May, it signed a joint research contract with Organoids. It builds an R&D platform that makes Organoid's genomic information into DB. Organoid develops an organoid model using tissue samples from patients, and JW Pharma is responsible for decoding the genes of the organoid model and building a platform that accumulates the information. JW Pharma's R&D investment is also increasing. JW Pharma estimated this year's R&D investment cost at 85 billion won, up 65.7% from last year.
- Company
- Novartis nears reimb for its 2 ultra-high-priced new drugs
- by Eo, Yun-Ho Jul 19, 2022 05:16am
- With Novartis Korea nearing reimbursement listing for its 2 ultra high-priced drugs, how the two drugs will progress is receiving attention. The two Novartis drugs that have continuously raised issues since its domestic approval are ‘Kymriah (tisagenlecleucel) and Zolgensma (onasemnogene abeparvovec-xioi). Among the two drugs, Kymirah was first listed for reimbursement in April, and the drug pricing negotiations with the National Health Insurance Service for Zolgensma were also completed recently. When Zolgensma passes deliberation by the Health Insurance Policy Deliberation Committee (HIPDC), the drug will also be applied the prior approval system like Kymriah. If approved, it will be the first time in the history of Korea’s insurance reimbursement system that two drugs were consecutively applied the prior approval system for reimbursement benefit. The reimbursement process for the drugs was far from smooth. And when considering the long wait endured by the patients, it wasn’t even that ‘quick.’ However still, given the unprecedented cost of administration and the immense fiscal investment required, as well as its ‘one-shot’ concept, the results achieved by the two drugs are quite encouraging. The gov't and pharmaceutical companies’ rapid response shone through for Kymriah The reimbursement of the ultra-high-priced one-shot CAR-T new drug Kymirah was made possible through the combined efforts of the government, pharmaceutical companies, and patients. Kymriah is indicated for the treatment of ▲ adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) after two or more lines of systemic therapy, and ▲pediatric and young adult patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (B-ALL) that is refractory or in second or later relapse. The company had submitted a reimbursement application for both indications. The drug started its reimbursement listing process after it was approved by the Ministry of Food and Drug Safety in March last year through the ‘approval-reimbursement review linkage system.’ Six months later, Kymriah was first put up as an agenda for NHIS’s Cancer Disease Deliberation Committee (CDDC) review, but the committee deferred its decision. Immediately upon news of the deferral, the Korea Leukemia Patients Organization among others strongly criticized the government and the pharmaceutical company. The KLPO had before criticized the authorities over the delay in Kymriah’s agenda being put up for deliberation by the CDDC. In the end, Kymriah’s reimbursement agenda passed the CDDC review in October of the same year. This was also the first day HIRA disclosed the results of CDDC deliberations to the public. Also, Kymriah's reimbursement agenda passed the first Drug Reimbursement Evaluation Committee (DREC) meeting held in 2022. After then, the company successfully completed drug pricing negotiations and officially listed Kymriah for insurance benefit in April. Slower but fast enough results derived for 'Zolgensma' reimbursement The progress made for Zolgensma was slower than that of Kymriah. Although both drugs are high-priced one-shot treatments developed by the same company, Zolgensma is a rare disease treatment. Novartis submitted its reimbursement application for the spinal muscular atrophy (SMA) treatment Zolgensma in May last year, but the agenda was put up for deliberations a year later, in May of this year. As Zolgensma is a rare disease drug, the pharmaceutical reimbursement standard subcommittee must first set a reimbursement guideline for the drug before undergoing DREC review. However, discussions were delayed due to repeated requests for data supplements made by the government and their submission by the pharmaceutical company. As a result, the reimbursement progress for Zolgensma progressed at a much slower speed than Kymirah, which had applied for reimbursement approximately a month before Zolgensma. However, the process sped up after DREC deliberations. After passing DREC deliberations on May 12th, Zolgensma entered drug pricing negotiations in the same month and reached a drug pricing agreement without period extensions before the 60-day negotiation period expired. As a result, Zolgensma will likely be reimbursed as early as next month (August), or in September at the latest given HIPDC’s schedule. Zolgensma is a gene therapy that contains genetic material that functionally replaces defective genes. The Ministry of Health and Welfare had approved the drug as the second advanced biopharmaceutical after Zolgensma. Advanced biopharmaceuticals are cell therapies or gene therapies that use live cells, tissues, or genetic material as ingredients.
- Company
- Daiichi Sankyo's CSR activities resumed in 3 years
- by Lee, Seok-Jun Jul 19, 2022 05:16am
- As ESG management has recently emerged as a hot topic, corporate social responsibility (CSR) activities are also drawing attention. ESG and CSR are different, but they are evaluated to be similar in large concepts. All are based on the premise that voluntary participation of CEOs and executives and employees should precede. ESG and CSR are difficult to start or continue. Daiichi Sankyo Korea resumed its Friendly CPR Day in three years, which was suspended in the aftermath of COVID-19. The campaign, which began in 2016, is a step toward developing into a long-term CSR that saved corporate identity. Analysts say that CSR will be reflected by President Kim Dae Joong (62 yrs old), the longest-serving Korean CEO of a multinational pharmaceutical company. He leads the company from 2010 to the present and serves as a supporter for continuous CSR activities as well as business expansion. A company official said, "Due to COVID-19, large-scale offline events of the campaign have been suspended over the past two years. As the pandemic situation has improved recently, it is seeking to resume in stages. Starting this year, we will hold a small-scale sincere campaign, Friendly CPR Day, which invited family members and acquaintances of employees." The Campaign is a differentiated social contribution activity in which executives and employees of Daiichi Sankyo Korea, a company specializing in cardiovascular relations, visit community elementary schools and provide CPR education. Since 2016, it has been held every year on its founding anniversary (July 16). Due to COVID-19, 2020 and 2021 were suspended. A total of 69 people participated in this year's campaign, including 12 CPR instructors from Daiichi Sankyo Korea, 46 family members and acquaintances, and 11 Observer. Considering the COVID-19 situation, the first and second education sessions were divided and shared the "general CPR process," one of the standard curriculum of the Korea Cardiopulmonary Resuscitation Association, for about 1 hour and 40 minutes each. For education, the know-how of cardiopulmonary resuscitation education of executives and employees, which has been accumulated for many years, was used. In addition to cardiopulmonary resuscitation education, practice using mannequins and automatic cardiac shock devices (AEDs) was conducted to teach how to apply CPR in emergency situations. Daiichi Sankyo Korea encourages all employees to obtain KACPR's public instructor certificate through its sincerity campaign. The company fully supports the necessary expenses for employees to obtain and maintain their licenses, and recognizes the time required as working hours. As a result, about 130 out of 220 employees currently have instructor certificates to educate the general public on CPR. Among Daiichi Sankyo Korea employees, there are cases where citizens were saved by using certificates in emergency situations that actually require CPR. Kim Dae Joong Daiichi Sankyo Korea CEO said, "The campaign is not a one-time event activity, but a long-term social contribution activity that utilizes Daiichi Sankyo Korea's vision and the identity of a cardiovascular company." The company's executives and employees are members of pharmaceutical companies that contribute to the public health, and will continue to make efforts to devote themselves to the public interest and fulfill their social responsibilities as corporate citizens." Participants in the event said, "We have gained knowledge that can be used in practice, such as cardiopulmonary resuscitation through the sincerity campaign. It was a precious time to share values about the company my parents work for and have a time to understand each other, he said. In addition to the campaign, Daiichi Sankyo Korea is carrying out various social responsibility through social contribution activities such as the "Sevikar Love Sharing Campaign" to support heart disease patients' surgery costs and the "Korean Association for Children with Leukemia and Cancer Donation."
- Company
- Samsung Bioepis announces effectiveness of Lucentis Similar
- by Kim, Jin-Gu Jul 19, 2022 05:16am
- Samsung Bioepis announced on the 18th that it has announced the results of research on the ophthalmic disease treatment "SB11 (Lucentis biosimilar, Ranibizumab)" at the ASRS conference held in New York from the 13th to the 16th (local time). Samsung Bioepis released the results of post-hoc analysis of phase 3 clinical data for macular degeneration patients through an oral presentation session at an academic conference on the 16th. The presentation was conducted by Neil M. Bressler, a professor at Johns Hopkins University who participated in phase 3 clinical trials of SB11. Samsung Bioepis has conducted phase 3 clinical trials for 705 patients in 9 countries. A comparative study based on 634 prescription data for 52 weeks has proven medical equivalence with the original drug. The primary efficacy evaluation indicators of clinical trials were how much CST decreased at the time of the 4th week and how much BCVA increased at the time of the 8th week. This study was a statistical analysis aimed at identifying the baseline factor that affects the therapeutic effect from the clinical trial data and then confirming whether the equivalence is proven even when analyzing the subgroups considering it. As a result, the company explained that the vision and anatomical measurements between SB11 and the original drug were similar. An official from Samsung Bioepis said, "We were able to further prove the medical equivalence with the original drug through post-analysis of the SB11 clinical phase 3 data." "We will focus on expanding sales so that SB11 can be the best treatment alternative for many patients," he said. SB11's original drug Lucentis is a treatment for ophthalmic diseases such as wet AMD and DME developed by Genentech. Annual sales amounted to 4.4 trillion won last year. Samsung Bioepis obtained permission to sell under the name BYOOVIZ in Europe and the United States in August and September last year, respectively. Subsequently, in June this year, the product was released by its partner Biogen in the U.S. market at a price about 40% lower than that of the original drug. In May this year, it was approved in Korea under the name 'AMELIVU'. In Korea, it signed a marketing partnership with Samil Pharmaceutical ahead of its market target.
- Company
- NTS will provide tax support for bio companies
- by Kang, Shin-Kook Jul 19, 2022 05:15am
- NTS CommissionerBiopharmaceutical companies are set to receive tax support from the National Tax Service. The National Tax Service (Commissioner Chang-ki Kim) held a roundtable meeting at the Incheon Free Economic Zone located in Songdo, Incheon to listen to the difficulties experienced by those in the field with leaders of small-to-mid-sized enterprises that are residing in the Songdo Bio Cluster. The roundtable meeting was prepared to listen to the tax-related difficulties experienced by SMEs in high-tech industries that represent Incheon as a region and devise tax support measures for their resolution. At the meeting, Commissioner Chang-ki Kim said, “We have been providing liquidity support by extending the payment deadline and providing early refunds for SMEs that are suffering from high prices, high interest rates, and high oil prices. We also have a tax support promotion task force in place based around tax offices nationwide to continuously monitor the damages in each region and provide customized tax support measures that fit their needs.” Commissioner Kim emphasized, “We are working to foster an environment that encourages corporate growth, by expanding exempting regular tax audits for SMEs in their early stages or those that created jobs to support economic revitalization, etc.” Commissioner Kim also added, “This year, we will simplify the document requirements to enable easier use of the prior review system for tax deduction provided to research and human resource development expenses while providing consulting on tax deduction and reductions that SMEs have difficulty with, as well as the family business succession system. Commissioner Kim added, “This year, we will simplify the document requirements to enable easier use of the prior review system for the tax deduction of research and human resource development expenses while providing consulting on tax deduction and reductions that SMEs have difficulty with as well as the family business succession system." The SME leaders that attended the meeting proposed ▲improving the tax credit system for integrated investments ▲reducint the tax audit burden ▲ expanding tax reduction for consigned R&D in the bioindustry ▲expanding tax deductions for companies that increase employment, etc. To such requests, Commissioner Kim said, “We will actively discuss the suggestions that were made with relevant departments so that the voices of the field can be reflected in the tax administration process.” Meanwhile, the Songdo Bio Cluster is located in Zones 4,5 (Bio cluster, high tech industry cluster) where companies and institutions in the bio-industry including universities, research institutions, hospitals, foreign companies, etc. are located. By 2030, about 700 companies and research institutes are expected to move in to the cluster. Major residents include Samsung Biologics, Celltrion, DM Bio, and Janssen Vaccine.
- Company
- Will social distancing resume?
- by Kim, Jin-Gu Jul 19, 2022 05:15am
- As the spread of the coronavirus is intensifying again, concerns in the pharmaceutical bio industry are also growing. Front-line companies seem to be paying keen attention to whether to resume social distancing measures, while asking executives and employees to strengthen personal quarantine rules ahead of the full-fledged summer vacation season. ◆ Please strengthen personal quarantine rules. & refrain from face-to-face meetings According to the Korea Centers for Disease Control and Prevention on the 13th, as of midnight on the 11th, there were 37,360 new confirmed patients in Korea. It is the first time in more than two months that the number of new confirmed patients in Korea has exceeded 30,000 since May 17 (36,31). The quarantine authorities believe that COVID-19 will be prevalent again. The government has announced the announcement of new quarantine measures in preparation for the re-pandemic in summer. The pharmaceutical bio industry is paying keen attention to the government's announcement of quarantine measures. Social distancing measures are not expected to be implemented immediately, but various scenarios are under consideration because the possibility cannot be completely excluded depending on the spread. Most companies do not have separate internal guidelines. However, the government plans to comprehensively review the government's announcement and the spread of COVID-19 and take measures such as refraining from face-to-face meetings and recommending distributed vacations. An official from a local pharmaceutical company said, "We did not take any special measures internally. We reiterated compliance with personal quarantine rules to employees." If we resume distancing measures, guidelines such as refraining from face-to-face meetings will be issued to executives and employees accordingly," he said. An official from a multinational pharmaceutical company said, "If at least one confirmed patient is found in the company due to the recent re-proliferation of COVID-19, new guidelines are expected to be prepared, such as expanding telecommuting internally. ◆ Increasing tension in factories and research institute In particular, factories and research institutes seem nervous about the re-proliferation of COVID-19. This is because, like when COVID-19 was rampant in the past, if a COVID-19 confirmed patient occurs, all of the departments are likely to go into self-quarantine for a certain period of time. An official from a domestic pharmaceutical company said, "Unlike the early stages of the COVID-19 crisis, the entire factory will not be shut down, but if all of the departments are self-isolated, it will inevitably disrupt the operation of the line." The official said, "We are paying attention to the possibility of a sharp increase in the number of COVID-19 confirmed cases in Korea during the summer vacation scheduled for early August," adding, "We have already had a special request for factory or research institute employees regarding summer vacation. If the situation becomes serious, measures such as distributed vacation may be recommended, he explained. Pharmaceutical factories are also mindful of the possibility that supply and demand difficulties for cold medicines and antipyretics will expand again. An official from a pharmaceutical company, who operated an emergency operation system at the time of supply and demand shortage earlier this year, said, "We have secured enough inventory in preparation for the possibility of supply and demand again." ◆Marketing and sales representatives, concerned about resuming distancing A marketing officer at a domestic pharmaceutical company said, "Distancing measures are not expected to be implemented immediately, but if the situation becomes serious, there is a possibility that it will resume. It's only recently that offline events have been possible. If distance measures are resumed, marketing activities will inevitably be disrupted." "We're already full of offline marketing events for the next two or three months. Confusion is expected to be severe over whether to push ahead with the scheduled event," he added.
- Company
- GC WellBeing transfers raw materials technology to Japan
- by Jul 18, 2022 06:06am
- GC Wellbeing (CEO Kim Sang-hyun) announced on the 15th that it has signed a technology transfer contract with Japan's Healthy Navi for the functional raw material Green-Cera F. Healthy Navi is a company in charge of product development and distribution of functional and general food ingredients in Japan. Green-Cera F is a raw material recognized by the Ministry of Food and Drug Safety for its functionality that can help stomach health by protecting the gastric mucosa. Through non-clinical tests, it has been confirmed that this raw material can help stomach health, such as antioxidant, anti-inflammatory, protecting the gastric mucosa, and increasing the amount of gastric mucus. In addition, through human application tests, statistically significant improvement was shown in the gastrointestinal liver symptom scale item. Through this contract, GC Wellbeing provides Green-Cera F to Healthy Navi and receives royalties for raw material sales in Japan. Healthy Navi will secure Green-Cera F's exclusive supply rights to Japan and the right to develop and launch products using this raw material. The company plans to further accelerate the overseas expansion of excellent functional materials held under this contract and expand markets such as Asia, the U.S., and Europe outside Japan. An official from GC Wellbeing said, "This contract is the first case of technology transfer of its functional raw materials overseas." "We plan to actively promote overseas expansion of our company's functional materials in the future," he said. GC Wellbeing is researching and developing functional raw materials derived from various natural products, which can help joint and cartilage health.
- Company
- SK’s epilepsy drug makes over ₩400 billion in 3 years
- by Chon, Seung-Hyun Jul 15, 2022 05:57am
- SK Biopharmaceuticals’s new anti-epileptic drug ‘Xcopri’ has brought in a total of ₩400 billion in upfront payments and milestone payments over the past 3 years. This is the largest amount of cash secured by a new drug that was licensed out by Korean pharmaceutical companies. According to the Financial Supervisory Service on the 14th, SK Biopharmaceuticals signed a licensing deal with the Brazilian pharmaceutical company Eurofarma Laboratorios SA for its anti-epileptic drug Xcopri. Under the agreement, SK Biopharmaceuticals will receive an upfront payments of $15 million and up to $47 million in milestone payments which are paid when each phase of development, approval, etc. is completed. The company will also separately collect royalties proportional to net sales upon Xcopri’s commercialization. Under the licensing agreement, Eurofarma will sell cenobamate in 17 Latin American countries including Brazil and Mexico. Eurofarma, which owns expertise in the sales and marketing of central nervous system (CNS) disorder treatments owns a sales network throughout Latin America. Cenobamate is a new anti-epileptic developed solely by SK Biopharmaceuticals from its initial development to US FDA approval as a treatment for partial-onset seizures in adults. It simultaneously regulates 2 targets related to excitatory/inhibitory signaling that is known to cause epilepsy to reduce seizure frequency. SK Biopharmaceutical received approval for cenobamate under the brand name ‘Xcopri’ from the US FDA in November 2019 and has been directly selling the drug through its US subsidiary SK Life Science ever since. SK Biopharmaceutical has been entering overseas countries other than the US by licensing out cenobamate to its local partners. SK Biopharmaceutical entered into a licensing agreement last February with the Swiss pharmaceutical company Arvelle Therapeutics to transfer technology on cenobamate for up to $530 million. At the time, SK Biopharmaceutical received an upfront payment of $100 million with no obligation of return. In October 2020, the company entered into an exclusive licensing agreement with Ono Pharmaceutical for Ono to develop and commercialize Xcopri in Japan. Under the agreement, SK Biopharmaceutical received an upfront payment of ¥5 billion with no obligation of return, and will also be eligible to receive up to ¥48.1 billion based on the achievement of certain regulatory and commercial milestones, as well as double-digit royalties on net sales generated in Japan. In November last year, SK Biopharmaceutical licensed out 6 new central nervous systems (CNS) drugs including cenobamate to Ignis Therapeutics. Under the deal, SK Biopharmaceutical received an upfront payment of $20 million, a milestone payment of $15 million, and royalties on net sales in the future. Through the technology export, SK Biopharmaceutical acquired 150 million shares of Ignis (share amounts to 44.9% including common stock). And in December last year, SK Biopharmaceutical signed a licensing deal with Endo Group for the commercialization of its epilepsy drug cenobamate across Canada. Under the deal, SK Biopharmaceutical received an upfront payment of $20 million in USD. The company will also be able to receive up to $21 million in Canadian dollars based on the achievement of certain regulatory and commercial milestones in the future. Paladin Labs Inc., a Canada-based operating subsidiary of Endo, will be responsible for all commercial activities related to cenobamate in the region, including its release. Endo is a global healthcare company headquartered in Ireland. In addition to upfront payments, the company has also received milestone payments upon cenobamate’s approval abroad. SK Biopharmaceutical received $123.22 million from its European partner Angelini Pharma as milestone payments last year. Angelini Pharma (formerly Arvelle Therapeutics UK) has collected additional milestone payments after receiving marketing authorization from the European Commission in March last year. SK Biopharmaceutical’s cash inflow from upfront payments and further milestones from the technology transfer of cenobamate is $278.22 million and ¥5 billion. Based on the recent exchange rates, the company had secured about ₩400 billion through upfront and milestone payments through technology transfer with cenobamate. This is estimated to be the largest amount earned from the technology transfer of a single new drug developed in Korea. In 2015, Hanmi Pharmaceutical received the largest amount as an upfront payment, €240 million (approximately ₩260 billion, to transfer the license of its 3 new diabetes drugs to Sanofi. No additional milestone occurred and all rights were returned to Hanmi Pharmaceutical. Yuhan Corp’s new anticancer drug ‘Leclaza (lasertinib)’ received $150 million (approximately ₩190 billion) in upfront and milestone payments. Yuhan Corp has made a licensing deal with Janssen biotech in November 2018. At the time, the company received an upfront payment of $50 million with no obligation of return. Yuhan Corp received a milestone payment of $35 million from Janssen in April 2020 for lasertinib. At the time, Janssen had paid an additional milestone to Yuhan Corp when it started a clinical trial for combination therapy using amivantamab and lasertinib. Yuhan Corp had collected an additional $65 million in milestone payments when Janssen started recruiting subjects for the Phase III trial of its self-developed anticancer drug amivantamab and lasertinib combination.
