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- 2026-04-12 18:23:58
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- Gov purchased ₩200 billion worth of COVID-19 vaccines
- by Chon, Seung-Hyun Mar 23, 2022 05:51am
- The COVID-19 vaccine, which incorporates technology from domestic bio companies, will be supplied for the first time in Korea. SK Bioscience announced on the 21st that it has signed a pre-purchase contract with the KDCA for the COVID-19 vaccine worth 200 billion won. The contract volume is 10 million inoculations, and SK Bioscience will sequentially supply the amount according to the Korea Centers for Disease Control and Prevention's inoculation plan when the development of GBP510 is completed. GBP510 is a candidate substance for the COVID-19 vaccine jointly developed by SK Bioscience with IPD. GSK's immune-enhancing technology was also used. Phase 3 clinical trials are currently underway. SK Bioscience self-evaluated, "Korea's No. 1 COVID-19 vaccine, which checks the safety and effectiveness of Phase III clinical trials including Koreans, will be supplied in Korea." SK Bioscience independently produces and supplies two of the five major COVID-19 vaccines licensed in advanced countries such as the United States and the EU (AstraZeneca and Novavax) in Korea. SK Bioscience began consignment production of the undiluted and finished product of the COVID-19 vaccine AZD1222 developed by AstraZeneca last year, and this year, it supplied Nuvaxovid, a synthetic antigen-type COVID-19 vaccine with high safety and proven efficacy. GBP510 was selected for the Wave2 project of the international organization CEPI and is undergoing clinical trials with a total development cost of $213.7 million. In the first half of this year, it is planning to obtain a domestic item license, the WHO emergency license, and the EUA by overseas country. Recently, Rolling Review documents have been submitted to the MHRA for prompt approval. Ahn Jae-yong, president of SK Bioscience, said, GBP510 is the result of SK technology, the government's willingness to leap forward as a biopower, and the cooperation of global organizations supporting vaccine development for public health rights." Starting with GBP510, we will develop products to prepare for various viral infectious diseases and establish ourselves as a leading company in the global vaccine market, he said.
- Product
- Butterfly effect caused by brand name purchase
- by Kim JiEun Mar 23, 2022 05:50am
- From Rx drugs to OTC drugs, front-line pharmacies have recently had much time since the outbreak of COVID-19. Some say that pharmacy sales are also the biggest boom since the division of labor. Obviously, sales of generic drugs for certain diseases in most pharmacies have increased. However, pharmacists point out that there are concerns about the current situation as sales increase due to increased OTC sales. From Rx to OTC Pharmacists are most concerned about the increased demand for OTC centered on consumers' specific brand name. Due to the incident that began with Director Jeong Eun-Kyeong's remarks, patients visited various pharmacies, so there was no stock of Tylenol. Nine months have passed since the outbreak in June last year, inventory of Tylenol has not been available at front-line pharmacies. Cold drugs Coldaewon, Theraflu, Cough syrup, Eunkyosan Ext., Pueraria Root have driven consumer demand. Due to the influence of SNS or online, demand has increased because a list of essential OTC drugs for COVID-19 home treatment has been shared on SNS or online. An official from a pharmacy chain said, "These days, consumers tend to stick to certain products or ingredients regardless of their diseases because they have such a strong belief in information they have encountered through the Internet or SNS." The official said, "In a series of situations, starting with the Tylenol crisis, followed by Coldaewon, Theraflu, Cough syrup, Eunkyosan Ext., and Pueraria Root, patients' unilateral nominations are prioritized over pharmacists' consultation and choice. I can recommend drugs depending on the patient's personal disease or condition through consultation with a pharmacist, but such an opportunity has disappeared." Accelerated cold-drug out of stock Butterfly effect brought about by demand for product name Some analysts say that the rapid influx of demand for certain generic drugs in the early stages of home treatment is the beginning of the current massive shortage of generic drugs related to colds. The demand for certain cold medicines has driven pharmacists to become anxious to secure inventory. They say that certain products are not easily purchased at pharmacies, stimulating consumer anxiety, leading to excessive demand for cold medicine. Pharmacists said that if the pharmacist had been able to choose and recommend products to suit the patient's symptoms or needs at a time when demand for cold medicine soared, the cold medicine shortage could have been less situation or delayed. A pharmacist in Seoul said, "Currently, there is generally no stock of products to sell when patients visit cold medicines, effects, or oriental medicine. Of course, demand has soared and this is the root cause of the cold medicine shortage crisis. However, it is true that it accelerated the shortage because it preferred certain products and certain ingredients." Pharmacist Lee said, "If the pharmacist had been able to combine or distribute drugs based on ingredients according to the patient's personal situation or disease, the current situation could have been further delayed." Pharmacist Lee added, "As demand is focused on Rx drugs and this leads to sold out, it has caused excessive demand due to anxiety."
- Policy
- Rozlytrek & Vitrakvi are likely to be listed in April
- by Lee, Tak-Sun Mar 22, 2022 05:54am
- Bayer Korea's Vitrakvi and Roche Korea's Rozlytrek completed drug price negotiations and are likely to register their benefits in April. Both drugs are used to treat solid cancer in adults and children with confirmed NTRK gene fusion. If NTRK gene fusion is confirmed, it can be administered regardless of cancer. According to the industry on the 21st, the two drugs are likely to complete drug price negotiations with NHIS and register their benefits in April. Rozlytrek and Vitrakvi were granted permission in April 2020 and May 2020, respectively. Rozlytrek and Vitrakvi are equally used in adult and pediatric solid cancer treatments with neurotic tyrosine receptor kinase (NTRK) gene fusion. Rozlytrek also has a local progressive or metastatic non-small cell lung cancer indication that is positive for ROS1 in adults. Rozlytrek showed 56.9% ORR in a clinical trial (STARTRK-2) conducted in patients with solid cancer positive for the NTRK fusion gene. More than half of the subjects were confirmed to have decreased tumors. Vitrakvi also showed 75% ORR in clinical trials of 55 people whose NTRK gene fusion was confirmed. The two drugs passed the HIRA's Cancer Disease Review Committee in May last year and were reviewed by the Drug Benefit Assessment Committee in November of the same year. As a result of the deliberation, Vitrakvi recognized the appropriateness of the benefit, but in the case of Rozlytrek, the appropriateness was recognized if the conditions for an additional drug reduction and an appropriate refund rate were accepted. Vitrakvi was also recognized for adequacy, but there was also a clue that Rozlytrek's cost-effectiveness evaluation results need to be further considered. The two drugs with the same efficacy were simultaneously placed on the same line and the evaluation was conducted. Since then, the two drugs have been negotiated with NHIS. However, they failed to reach a conclusion within 60 days, the deadline for negotiations, and began additional negotiations. The NHIS posted on its website that negotiations on the two drugs have been completed. An industry official said, "As announced by NHIS, negotiations on the two drugs have been completed and we understand that they will be reimbursed in April." If the two drugs are reimbursed, it is expected that new treatment benefits will be given to cancer patients whose NTRK gene fusion has been confirmed.
- Company
- Seqirus 'will introduce the first adjuvanted flu vaccine'
- by Mar 22, 2022 05:53am
- A multinational pharmaceutical company has bravely thrown its hat into the domestic influenza vaccine ring that is led by Korean companies such as GC Pharma and SK Bioscience, etc. The company, named Seqirus, is attempting to enter the Korean market equipped with the solid technology it accumulated through its sole focus on influenza vaccines. Seqirus is a vaccine company specializing in influenza vaccines that became the company it is after the influenza department of the Australia-based pharmaceutical company CSL acquired Novartis’s influenza vaccine business. The company has pursued vaccines, only influenza vaccines for over a century, and is known for its extensive influenza vaccine portfolio that covers a wide range of egg-based, cell culture-based, and adjuvanted vaccines. Its annual sales amount to ₩2 trillion. Seqirus's entrance into the Korean market was prompted by the rise of the COVID-19 pandemic after the sole manufacturer of cell-based vaccines in Korea, SK Bioscience, was unable to manufacture its influenza vaccines due to its manufacture of consigned COVID-19 vaccines. Thus, the Korean government granted emergency use authorization for Seqirus's cell culture-based flu vaccine ‘Flucelvax’ in Korea. Also, using the opportunity as momentum, Seqirus made the decision to start the direct supply of its egg-based Afluria that had been marketed through Boryung Biopharma until then. During an interview with Dailpharm, Jonathan Anderson, Medical Head of the International Region of Seqirus, said, “Although there are many excellent companies in Korea that already focus on the development and manufacture of influenza vaccines, Seqirus has strengths of owning various platforms in the area. As a research-based company, we are developing technology for cell culture-based vaccines, adjuvanted vaccines, and self-amplifying mRNA vaccines.” [Interview] Jonathan Anderson Medical Head of the International Region of Seqirus Among its various products, Seqirus has high expectations for its adjuvanted influenza vaccine ‘Fluad’ General flu vaccines can be less effective in immunocompromised elderly, or when the vaccine strain does not coincide with the epidemic, or due to egg-adaptations, etc. In such cases, adjuvanted flu vaccines can improve immune reaction and increase prevention. The ‘MF59’ used in Fluad is an adjuvant that had also been used in 2009 during the swine flu. ‘MF59’ is made using squalene that is produced in the liver, which induces an immune response in the injection site and promotes antigen uptake to increase immune response by activating T cells and B cells. In other words, the adjuvanted vaccine can achieve a strong antibody response even with a small amount. Anderson said, “Real-world results showed that the adjuvanted vaccine showed a better effect in elderly patients over the age of 65.” He added, “Many still get infected with influenza during the influenza season and progress to hospitalization or even death. With the social burden still high for influenza, adjuvanted vaccines could rise as a new alternative.” Anderson added that in terms of safety, the adjuvanted vaccine showed a higher rate of local reactions such as injection site pain than general vaccines, but the reactions were mostly mild or moderate and were resolved naturally over time. Based on its efficacy and safety data, Fluad was approved in 2020 in the US as the world’s first adjuvanted influenza vaccine allowed for use in people aged 65 years or older. Seqirus’s Korea, the Korean subsidiary of Seqirus is working to speed up the introduction of Fluad in Korea. As no adjuvanted flu vaccine exists in the Korean market yet, Fluad's approval by the MFDS is expected to change the domestic flu vaccine market. As Fluad has been introduced to Korea in the past, no separate clinical trial will be required for its introduction to Korea. Anderson said, “Seqirus plans to promptly introduce its vaccine portfolio to Korea. We will make the most effort to fully explain our data through close discussions with the healthcare authorities.
- Company
- GSK’s immuno-oncology drug Jemperli applies for approval
- by Eo, Yun-Ho Mar 22, 2022 05:53am
- Another immuno-oncology drug is set to soon be introduced to Korea. According to industry sources, GSK Korea has applied for the approval of its PD-1 inhibitor ‘Jemperli (dostarlimab),’ and is undergoing discussions with relevant authorities. If approved, Jemperli will become the third PD-1 inhibitor to be approved in Korea after ‘Opdivo (nivolumab),’ and ‘Keytruda (pembrolizumab).’ Unlike the other two drugs that started as a melanoma treatment, Jemperli was approved for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen by the FDA in April last year. In addition, Jemperli was additionally approved for adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumors in August of the same year. GSK plans to continue adding indications to endometrial cancer in Korea as well. Meanwhile, Jemperli demonstrated its efficacy through the multi-cohort GARNET trial that enrolled patients with dMMR recurrent or advanced endometrial cancer who have progressed on or following prior treatment with a platinum-containing regimen. In the trial, treatment with Jemperli resulted in an objective response rate (ORR) of 43.5%) and a disease control rate of 55.6%. The median duration of response (DoR) had not been reached in these patients, and the probability of maintaining response at six months and 12 months was 97.9% and 90.9%, respectively.
- Company
- Esophageal cancer, added to indication of Opdivo·Keytruda
- by Eo, Yun-Ho Mar 22, 2022 05:53am
- Cancer immunotherapys are advancing into the esophageal cancer area one after another. According to related industries, Opdivo (Nivolumab) and MSD's Keytruda recently were added esophageal cancer indications in Korea. Opdivo obtained final approval from the MFDS last month and Keytruda on the 7th. With this permission, Opdivo can be prescribed as an auxiliary therapy for adult esophageal or GEJ cancer patients with residual pathological diseases after CRT. The efficacy of this drug against esophageal cancer was confirmed through a phase III clinical CheckMate-577 study. As a result of the study, the median PFS period for patients treated with Opdivo after surgery was 22.4 months, twice as long as 11 months for placebo-treated patients. The median treatment period of the Opdivo treatment group was 10.1 months, and the placebo group recorded 9 months. Keytruda is the primary combination therapy. This drug can be prescribed in combination with platinum-based anticancer drugs in the primary of non-removable local progressive or metastatic esophageal cancer and gastroesophageal junction cancer. The effectiveness of Keytruda in esophageal cancer was demonstrated through a phase 3 clinical KEYNOTE-590 study. The combination therapy of Keytruda and 5-FU+Cisplatin demonstrated statistically significant OS and PFS improvements over 5-FU+Cisplatin in all pre-designated study groups. Combination therapy with Keytruda, 5-FU, and Cisplatin reduced the risk of death by about 27% compared to 5-FU+Cisplatin, and the risk of disease progression or death by about 35%. It was analyzed that Keytruda, 5-FU, and Cisplatin reduced the risk of death by 38% and the risk of disease progression or death by 49% compared to 5-FU+Cisplatin in the patient group with PD-L1 expression rate of 10 or higher. Meanwhile, Keytruda recently listed primary lung cancer therapy on the insurance benefit list. Opdivo has recently slowed the expansion of gastric cancer benefits, but has not passed the Cancer Disease Review Committee.
- Company
- Celltrion was fined 13.9 billion won
- by Kim, Jin-Gu Mar 22, 2022 05:53am
- Financial authorities imposed a fine of 13.9 billion won on three Celltrion companies that prepared and disclosed financial statements in violation of accounting standards. The Financial Services Commission held its fifth regular meeting on the 16th and decided on this. The fines decided at the meeting are 6 billion won for Celltrion, 6.04 billion won for Celltrion Healthcare, and 992.1 million won for Celltrion Pharmaceutical. Fines of 415 million won were imposed on two people, including Celltrion CEO, and 483.9 million won on three people, including Celltrion Healthcare CEO, respectively. Penalties imposed on the three Celltrion companies and company managers totaled 13.93 billion won. An accounting firm that was judged to have neglected the audit process was also fined. 1.065 billion won was imposed on EY accounting firms and 410 million won on KPMG. Earlier on the 11th, Securities & Futures Commission under the Financial Supervisory Commission decided on measures such as recommending the dismissal of executives in charge and designating auditors for serious violations in the accounting process of the three Celltrion companies. According to the results of the investigation and supervision, these companies committed violations such as overestimating development costs, sales, and inventory assets, or not listing transaction notes with related parties in their financial statements. The Securities & Futures Commission has decided not to file a complaint with the prosecution, saying it is difficult to say that the violation was intentional. Accordingly, Celltrion was not subject to the Korea Exchange's transaction suspension.
- Company
- Concerns over fungal infection due to COVID-19
- by Eo, Yun-Ho Mar 21, 2022 05:56am
- There is concern about the gap in fungal infections due to the re-proliferation of COVID-19. The most commonly reported fungal infections in COVID-19 patients include COVID-19 associated pulmonic aspergillosis (CAPA), COVID-19 associated mucomycosis (CAM), and Candida auris. These COVID-19-related fungal infections can lead to serious diseases and deaths. If left untreated, CAPA-related morbidity reaches up to 80%, and CAM mortality is close to 100%. CAPA is a secondary fungal infection mentioned as a clinical complication of COVID-19 infection in the government's COVID-19 response guidelines, and CAPA has been confirmed in Korea. ◆The number of patients who need antifungal drugs in Korea also surged According to the KSID Autumn Conference presentation data in November last year, 57.8% (126/218) of 218 patients with severe COVID-19 were treated by ICU, and the cumulative incidence rate of CAPA related to COVID-19 was 4.5% (10/218) and 11.2% (10/89) of COVID-19 patients admitted to intensive care units. In-hospital mobility was 11.9% (26/218) in COVID-19 patients and overall mobility in CAPA patients was 50% (5/10). It was found that CAPA secondary infection affected the survival of COVID-19 patients. COVID-19-related CAPA mainly occurs in severe COVID-19 patients who use ventilators in intensive care units, and patients often show non-specific symptoms, and it is difficult to diagnose because samples need to be collected deep in the lungs. Choo Eun-joo (Professor of Infectious Medicine at Bucheon Hospital at Sooncheonhyang University) said, "As experienced through the COVID-19 pandemic, it is important to preemptively secure drugs necessary for treating acute infectious diseases at the government level. New antimicrobial and antifungal drugs, which are essential for treating infectious diseases, are having difficulties in development around the world despite high clinical needs," she said. Surgical surgery and antifungal agents including Amphotericin B, Posaconazole or Isavuconazole can be used for COVID-19-related CAM treatment, and Voriconazole is not recommended for CAM treatment. Posaconazole has indication for the treatment of CAPA patients in Korea, so if CAPA or CAM is suspected in COVID-19 patients, Cresemba (Isavuconazole) is the only drug that can be used preemptively at the same time as fungal culture. Cresemba is an antifungal agent that has indications for both invasive CAPA and invasive CAM. Cresemba was designated as a national essential drug in June 2021. This drug is licensed and used in March and October 2015, respectively, in the United States and Europe (EMA), but it is not reimbursed in Korea. Professor Choo said, "In Korea, new antibiotics are allowed, but insurance benefits have not yet been registered. There are no antibacterial and antifungal drugs that have entered the right to benefit for the past five to seven years. Drugs necessary to treat fatal infectious diseases should not be evaluated only from an economic perspective, as they play a key role in preventing the spread of infectious diseases as well as the survival of individual patients."
- Product
- Paxlovid shortage to be resolved with Molnupiravir approval?
- by Jung, Heung-Jun Mar 21, 2022 05:55am
- The shortage of Paxlovid at pharmacies is expected to be partially resolved with the government's emergency approval of Merck (MDS)’s oral COVID-19 treatment ‘molnupiravir.’ On the 18th, the Central Disease Control Headquarters had announced that 88,276 courses of Paxlovid remain in stock in Korea. Also, with the grant of RAT(rapid antigen test)-based confirmation of COVID-19, the average daily prescription of Paxlovid increased over twofold from 2,404 in the second week to 5,184 in the third week of this month. With more than 300,000 new confirmed cases occurring steadily, the domestic inventory of Paxlovid is expected to be exhausted by the end of this month. The government is planning to introduce additional courses of Paxlovid in Korea soon, but many base pharmacies are already out of stock and unable to dispense the drug. Pharmacy A at Seoul said, “The amount and period of Paxlovid shipments aren’t constant, but we receive around 100 courses per shipment, and this doesn’t last a week at the current prescription rate. We have none in stock right now.” It is expected that the government seems to be working to expand treatment options through the emergency approval of molnupiravir. The government had previously conducted a review on the emergency use of the drug in November last year but had withheld approval due to poor preventive effects. Although the MFDS did not disclose the specific schedule for approval, the government did express its intention to start the review. If so, the drug is expected to be approved this month at the earliest. The Korean government had previously signed an advance purchase agreement with Merck for 242,000 courses of its drug. If the drug is approved under the emergency approval process, the drug is expected to be distributed through the existing base pharmacies because a real-time demand monitoring system has been well established in the pharmacies and is easily manageable by the local government. Pharmacy A said, “We have received no news about molnupiravir yet, but since there are already enough base pharmacies, I don’t think the government will separately designate more for the drug.” However, as the method of administration and eligible sublets differ for the two drugs, additional education and guidance will be provided for the use of molnupiravir. Both drugs are taken twice a day for 5 days, but the total amount of capsules taken differs, 30 for Paxlovid and 40 for molupiravir. Also, the kind of side effects that arise and the subjects allowed for use differ. Earlier, the Korea Pharmaceutical Association had prepared a medication guide for patients using Paxlovid. Therefore, a medication guide for molnupiravir is also expected to be prepared after its approval and indication are finalized.
- Company
- 5 companies challenge breast cancer drug Ibrance’s patent
- by Kim, Jin-Gu Mar 21, 2022 05:55am
- Pic. of Ibrance The number of companies challenging the patent of Pfizer’s breast cancer treatment ‘Ibrance (palbociclib)’ has increased to 5. According to the pharmaceutical industry, Boryung Pharmaceutical, Shinpoong Pharm, Daewoong Pharmaceutical, and Samyang Holdings had filed a series of claims to confirm the passive scope of rights on Ibrance’s crystalline form patent. Kwang Dong Pharmaceutical had been the first to challenge the patent on the 3rd of this month. With the additions, a total of 5 companies will be attempting to avoid the crystalline form patent of Ibrance. In the case of Kwang Dong Pharmaceutical, the company had also received approval for a bioequivalence test to develop a generic version of Ibrance. Ibrance’s crystalline form patent will expire on February 8th, 2034. If the companies succeed in avoiding the patent, they will be able to release a generic version after the drug’s substance patent expires on March 22nd, 2027. The substance patent was originally set to expire on January 10th, 2023, but Pfizer had extended the duration of the patent by over 4 years for the time taken on clinical trials and permits. If generic companies additionally challenge to invalidate the extended term of the patent, it is possible that the date of release of the generic products may be further advanced. Until now, generic companies have not aggressively pursued patents challenges for anticancer drugs as the chances of success of the generic is not high due to the high preference of original drugs in the field. Therefore, the development and release of generics after overcoming the patents was not profitable for the companies. Despite the barriers, the reason why so many companies are challenging Ibrance’s patent is because of the reputation built by the drug in the breast cancer treatment market. According to the market research institution IQVIA, Ibrance has continued to expand by double-digit sales every year since it was approved in Korea in August 2016. In fact, Ibrance's sales, which recorded ₩6.6 billion in 2017, then to ₩25.3 billion in 2018, ₩43.7 billion in 2019, ₩57.3 billion in 2020, and to ₩65.6 billion in 2021. Also, the fact that domestic companies started to make an impact in the generic market for anticancer drugs, which had been considered impenetrable, can also be a reason for the increased challenges filed against Ibrance. Recently, Hanmi Pharmaceutical, Samyang Holdings, Boryung Pharmaceutical, and Chong Kun Dang had been showing significant performance in the market. Hanmi had released its generic version of Bayer’s liver cancer treatment Nexavar, ‘soranib,’ Samyang released BMS’s Taxol generic ‘Genexol,’ Chong Kun Dang released generic version of AstraZeneca’s lung cancer treatment Iressa, ‘Iretinib' to chase the market occupied by original drugs.
