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- 2026-04-08 16:59:23
- Policy
- Moderna will only supply Spikevax Duo 2 in Korea
- by Lee, Hye-Kyung Jan 18, 2024 06:07am
- Moderna Korea has discontinued the supply of all other vaccines, leaving only its latest version, Spikevax Duo 2 (elasomeran, davesomeran) in circulation among the 5 COVID-19 vaccines it had received approval for in Korea. On the 17th, the Ministry of Food and Drug Safety (MFDS) received a report on Moderna’s supply discontinuation of ‘Moderna Spikevax Inj,’ ‘Moderna Spikevax 2 Inj,’ ‘Spikevax inj,’ and ‘Spikevax 2 Inj.’ Moderna stated that it is “producing, importing, and supplying a new updated vaccine in response to the emergence of new coronavirus variants," and that it has been “supplying the latest updated version of Spikevax Inj that protects against the latest variants since October 2023.’ Moderna’s most recently updated version is called ‘Spikevax Duo 2 Inj', and its entire domestic supply is contract manufactured by Samsung Biologics. Spikevax Duo 2 Inj was granted Emergency Use Approval by the MFDS on September 27th last year for adolescents and adults aged 12 years and older against the XBB.1.5 subvariant of the SARS-CoV-2 virus. In preparation for the winter vaccination season, national regulatory agencies and international public health organizations have recommended countries update their COVID-19 vaccines to monovalent vaccines that include protection against the XBB.1.5 variant. Moderna has published clinical data confirming that its XBB.1.5 targeted monovalent vaccine provides neutralizing antibody responses to the variants BA.2.86, EG.5, and FL.1.5.1 in addition to XBB subvariants XBB.1.5, XBB.1.16 and XBB.2.3.2. The most common local adverse reaction following the use of Spikevax Duo 2 was injection site pain. The most common systemic adverse reactions were headache, fatigue, myalgia, and chills. Its safety profile was consistent with what is known for the original Spikevax vaccine. Meanwhile, Moderna has been ranked as the No. 1 domestic pharmaceutical company in terms of production volume in 2022 with its COVID-19 vaccine alone. According to the '2023 Food and Drug Statistics Yearbook', Moderna's production volume amounted to KRW 1.2756 trillion in 2022, driven by the production of 2 dosage forms of its Spikevax Inj vaccine.
- Company
- MA manager files complaint on NHIS official's abuse of power
- by Eo, Yun-Ho Jan 18, 2024 06:07am
- A controversy has arisen over the abuse of power made by an official from the National Health Insurance Service’s Department of Pharmaceutical Benefits. According to industry sources, B, a market access (MA) manager at pharmaceutical company A, filed a civil complaint with the Anti-Corruption & Civil Rights Commission’s e-People page, alleging unfair treatment from C, an official from the NHIS Department of Pharmaceutical Benefits. It was confirmed that B had attached a recording of the conversation with C with the complaint, alleging unfair treatment (abuse of power) by a public institution. It was reported that B filed the complaint through individual judgment rather than as part of company-level actions. The Department of Pharmaceutical Benefits is in charge of negotiating insurance prices of drugs with pharmaceutical companies during the reimbursement listing process. This drug pricing negotiation is a mandatory process for new drug reimbursement and is regarded as the last gateway to listing in the pharmaceutical industry. The industry has been expressing mixed views on B’s actions. "I think it was a little hasty," said one multinational pharmaceutical company’s pricing manager. “Frictions do occur and strong words are exchanged with the NHIS in the pricing negotiation process, but we are all basically partners working together for the same goal of ensuring patient access. I doubt any power play abusive enough to be reported to the e-People website would have been made in the process.” On the other hand, another representative of a multinational pharmaceutical company said, "There are definitely some people who have an overbearing attitude. Reimbursement listing is the crucial determinant of the success or failure of a drug, and the NHIS holds the key. Any wrongful actions in this crucial process should be corrected promptly."
- Policy
- Drug price cuts will be applied in bulk next month
- by Lee, Tak-Sun Jan 18, 2024 06:07am
- A number of products are expected to receive price cuts next month as a result of the second round of reevaluations the government conducted on the insurance price ceiling of listed drugs. The drug price adjustments, which were initially set to be applied in January, were pushed back to February. Also, in consideration of the returns and difference settlements that need to be made by pharmacies, sufficient time is expected to be given between the announcement and the effective date of the pricing adjustments. According to industry sources on the 17th, the second round of negotiations after reevaluation of the insurance price ceiling of listed drugs will be completed this month and be reported to the Health Insurance Policy Deliberation Committee (HIPDC). About 3,220 products were subject to the second round of negotiations. As this includes all of the evaluated items, some that are not subject to pricing adjustments are also included in the negotiations. Therefore, it is expected that the actual number of products that receive price cuts will be fewer than this. In the first round of reevaluations that were conducted in September last year, 12,800 items were subject to negotiations, but 7,400 items were applied pricing adjustments. The second round of price ceiling reassessment will cover some specialty oral drugs and aseptic drugs that were included in the bioequivalence demonstration by the Ministry of Food and Drug Safety in 2020. The second round of reevaluations included some prescribed oral drugs and aseptic drugs that were required to demonstrate bioequivalence by the MFDS in 2020. Initially, the Ministry of Health and Welfare had planned to apply the drug price adjustments in January after reporting the results to HPIDC in December last year. However, it was postponed in February due to concerns about the burden borne by pharmacies. Also, drug price ceiling adjustments following the investigation into actual transaction prices had been set to be applied in January at the time. However, this was also postponed thereafter. Therefore, the adjustment period will likely be further delayed to after March, as the results were not reported to HIPDC’s meeting this time. The pricing adjustment date for the second round of price ceiling reevaluations is also expected to be a few days after the first of next month, just as it had been in the first round of price ceiling reevaluations. In the first round, the adjustments were announced on Aug. 23 last year, notifying its implementation on Sept. 1, but the actual implementations were made on Sept. 5 to account for return and settlement confusion among pharmacies. Meanwhile, the reevaluation of the price ceiling of listed drugs is being conducted to maintain or reduce the price of listed drugs depending on whether the drug meets the requirements of self-bioequivalence testing and DMF listing. If the listed drug satisfies both requirements, the ceiling price is maintained as is; however, if the drug satisfies only one of the two requirements, the price is reduced to 85%, and to 72.25% if both requirements are not met.
- Policy
- Stability data requirement eased for metformin approvals
- by Lee, Hye-Kyung Jan 17, 2024 05:29am
- The Ministry of Food and Drug Safety (Minister Yu-Kyoung Oh) will change and ease the stability test submission data requirements for approvals (and changes) of metformin-containing preparation that had been strengthened following the detection of an impurity (N-nitrosodimethylamine (NDMA, NDMA). Metformin is used for the treatment of Type 2 diabetes and has been approved for 120 single-agent and 1,227 combination drug products. The government’s action follows a scientific analysis of NDMA-related stability test data that have been submitted to the MFDS to date and the conclusion that the changed data requirements are sufficient to ensure the quality of the drugs within their expiration date. The MFDS had strengthened the data submission requirements since July 2020 after NDMA was detected in metformin products to strictly control the impurity level to be lower than the standard. The stability test data required for product approval (and changes) has been strengthened to the level of new drugs. As a result, companies had to submit 12 months of long-term storage stability test data when applying for new approvals or changes to their metformin products. However, in the future, the companies will again only need to submit 6 months of long-term storage test data. The MFDS expects this improvement to help ensure the rapid development and launch of metformin products and access to treatment for patients and will continue to make the best efforts to operate Korea’s drug approval system flexibly and reasonably based on its expertise in regulatory science.
- Company
- Orion bids KRW 548.5 bil to enter the pharma industry
- by Kim, Jin-Gu Jan 17, 2024 05:29am
- The Orion Group has become the largest shareholder of LegoChem Biosciences, a prime new drug developer. With the acquisition of LegoChem, Orion is expected to jump into the pharmaceutical bio-industry in earnest, breaking away from its previous passive activities such as signing a memorandum of understandings, making indirect investments, and establishing joint ventures. According to industry sources on the 16th, Orion announced on the 15th that it will acquire 9.36 million and 3,283 shares of LegoChem Biosciences for KRW 54.85 billion. After the acquisition, Orion will possess a 25.73% stake in the company, making it the largest shareholder of LegoChem Biosciences. Orion will acquire 7,963,282 million new shares via a third-party allocated capital increase at an additional KRW 469.8 billion. It will also purchase 1.4 million existing stocks from Orion’s largest stakeholders, CEO Yong-Zu Kim (1.2 million shares) and President Se-jin Park (0.2 million shares). Orion’s subsidiary, Pan Orion Corp., which is located in Hong Kong, will take charge of the acquisition procedure. After Pan Orion, which is a holding company for 7 corporations finalizes the acquisition, a holding company for seven entities in China, completes the acquisition process, Orion will incorporate LegoChem Biosciences as its affiliate. Orion is expected to enter the pharma-bio industry in earnest with the acquisition of the new drug developer LegoChem Biosciences. Orion announced its entry into three new businesses in 2020 and pointed to the pharmaceutical bio industry as one of them. However, before the acquisition of LegoChem Biosciences. However, as the company had only shown activity in the diagnostics business and mainly focused on laying the foundation for overseas businesses before the acquisition, the industry’s evaluation was that the company had sought to indirectly enter the market through joint ventures, etc., taking a step back from making direct investments. In 2020, Orion signed an MOU with diagnostic kit maker Sugentech, and in 2021, it signed a license-out agreement with Genomictree for its early diagnosis technology for colorectal cancer. The same year, it formed a joint venture in China with Shandong Lukang Pharmaceutical. In 2022, the company signed a joint development agreement with Quratis to jointly develop a vaccine for tuberculosis. In December 2022, the company established Orion Biologics. Orion Biologics is a 6:4 joint venture between Orion Holdings, the group's holding company, and Hysense Bio, a dental disease treatment venture company. However still, Orion Biologics is considered to be focusing on supporting the company’s diagnostic and vaccine business in China rather than Korea’s pharma-bio industry. But with the acquisition of LegoChem Biosciences, Orion is seemingly making entry into the pharma-bio industry in earnest. The company seems to be focusing the group's pharmaceutical bio business capabilities on LegoChem Biosciences while maintaining the existing management and operating system for the rest of its businesses. The pharmaceutical industry is paying attention to the potential of LegoChem Biosciences that Orion seeks to acquire. LegoChem Biosciences specializes in the development of antibody-drug conjugates (ADCs), which have recently attracted great interest from global big pharmas. LegoChem Biosciences has signed more than 10 technology transfer agreements in the ADC field since 2015. Starting with the technology transfer to China's Fosun Pharma in 2015, the company has made 13 known technology transfers. Of these, 4 candidates have entered the clinical stage. In addition to the upfront payment, the company is expected to receive additional milestone payments upon achievement of commercial milestones. The most recent deal was signed in December last year. The company signed a technology export agreement with the multinational pharmaceutical company Janssen for its ADC drug candidate 'LCB84'. LCB84 is an ADC candidate drug that can target various solid tumors, including triple-negative breast cancer and non-small cell lung cancer. LegoChem Biosciences has a proprietary ConjuAll linker. An ADC consists of a linker, a payload (drug), and an antibody. The ConjuAll linker is believed to be able to overcome the release of cytotoxic drugs in the blood and attack normal cells. Based on this potential, the company has a market capitalization of more than KRW 1.5 trillion on the KOSDAQ market as of the closing price on the 15th. It ranks 28th in market capitalization on the KOSDAQ market. It ranks 7th among pharma-bio companies listed on KOSDAQ.
- Company
- KRPIA's new BOD is full of Korean members
- by Eo, Yun-Ho Jan 17, 2024 05:29am
- KRPIA has launched its new board of directors for the 2024 New Year. The Korean Research-based Pharmaceutical Industry Association (KRPIA) has recently announced its new board of directors (BOD). The new BOD stands out as it is primarily made up of Korean members. Among the 13 BOD members, which includes KRPIA chairman Dong-Wook Oh (CEO of Pfizer Korea), only two are foreign nationals, making up 85% of the board as Korean members. Because multinational pharmaceutical companies appointing Koreans as CEOs of their Korean branch instead of foreign nationals, it has likely led to the BOD members consisting primarily of Korean members. CEO of Astellas Pharma Korea, Junil Kim, CEO of Bayer Korea, JinA Lee, and CEO of MSD Korea, Albert Kim, are Koreans who were newly appointed last year. Of note, Albert Kim holds Canadian nationality. New foreign members of the BOD include Maurizio Borgatta, CEO of GSK Korea, and Christoph Hanman, CEO of Merck Korea. Meanwhile, KRPIA is facing substantial changes in the coming years. The association has recently appointed Choi In-Hwa, an executive at Roche Korea, to oversee the association's policy business following the retirement of Kim Min-Young (currently the Director of Market Access at Gilead Sciences Korea), who left the position in February of last year. This appointment fills the vacancy after a year. Additionally, the current chairman of the association is also nearing the end of the term. Chairman Oh Dong-Wook's term is set to expire this month (January), and it is expected that a new chairman will be appointed in February. Chairman Oh has been leading the association since his appointment as chairman in 2021.
- Policy
- High-priced drugs receive reimb in the new year
- by Lee, Tak-Sun Jan 17, 2024 05:29am
- Ultra-high-priced drugs whose costs exceed KRW 100 million are being listed for reimbursement one after another in the new year. Following Koselugo’s reimbursement this month, Luxturna, which will cost KRW 1 billion, is expected to be reimbursed next month. With such ultra-high-priced drugs being listed one after another, voices have been rising on the need to strengthen post-listing management to efficiently manage the financial expenditures of Korea’s national health insurance. According to industry sources on the 16th, ‘Luxturna Inj,' an ultra-expensive drug that costs KRW 950 million, has completed drug pricing negotiations with the NHIS and is set to be reported to the Health Insurance Policy Deliberation Committee this month. The drug is a ‘one-shot treatment’ that shows an effect after a single dose, similar to previously listed drugs like Kymriah and Zolgensma. Luxturna is indicated for the treatment of adult and pediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells. It is estimated that there are about 50 patients who are eligible to receive LUXTERNA in Korea. The issue is its high price. The drug costs about USD 710,000 per single dose in the US, which roughly translates to KRW 950 million in Korean won. Feeling burdened by the high price, patients have been awaiting the drug’s reimbursement listing since it was approved by the Ministry of Food and Drug Safety in September 2021. However, a sense of anxiety filled the air when Luxturna’s pricing negotiations, which began in September, failed to finish within the set deadline and extended the deadline. Fortunately, the two sides quickly reached an agreement during the extended negotiation period. The company and the government reportedly shared the price burden at a reasonable level through the risk-sharing agreement system. Since this drug is an ultra-high-priced one-shot treatment like Kymriah and Zolgensma, it is likely to raise follow-up management issues even after listing. Ultra-high-priced KRW 950 million Luxturna awaiting to be reimbursed in Korea The neurofibromatosis treatment Koselugo Cap (selumetinib, AstraZeneca) has been reimbursed from the 1st of this month. The drug has succeeded in receiving reimbursement listing for 2 years and 6 after filing an application in June 2021. The expanded scope of subjects eligible for waiving submission of pharmacoeconomic evaluation data (PE exemption drugs) that was implemented in January last year played a decisive role in its reimbursement listing. The company agreed upon three risk-sharing types of RSA – the refund type, expenditure cap type, and initial treatment cost refund type – with the NHIS reducing the burden of health expenditures on the government’s part. With the reimbursement listing, patients only need to a copayment rate of 10% of the annual cost of KRW 200 million required for its use, reducing the burden to a KRW 10 million range. The cost of new drugs being listed recently is well over KRW 100 million. Zolgensma, which was listed for reimbursement in 2022, is currently the most expensive drug on the reimbursement list, at a price of KRW 1.98173 billion per kit. With these high-price drugs increasing healthcare expenditures, health authorities are also focusing on the post-listing management of these high-priced drugs. With the introduction of Kymriah and Zolgensma, a performance evaluation system that applies reimbursement through post-evaluations has been introduced. HIRA is seeking to broaden the scope of the system to manage PE exemption drugs and has been also promoting the reevaluation of existing drugs. From this year, it also established the 'Pharmaceutical Performance Evaluation Department, which will be responsible for the post-listing management of listed high-priced drugs. The NHIS plans to secure the financial soundness of its system by advancing the risk-sharing agreement system. To this end, it plans to minimize financial uncertainties by applying a performance-based risk-sharing system at the patient level and strengthening follow-up management of drugs using systems including the price-volume agreement system. The government’s plan for managing high-priced drugs is also expected to be included in the 2nd Comprehensive National Health Insurance Plan that is expected to be announced this month.
- Company
- Whan In has exclusive distribution rights for Sanofi's Arava
- by Kim, Jin-Gu Jan 16, 2024 06:09am
- On the 10th, Whan In Pharm had signed an exclusive promotion & distribution agreement with Sanofi-Aventis Korea for Arava tablet in Korea. On the 10th, Whan In Pharm announced that the company signed an exclusive promotion and distribution agreement with Sanofi-Aventis for Arava Tablet, a rheumatoid arthritis treatment containing the active ingredient leflunomide, in Korea. Whan In Pharm is recognized for its business specialization in the central nervous system (CNS) field. Through this agreement, Whan In Pharm plans to expand its business focus into areas beyond the CNS. Arava Tablet is a drug for alleviating rheumatoid arthritis symptoms, active psoriatic arthritis symptoms, and others. The drug is steadily generating sales of around 6 billion won every year. “We are pleased to announce our first partnership in the non-CNS field with Sanofi,” Lee Wonbum, CEO of Whan In Pharm, stated. “We anticipate that our collaboration with Sanofi will drive mutual growth and enhance our market competitiveness in the rheumatology field. “We are thrilled to establish a strategic alliance with Whan In Pharm, a company with a proven track of success in the CNS field. Through this partnership, we anticipate that we will be able to steadily supply Arava, an important treatment for Rheumatoid Arthritis, to patients in need,” Suk Sang Kyu, Foundation Business Unit Head at Sanofi-Aventis Korea stated.
- Policy
- Caution required for use of ADHD drug methylphenidate
- by Lee, Hye-Kyung Jan 16, 2024 06:09am
- The warnings and precaution section of the attention deficit hyperactivity disorder (ADHD) treatment ‘methylphenidate’ is expected to add warnings for increased intraocular pressure and glaucoma. The Ministry of Food and Drug Safety (MFDS) prepared a change to the label of drugs that contain methylphenidate based on a review of the safety information on methylphenidate products by the U.S. Food and Drug Administration (FDA) and is conducting an opinion inquiry until the 26th. 14 methylphenidate products are currently approved in Korea, including Janssen Korea’s ‘Concerta OROS Er Tab,’ Whan In Pharm’s ‘Penid Tab,’ and Myung-In Pharm’s ‘Perospin Tab.’ The labeling change will be made separately, for ‘delayed release capsule’ products ‘film-coated extended-release tablets,’ and ‘uncoated immediate release tablets.’ The updated general warnings and precautions for delayed-release capsule products will include increased intraocular pressure and glaucoma. Due to reports of increased intraocular pressure (IOP) associated with methylphenidate treatment, the warning and precautions section will be changed to state that patients with abnormally elevated IOP should only be prescribed treatment if the benefits outweigh the risks. Patients with a history of abnormal IOP elevation or open-angle glaucoma should have their IOP monitored closely during treatment. For the extended-release film-coated tablets, ‘very rare motor and verbal tics’ will be added to the post-marketing surveillance data as an adverse event, and the general warnings and precautions will specify that patients should be monitored periodically for the onset and worsening of tics during methylphenidate therapy in addition to conditions such as IOP elevation and glaucoma and that treatment should be discontinued when clinically appropriate. The general warnings and precautions section for uncoated immediate-release tablets will include ‘Clinical evaluation of tics should be performed prior to use as well as family history,’ in addition to IOP elevation and glaucoma. During treatment with methylphenidate, patients should be regularly monitored for the onset and worsening of tics or Tourette syndrome, and treatment should be discontinued when clinically appropriate.’ Meanwhile, the treatment efficacy of methylphenidate ADHD has been demonstrated in clinical trials in children and adolescents aged 6 to 17 years of age and adult ADHD patients aged 18 to 65 years who meet the who meet the DSM-IV criteria.
- Company
- Gov't will reduce fines for companies that adopt CPs
- by Kang, Shin-Kook Jan 16, 2024 06:08am
- A revised Fair Trade Act that grants benefits, such as reduced penalty surcharges to companies that have adopted and excellently operated a Fair Trade Compliance Program (CP), will be enforced on June 21st this year. On the 15th, the Fair Trade Commission announced that it would prepare sub-statutes, including the Enforcement Decree and Notification of the revised Fair Trade Act , to stipulate standards and procedures for the implementation of the system in February for the timely enforcement of the revised Fair Trade Act CP is an internal compliance system that companies establish and operate independently to comply with fair trade-related laws and regulations. The system, which includes training and supervision, was introduced proactively by the private sector in 2001. The FTC has been providing various benefits to companies that introduced and operated CPs to activate the CP system since its introduction, and has been operating a CP rating system since 2006 to grant differentiated benefits based on operational performance to induce the sound operation of the system. However, as the CP system is based on established rules rather than the law, the government had difficulty preparing incentives to actively induce and operate the CP. To address these issues, the FTC amended the Fair Trade Act in June last year to legislate the CP system, and CP operation rating system, and prepare a legal basis to provide support such as fine reductions or rewards to companies that have excellently operated their CP. Also, to promote the implementation of CP in companies, the FTC plans to minimize the burden on companies by reducing the cost of introducing and operating CP and making it easier and simpler to apply for rating evaluations, and providing more substantial benefits to excellent CP companies, such as reducing penalty surcharges, lowering the Korea Credit Guarantee Fund fee rate, and award premiums when assessing implementation of the fair trade agreement with franchisees and agents. An FTC official said, "We expect the number of companies introducing and operating CP to increase with the establishment of a legal basis for the CP system and support, such as penalty fine reductions. The number of companies that applied for CP rating evaluations had increased to 28 companies in 2023 when the legal basis for the CP system had been prepared. This is a 1.75-time increase from the 16 companies that applied in 2022.”
