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- 2026-03-17 11:06:21
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- Shionogi COVID tx developed by Ildong has been approved
- by Kim, Jin-Gu Feb 25, 2022 05:56am
- Ildong Pharmaceutical announced on the 23rd that it has been approved by the MFDS to change the clinical trial plan of Shionogi's oral COVID-19 treatment candidate "S-217622" under development in Korea. Earlier, Ildong Pharmaceutical applied to change its clinical plan in the direction of confirming the results of each phase by modifying the existing plan to conduct phase 2b/3 clinical trials of S-217622 at once and dividing it into phase 2b and phase 3. Ildong Pharmaceutical plans to separate and check the validity and safety of Phase 2b and Phase 3 while continuing the existing clinical trials that have been conducted in Korea since the beginning of this year. This is to accelerate commercialization in line with changes in Shionogi's S-217622 development strategy and clinical plan. Shionogi is said to have recently confirmed significant results related to the COVID-19 virus suppression effect in phase 2a clinical trials. Ildong Pharmaceutical explained that it is planning to commercialize the EUA based on the interim results after completing the process up to phase 2b. The changed clinical trial plan is designed to be divided into a group (Cohort A) that conducts phase 2a, phase 2b, and phase 3 clinical trials for mild and moderate patients, respectively, and a group (Cohort B) that conducts phase 2a and phase 2b/3, respectively. The total size of the global clinical trial conducted by Shionogi is 1260 for cohort A and 600 for cohort B, of which 200 patients are eligible for clinical trials in Korea. S-217622 is a mechanism that inhibits the proliferation of viruses in the body by inhibiting the protease (3CL-protase) of the SARS-CoV-2 virus that causes COVID-19. Currently, global clinical trials are underway in Korea, Japan, Singapore, Vietnam, and Europe.
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- Yuhan’s ‘Leclaza’ makes ₩4.1 billion in 6 months
- by Chon, Seung-Hyun Feb 24, 2022 05:58am
- Yuhan Corporation's new drug ‘Leclaza’ has made ₩4.1 billion in its first year of release. In only 6 months since its sales began in earnest with reimbursement listing in July, Leclaza rose to the top among homegrown anticancer drugs, raising expectations on its potential for commercial success. According to the pharmaceutical research institution IQVIA on the 22nd, Leclaza recorded ₩4.1 billion in sales last year. After raising ₩1.5 billion in Q3, sales rose to ₩2.6 billion in Q4. Leclaza is the 31st homegrown new drug that was approved for the treatment of non-small cell lung cancer in January last year. It is indicated for patients with locally advanced or metastatic non-small cell cancer who have developed resistance to the T790 mutation after using 1st or 2nd generation EGFR TKIs. Before ‘Leclaza,’ the treatment options available for prescription in Korea were first-generation EGFR-TKIs ‘Iressa (gefitinib)’ and ‘Tarceva(erlotinib),’ and second-generation EGFR-TKIs ‘Giotrif (afatinib) and ‘Vizimpro (dacomitinib),’ and third-generation EGFR-TKI ‘Tagrisso (Osimertinib).’ Yuhan Corp made its debut in the market in July last year after being listed for reimbursement. The drug received the reimbursement approval only 165 days since its authorization using the ‘approval-benefit appraisal linkage system.’ The drug was approved its reasonableness of receiving medical care benefits was recognized in the cost-effectiveness aspect, as the drug ‘is therapeutically equivalent to Tagrisso (osimertinib) while being cheaper. Leclaza’s sales exceeded expectations, making ₩4.1 billion in the first 6 months. In general, anticancer drugs used in large hospitals may only be prescribed after passing reviews of drug committees in each hospital, therefore it takes a considerable amount of time for such drugs to generate sales after their release. Leclaza rose to the ranks and took the lead among domestically developed anticancer drugs as the most sold product during the past 6 months. Other homegrown anticancer drugs approved before Leclaza in Korea include Supect, Dongwha Pharm’s Milican, Chong Kun Dang’s Camtobell, Sam Sung Pharmaceutical’s Riavax, Hanmi Pharmaceutical’s Olita. Among the drugs, Supect’s sales recorded ₩7.4 billion last year, but its sales in the second half of the year were ₩4.1 billion, similar to Leclaza. Supect is the 18th homegrown novel drug that was approved in January 2012 for the treatment of chronic myeloid leukemia. Camtobell’s only made ₩3.8 billion last year, and other products have been revoked their licenses or withdrawn from the market. Therefore, Leclaza is the first to demonstrate the possibility of commercialization among homegrown anticancer drugs. Leclaza had started being prescribed at a rapid pace after landing in large hospitals with reimbursement. Leclaza can be prescribed in the ‘Big 4’ tertiary hospitals in Korea - the Seoul National University Hospital, Sinchon Severance Hospital, Samsung Seoul Medical Center, and the Seoul Asan Medical Center - and 30 other medical institutions including the National Cancer Center, Seoul National University Bundang Hospital, Seoul St. Mary's Hospital, Chonnam National University Hwasun Hospital, Kyungpook National University Chilgok Hospital, and the Pusan National University Hospital. In Yuhan Corp’s IR data that was recently released, the company presented its mid-to-long-term goal of “rising to the ranks in the global market by becoming the first homegrown new drug to earn over $1 billion (₩1.2 trillion) in annual sales with Leclaza.”
- Company
- It was improved by changing the targeted therapy formulation
- by Eo, Yun-Ho Feb 23, 2022 05:50am
- According to related industries, Pfizer Korea's breast cancer treatment Ibrance(Palbociclib) has obtained an item license in a type of tablet not a capsule, six years after its launch in Korea. Also, Takeda is also preparing to introduce a tablet formulation of "Zejula (Niraparib toosylate monohydrate)," a treatment for ovarian cancer. It's easy to use both "Ibrance tablet" and PPI Ibrance is the first targeted anticancer drug developed among CDK4/6 inhibitors to be used as a standard treatment along with endocrine therapy in the treatment of patients with progressive or metastatic hormone receptor-positive breast cancer. In postmenopausal women, it is used in combination with "Aromatase inhibitors" for primary treatment and with Fulvestrant for secondary treatment, lowering the risk of disease progression and death in stage 4 breast cancer patients and prolonging survival. Pfizer changed the existing Ibrance capsule formulation to tablets and improved the patient's administration convenience. Ibrance tablet contains biologically the same active ingredient as conventional capsules, but can be taken regardless of food. By coating the tablet with a film, it can also be administered with a Proton Pump Inhibitor or antacids used to control gastrointestinal disorders and diarrhea, which are treatment side effects that usually appear in cancer patients. Zejula, minimize the number of pills pt takes Zejula is a PARP inhibitor and targets the BRCA gene. Lynparza of AstraZeneca Korea, a drug of the same family, has already been released in Korea. The conversion of PARP inhibitors to tablet formulations has the advantage of minimizing the number of pills. This drug has a variety of indications, including monotherapy in adult patients (including ovarian cancer or primary peritoneal cancer) who responded to ▲1st and 2nd platinum-based chemotherapy, and ▲3rd or higher chemotherapy, that is, quaternary monotherapy. Among them, benefits for primary and secondary maintenance therapy are recognized, and benefits are not applied to BRCA-negative patients. The new formulation requires a separate benefit registration procedure. Even if the indications may be different and the same indication is the same, the validity of the changed formulation should be confirmed. It remains to be seen whether anticancer drugs with new formulations will be able to quickly convert prescriptions.
- Company
- Lilly-RosVivo signed a contract to transfer diabetes txs
- by Eo, Yun-Ho Feb 23, 2022 05:49am
- Nexturn Bio announced on the 22nd that its U.S. subsidiary RosVivo Therapheutics has signed a "MTA (Material Transfer Agreement)" with Eli Lilly for commercial development of a new drug candidate for diabetes treatment, "RSVI-301. MTA is a contract concluded by the counterparty to verify the efficacy and research results of the drug through experiments. Lilly will review and acknowledge animal experiment data and reaffirm the excellence of RSVI-301 through this MTA. RosVivo's RSVI-301 is a new drug candidate that can fundamentally treat diabetes by restoring the function of beta cells that secrete insulin, the cause of diabetes, and lowering insulin resistance. In the last RSVI-301 diabetes-causing animal test, it was found to be effective in treating obesity, fatty liver, and gastrointestinal disorders. An official from RosVivo said, "The signing of an MTA with Eli Lilly, a global diabetes treatment company, proves the possibility of new drug candidates," adding, "Love calls from various global pharmaceutical companies continue."
- Company
- Endless evolution of cancer immunotherapy
- by Eo, Yun-Ho Feb 22, 2022 05:54am
- According to related industries, news of approval for the expansion of domestic indications of cancer immunotherapy Opdivo (Nivolumab) and Keytruda (Pembrolizumab) in PD-1 inhibition mechanisms continues. Although it is the same mechanism, it is competing by securing different indications. In the case of Opdivo, two postoperative adjuvant therapy and three combined therapy indications were added. Postoperative adjuvant therapy in patients with esophageal cancer or gastroesophageal junction cancer with residual pathological diseases after receiving chemotherapy (CRT) as a preoperative adjuvant therapy and Postoperative adjuvant therapy in patients with root resection were added. Combination therapy with Carboplatin, Paclitaxel, and Bevacizumab as the primary treatment for metastatic or recurrent non-small cell lung cancer patients without EGFR or ALK mutation and combination therapy with Cabozantinib as the primary treatment of advanced Neoplasmine, and Fluoropyrimidine, Oxaliplatin and combination therapy with Yervoy (Ipilimumab) was also added to the treatment of adult patients with metastatic direct bowel cancer with microsatellite instability-high (MSI-H) or dMMR that recurred after Irinotecan treatment. As a result, Opdivo can be used alone or with other treatments such as melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell cancer, typical Hodgkin lymphoma, head and neck squamous cell cancer, urinary epithelial cell cancer, gastric cancer, gastroesophageal adenocarcinoma, esophageal cancer, and direct bowel cancer. In the case of Keytruda, it entered the field of renal and endometrial cancer through Lenvima combination therapy. The permission for the first-line treatment indication for renal cell cancer was based on data from the CLEAR study (KEYNOTE-581/Study 307), a phase 3 clinical trial. In the CLEAR study, Keytruda-Lenvima combination therapy demonstrated statistically significant Progression-Free Survival (PFS) and Overall Survival (OS) improvements over the existing treatments Sunitinib. Keytruda-Lenvima combination therapy reduced the risk of disease progression or death by 61% and the risk of death by 34% compared to Sunitinib.
- Company
- Samsung Bioepis' biosimilar had ₩1.5 trillion
- by Chon, Seung-Hyun Feb 22, 2022 05:54am
- Samsung Bioepis products sold overseasBiosimilar products developed by Samsung Bioepis generated 1.5 trillion won in sales overseas last year. It increased by more than 10% from the previous year, the largest ever. According to Samsung Bioepis on the 18th, five biosimilars recorded a total of $1.255.1 billion (about 1.5 trillion won) in overseas markets last year. It achieved maximum sales, up 11% from $1.125.8 billion in 2020. With Samsung Bioepis' marketing partner Biogen, it is a statistic that collects Organon's performance. Biogen sells three types of biosimilars in Europe: Enbrel, Remicade, and Humira for autoimmune diseases. Organon sells these three products in the rest of the country except Europe and Korea. In the United States, only Remicade biosimilar are sold. Organon is also in charge of overseas sales of two types of biosimilars, Herceptin and Avastin. Last year, sales of biosimilars sold by Biogen reached $831.1 million, up 4% from the previous year. Sales of organon rose 28% year-on-year to $424 million. Samsung Bioepis explained, "We achieved the largest annual product sales in overseas markets last year based on close marketing cooperation with partners and thorough supply chain management." Samsung Bioepis was approved for sale of biosimilar SB11 of Lucentis, an ophthalmic disease treatment, in Europe and the United States last year. SB11 will be sold by Biogen under the product name Byooviztm in the United States and Europe. Under the license agreement with Genentech, Samsung Bioepis can sell its products in the United States from June 2022 before Genentech's expiration of the relevant SPC (Additional Protection Certification, Supplementary Protection Certification). In other regions, it can be sold after Genentech's SPC expires. An official from Samsung Bioepis said, "Based on last year's results, we plan to work closely with our partners this year to expand product sales," adding, "We will further strengthen our position as a leading company in the global biosimilar industry by expanding our product portfolio to eye diseases."
- Company
- Kymriah is expected to be able to register insurance benefit
- by Eo, Yun-Ho Feb 21, 2022 05:59am
- Kymriah, an ultra-high-priced one-shot treatment, is expected to be covered by insurance benefits as early as April. According to related industries, Novartis Korea's CAR-T new drug Kymriah officially began drug price negotiations with NHIS in the last week of the same month after passing the Drug Benefit Evaluation Committee of the HIRA on January 13. Considering that the drug price negotiation deadline is 60 days, the negotiations should be completed at the end of March. If so, the Health Insurance Policy Committee, the final decision body for drug benefits, is usually held at the beginning of each month, and if Kymriah's price negotiations are concluded in March, it will be possible to register them in April. Pharmaceutical price negotiations themselves may break down, and the possibility cannot be ruled out that discussions will not end within the negotiation deadline. Recently, more and more cases are extending the deadline for negotiations. Since Kymriah is ultra-high-priced, it is not expected that it will be smooth to find an agreement between the government and pharmaceutical companies. Kymriah's indications are ▲Diffuse Large-B-Cell Lympoma (DLBCL) adult patient treatment after two or more systemic treatments and ▲ post-transplantation recurrence or secondary recurrence in children and young adult patients under the age of 25 and subsequent B-Acute Lymphoblastic leukemia (B-ALL). There is a difference in standards for Kymriah's two indications. B-ALL applies only to Expenditure Cap, but in the case of DLBLC, a performance-based type was added. This means that pharmaceutical companies share part of the drug price according to treatment performance for all DLBCL patients. The problem is that unlike conventional drugs that are mass-produced, the manufacturing cost is astronomically high due to the nature of Kymriah, which produces one batch of cells extracted from patients, and the cost burden of pharmaceutical companies increases in the event of a patient with an Expenditure Cap or higher. Novartis Korea's efforts are essential to the goal of conclusion of drug price negotiations, but it remains to be seen whether this will lead to achievement. About 200 DLBCL and B-ALL patients who have refused or recurred to existing treatment are in critical condition, with only six months of life expectancy due to no alternative treatment options or no standard treatment until Kymriah is approved. The median survival period of DLBCL patients who failed secondary treatment in Korea is around 4.73 months, and about 70% of patients who failed secondary treatment repeatedly perform rescue chemotherapy.
- Company
- Development of Xolair biosimilars is in full swing
- by Ji Yong Jun Feb 21, 2022 05:58am
- Xolair (Novartis)Domestic and foreign bio companies have started to develop Xolair (Omalizumab) biosimilars which patents expire in two years. The development stage of Celltrion, a domestic company, is the fastest. According to Clinical Trials, a clinical registration site of the NIH on the 17th, six clinical trials of Xolair biosimilars are currently registered. Three companies, Celltrion, Theba in the UK, and CSPC in China, are conducting phase 3 clinical trials, while three are in phase 1 clinical trials, including Zhejiang Huahai Pharmaceutical in China, Generium in Russia, and Syneos Health in the United States. Xolair is a treatment for allergic asthma and chronic urticaria. It was jointly developed by Genentech and Novartis, subsidiaries of Roche. Based on the two companies' earnings announcements, Xolair's sales last year amounted to 4.2 trillion won, up 10.5% from the previous year. Xolair will be challenged by biosimilars from 2024. Xolair patents expire in Europe in 2024 and in the United States in 2025, respectively. Celltrion is analyzed as the fastest place to develop Xolair biosimilars. Celltrion is conducting phase 3 clinical trials of the Xolair biosimilar CT-P39. The end of the clinical trial is expected to be January next year. Considering the period of the European licensing process, it is expected that biosimilars will be released in time for Xolair's patent expiration. Teva, a British pharmaceutical company, is closely chasing this. Teva is conducting phase 3 clinical trials of the Xolair biosimilar TEV-45779. However, the end of the clinical trial is expected to be June 2024, later than Celltrion. China's CSPC entered phase 3 clinical trials of the Xolair biosimilar SYN008 earlier than Teva, but it is still in the pre-patient recruitment stage. In addition, Generium's GNR-044 has ended phase 1 clinical trials, while Zhejiang Huahai Pharmaceutical's HS632 and Synos' BP11 are undergoing phase 1 clinical trials. Due to the clinical progress of companies, Celltrion is likely to take over the first mover of Xolair biosimilars. First mover is considered a top priority when evaluating the competitiveness of biosimilars. This is because biosimilars generate profits by bringing the market share of the original market. Celltrion's biosimilars Remsima and Truxima, which were released as first movers, are prominent in the European market. According to Celltrion, as of the third quarter of last year, the European market share was 54% for Remsima and 34% for Truxima.
- Company
- Vitrakvi's price negotiation has been extended
- by Eo, Yun-Ho Feb 18, 2022 05:55am
- According to related industries, both Roche's Rozlytrek (NTRK) anticancer drugs, Roche Korea's Rozlytrek and Bayer Korea's Vitrakvi, failed to conclude discussions with the NHIS (60 days) in January. The two drugs seeking the PE system passed the HIRA's Drug Benefit Evaluation Committee last year, but are in the final stage. If the extended negotiations are concluded as soon as possible, both drugs can be applied in March, but as they are the first drugs to be applied to multiple solid cancers only for certain genetic mutations, it remains to be seen whether the government and pharmaceutical companies can reach an agreement. Among adult and pediatric patients with NTRK gene fusion without acquisition-resistant mutations, Rozlytrek and Vitrakvi are highly likely to undergo severe morbidity during local progression, metastasis, or surgical resection, and can be used to treat solid cancer patients who have progressed after conventional therapy or do not have suitable treatments currently available. Meanwhile, Rozlytrek's approval was determined based on experimental data from phase 1/2 STARTRK-NG trials and phase 2 clinical trials in pediatric patients, STARTRK-1, and ALKA-372-001. In the STARTRK-2 study, Rozlytrek reduced tumors in more than half to 56.9% of patients with solid cancer (ORR) positive for NTRK fusion genes. Patients were conducted in 10 different solid cancer patients, and the duration of the reaction was observed to be 10.4 months. Vitrakvi's approval was based on a phase 1 test for adults aged 18 or older, a phase 2 NAVIGATE test for adults and children aged 12 or older, and a phase 1/2 SCOOT study for pediatric patients aged 1 month to 21 years old, including primary CNS tumors. According to the efficacy evaluation of a total of 55 people whose NTRK gene fusion was confirmed from three studies,Vitrakvi achieved an objective response rate (ORR) of 75% and 53% in various carcinomas (soft tissue sarcoma, infant fibroma, salivary gland cancer, lung cancer, melanoma, colon cancer, bile duct cancer, breast cancer, and pancreatic cancer).
- Company
- AstraZeneca wins second trial on ‘Forxiga substance patent'
- by Kim, Jin-Gu Feb 18, 2022 05:55am
- AstraZeneca, the original drug maker of the SGLT-2 inhibitor for the treatment of diabetes, ‘Forxiga,’ won the second trial over its substance patent. The ruling has abruptly put a hold on Dong-A ST’s plans for the early release of its Forxiga latecomer. The industry interpreted this as a crisis for the ‘pro-drug strategy’ that has been gaining attention as a breakthrough in overcoming the substance patent of originals. On the 17th, the Patent Court of Korea overturned the first instance court ruling and ruled in favor of AstraZeneca in its appeal against Dong-A ST to overrule the Intellectual Property Trial and Appeal Board (IPTAB)’s decision. The IPTAB had previously ruled in favor of Dong-A ST. The Patent Court of Korea judged that the Forxiga prodrug (product name Dapaflo) falls within the scope of the patent of AstraZeneca's Forxiga’s active ingredient. The ruling has put a stop to Dong-A ST’s early release strategy. Dong-A ST had planned to release a Forxiga latecomer exclusively if it wins in the appeal. However, losing the second trial, Dong-A ST can now only release its latecomer drug after April 7th 2023, after Forxiga’s substance patent expires. The prodrug strategy that gained industry interest is also in peril. Dong-A ST was the first in Korea to attempt evasion of Forxiga’s substance patent using the prodrug strategy. The industry believed that this attempt may become a new breakthrough in overcoming the 'impenetrable' substance patents of original drugs. Pro-drug is a ‘pro’ drug that is considered a similar but different drug from the original drug. Its chemical structure is partially different in its substituents with the original drug until administration. However, once administered, the drug shows the same effect as the original drug. In principle, it may seem similar to salt-modified drugs, but the difference Is clear. Salt can be changed through simple ion bonding, and the chemical structure of the drug does not change. However, prodrugs change the substituents through a more difficult covalent binding method. It has a different chemical structure to the original drug. The key issue in the patent suit was whether a prodrug could be considered a completely new substance. The Patent Court of Korea had determined prodrug partially improved form an existing substance.
