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- 2026-04-11 17:01:29
- Company
- GC Pharma sells GSK's new shingles vaccine Shingrix together
- by Kim, Jin-Gu Oct 07, 2022 06:03am
- ShingrixGC Pharma and GSK will jointly sell the shingles vaccine Shingrix. The two companies are expected to sell a new shingles vaccine as early as the end of this year. According to the pharmaceutical industry on the 6th, GC Pharma and GSK recently signed a co-promotion contract for Shingrix and started product training for salespeople before its full-scale release. It is expected that the product will be released at the end of this year. GSK obtained Shingrix permission from the Ministry of Food and Drug Safety in September last year. It was originally planned to be released in February this year, but the schedule was delayed. Shingrix is a vaccine used to prevent herpes zoster in adults over the age of 50 and immunocompromised people over the age of 18. When Shingrix is released, it is expected to be the third shingles vaccine in Korea after MSD Zostavax and SK Bioscience's Sky Zoster. It is evaluated that the effect of preventing shingles confirmed in clinical trials is superior to that of the two existing vaccines. In Shingrix clinical trials (ZOE-50) for adults over the age of 50, the effect of preventing shingles was 97% at 3.2 years after vaccination. In clinical trials (ZOE-70) for those aged 70 or older, it was 90% at 3.7 years after vaccination. In the case of Zostavax, a competitive product, it has a preventive effect of 51% for those over 50 and 41% for those over 70. Sky Zoster demonstrated Zostavax and specific heat in clinical practice. It is analyzed that there is no significant difference from Zostavax in terms of prevention rate. GC Pharma has experience in co-selling MSD's shingles vaccine Zostavax in the past. Since 2013, GC Pharma has co-sold Zostavax for eight years until 2020 through a contract extension once after signing a co-promotion contract with MSD. In the process, Zostavax has grown into a large item with annual sales of 80 billion won. However, SK Bioscience launched its competitive product Sky Zoster at the end of 2017, and sales have decreased significantly since 2020 due to the prolonged Corona crisis. According to IQVIA, a pharmaceutical market research firm, Zostavax sales last year amounted to 27 billion won, down 68% in four years from 83.7 billion won in 2017. This year, sales were only 11.6 billion won until the first half of the year. The pharmaceutical industry expects Shingrix to lead the domestic shingles vaccine market to rebound. In the global market, Shingrix's sales, which had already been dampened by the Corona crisis, began to recover in the second half of last year. In the first half of this year, Shingrix's global sales were £1.429 billion, more than doubling compared to the same period last year. An official from GC Pharma and GSK Korea said, "There is nothing to mention regarding Shingrix's domestic sales."
- Policy
- Innovative pharmaceutical companies' new drug tx
- by Lee, Jeong-Hwan Oct 07, 2022 06:03am
- It was also pointed out that the government is delaying the preparation of a sub-law of a clause that favors the price of new drugs developed by innovative pharmaceutical companies in the Special Act on the Promotion of the Pharmaceutical Industry. Critics say that it has not been active in subsequent legislation such as enforcement ordinances and enforcement rules for the fourth year of legislation. On the 5th, Rep. Nam In-soon of the Democratic Party of Korea claimed, "We need to come up with a policy of preferential treatment for new drugs made by innovative pharmaceutical companies as soon as possible." Nam is criticizing the government for being indifferent to follow-up legislation even though the law on the addition of the upper limit on health insurance medical care benefits was implemented in December 2018 for new innovative pharmaceutical companies unrelated to the Korea-U.S. FTA trade issue. In particular, considering that improving the self-sufficiency rate of raw materials is an important task, it was also suggested that it is necessary to consider preferential treatment for related raw materials such as infectious disease vaccines such as COVID-19 and innovative new drugs. Rep. Nam In-soon said, "The government has designated bio-health as the so-called Big3 industry and has been pushing for a plan to promote bio-digital health as a major export industry and improve public health by spreading digital healthcare and big data-based advanced and precision medical care." Representative Nam said, "There are only generic drug preferential regulations for innovative pharmaceutical companies, but there are no drug preferential regulations for new drugs, so the contradictory situation of encouraging generic development over new drugs continues." She then said, "We are also implementing a policy that favors drug prices for the first approved new drugs in Japan and Taiwan and new drugs from companies that have conducted clinical trials in Korea." She added, "To become a global hub of bio and digital health, not only support such as preferential drug prices for innovative pharmaceutical companies, but also various support measures such as training R&D and manpower, financial support, overseas expansion support, and reduction of levies."
- Policy
- The incidence of adverse effects in Alecensa is 80%
- by Lee, Hye-Kyung Oct 06, 2022 06:05am
- A five-year post-marketing survey (PMS) of the Anaplastic Lymphoma Kinase (ALK) mutant non-small cell lung cancer treatment Alecensa 150mg showed 1012 significant drug abnormalities that could not rule out causality. The permit will be changed with 20 and 122 cases of serious drug adverse reactions and unexpected drug adverse reactions that cannot be excluded from causal relationships, respectively. The Ministry of Food and Drug Safety announced that it will prepare an order (proposal) to change the permission based on the results of the investigation after marketing Alecensa in Roche Korea and conduct an opinion inquiry until the 19th. Eisai Korea obtained an item license for Fycompa film coated tab on July 10, 2015. Alecensa received a domestic item license in October 2016 for the treatment of ALK-positive local progressive and metastatic non-small cell lung cancer patients who had been treated with Xalkori. After expanding the indication to primary treatment in 2018, Alecensa sales exceeded Xalkori, which is 20.3 billion won, from 10.4 billion won in 2018 to 22.1 billion won in 2019. Since then, it has expanded to 29.3 billion won in 2020 and 32.7 billion won in 2021. As a result of a five-year post-marketing survey of 345 people under the patient registration program in Korea, the expression rate of abnormal cases was reported to be 80.29% (277/345 cases, a total of 1012 cases), regardless of causality. Among them, 4.64% (16/345 people, 20 cases) of serious drug abnormalities were reported, including mouth inflammation, increased blood bilirubin, increased blood creatine phosphorylase, increased blood creatinine, peripheral edema, fever, and death. Unexpected drug abnormalities such as decreased red blood cell volume rate decreased red blood cell count, joint pain, muscle weakness, dizziness, and nephropathy were found to be 24.06% (83/345 cases, 122 cases). The Ministry of Food and Drug Safety plans to change the permit after hearing opinions on the change order.
- InterView
- “Sanofi’s flu vaccine is different...has 100-year legacy"
- by Oct 06, 2022 06:05am
- Sanofi has been making unexpected strides in Korea's flu (influenza) vaccine market this year. The company has not only made a bid for the National Immunization Program (NIP) for the first time this year, but it also started supplying its flu vaccines exceptionally quickly. Multinational pharmaceutical companies usually start the supply of their flu vaccines in October every year due to the longer time required for their release in Korea. However, Sanofi received the approval to release their vaccines at the same time as domestic vaccines and started distributing in mid-August. Its supply price is also not so different from domestic flu vaccines. Sanofi's unprecedented move is not unrelated to this year’s influenza outlook. This year, influenza, which had been on the low side due to COVID-19, is predicted to rise for the first time in 3 years this year. The Korea Disease Control and Prevention Agency issued a nationwide influenza warning last month. According to KDCA, the proportion of suspected flu patients per 1,000 people on the 39th week (September 18th-24th) was 4.9, exceeding the epidemic standards. In particular, Type A H3N2, which is expected to become the dominant strain this year is a successor of the ‘Hong Kong Flu,’ and is known as one of the most virulent strains. This is why the KDCA has been actively encouraging flu vaccinations. Although the 9 types of quadrivalent flu vaccines distributed in Korea are thought to have similar prevention effects, a closer look shows that there are differences. Some vaccines cannot be administered to infants or patients with cardiovascular diseases. Also, domestic vaccines can be administered to pregnant women, but their safety has not been demonstrated through clinical trials. Vaxigrip Tetra (Sanofi) and Fluarix Tetra (GSK) are the only flu vaccines that can be administered in all high-risk groups. This is why Sanofi, which is standing at the same level as domestic companies in terms of price, supply timing, and amount, is showing confidence this time. During an interview with Daily Pharm, Guan Lee Ang, Country Medical Lead at Sanofi Korea, said, “With over 100 years of history in developing vaccines, Sanofi owns a vaccine portfolio for over 20 types of infectious diseases. Our quadrivalent flu vaccine, ‘Vaxigrip Tetra,’ has verified safety and immunogenicity with robust clinical data. Vaxigrip Tetra’s differentiated strength lies in how it is the only vaccine to have verified efficacy and safety in the high-risk group.” Guan Lee Ang, Country Medical Lead at Sanofi Korea The high-risk group, infants over 6 years of age, pregnant women, cardiovascular patients, etc., are known to be at 10 times higher risk of acute myocardial infarction and at 8 times higher risk of strokes when infected with influenza. Infants and children are also at high risk of pneumonia as a related complication. Influenza infection can also lead to death, and an estimated 70-85% of those deaths were observed in patients over the age of 65. Clinical trial results showed that influenza infections from vaccine-like virus strain were reduced by 68%, and infection from all A&B types of influenza virus was reduced by 72% in infants aged between 6 months to 35 months when vaccinated with Vaxigrip Tetra. The risk of influenzas infection in pregnant women was also reduced by up to 72%. Also, the study showed vaccination was related to a reduction in the mortality rate in patients with myocardial infarction or high-risk coronary artery disease. The problem lies in the low public awareness of the need to receive influenza vaccines. Due to the prolonged COVID-19 crisis, people have been receiving vaccinations every 3 to 6 months, which led to increased fatigue over vaccinations and decreased reliability. Also, some are expecting influenza to not spread as much due to the small number of flu patients and the cultural specificity of how people are continuing to wear masks even after the mandatory outdoor mask regulation was lifted, In response, Sanofi's Vaccine Division is concentrating on reinforcing flu awareness. While carrying out a campaign to raise awareness of influenza among the general public, the company plans to hold a webinar for healthcare professionals on the preventive benefits of vaccinations based on clinical data. Ang said, “65% of employees in the vaccine division serve in departments related to quality testing, and most of the vaccine production period is devoted to quality testing. Also, we are working with distributors who have established thorough cold chains to stably supply our high-quality products. We will continue to strive to improve access to influenza vaccines for high-risk groups and improve public health in Korea.”
- Policy
- MFDS prepares clinical trial guidelines for COVID-19 drugs
- by Lee, Hye-Kyung Oct 06, 2022 06:05am
- The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) published and distributed the ‘Clinical trial guideline on antiviral treatments for mild-to-moderate COVID-19 infections’ to support the rapid development of COVID-19 antivirals by guiding companies on the new clinical outcome parameters and methods for designing flexible clinical trials. The guideline was prepared to promote the preparation of a rapid clinical support platform to support the development of COVID-19 vaccines and treatments, which was part of the 100 Tasks for Food and Drug Regulatory Innovation that the MFDS had announced on August 11th. The guideline contains the additional new clinical outcome parameters required for clinical trials on mild-to-moderate COVID-19 patients and includes considerations that need to be made in selecting subjects, clinical treatment effect evaluation methods, efficacy evaluation, and in designing and performing clinical trials. The existing clinical outcome parameter was effective in preventing severe COVID-19, however, due to the decrease in severe COVID-19 patients, this parameter had made it difficult to perform clinical trials. Therefore, a new indicator had to be inevitably set in line with the COVID-19 situation, which is why the government added symptom improvement as a new parameter. The MFDS said, “the addition of the new clinical outcome parameter will aid rapid development of treatments by enabling easier progress of clinical trials, including faster recruitment of clinical trial subjects. We have improved the predictability and transparency of the trials by allowing companies to introduce an adaptive design in preparing clinical trial protocols so the number of test subjects can be appropriately changed based on the results of the interim analysis.” Also, if the company has received approval for a clinical trial plan in advance, the trial can be conducted without additional approval, which is also expected to help reduce the period. As the trial is conducted on infectious patients, the guideline also guides companies on the major considerations that require attention when conducting non-face-to-face clinical trials and case studies. More information can be accessed on the MFDS website (www.mfds.go.kr) > Legislative data > Resources > Guide/Guidelines.
- Company
- Daewoong Pharmaceutical launches botulinum drug in the UK
- by Chon, Seung-Hyun Oct 06, 2022 06:05am
- The botulinum toxin drug developed by Daewoong Pharmaceutical has been released in earnest in the European market. Daewoong Pharmaceutical announced on the 5th that Nabota, a botulinum toxin drug, was officially released in the UK under the product name Nuceiva. It started selling in the UK last month through Daewoong Pharmaceutical's overseas partner Evolus. The UK is the largest single market in Europe, accounting for about 30% of the European botulinum toxin market worth 650 billion won per year. Evolus, a North American and European beauty indication partner of Daewoong Pharmaceutical, is in charge of Nuceiva's distribution and marketing in the UK. Evolus formed a strategic partnership with Wigmore, a local British distributor with a history of more than 35 years, and established a specialized distribution network. Since the beginning of this month, the latest knowledge and Nuceiva product training have been conducted for local medical personnel. Daewoong Pharmaceutical and Evolus will also enter other European countries with high marketability, such as Germany and Austria, to target the European market in earnest. Park Sung-soo, vice president of Daewoong Pharmaceutical, explained, "With the release of Nuceiva in the UK, we have officially entered the U.S. and Europe, the world's No. 1 and No. 2 botulinum pharmaceutical markets." "We will actively promote Nabota's excellent product power in the global market and contribute to enhancing K-Bio's status," he said.
- Company
- ILSUNG signs 3rd generation CCB HTN tx co-promotion
- by Lee, Seok-Jun Oct 06, 2022 06:05am
- ILSUNG, Intro Bio Pharma, and Pharmavision, have signed a partnership for Azelnidipine copromotion. According to ILSUNG on the 4th, Intro Bio Pharma received the first approval in Korea for Azelnidipine-based medicine in September 2021. Azelnidipine is a third-generation CCB hypertension treatment (Calblock) developed by Daiichi Sankyo Korea in Japan. Compared to Amlodipine, it has excellent blood pressure drop effect and fewer side effects, so it is most commonly used in Japan along with ARB hypertension treatment. It is known to have an excellent blood pressure control effect when used in combination with ARB series. Intro Bio Pharma and Pharmavision selected ILSUNG, which has strength in general hospitals, as a partner for Azelnidipine. Amlodipine has recently passed the Pharmaceutical Affairs Evaluation Committee and is expected to be listed. What is unique about this three-way contract is that Pharmavision, a research, and development venture that was established in 2019 and has completed the transfer of about 20 pharmaceutical technologies to many pharmaceutical companies so far. Based on R&D technology, Azelnidipine cooperation between Intro Bio Pharma, a pharmaceutical R&D venture company Pharmavision, and ILSUNG, which is taking a leap forward through innovation, can be a new B2B model. Kim Byung-jo, head of ILSUNG's development division (executive director, Ph.D. ), said, "Azelnidipine can be a new alternative for hypertension patients who have difficulty controlling blood pressure with Amlodipine or Lercanidipine HCl CCB hypertension treatment." Through three-way cooperation, it will become a necessary and differentiated item for patients.
- Company
- Koselugo is keen to discuss the registration of benefits
- by Eo, Yun-Ho Oct 05, 2022 06:11am
- Attention is focusing on whether Koselugo, a drug-free treatment for neurofibroma, will succeed in registering insurance benefits. According to related industries, AstraZeneca's new neurofibromatosis drug Koselugo is under final coordination at the Drug Benefit Standards Subcommittee. AstraZeneca quickly supplemented the data in May and resumed discussions on registration at the HIRA Drug Benefit Evaluation Committee in March. As it is a rare disease area where there were no treatment options, it remains to be seen whether Koselugo will be able to draw a decision this time. Neurofibroma has relied on symptomatic treatment without proper treatment. Neurofibroma is a rare disease in which tumors occur in nerve tissue, bones, and skin, and about 85% are type 1 in which the NF1 gene of the 17th chromosome long arm is mutated. This disease begins with 1~3cm sized cafe au lait macules appearing in children. It experiences symptoms such as brain tumors at the age of 6 and scoliosis at the age of 6 to 10. In adults, Lisch nodule, which occurs in the iris, is mostly found. It is a method of removing possible areas through surgery or chemotherapy and radiation treatment. However, most of the surgeries recur, and most of them are major surgeries, so both medical staff and patients are burdened. In particular, pediatric patients often have to take painkillers even after several surgeries and suffer from speech and motor disorders. Koselugo is a treatment jointly developed by AstraZeneca and MSD. It blocks MEK activity and inhibits cell line growth. In the SPRINT phase 2 clinical trial on which the permit was based, Koselugo reduced tumor size by more than 20% in 68% of administered patients, achieving the primary evaluation index, ORR. In addition, 82% of patients who showed partial reactions continued to respond for more than 12 months. Half of the patients who did not receive treatment suffered from disease progression after 1.5 years, and only 15% of the patients who used Koselugo developed the disease up to three years ago.
- Opinion
- [Reporter’s View] Real crisis will come after COVID-19
- by Kim, Jin-Gu Oct 05, 2022 06:11am
- Contrary to the hopes that peace will come with the end of the COVID-19 crisis so near, another crisis of the ‘three highs’ - high exchange rates, high interest rates, and high inflation – has now arrived. Experts are predicting shock waves at the level of the 1997 IMF crisis and the 2009 global financial crisis or severer. Externally, the exchange rate, trade balance, and current account are shaking at the same time. Internally, red lights are flaring in Korea’s growth rate, price level, and interest rates. The future outlook is also bleak. Negative prospects are pouring in, that the low growth will continue for the time being, resulting in fewer jobs and a contraction in investment. Some analysts believe we have already entered stagflation, in which high inflation and economic downturn occur at the same time. Obviously, the domestic biopharmaceutical industry cannot be immune to this macroeconomic trend. The high exchange rates, high interest rates, and high inflation constrain the pharma and bio companies from all directions. Anxiety is growing bigger and bigger, and with the growing anxiety, companies contract. Given that the long-term investments made by the industry are just beginning to bear fruit, concerns are being voiced that the potential of the K-pharmaceutical and bio industry will be nipped in the bud, without blooming to its full potential. The Korean pharmaceutical and bio industry is considered to have made good progress during the past 3 years in the COVID-19 crisis. Some companies have used the crisis as an opportunity to grow significantly or to attract large-scale investments. It is not that the industry has fared well, but it is difficult to say that the COVID-19 crisis has been overcome solely by the capabilities owned by Korea’s pharmaceutical and bio industry. Pharmaceuticals are consumer staples, therefore, the industry was not greatly affected by the surge of confirmed COVID-19 cases or strengthened social distancing measures, etc. Also, much of the cash released through the quantitative easing measures competitively carried out by countries had flowed into the industry. In such a sense, it is true COVID-19 did not greatly impact the pharmaceutical industry as much as other industries. The government believes that COVID-19 will turn into an endemic by early next year. The pandemic is finally coming to an end. With the declaration of an endemic so near in sight, the pharmaceutical and bio companies are now on the testing bed. How well the companies have built their foundation will be tested in the era of the ‘three highs.’ Experts have contrasting views on how long the factors of concern represented by the ‘three highs’ will last. However still, one thing certain is that the companies must now brace for the long-term recession that is certain to come. Executives would need to make cool-headed judgments about the situation and set the right direction. The real crisis has only just begun.
- Company
- Moderna's Spikevax bivalent Original/Omicron BA.1
- by Oct 05, 2022 06:11am
- Moderna announced on the 4th that it conducted Spikevax bivalent Original/Omicron BA.1 launch Webinar, a divalent vaccine containing omicron, on September 29. At the event, Jin Beom-sik, head of the Infectious Medicine Center at the National Medical Center, was the chairperson, and Kim Hee-soo, vice president of Moderna Korea's medical department, was the speaker. With a total of 2,124 participants, the next generation of COVID-19 showed keen interest in the vaccine by domestic medical staff. Spikevax bivalent Original/Omicron BA.1 is a next-generation bivalent vaccine that combines 25μg of the existing Moderna COVID-19 vaccine and 25μg of a vaccine candidate substance targeting the omicron mutation (BA1). On the 8th of last month, it was approved for emergency use by the Ministry of Food and Drug Safety as a vaccine to prevent COVID-19 over the age of 18. From the 11th, a divalent vaccine can be vaccinated. The main announcement on this day is phase 2/3 clinical data that evaluated the efficacy of Spikevax bivalent Original/Omicron BA.1. In this clinical trial, Spikevax bivalent Original/Omicron BA.1 met all major evaluation variables, including neutralizing antibody responses, compared to existing COVID-19 vaccines in participants without a history of COVID-19. The divalent vaccine booster shot increased the GMT for Omicron by eight times. Spikevax bivalent Original/Omicron BA.1 induced stronger neutralizing antibody transliteration for omicron sub mutants BA.4 and BA.5. Based on pre-vaccination, the geometric mean multiple increases (GMFR) for BA.4 and BA.5 mutations was 6.3 times that of the divalent vaccine, which was 3.5 times greater than that of the conventional vaccine. These results were consistent regardless of the presence or absence of COVID-19, including those aged 65 or older. Spikevax bivalent Original/Omicron BA.1 showed an effect consistent with the reactivity and safety profile of the currently approved booster. An official from Moderna Korea said, "According to the recently announced government's COVID-19 vaccination plan, timely vaccination with the latest vaccine is an effective way to protect the health of the public from the potential re-proliferation of COVID-19 this winter."
