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- 2025-12-25 04:43:00
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- Cephalosporin CMOs discontinue or downsize business
- by Kim, Jin-Gu May 03, 2022 06:09am
- CMO companies that have been manufacturing cephalosporin antibiotics upon consignment are either shutting down or reducing their business one after another. Given the limited number of domestic manufacturers, existing consignors are in a rush to find new consignees. Due to this, industry concerns are rising over how this breakaway among consignees may accelerate due to the increased production cost and lead to an antibiotic crisis in the second half of the year. ◆3 CMOs discontinue or reduce manufacture in 6 months According to industry sources on the 3rd, A mid-sized pharmaceutical company, Company A, recently delivered its plan to discontinue the manufacture of cephalosporin to its consignees. The company had agreements to contract manufacture 4-5 cephalosporins. By product, 4 to 10 pharmaceutical companies had entrusted the manufacture of their products to this company. An official from Company A said, “We haven’t officially decided to withdraw the business, but are considering up to withdrawal in our final review.” Other companies are also discontinuing or reducing contract manufacture of cephalosporins one after another. A large pharmaceutical company, Company B, had reduced its CMO business for cephalosporin last year. Recently, another large pharmaceutical company, Company C, decided to discontinue its cephalosporin CMO business. An official from Company C said, “We are not planning to completely close down the cephalosporin business. We plan to continue selling our products but change our directly-manufactured products to contract manufacturing products.” In the case of the mid-sized pharmaceutical company, Company D, their contract manufacture of cephalosporins on consignment has been temporarily suspended due to its factory relocation process for the past 2 years. Consequently, all the consignors that hired the CMOs above for their cephalosporin products now have to find new CMOs. Among the 10 companies in Korea that manufacture cephalosporin antibiotics upon consignment, currently, the manufacture of cephalosporins in at least 4 companies is disrupted. The industry estimates that there will be more companies planning to discontinue or reduce the manufacture of cephalosporins. An official from a cephalosporin CMO said, “With many major CMOs leaving the field, not many CMOs that manufacture cephalosporin antibiotics are left in Korea now. This is why there has been a significant increase in the number of inquiries about the consignment production of cephalosporins. We are asking some pharmaceutical companies for their understanding as we cannot accept all the manufacturing requests.” he explained. ◆Triple distress due to ’surge in raw material prices+fixed supply price+reduced prescriptions' CMO companies that are considering market withdrawals say that ‘it is not profitable' to continue the business. The increased price of raw materials and despite the fixed supply price maintained by national insurance have deteriorated profitability. Most of the major raw materials used to manufacture cephalosporin antibiotics are imported from China and India. The price of such raw materials has increased 10-20% going through the COVID-19 crisis. And the recent rapid changes in the major exporter China’s internal situation have left companies with difficulty obtaining even these materials. An official from a CMO said, "The Chinese government stopped the operation of raw material factories for 3-4 months earlier this year due to their hosting of the Winter Olympics. Also, the lockdown of major cities in China has due to the resurge of COVID-19 cases, further decreasing the supply of raw materials.” He added, “Meanwhile the price of the products has not changed at all as they are listed for reimbursement in the National Health Insurance. Labor costs have also increased significantly recently. We cannot even attempt to maximize profit by increasing production due to the 52-hour workweek rule.” Another CMO official said, “The is almost no profit in manufacturing first or second-generation cephalosporins. Their profitability has worsened with the significantly reduced use of such antibiotics. Our company has discontinued contract manufacture the first and second-generation antibiotics, and will continue to manufacture the other third and fourth generation antibiotics.” The industry expressed rising concerns that if prolonged, the situation may worsen and result in a shortage of cephalosporin supply in Korea after this fall. An official from the pharmaceutical industry said, “With the existing CMOs increasing manufacturing of cephalosporin antibiotics, I believe no issue will rise for now. However, after the COVID-19 crisis subsides and the number of respiratory infections increases to the level recorded in the average year, there is a possibility that a supply shortage of cephalosporin antibiotics will arise.” Cephalosporins, or cepha-class antibiotics, are widely used to treat respiratory conditions including pneumonia, pharyngitis, tonsillitis, and bronchitis. Since the Ministry of Health and Welfare has mandated the separation of its manufacturing facilities since 2012, it has been produced only in plants equipped with dedicated lines for the manufacture of cephalosporins.
- Company
- GSK Consumer Healthcare Korea appoints Dongwoo Shin as CEO
- by May 03, 2022 06:09am
- Dongwoo Shin, General Manager of GSK Consumer Healthcare Korea GSK Consumer Healthcare Korea announced that it has appointed Dongwoo Shin (55) as the new head of its Korean subsidiary. The new General Manager has graduated from Hanyang University with a BA in Philosophy and a MA in Philosophy from the University of Rochester. After serving in various companies including Coca-Cola Korea, 20th Century Fox Home Entertainment Korea, and the Consumer Healthcare division of L'Oreal Korea, Shin was appointed Head of Consumer Healthcare Business at Sanofi Korea. Since then, Shin has severed as the head of various other pharmaceutical companies, including as the General Manager of Consumer Healthcare at Pfizer Korea and the General Manager of GSK Consumer Healthcare Hong Kong. The new GM Shin owns expertise in leading the consumer business with company and brand growth strategy development, innovative driving force, and optimized organizational operations, and is known to have a high understanding of the consumer health business as he had led the consumer health care business of major global pharmaceutical companies such as Pfizer and Sanofi from their initial establishment. While serving as the GM of GSK Consumer Healthcare Hong Kong, Shin had successfully merged with Pfizer Consumer Healthcare and achieved a successful business turnaround in just 2 years through stable organization and innovative management. As the General Manager of GSK Consumer Healthcare Korea, Shin will complete the company’s spin-off from GSK and drive the company’s transformation and launch as Haleon. Meanwhile, GSK Consumer Healthcare had globally announced its new official name as ‘Haleon’ in February and is preparing its spin-off from GSK mid-year. In consideration of the time required for preparations and changing product packaging, the company will retain its current company name (GSK Consumer Healthcare Korea) for the time being.
- Company
- COVID-19 vaccine SKYCovione has been applied
- by Kim, Jin-Gu May 03, 2022 06:08am
- SKYCovione, a coronavirus vaccine developed by SK Bioscience SK Bioscience announced on the 29th that it has applied for an item permit for the COVID-19 vaccine candidate GBP510. SK Bioscience predicted that it will be able to commercialize it in the second half of the year after obtaining approval from the MFDS. The name of the vaccine applied through item approval was SKYCovione Multi Injection. If the MFDS approves the item license, SKYCovione will be the first COVID-19 vaccine in Korea. SKYCovione's item approval is carried out through a rapid approval process for official item approval, not EUA. If approval is completed, it is expected to be commercialized during the second half of the year. In March, SK Bioscience signed a domestic supply contract with KDCA and SKYCovione for a total of 10 million doses. SKYCovione is immunogenic with only one inoculation. SKYCovione will be supplied around the world through COVAX Facility after obtaining a domestic item license. In addition, SK Bioscience plans to register SKYCovione on the WHO Emergency Use List (EUL) and acquire EUA by foreign countries such as Europe. SKYCovione is a synthetic antigen-type COVID-19 vaccine developed in collaboration with global organizations and companies centered on SK Bioscience. Institute for Protein Design (IPD) and SK Bioscience jointly developed it. From the early stages of development, it received funding from the Bill & Melinda Gates Foundation (BMGF) and the Infectious Disease Prevention Vaccine Union (CEPI). In addition, GSK's Adjuvant (Adjuvant) AS03 was applied to increase the immune response and induce a high level of neutralizing antibodies. SK Bioscience announced that it has confirmed excellent immunogenicity and safety in the recently completed phase 3 clinical trials. Phase 3 clinical trials were conducted on 4,037 adults aged 18 or older in six countries, including Korea, Thailand, Vietnam, New Zealand, Ukraine, and the Philippines. Vaxzevria, AstraZeneca's COVID-19 vaccine, was examined for the immunogenicity and safety of SKYCovione as a control vaccine. As a result, it was found that all of them had superior immunogenicity and safety compared to Vaxzevria. At the time of SKYCovione's second inoculation, neutralizing antibodies were formed 2.93 times higher than that of the control vaccine. SKYCovione's antibody conversion rate (subjects with a quadruple increase in neutralizing antibodies after inoculation) was 98%, which was more than 10% higher than the antibody conversion rate of 87% of the control vaccine, showing a statistically significant difference. Even in the elderly aged 65 or older, the antibody conversion rate of those who were vaccinated with SKYCovione exceeded 95%, showing a significant difference compared to the control vaccine (79% of the elderly antibody conversion rate). The cellular immune response, which plays an important role in lowering the severity of COVID-19 infection, was also at the level of equal to or higher than that of the control vaccine. In the case of safety, SKYCovione showed an abnormal response rate similar to that of the control vaccine. It was confirmed that no special safety problems were reported during the clinical trial period. SK Bioscience expects SKYCovione to give new vaccine options to some classes who refused to vaccinate the existing COVID-19 vaccine. Unlike the existing COVID-19 vaccine with new technology, the synthetic antigen method has been widely used in various vaccines so far, proving its safety. In addition, unlike existing mRNA vaccines that require ultra-low temperature storage, refrigerated distribution and long-term storage of 2-8 degrees will contribute to increasing vaccination rates in underdeveloped countries that do not have expensive ultra-low temperature facilities. SK Bioscience plans to conduct additional clinical trials so that SKYCovione can be widely used in quarantine in the endemic era. These include booster shot clinical trials for existing COVID-19 vaccinations, cross-vaccination booster shot clinical trials, clinical trials for adolescents, and extended clinical trials for mutant viruses such as omicrons. In particular, phase 3 clinical trials for those aged 12 to 17 are expected to enter within the first half of the year. Roger Connor, CEO of GSK's Global Vaccine Business Department, said, "As COVID-19 endemics are predicted, demand for vaccines that are easy to distribute is expected to continue to increase." He said, "SKYCovione, which combines GSK immune enhancers, will play a very important role in the prevention of the endemic era." Ahn Jae-yong, president of SK Bioscience, said, "It is a new feeling that the first COVID-19 vaccine in Korea has reached the final stage for release." He said, "We will do our best to continue to cooperate with global organizations and companies to become an innovative bio company that competes on the global stage without being complacent."
- Company
- Generics for Xarelto with sales of ₩60 billion are com
- by Kim, Jin-Gu May 03, 2022 06:08am
- Competition of generic products is in full swing in the new oral anticoagulant (NOAC) market of Rivaroxaban ingredients worth 60 billion won a year. With more than 20 companies' generics pouring in in earnest since the fourth quarter of last year, Chong Kun Dang seems to be one step ahead. In the pharmaceutical industry, it is analyzed that this is the result of Chong Kun Dang's preoccupation with the market by pushing ahead with the release of generic before the patent expires. ◆Expanding the influence of generics for Xarelto According to UBIST, a pharmaceutical market research firm, on the 23rd, the market size of outpatient prescriptions for Rivaroxaban-based anticoagulants in the first quarter is estimated to be 16.8 billion won. It increased by 13% compared to 14.8 billion won in the first quarter of last year. It is analyzed that the overall market size has also expanded with the addition of generic. During the period, the prescription amount of Xarelto, an original product, fell 4% from 14.8 billion won to 14.2 billion won. Analysts say that growth has decreased due to the release of generic. Bayer has delayed the reduction of drug prices due to generic registration through administrative litigation. Generic posted a total of 2.6 billion won in prescription performance in the first quarter of this year. Since the first generics came out in the second quarter of last year, they are gradually increasing their influence. As of the first quarter of this year, the market share of Rivaroxaban reached 16%. ◆Chong Kun Dang's Rivaroxaban ranked first among generics While generic is gradually expanding its influence, Chong Kun Dang's Rivaroxaban is located at the highest position among generic products. The first quarter prescription is 600 million won. This is interpreted as the result of Chong Kun Dang's preoccupation with the market by pushing ahead with the release of generic before the patent expires. Chong Kun Dang released Riroxia as generics for Xarelto in May last year. At that time, it was five months before the expiration of the Xarelto patent (October 2021). In the pharmaceutical industry, it is interpreted as Chong Kun Dang's winning move to dominate the Xarelto's generic market. Based on the victory of the Eliquis patent dispute, domestic companies have sold generics for Eliquis since July 2019. Sales of generics for Eliquis were suspended in April last year when the Supreme Court overturned the first and second trials and sided with the original company. Chong Kun Dang was the most active in promoting generics for Eliquis, causing great damage. In this situation, it was quickly replaced by generics for Xarelto, which has only a few days left before the expiration of the patent. Chong Kun Dang's winning move is somewhat correct. The cumulative prescription recorded by Chong Kun Dang over the past 11 months is 1.8 billion won. It is higher than the prescription performance (1 billion won) for 11 months after the release of generics for Eliquis. ◆ Since October last year, market competition is expected to heat up The pharmaceutical industry predicts that competition between generics for Xarelto will intensify in the future. Except for Chong Kun Dang, other generic companies joined the market in earnest in the fourth quarter of last year. Since October last year, when the Xarelto patent expired, 22 companies, including Samjin Pharmaceutical and Hanmi Pharmaceutical, have poured out 66 items of generics for Xarelto. It was five months after Chong Kun Dang entered the market. They are rapidly expanding their influence. Excluding Riroxia, the total prescription amount of generic for Xarelto increased 2.5 times from 400 million won in the fourth quarter of last year to 1 billion won in the first quarter of this year. After the second quarter, competition for generic is expected to intensify. This is because more than 20 companies have yet to officially release their products after receiving Xarelto permission and benefits. Generics are predicting aggressive promotions with price competitiveness. Based on Rivaroxaban 10mg, the upper limit price of Riroxia is 1,312 won. Most of the remaining companies listed at 1,115 won. Samjin Pharmaceutical's generic costs 770 won, and Ildong Pharmaceutical's generic costs 760 won.
- Company
- Nerlynx reattempts at reimb after failing CDDC review
- by Eo, Yun-Ho May 02, 2022 06:03am
- An adjuvant therapy drug for breast cancer, Nerlynx, that failed to receive reimbursement in its first attempt is reattempting reimbursement in Korea. According to industry sources, Bixink Therapeutics plans to apply for insurance benefits for its oral HER2 inhibitor Nerlynx (neratinib) in the second half of this year. The drug reached deliberations by the Cancer Disease Deliberation Committee in February, but the committee did not reimbursement standards for the drug. Nerlynx, which was originally developed by the US-based Puma Biotechnology, was first approved FDA approval as an extended adjuvant treatment for early-stage HER2-positive breast cancer in July 2017. Its indication in the US had been extended to the treatment of metastatic HER2-positive breast cancer in February 2020. Bixink introduced Nerlynx to Korea in October last year as ‘extended adjuvant therapy for patients with early-stage HER2 receptor-positive and hormone receptor-positive breast cancer who have completed adjuvant(postoperative) trastuzumab-based therapy less than one year ago.’ Nerlynx has received attention for being effective in brain metastasis by penetrating the blood-brain barrier (BBB), which had been considered a limitation among existing drugs. In fact, Nerlynx has been recommended in the US 2022 NCCN guidelines and the 2022 Korean clinical practice guideline for the treatment of early-sate breast cancer and metastatic breast cancer. However, as Korea’s reimbursement system is conservative towards accepting maintenance therapies, whether Nerlynx may pass the tight barrier and be listed for reimbursement remains to be seen. Joohyuk Sohn, Professor of Medical Oncology at Shinchon Severance Hospital said, “Recurrent or metastatic breast cancer cases that occur from relapse in patients with early-stage breast cancer lead to serious life-or-death situations. I hope that the addition of Nerlynx to the existing standard of care will help increase the number of cured patients in the field of high-risk HER2-positive breast cancer.” Meanwhile, Nerlynx reduced the risk of recurrence or death by 42% and the risk of brain metastasis or death by 59% in women with early-stage HER2-positive breast cancer in the long term in a 5-year follow-up study.
- Company
- Will the flu vaccine market rebound?
- by May 02, 2022 06:03am
- As the obligation to wear outdoor masks is lifted from today, attention is being paid to whether there will be a new change in the influenza vaccine market this year. This is because the importance of flu vaccination increases as the possibility of flu infection, especially COVID-19, increases if taking off the mask. Prime Minister Kim Bu-gyeom announced a change in the guidelines for wearing masks at a meeting of the COVID-19 Central Disaster and Safety Countermeasure Headquarters on the 29th of last month. According to the announcement, the obligation to wear a mask outdoors will be lifted from May 2. More than 50 people who are at high risk of infection do not have to wear masks except when watching rallies, events, performances, and sports games. The lifting of the obligation to wear outdoor masks is also expected to change the flu vaccine market. Recently, the flu vaccine market has drawn a sharp inflection line with COVID-19. According to the MFDS, the flu vaccine, which was approved for national shipment in 2020, reached 30.4 million doses, up 20% from the previous year, but decreased to 28.56 million doses last year. The industry expects that the return rate of flu vaccines will also increase by more than 10% this year. This is because the number of consumers looking for a flu vaccine decreased as the flu incidence rate fell during the COVID-19 pandemic. According to the KDCA, the vaccination rate for the elderly was 73.0% last season (2020-2021), 12.0%p lower than the target vaccination rate of 85.0%. The infant vaccination rate was 73.4% and 50.4% respectively for the first and second subjects, which were 6.6%p and 9.6%p lower than the target vaccination rate. Experts predict that the possibility of catching the flu will increase if both social distancing and wearing masks are lifted this year. If COVID-19 becomes an endemic disease, there will be more cases of both flu and COVID-19. Kim Yoon-kyung, a professor of pediatrics at Korea University Ansan Hospital, said, "The probability of simultaneous infection will inevitably increase if the COVID-19 virus spreads again in a situation where there is a risk of infection because the influenza vaccine is not inoculated. Currently, in the case of RS virus without a vaccine, cases of simultaneous infection with COVID-19 are quite confirmed, he said. "In the case of simultaneous infection, not only the severity of the disease increases, but treatment can be very difficult due to quarantine problems." In a survey of 500 domestic medical staff conducted by Seqirus Korea, a specialized flu vaccine developer, 7 out of 10 respondents (69.4%) would become more important after the COVID-19 pandemic, and 94% recommended flu vaccinations to visiting patients. Distrust of vaccines in general is pointed out as a decrease in the inoculation rate. This is because the public's view of the entire vaccine has changed negatively as side effects of the COVID-19 vaccine have been reported. Professor Kim said, "When concerns about certain vaccines grow, the other vaccines are avoided. However, since the influenza vaccine has been safely inoculated for so long, the society is also emphasizing this point and finding ways to overcome concerns. As influenza is a virus that can be as powerful as COVID-19 if antigenic mutations occur at any time, it is very important to prevent it with continuous vaccination."
- Company
- Rozlytrek can be prescribed with reimb in Korea
- by Eo, Yun-Ho May 02, 2022 06:02am
- The tumor-agnostic drug Rozlytrek may now be prescribed at general hospitals in Korea. According to industry sources, Roche Korea’s NTRK(Neurotrophic tyrosine receptor kinase) targeted anticancer therapy Rozyltrek (entrectinib) has passed the drug committees of medical institutions including the Seoul National University Hospital, Severance Hospital, and Chungnam National University Hospital. With its competitor, Bayer Korea’s Vitrakvi (Larotrectinib) also being prescribed in SNUH since Q1 this year and both drugs being applied insurance benefit from this month, prescriptions for the drugs are expected to start in earnest in the field. The two drugs may be used in most tumor types with identified NTRK gene fusions. However, reimbursement for the drugs is limited to types of tumors mentioned in the NCCN guidelines. Rozlytrek, which was approved as an orphan drug in April last year may be prescribed for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have an NTRK gene fusion without a known acquired resistance mutation and for adult patients with locally advanced ROS1-positive or metastatic NSCLC. Rozlytrek was approved based on Phase I/II STARTRK-NG trial on pediatric patients, as well as the pivotal Phase II STARTRK-2 and Phase I STARTRK-1 and ALKA-372-001 trials. In the Phase II STARTRK-2 study, Rozlytrek reduced tumors in more than half (objective response rate [ORR] = 56.9%) of people with NTRK fusion-positive solid tumors. Objective responses to Rozlytrek were seen across 10 different solid tumor types with a median duration of response (DoR) of 10.4 months. Also, the sub-analysis results of Rozlytrek in Asians presented at the ESMO Asia 2020 that was held last year gained much attention. The sub-analysis results in Asians showed that the ORR was 69.2%, the median DoR 10.4 months, and the median progression-free survival (PFS) 14.9 months in 13 patients with NTRK gene fusion-positive solid tumor who received Rozlytrek. However, the overall survival rate was not provided. The median ORR was 69.9% and median DoR 14.9% in ROS1-positive NSCLC patients, with a median OS of 28.3 months and median PFS of 13.6 months. Ahn Myung-Ju, professor of Hemato-Oncology at Samsung Medical Center said, “I hope the introduction of Rozlytrek in Korea and the clinical evidence that confirmed the drug’s potential in Asians will aid the establishment of a virtuous cycle of precision medicine in Korea, a cycle which provides personalized treatment according to the patients’ genetic characteristics for rare cancer patients who had no therapeutic alternatives and their treatment information leading back to research and development.”.
- Company
- Daewoong - AZ Targets Asian Market with Crezet
- by Chon, Seung-Hyun May 02, 2022 06:02am
- From the third row on the left, Woo Jung-ja, executive director of AstraZeneca Korea, Kim Yoon-kyung, CEO of AstraZeneca Korea, CEO Kim Sang-pyo, CEO of Daewoong, and Park Sung-soo, general vice president of DaewoongDaewoong Pharmaceutical, along with AstraZeneca Korea, is pushing to target the Asian market for Crezet, a hyperlipidemia treatment. Daewoong Pharmaceutical signed a cooperative contract with AstraZeneca Korea on the 27th and agreed to push for Crezet exports to Indonesia, Thailand, the Philippines, and Malaysia. Crezet is a composite of Rosuvastatin Calcium and Ezetimbe. The signing ceremony was held at AstraZeneca headquarters in Gangnam-gu, Seoul. Jeon Seung-ho, CEO of Daewoong Pharmaceutical, Park Sung-soo, vice president of Daewoong Pharmaceutical, and Kim Sang-pyo, CEO of AstraZeneca Korea, Jo Feng, president of AstraZeneca Asia, and presidents of Indonesia, Thailand, Philippines, and Malaysia participated online. With this contract, the two companies plan to apply for Crezet's permission in Thailand, the Philippines, and Malaysia next year, starting with Indonesia this year. Daewoong will be in charge of obtaining permits, producing and exporting products, while AstraZeneca Korea will be in charge of distributing and selling products in the country. The total hyperlipidemia market in four countries, including Indonesia, is about $622 million (about 750 billion won), and demand for complex drugs that have improved drug convenience is also steadily increasing. Daewoong's own hyperlipidemia treatment Crezet is a Rosuvastatin Calcium and Ezetime complex that has an excellent effect on LDL-cholesterol drop, lipid level improvement, and delay in Atherosclerosis progression. Phase 3 studies have proven excellent safety, and it is highly convenient to take medicine because it can be taken once a day regardless of meals. Jo Feng, president of AstraZeneca Asia, said, "Based on the expertise, leadership, and partnership with Daewoong in the Asian chronic disease treatment market, we will cooperate to deliver good options for patients to maintain a better quality of life." Kim Sang-pyo, CEO of AstraZeneca Korea, said, "AstraZeneca has continued to invest to grow together through cooperation with domestic partners striving to promote health care. This agreement will mark a new milestone in our partnership with Daewoong Pharmaceutical, which has continued to grow in the domestic and Asian markets." Jeon Seung-ho, CEO of Daewoong Pharmaceutical, said, "Based on Daewoong Pharmaceutical's excellent production and global licensing capabilities, we will advance Crezet to four Asian countries and develop it as a good opportunity for the two companies to cooperate in the global market beyond Korea."
- Company
- The size of the DPP-4 diabetes Rx market is decreasing
- by Apr 29, 2022 05:42am
- DPP-4 inhibitor-based drugs used to treat diabetes continue to decline this year. Sales of prescriptions for major products such as Janumet, Trajenta, and Galvus fell one after another. LG Chem's Zemimet, which rose to No. 1 in the market last year, is the only top-tier item to grow, recording 23 billion won in quarterly prescriptions. According to UBIST, a pharmaceutical market research firm on the 29th, the market for diabetes treatments affiliated with DPP-4 inhibitors in the first quarter was estimated at 151.2 billion won. It decreased 2.2% from 154.6 billion won a year earlier. The top six products, which record more than 10 billion won in quarterly prescriptions, saw their prescriptions fall. Representatively, MSD's Januvia series, which has led the DPP-4 inhibitor market, all showed a decline. Januvia recorded 10.7 billion won, down 7.1% from the previous year. During the same period, sales of Janumet and Janumet XR also fell 6.6% and 0.7%, respectively, to 18.4 billion won and 12.4 billion won. It is analyzed that the reduction in the drug price of the Januvia series had a partial effect on the reduction of prescription amount. MSD voluntarily lowered the drug price of the Januvia series in February due to a trade-off agreement with the government. It is a condition to expand Keytruda benefits, an immuno-cancer drug with a high financial burden. Since March, drug prices in the Januvia series have fallen by an average of 6%. Sales of Beringer Ingelheim's Trajenta and Trajenta Duo also fell slightly. Trajenta fell 2.0% year-on-year to 15.3 billion won and Trajenta Duo fell 1.2% to 16.4 billion won, respectively. Galvus and Galvusmet fell 25.0% and 18.0% respectively last quarter to 1.6 billion won and 7.8 billion won in prescriptions. Hanmi Pharmaceutical, Angook Pharmaceutical, and Angooknewpharm, which acquired generic for exclusivity as salt-changing drugs, announced the release of generic for Galvusmet in January. In March, more than 10 generics poured out. Among products from multinational pharmaceutical companies, AstraZeneca's Onglyza series also fell 5.6% to 6.7 billion won this year from 7.1 billion won last year. ◆Zemimet of LG Chem, which ranked first, will grow 7% this year LG Chem, the No. 1 DPP-4 inhibitor market, continued to grow despite the drop in prescriptions by multinational companies. Zemimet, a domestic DPP-4 inhibitor developed by LG Chem, increased by 7.0% from the same period last year and raised the prescription amount by 23 billion won. There is a difference of about 5 billion won from second-place Janumet. Single-agent Zemiglo also rose 3.4% from 9.4 billion won to 9.7 billion won. Zemimet recorded 90.8 billion won in annual prescriptions last year. It beat Janumet, which was the No. 1 market leader for the first time last year. Dong-A ST's Suganon family, generics in the DPP-4 inhibitor market, is also growing. Suganon and combination of Sugamet expanded their prescriptions by 5.2% and 14.2% respectively in the first quarter of this year. The quarterly prescription for the two products recorded 8.3 billion won. Products introduced overseas by domestic pharmaceutical companies such as Guardlet and Nesina have all fallen in prescriptions. The Nestina series, which Takeda handed over its rights to Celltrion fell 8.5% from the previous year to 7.5 billion won in prescriptions last quarter. During the period, Guardlet, introduced by JW Pharmaceutical from Japan's Sanwa Chemical Research Institute, fell 14.3% to 1.5 billion won. Guardmet was discontinued from the third quarter of 2020 due to impurity problems.
- Company
- Zolgensma makes one step towards reimbursement
- by Eo, Yun-Ho Apr 29, 2022 05:42am
- Discussions on the reimbursement of ‘Zolgensma’ are finally making progress. According to industry sources, reimbursement of Novartis Korea’s Spinal Muscular Atrophy (SMA) treatment Zolgensma (onasemnogene abeparvovec-xioi) will be deliberated by the Drug Reimbursement Evaluation Committee of the National Health Insurance Service in coming May. This progress was made in one year since the company submitted its application for the reimbursement of Zolgensma (onasemnogene abeparvovec-xioi) through the approval-benefit appraisal linkage system. As such, what result this high-priced one-shot treatment will bring remains to be seen. As Zolgensma is an orphan drug, the drug must first go through the Drug Reimbursement Standard Subcommittee to set a reimbursement standard and then pass DREC, but discussions had been delayed due to repeated requests and submissions of supplementary data between the government and pharmaceutical companies. Considering that the company’s new CAR-T drug ‘Kymirah (tisagenlecleucel) was listed for reimbursement on the first of April, the company’s two drugs are showing some difference in their speed of reimbursement. 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. Under the ‘Safety and Support Act for Advanced Regenerative Medicine and Advanced Biopharmaceuticals,’ advanced biopharmaceuticals can receive differentiated safety management including long-term follow-up studies and support for R&D and product commercialization. Despite being a one-shot treatment, the price of the single-shot costs 2.5 billion won in the U.S. and 1.89 billion won in Japan. Due to the high price, the listing process for Zolgensma in Korea is also expected to walk a rocky road. However, expectations for its efficacy are very high. The Phase III SPR1NT and STR1VE-EU results for Zolgensma that were presented recently gained much attention. In the SPR1NT study, all pediatric SMA patients with two SMN Type 2 gene copies (Cohort 1) that were treated presymptomatically survived without requiring ventilatory or nutritional assistance, and achieved sitting independently for 30 seconds or more. Most (11/14) patients achieved age-appropriate motor milestones within the World Health Organization (WHO) window of normal development. In the STR1VE-EU study, most pediatric patients (82%) that were treated with Zolgensma, including those with severe SMA, achieved motor milestones unseen in the natural history of SMA Type 1.
