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- 2026-05-05 03:45:34
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- GC Pharma, reapplying to FDA for approval of immunoglobulin
- by Chon, Seung-Hyun Jul 19, 2023 12:20am
- Green Cross Ochang Factory GC Pharma planned to enter the US market first with 5% products and later with 10% products undergoing clinical trials. However, as the approval of the 5% product was delayed, the company changed its strategy to release the 10% product, which has greater marketability, to the US market first. GC Pharma completed phase 3 clinical trials in North America for IVIG-SN10% 'ALYGLO' in 2020 and submitted an application for product approval to the FDA in February 2021. However, in February of last year, it received a notice from the FDA to postpone the approval of the product. Due to the COVID-19 situation, a non-face-to-face evaluation was conducted in the fourth quarter of 2021, but the FDA decided to postpone the approval because of the need for an on-site inspection of the production facility. From April 17th to 28th, the FDA inspection team conducted an inspection of production facilities and quality systems such as fractionation, stagnation, and finished products of IVIG-SN at GC Pharma's Ochang plant. A GC Pharma official said, “We are aiming to obtain product approval early next year and launch it in the US market in the second half of next year.
- Company
- FDA accepts NDA for HLB’s rivoceranib
- by Lee, Seok-Jun Jul 18, 2023 05:29am
- HLB’s hepatocellular carcinoma treatment ‘rivoceranib’ has now entered FDA’s review. Yang-Gon Jin, Chairman of the HLB Group, announced on the morning of the 17th that “HLB’s US subsidiary Elevar received an ‘NDA Filing Acceptance’ letter from the FDA.” Elevar submitted a new drug application (NDA) for rivoceranib on May 16 after completing a global Phase III study evaluating the efficacy and safety of rivoceranib+camrelizumab therapy. The FDA assigned a target action date of May 16, 2024, under the Prescription Drug User Fee Act (PDUFA). Therefore, the decision will be made for the new drug within 10 months. With the FDA’s acceptance of the NDA, the company plans to accelerate preparations for commercialization, such as expanding drug sales licenses and establishing joint marketing execution strategies. Also, the company is preparing for the on-site scheduled on-site FDA CMC (Chemical Manufacturing and Controls) inspection together with Jiangsu Hengrui Medicine. HLB holds the global patent for the targeted anticancer therapy rivoceranib. HLB Life Sciences holds the sales rights for rivoceranib in Korea and partial profit rights for the drug in Europe and Japan. Jiangsu Hengrui Medicine owns the sales rights in China. Elevar Therapeutics, Inc. holds global rights in all other regions.
- Company
- Boehringer Ingelheim releases SGLT2+DPP4 combo Esgliteo
- by Jung, Sae-Im Jul 18, 2023 05:29am
- On the 17th, Boehringer Ingelheim announced it had launched its type 2 diabetes treatment ‘Esgliteo (empagliflozin+linagliptin)’ in Korea. Esgliteo is a fixed-dose combination of Boehringer Ingelheim’s original SGLT-2 inhibitor ‘Jardiance (empagliflozin)’ and DPP-4 inhibitor ‘Trajenta (linagliptin). The company developed a small-sized drug – 8.1mm in diameter - to improve the convenience in intake and medication adherence for patients that difficulty taking pills. Two options - 10mg/5mg, and 25mg/5mg – of Esgliteo are offered for patients who need further blood sugar control. Esgliteo is now the only fixed-dose dual combination drug of an SGLT2 inhibitor and DPP-4 inhibitor that was released in Korea with reimbursement. Esgliteo demonstrated a superior blood sugar-lowering effect as well as therapeutic benefit that exceeds the effect shown by each individual ingredient. The complementary mechanism of action allows the combination drug to provide an excellent blood sugar control effect. According to a Phase III clinical trial, Esgliteo showed an improved blood glucose reduction effect at 24 weeks compared to empagliflozin and linagliptin monotherapy in type 2 diabetic patients who experienced insufficient glycemic control on metformin. After the Ministry of Health and Welfare issued a notification on its reimbursement, Esgliteo was listed and granted reimbursement from May 1st. Type 2 diabetes patients whose HbA1c is 7% or higher after using a two-drug regimen for over 2-4 months can use Esgliteo with reimbursement if he or she wishes to use it as part of a three-drug regimen that includes metformin. Ina Hwang, Head of Marketing at Boehringer Ingelheim Korea, said, ” In line with the rising importance of combination therapy for Type 2 diabetes, We are pleased to be able to offer Esgliteo, which offers the treatment benefits of both active ingredients with improved convenience in intake for Type 2 diabetes patients in Korea.”
- Company
- SGLT-2i Envlo may be prescribed at general hospitals
- by Eo, Yun-Ho Jul 18, 2023 05:29am
- Daewoong Pharmaceutical’s SGLT-2 inhibitor, ‘Envlo’ can be prescribed at general hospitals in Korea. According to industry sources, the diabetes treatment Envlo (Enavogliflozin) that was released with reimbursement in May passed the drug committees (DCs) of various medical institutions in Korea including the Samsung Medical Center and Korea University Anam Hospital. Envlo, which was approved as the 36th new homegrown drug, is the first SGLT-2 inhibitor class diabetes drug that a Korean pharmaceutical company succeeded development and localization of. Priced at KRW 611, Envlo may be used as ▲monotherapy, ▲metformin combination therapy, and metformin and gemigliptin combination therapy in Korea. At a dose of 0.3mg, which is 1/30th the dose of other same-class treatments, Envlo demonstrated more than equivalent blood glucose-lowering effects and safety. Also, the drug was found to improve cardiovascular risk factors such as weight, blood pressure, and lipids. The company has applied for the DC review for Envlo at various major medical institutions around the nation and plans to further extend its prescription area in the future. Meanwhile, Daewoong Pharmaceutical received marketing approval for its envagliflozin+metformin combination, ‘Envlomet ST Tab.’ recently. In line with Korea’s trend that expands the use of SGLT-2 inhibitors, the company is preparing an Envlo-based combination drug lineup for diabetes as well.
- Company
- MSD Korea expands ERP to all departments
- by Jung, Sae-Im Jul 17, 2023 05:30am
- MSD Korea, which had notified the closure of the General Medicine division that sold the diabetes treatment Januvia, has extended the conditions for its early retirement program (ERP). With the company’s large-scale layoff raising conflicts with employees and the low rate of applications, the company seems to have changed its tactics to reshuffling. According to industry sources on the 15th, MSD Korea announced introduced a broader ERP program that allows a wider range of subjects to apply for early retirement with expanded conditions. The changed conditions allow employees from all departments, not only the General Medicine division but all divisions. The excess severance pay was also raised to a maximum of KRW 120 million. As excess severance pay, employees that served ▲ less than 5 years will receive KRW 70 million, ▲ 5 years or over will receive 100 million, and ▲ 15 years or over will receive KRW 120 million. In addition, 20 early applicants will additionally receive KRW 10 million. For example, if an employee who has worked for 15 years applies for ERP, he or she will receive an additional KRW 120 million as excess severance pay, equivalent to 40 months’ worth of monthly basic salary. If he or she is an early applicant, he or she will receive up to KRW 130 million. This is the highest amount offered in the industry. The previous conditions for ERP presented by MSD Korea were ▲an employee in the GM division, ▲basic severance pay of 2n+10 (service year*2+10 months of basic monthly pay), ▲ basic severance pay limit set as 48 months, and ▲excess severance pay of KRW 200 million. The conditions of being ▲an employee in the GM division and ▲excess severance pay of KRW 200 million conditions were extended significantly. The application deadline is July 20th. The resignation date of GM unit employees will be July 31st, and others August 31st. GM employees who applied for voluntary retirement through ERP last month will also benefit from the raised standards. In addition, they will be paid an additional 10 million won regardless of whether they applied early or not. On the reason the background of why the ERP was expanded, MSD Korea said, "After the decision was made to close our GM business, we have been seeking the best way to support our employees. Ahead of the organizational restructuring that will take place on August 1st, we carefully reviewed the opinions and suggestions of our various employees and decided to expand the ERP and severance package. We have been carrying out an external career support program while offering an improved ERP package for our internal business organizations and CO (Commercial Operations) units from July 10th to 20th,”
- Company
- BsAb lymphoma treatment Lunsumio will soon land in KOR
- by Eo, Yun-Ho Jul 17, 2023 05:30am
- The new bispecific antibody treatment for lymphoma, ‘Lunsumio’, will soon land in Korea. According to industry sources, the Ministry of Food and Drug Safety is in its last stages of review for the product approval of Roche Korea's follicular lymphoma drug Lunsumio (mosunetuzumab), which was designated as the first drug subject to Korea’s Global Innovative products on Fast Track (GIFT) system. Lunsumio was approved by the US Food and Drug Administration in December last year for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. The drug is a CD20xCD3 T-cell engaging bispecific antibody that binds to two different targets on cells - the immune T-cells that attack tumor cells and malignant B cells - to connect the immune cells with cancer cells. In Korea, the drug was designated as an orphan drug last year and was also designated an orphan drug by the US FDA and the EU EMA. Lunsumio demonstrated its potential through positive results from the Phase II GO29781 study of Lunsumio in people with follicular lymphoma. Study results showed that Lunsumio’s ORR was 80%(72/90), and the majority (57%) of patients maintained responses for at least 18 months. A complete response of 60% (54/90) was also observed in these patients with a median duration of response (DOR) was 22.8 months. Meanwhile, the GIFT program provides support from the initial development stage of innovative new drugs to allow faster commercialization of new drugs. The program may allow drugs to reduce the approval review period by up to 75%. Drugs subject to GIFT can receive various support that accelerates commercialization, including ▲support for regulatory approval, ▲rolling review, ▲close communication between the reviewer and developer through product presentation and supplementary briefing sessions, and ▲expert consulting by regulation experts.
- Company
- Danicopan has been designated for GIFT
- by Eo, Yun-Ho Jul 17, 2023 05:30am
- Danicopan, a combination partner of Soliris, was designated as a GIFT at the same time as this orphan drug designation. The Ministry of Food and Drug Safety recently announced that AstraZeneca's Danicopan (ALXN2040) will be designated as an orphan drug and GIFT in Korea. Danicopan, a candidate for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), has been designated as an orphan drug for PNH treatment in the United States and Europe and has been selected as a breakthrough therapy by the US FDA and as a PRIME target by the European EMA. Danicopan demonstrated efficacy as a potential complementary treatment in patients with PNH who experienced clinically significant extravascular hemolysis in the phase 3 ALPHA study. This is the first case in which factor D inhibitors have confirmed positive effects in phase 3 clinical trials. A prespecified interim analysis compared hemoglobin levels with a placebo after 12 weeks of treatment, resulting in a statistically significant improvement. According to the study, Danicopan and Ultomiris combination therapy showed statistically and clinically significant improvement in treatment parameters. These indicators include improvements in hemoglobin levels, blood transfusions, and fatigue scores, and a functional evaluation of chronic disease treatment, from the start of treatment. Danicopan is conducting research on combination therapy for C5 inhibitors, such as Soliris and Ultomiris. Lee Jong-Wook, a professor of hematology at Seoul St. Mary's Hospital who participated in the ALPHA study, explained, "The therapeutic effect of C5 inhibitors on PNH has been proven. However, although the number is small, patients still suffer from the burden of blood transfusion due to anemia and extravascular hemolysis." Meanwhile, GIFT is a program that supports innovative drugs from the beginning of clinical development so that they can be commercialized quickly, and can shorten the approval review period by up to 75%. GIFT recipients will receive support for rapid commercialization, such as support for the preparation of approval materials, application of a rolling review that reviews prepared materials first, close communication between reviewers and developers such as item briefings and supplementary briefings, and professional consulting related to regulations.
- Company
- "Cibinqo secures solid data in atopic dermatitis"
- by Jung, Sae-Im Jul 13, 2023 05:35am
- 'Cibinqo (abrocitinib),' the third JAK inhibitor to be introduced for atopic dermatitis in Korea, will be reimbursed starting this month. Healthcare professionals have expressed high expectations for Cibinqo, as the drug has accumulated robust data in treating severe atopic dermatitis. On the 11th, the Korean pharmaceutical company Hanmi Pharmaceutical held a press conference to celebrate the reimbursement of Cibinqo, an oral atopic dermatitis treatment, at the Seoul Dragon City Hotel in Yongsan-gu, Seoul. Professor Yong-Hyun Jang of the Department of Dermatology at Kyungpook National University Hospital explained the background and significance of Cinbinqo's reimbursement for atopic dermatitis in Korea. Professor Yong-Hyun Jang of the Department of Dermatology at Kyungpook National University Hospital is presenting at the press conference celebrating the reimbursement and listing of Cibinqo Cibinqo is a Janus kinase 1 (JAK1) inhibitor that was approved by the Ministry of Food and Drug Safety in November 2021. It is also the 4th JAK inhibitor in Korea and 2nd JAK class treatment to be introduced by Pfizer. Unlike Xeljanz, which is used only for ulcerative colitis, Cibinqo can also be used for the treatment of severe atopic dermatitis. Cibinqo was granted reimbursement this month. The 50mg, 100mg, and 200mg doses of Cibinqo were listed at KRW 11,087, 17,739, and 25,942 respectively. The ceiling price is known to be set at 88% of the calculated average price of its substitutes. With the listing of Cibinqo, patients with severe atopic dermatitis now have a much wider range of new treatment options. In addition to the biological agent ‘Dupixent’ that was first introduced, 3 JAK inhibitors – the already-reimbursed Olumiant (baricitinib) and Rinvoq (upadacitinib), and Cibinqo – are now available for use in Korea. Among these treatments, Dupixent, Rinvoq, and Cibinqo can be used in adolescent patients aged 12 and above. Although being a latecomer, Cibinqo received recognition for having acquired solid data in atopic dermatitis from various clinical trials. 6 Phase III clinical trials, including JADE DARE, JADE COMPARE, and JADE TEEN, have been conducted. Cibinqo was the first drug that attempted to directly compare (head-to-head) its efficacy and safety with the biological agent Dupixent, and Cinbinqo was observed for the possibility of deterioration upon dose reduction or discontinuation of treatment after initial response, and evaluated on its ability to recover from the reaction. By confirming the drug’s effect on patients that showed no response to Dupixent, the company accumulated grounds for patients to switch to Cibinqo. The rapid improvement of itch, which was observed in various clinical trials of Cibinqo, is expected to significantly improve patient’s quality of life. Jang explained, "Itch is a very important symptom in atopic dermatitis. It causes patients to scratch their skin, weakens the skin barrier, and exacerbates inflammation as a secondary reaction. Cibinqo showed a rapid and significant improvement in itch from the day after initial administration, increasing patients' quality of life. Also, more patients reached the target response rate for the Eczema Area and Severity Index (EASI). We believe Cibinqo will benefit patients who are suffering from severe itch." Cibinqo has also demonstrated additional benefits in patients who did not respond to Dupixent. The JADE EXTEND study investigated the effect of switching to Cibinqo from Dupixent in patients who received Dupixent in the JADE COMPARE study. The patients were further divided into those that responded to Dupixent and those that didn’t respond to Dupixent. In the arm that did not respond to Dupixent, 80% achieved EASI-75 (75% improvement based on the Eczema Area and Severity Index). Also, 77% achieved an improvement of 4 points or more on the Peak Pruritus Numerical Rating Scale (PP-NRS). This is expected to serve as evidence when companies of JAK inhibitors apply for reimbursement extensions to cover patients switching from Dupixent. Jang stated, "Unlike other JAK inhibitors, Cibinqo holds significance as it conducted various studies solely in the field of atopic dermatitis, which is significant. With the basis for switching treatments established, we expect reimbursement extensions to follow in the near future. We are currently collecting various opinions in academia as well.”
- Company
- Schizophrenia drug Invega Hafyera lands in general hospitals
- by Eo, Yun-Ho Jul 13, 2023 05:35am
- The long-acting formulation of the schizophrenia drug ‘Invega’ has landed in general hospitals in Korea. According to industry sources, Invega Hafyera 1092mg/1560mg (paliperidone palmitate), Janssen Korea’s extended-release injectable suspension for patients with schizophrenia that is injected every 6 months, has passed the drug committees of medical institutions in Korea, including Seoul Asan Medical Center. Janssen has been continuously working to create a prescription environment since it was listed for reimbursement in May. Invega Hafyera was approved by the Ministry of Food and Drug Safety in September 2022. The 1-month extended-release injectable formulation of the same drug, Invega Sustenna, had been approved in July 2010 and granted reimbursement in November 2015. With reimbursement, the drug is covered for all patients with schizophrenia in Korea, including first-episode patients. The 3-month extended-release injectable formulation, Invega Trinza, was approved in June 2016 and is being reimbursed from September 2016. Invega Hafyera is indicated for use in patients who have been adequately treated with: Invega Sustenna (once-a-month extended-release injectable suspension) for at least 4 months; or Invega Trinza (every-three-month extended-release injectable suspension) for at least one three-month cycle. Patients who wish to switch to Invega Hafyera from Invega Sustenna 156mg receive Invega Hafyera 1092mg, and those switching from Invega Sustenna 234mg receive Invega Hafyera 1560mg as an initial dose. In the case of Invega Trinza 546mg and 819mg, patients may switch to Invega HafyeraTM 1092mg, and 1560mg, respectively. The safety and tolerance of the every-six-month injectable Invega Hafyera were confirmed through the PSY3015 study. Se Hyun Kim, Professor of Psychiatry at Seoul National University Hospital, said, “Invega Hafyera can offer a broader range of benefits to patients who have seen a stable effect with Invega Sustenna or Invega Trinza. The new formulation offers an opportunity to lower the barrier to injectable treatments for schizophrenia patients in Korea.” Kim added, “The long-acting injectable formulation allows continuous treatment with its stable medication adherence and improved convenience, and can provide benefits such as returning to society and regaining confidence for patients with schizophrenia.” In schizophrenia, the risk of worsening or relapsing symptoms is high with low medication adherence. The long-acting injectable formulations offer a benefit in that aspect as it improves medication adherence over oral formulations, reduce medical cost and relapse or rehospitalization rates, improve symptoms and social function of the patients (when switching to a long-acting injectable formulation), and offer convent administration. The treatment guidelines for schizophrenia in Korea allow long-acting injectable formulations to be administered to patients in all patients, from early to chronic stages.
- Company
- Samsung Biologics, cumulative order amt exceeded 2 trillion
- by Hwang, Jin-joon Jul 11, 2023 05:41am
- Panoramic view of Samsung BiologicsSamsung Biologics announced on the 10th that it has signed a main contract for biopharmaceutical consignment manufacturing (CMO) worth 511.1 billion won from global pharmaceutical company Novartis. Through this contract, the cumulative amount of orders received this year increased to 2.3387 trillion won. This contract with Novartis was signed one year after the letter of intent (LOI) of 100 billion won in June last year. Samsung Biologics and Novartis signed a main contract with a size that is five times larger than the previous LOI. Samsung Biologics signed a CMO contract worth 1.2 trillion won with global pharmaceutical company Pfizer on the 4th before signing a large-scale contract with Novartis. The amount of orders received from Pfizer and Novartis alone amounts to 1.7 trillion won. This is similar to last year's total order amount of 1.7835 trillion won. Samsung Biologics is increasing large-scale, long-term contracts while securing major global big pharma customers. It has secured 13 of the top 20 global pharmas as customers. Samsung Biologics is strengthening its ability to win orders based on its competitiveness in the global No. 1 production capacity (CAPA), speed, and quality. Samsung Biologics started with the 30,000-liter plant 1 in 2011 and expanded the 154,000-liter plant 2 in 2013. In 2015, a third plant with a capacity of 180,000 liters was built. Starting in 2020, construction began on the 240,000-liter class 4 plant, the world's largest single plant, and began full operation last month. The total production capacity is 604,000 liters. Samsung Biologics started construction of its 5th plant in April to preemptively respond to the market's demand for biopharmaceutical CMO. Completion is targeted for April 2025. When completed, the total production capacity will be 784,000 liters. Through process innovation, Samsung Biologics has shortened the technology transfer period, which is essential for biopharmaceutical production, to three months, half of the industry average. Process optimization was carried out through a specialized technology transfer team. The deployment success rate of Samsung Biologics is over 98%. A batch refers to a biopharmaceutical production unit. The cumulative number of regulatory approvals was 231. Samsung Biologics is strengthening its capabilities to respond to the demand for next-generation drugs such as antibody-drug conjugates (ADCs). In April of this year, it invested in Araris Biotech, an ADC treatment technology development company, through the Life Science Fund. It also plans to have an ADC production facility by 2024. Samsung Biologics plans to actively respond to the blockbuster drug market, such as Alzheimer's treatment. Based on the world's largest production capacity, it plans to expand orders by focusing on products that require mass production and products that newly expand indications. It plans to win orders for the 5th plant targeting Alzheimer's treatment, which has a lot of unmet demand. An official from Samsung Biologics said, "We have expanded our global bases, mainly in North America, to narrow the physical distance with our customers and provide prompt services." "We opened a sales office in New Jersey in March of this year following San Francisco in October 2020 to provide services to global customers," he said.
