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- 2026-03-17 02:03:10
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- 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.”.
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- 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.
- Company
- Sale of Atozet generics exceeds its orignial in 1 year
- by Kim, Jin-Gu Apr 29, 2022 05:42am
- The combination drug market for dyslipidemia treatment using the atorvastatin+ ezetimibe combination has increased twofold with the sudden growth of its generics. Moreover, the market share of the generics exceeded that of the original in Q1 of this year. The rapid expansion of the market last year is interpreted to be due to more than 100 companies joining in the competition after receiving approvals for their generics last year. ◆Atozet market increase twofold in 1 year due to entry of generics According to the market research institution UBIST on the 28th, outpatient prescriptions of atorvastatin+ ezetimibe combination drugs recorded ₩44 billion in Q1. This is a 109% increase from the ₩21.1 billion in Q1 last year. In other words, the market size had increased over twofold in just one year. The preference and prescriptions for the ‘statin+ezetimibe’ combination had been continuously increasing in the front line over the past few years. Sales of the original atorvastatin+ ezetimibe combination drug, Atozet, had also steadily increased during the period. Prescriptions of Atozet in Q1 recorded ₩21.4 billion, a 1% increase from the same period of the previous year (₩21.1 billion) The market has expanded rapidly since Q2 last year when generic products started entering the market in earnest. In fact, prescriptions of Atozet generics recorded ₩7.1 billion in Q2 last year, which surged to ₩15 billion in Q3 and ₩19.8 billion in Q4. In particular, sales of the generics recorded ₩22.7 billion in Q1 this year and exceeded that of the original (₩21.4 billion). A lot of Atozet generics entered the market after Q2 last year. Chong Kun Dang opened up the door for the entry of generics. Chong Kun Dang received approval for ‘Lipilouzet’, a combination drug that contains the same ingredients as Atozet in October 2020. In January of the following year, 21 companies received approval for their authorized generics of Lipilouzet. Authorized generics refer to already approved generic products with different packaging. Latecomer generics joined the competition in February. 89 companies received approval for Atozet generics then, and two more companies joined in June last year. In total, 113 companies currently own Atozet generics. Chong Kun Dang and other companies that were authorized to manufacture authorized generics of Lipilouzet released their products a month in advance. The companies had entered the market by listing their products on the reimbursement list in April last year. Other companies followed in May after receiving insurance reimbursement, totaling the number of competitors to 83. ◆Latecomers make rapid strides… authorized generics of Lipilouzet fail to preoccupy market Among the generics, Daewoong’s Litorvazet has made the most success. Litorvazet sold ₩3 billion in prescriptions in Q1. Following Litorvazet, Boryung’s L50 sold ₩2.1 billion, Jeil Pharm’s Lipitor Plus ₩2 billion, Yuhan Corp’s Atovamibe ₩1.9 billion, and HK.Inno.N’s Zepitor ₩1.4 billion. What’s interesting is that only 2 of the Top 5 generics – L50 and Zepitor- are Lipilouzet authorized generics. Even when broadening the scope to the top 10 generics, only 4 of the 10 items are Lipilouzet authorized generics. Among Atozet generics, the first generic Lipilouzet’s price is highest at ₩1,037, and Lipilouzet authorized generics are priced at ₩881, with other latecomers including Litorvazet set at ₩637 or lower. Lipilouzet received the highest price among generics at 53.55% of the original price by satisfying both the ‘direct bioequivalence testing’ and ‘Regulation on Registration of Drug Substances (DMF)’ requirements. Unable to satisfy the direct bioequivalence testing requirements, authorized generics received a price 15% lower than that Lipilouzet. Other latecomer generics had to receive a price even 15% lower. The stepped pricing system that was implemented in July 2020 requires the price of latecomer generics to be set 15% lower when over 20 products of the same item are already listed. In other words, the latecomer generics such as Litorvazet are showing good performance, increasing prescriptions by 61% compared to Lipilouzet Tab and by 71% compared to authorized generics of Lipilouzet Tab. When considering that Lipilouzet and the authorized generics have been released a month prior to the latecomer generics, the drugs enjoyed little market preoccupation effect. On the other hand, generic companies for authorized generics of Lipilouzet Tab had attempted to receive a pricing premium and preoccupy the market by paying an upfront payment to Chong Kun Dang but were unable to see as much profit as expected. The industry analyzed that consignees including Chong Kun Dang, Jinyang Pharm, Dongkoo Biopharma, Withus Pharm, and Dasan Pharmaceutical had made the most profit. Currently, Jinyang Pharm has the largest number of consignors. The company has been manufacturing and supplying Atozet generics to 26 companies including Daewoong Pharmaceutical. Chong Kun Dang is in charge of producing products for 21 companies including Boryung Pharmacuetical and HK Inno.N. Also, Dongkoo Biopharma (20 companies), Withus Pharm (15 companies), and Dasan Pharmaceutical (11 companies) also CMO generics for other companies.
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- LG Chem will jointly sell Nesp & Regpara with Kyowa Kirin
- by Kim, Jin-Gu Apr 29, 2022 05:41am
- LG Chem announced on the 28th that it has signed a contract with Kyowa Kirin Korea to jointly sell two drugs, Nesp(Darbepoetin Alfa) and Regpara (Cinacalcet Hydrochloride)' in Korea. LG Chem is in charge of sales at the clinics level, and Kyowa Kirin Korea is in charge of sales at the general hospital level. Nesp is a continuous hematopoietic agent used to treat anemia in patients with chronic kidney disease. It is prescribed for hemodialysis or peritoneal dialysis patients or patients with chronic kidney disease before dialysis. LG Chem explains that treatment is highly convenient because it only needs to be administered once every one to two weeks. Since its release in South Korea in 2010, it has been steadily generating more than 20 billion won in sales. According to IQVIA, a pharmaceutical market research firm, Nesf's sales last year were 21.1 billion won. Regpara is a treatment for secondary parathyroidism in patients with chronic kidney disease. It can be treated with oral administration once a day. Secondary parathyroidism is a disease in which excessive production of parathyroid hormones continues due to decreased renal function and the size of parathyroid glands increases, and is known to be a progressive disease that intensifies as chronic kidney disease progresses. Regpara's revenue last year was 6.2 billion won. With the joint sales of Nesp and Legpara, LG Chem can expect about 27 billion won. LG Chem explained that the two drugs have the largest market share among drugs of the same family. Synergy with existing products is also expected. LG Chem has Espogen, the first-generation hematopoietic agent, and Nestykal, a treatment for hyperkalemia. Through this joint sale, the company plans to present expanded treatment options to medical staff with kidney disease. An official from LG Chem said, "We will continue to present various treatment options with customer value as the top priority. We will do our best to expand the market as soon as possible based on our strong national sales network and long business experience in the area of kidney disease." An official from Kyowa Kirin Korea said, "We expect that the joint sales partnership between Kyowa Kirin Korea and LG Chem will further increase the awareness of Nesp and Regpara to hospitals, clinics, and small and medium-sized hospitals. The two companies will make efforts to deliver higher levels of information and supply stable products to medical staff."
- Company
- Immunotherapy Opdivo reattempts reimb in gastric cancer
- by Eo, Yun-Ho Apr 28, 2022 06:07am
- The cancer immunotherapy Opidvo is again attempting to receive insurance benefits for its gastric cancer indication. According to industry sources, ONO Pharma Korea and BMS Korea’s PD-1 inhibitor immunotherapy drug ‘Opdivo (nivolumab)’ will be presented for deliberation by the Cancer Disease Deliberation Committee of the Health Insurance Review and Assessment Service on the 18th of next month. In Korea, Opdivo was approved ‘as first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma’ in June last year. With the added indication, the drug became the first and only domestically approved cancer immunotherapy for gastric cancer. However, Opdivo failed to receive reimbursement for the indication at the CDDC in February. At the time, the CDDC decided not to set reimbursement criteria for Opdivo in ▲ advanced or metastatic gastric adenocarcinoma, gastroesophageal junction cancer, and esophageal adenocarcinoma, and ▲ inoperable malignant pleural mesothelioma, Therefore, the industry’s eyes are on whether the company will be able to succeed in applying for reimbursement in gastric cancer this time. Gastric cancer is considered to be the most important field in need of extended reimbursement for immunotherapy drugs after lung cancer. Gastric cancer is the most prevalent cancer and the fourth most common cause of cancer deaths in Korea. Although gastric cancer has a favorable survival rate when detected in its early stages, the relative survival rate drops to 5.9% with distant metastasis. In particular, the current stand of care for HER2-negative gastric cancer is chemotherapy due to the unavailability of new drugs approved for first-line treatment for the past decade. Opdivo is expected to become a suitable alternative for these patients. Meanwhile, the efficacy of the combination therapy using Opdivo was demonstrated in the large-scale, Phase III CheckMate-649 trial. The median overall survival (mOS) of patients was 13.8 months for all patients randomly assigned to receive the Opdivo combination, a 20% reduction in risk compared to the 11.6 months in the control group. In PD-L1 positive patients (CPS ≥ 5), the Opdivo combination group’s mOS was 14.4 months, which was a 29% reduction in risk compared to the 11.1 months of the control group. Also, Opdivo improved the overall response rate (ORR) by 12% in the all-randomized population, and by 15% in PD-L1 positive patients (CPS ≥ 5). The complete response (CR) rate was also higher for the Opdivo combination group for both the all-randomized population and PD-L1 positive patients.
- Company
- Sales of SGLT-2 diabetes drugs increased by 15%
- by Apr 28, 2022 06:06am
- The SGLT-2 inhibitor market, which surpassed 150 billion won in annual prescriptions last year, also grew 15% in the first quarter, surpassing 40 billion won in quarterly prescriptions. single and combination drugs have grown evenly. According to UBIST, a pharmaceutical market research firm, on the 28th, the total amount of outpatient prescriptions for SGLT-2 inhibitors in the first quarter was 40.2 billion won, up 15.0% from 34.8 billion won a year earlier. The quarterly prescription for SGLT-2 inhibitors, which was in the early 20 billion won in 2019, has nearly doubled in two years. The SGLT-2 inhibitor has been released as a type 2 diabetes treatment, expanding the disease group to the heart and kidneys, and indications are expanding. The SGLT-2 inhibitor is a mechanism that inhibits the reabsorption of glucose from the kidneys and releases glucose into the urine. This not only reduces blood sugar, but also reduces weight, kidney function, and blood pressure. This is why SGLT-2 inhibitors can also be used as heart and kidney drugs. Sales of AstraZeneca's Forxiga recorded the highest prescription amount of 11.6 billion won in the first quarter. This is an increase of 16.7% compared to 9.9 billion won a year earlier. Forxiga is leading the market with the most indications among competing drugs. It obtained indications of chronic heart failure in 2020 and expanded its scope to chronic kidney disease in August last year. All of them are the first of the SGLT-2 series. Beringer Ingelheim's Jardiance's prescription amounted to 10.3 billion won in the first quarter, up 5.2% from 9.8 billion won a year earlier. The gap with Forxiga widened in the first quarter of this year. In the first quarter of last year, Jardiance (9.8 billion won) had almost the same prescription as Forxiga (9.9 billion won), but it made a difference of 1.3 billion won. In November last year, chronic heart failure indications were added, and it is trying to expand its scope due to kidney disease. In particular, at HFpEF, Jardiance first released positive data. Handok's Suglat and MSD's Steglatro continue to perform poorly with quarterly prescriptions of less than 1 billion won. Prescription sales of Suglat and Steglatro in the first quarter were 900 million won and 400 million won, respectively. Compared to the same period last year, Suglat increased by 100 million won and Steglatro decreased by 100 million won. Unlike Forxiga and Jardiance, the two products are limited to type 2 diabetes, and clinical trials have not been conducted to expand their indications. They accounted for only 3.3% of the SGLT-2 inhibitor market. Xigduo achieved 10 billion won in prescription in the fourth quarter of last year. In the first quarter of this year, it also increased its prescription amount by 18.2% compared to the same period last year. During the same period, Jardiance Duo also increased its prescription amount from 5.4 billion won to 7 billion won, growing 28.5%. Jardiance Duo appeared in the market a year later than Xigduo, showing a difference of about 3 billion won. In the first quarter, prescriptions for SGLT-2 complex drugs amounted to 16.9 billion won, up 21.6% from 13.9 billion won a year earlier. Combination drugs have higher sales than single systems. In the first quarter of 2019, the prescription amount was 5.7 billion won, which was only one-third of the single system, and the quarterly prescription amount exceeded 10 billion won a year later, and 15 billion won last year. The gap between sales and single products has also narrowed significantly. Last quarter, the proportion of combination drugs and single drugs was 42:58.
- Company
- Who will follow SK Bio with its homegrown COVID-19 vaccine?
- by Kim, Jin-Gu Apr 28, 2022 06:06am
- The marketing authorization for SK Bioscience’s homegrown COVID-19 vaccine 'GBP510' is nearing approval. If the drug is approved within the first half of the year as planned, GBP510 will become the first homegrown vaccine to be ever approved. With the developer of the first vaccine set, who will be the No.2 and No.3 in line is gaining attention. Currently, Eubiologics, Cellid, and Geneone Life Science are speeding up trials for their COVID-19 vaccines. The issue at hand is how the companies will secure a comparator vaccine for comparative trials. SK Bioscience had been able to quickly conduct a Phase III trial after securing the necessary comparator vaccines early on, other companies are having trouble securing comparator vaccines. ◆Eubiologics secures comparator vaccines and prepares to initiate global Phase III trial According to the pharmaceutical industry on the 27th, Eubiologics received approval to initiate its Phase III trial for ‘EuCorVac-19’ in three countries in Africa. Eubiologics’s COVID-19 vaccine in development is a synthetic antigen vaccine, the same as SK Bioscience’s GBP510 or Novavax’s Nuvaxovid. The company’s procurement of comparator vaccines played a decisive role in the initiation of the company’s Phase III trial in Africa. The latecomers in the COVID-19 vaccine development industry have been conducting Phase III trials by comparing the efficacy and safety of its vaccines with previously approved vaccines rather than with large-scale clinical trials. SK Bioscience had also conducted a Phase III trial by comparing its vaccine with AstraZeneca’s vaccine. The comparator vaccine secured by Eubiologics for the African trial is not one of the 5 vaccines (Pfizer, Moderna, AstraZeneca, Janssen, Novavax) that were approved in Korea. Eubiologics plans to conduct a clinical trial that compares the efficacy and safety of its vaccine with a comparator vaccine and expects to receive approval for a trial in the Philippines as well. An official from Eubiologics said, “The clinical trial will start at the local site within the month. If the Phase III trial is completed in Africa, it will be listed for Emergency Use Listing by the WHO, and then be supplied around low-income countries after obtaining export approval. ◆Have entered Phase III trials in Korea but have trouble securing ‘comparator vaccines’ Securing comparator vaccines is an issue in conducting Phase III trials in Korea as well, as Korea requires ‘vaccines approved in Korea’ to be used as comparators for domestic trials. A pharmaceutical industry official explained that although SK Bioscience was able to secure a comparator vaccine relatively easily because of its past CMO agreement with AstraZeneca, the situation is different for other vaccine developers. Global vaccine developers are showing a lukewarm reaction to being selected as a comparator vaccine for domestic companies due to concerns over technology leakage. However, if a comparator vaccine is not secured, the domestic companies’ concern is that it would take that much longer for the companies to develop their vaccines. An official from EUbiologics said, “If SK Bioscience receives approval for GBP510, we may use the vaccine as a comparator, but this is not our immediate plan as we would need to change our clinical trial protocol to enable this. We are working closely with the government to secure a comparator vaccine among those that are already approved in Korea.” ◆Companies change paths or give up development strategies due to difficulty securing comparatorvaccines Other companies are also having difficulty securing comparator vaccines. Companies are changing the development strategy or abandoning the development itself due to difficulty in securing comparators and the increased global vaccination rates and the smooth supply of vaccines already available in the market. Cellid received approval for a Phase IIb trial for 'AdCLD-CoV19-1' in Korea in January this year. If the Phase IIb trial is completed, the company would also need to secure a comparator vaccine for comparative trials. Its approval will depend on how well the company procures a comparator vaccine. Cellid had applied for the Phase IIb and III trials at the same time in November last year but was only approved for the Phase IIb trial due to the lack of a comparator vaccine. After failing to conduct the Phase III trial, Celid has developed a two-track strategy to continue clinical trials of the vaccine for primary inoculation that was in development while developing vaccines for booster shots (additional inoculation). Geneone Life Science changed its strategy from developing a vaccine for primary inoculation to developing a booster vaccine. Earlier this month, the company announced that the company completed the registration of subjects for the Phase IIa clinical trial of 'GLS-5310', which is being developed as a DNA vaccine. After confirming the safety and efficacy of clinical trials in a Phase IIa trial, the company plans to continue studying its vaccine through Phase IIb and III trials exclusively as a booster vaccine. HK Inno.N completed Phase I trials for its ‘IN-B009’ in development as a synthetic antigen vaccine. However, the company is pondering whether to proceed with Phase II trials. An official from HK Inno.N said, “We have completed Phase I trial for our vaccine but haven’t submitted a clinical trial protocol for Phase II trial plan yet. We haven’t decided on our direction from there.” Genexine withdrew its development. Genexine was the first among domestic companies to start the development of a COVID-19 vaccine in June 2020. Although it has completed the Phase IIa trial for 'GX-19N' in Korea, the company gave up proceeding with Phase II and Phase III trials last month. GX-19N was being developed through a DNA vaccine platform. No other vaccine approved around the world had adopted the use of this platform. As comparative clinical trials require the use of a control vaccine from similar platforms, it was virtually impossible to secure a control vaccine. For this reason, a large-scale Phase III clinical trial was inevitable for the company, which was why Genexine decided to stop the development of its vaccine determining that its business feasibility was low.
- Company
- Novartis' anticancer drug/Rx division will be merged
- by Eo, Yun-Ho Apr 27, 2022 06:04am
- A change is expected in Novartis' subsidiary. Above all, the anticancer drug division and the Rx division, which have been operated independently, will be integrated. According to related industries, Novartis' Asia-Pacific Regional Headquarters has already been appointed as a representative of the integrated corporation. As a result, corporations such as Novartis Korea will also integrate their business units within this year. The anticancer drug division is led by CEO Shin Soo-hee, and the Rx division is led by CEO Yoo Byung-jae, who was appointed last year. The company consists of two business units, not only marketing and sales, but also support departments such as drug prices, rental, and permission. Therefore, if the integrated general manager is determined, manpower adjustment will be inevitable. Novartis' headquarters announced in April that it would introduce a new organizational structure and operating model designed to support innovation, growth and productivity goals as a pharmaceutical company looking forward to a new decade. As part of the reorganization, Novartis plans to merge its pharmaceutical and anti-cancer operations and create two independent commercial organizations, the U.S. Department of Innovative Medicine and the International Department of Innovative Medicine. Both organizations will have full profit and loss liability and customer experience, marketing, sales, sales ownership, and market access to each market across all treatment areas.
