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- 2025-12-24 13:49:19
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- Cibinqo lands in general hospitals in Korea
- by Eo, Yun-Ho Oct 25, 2022 05:46am
- Pfizer’s second Janus kinases (JAK) inhibitor ‘Cibinqo (abrocitinib) has landed and may be prescribed at general hospitals in Korea. According to industry sources, Pfizer Korea’s new JAK1 inhibitor drug (abrocitinib) has passed the drug committee (DC) reviews of the ‘Big 5 tertiary hospitals’ of Korea including the Seoul National University Hospital, Seoul Asan Medical Center, Seoul St. Mary’s Hospital, Asan Medical Center, and Sinchon Severance Hospital, as well as 24 medical institutions including Gangnam Severance Hospital, Korea University Guro Hospital, and Seoul National University Bundang Hospital. The company applied for its reimbursement listing in April, and as the agenda passed Drug Reimbursement Standard Subcommittee deliberations in August, prescriptions will be made quickly once reimbursement is applied. However, Lilly Korea’s ‘Olumiant (baricitinib),’ and ‘Abbvie’s ‘Rinvoq (upadacitinib)’ has already been receiving reimbursement for the atopic dermatitis indication since May, and when considering how the company made the strategic move to accept the weighted average price of its alternatives, its reimbursement progress is not on the faster side. The drug, which was approved for atopic dermatitis, is Pfizer’s follow-up of ‘Xeljanz (tofacitinib)’ that is set to compete with ‘’ Lilly Korea’s ‘Olumiant (baricitinib),’ ‘Abbvie's ‘Rinvoq (upadacitinib)’ in the same indication. Olumiant and Rinvoq were approved for reimbursement in May this year, and the reimbursement listing process for Cibinqo is also in progress. Cibinqo was approved in November of last year when the reimbursement listing for Olumiant and Rinvoq was being reviewed. As a JAK1 inhibitor, the drug modulates multiple cytokines involved in the pathophysiology of atopic dermatitis, including interleukin IL-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP). It is indicated for the treatment of adults and adolescents over the age of 12 with moderate-to-severe atopic dermatitis. Cibinqo demonstrated its efficacy through the Phase III trials JADE MONO-1, MONO-2, COMPARE, etc. The drug reduced the Eczema Area and Severity Index (EASI) by over 70% at week 12 and demonstrated improvement in itch relief in 2 weeks after initiating treatment. Its pivotal study, JADE Mono-1, was designed to evaluate the efficacy and safety of two doses (100 mg and 200 mg once daily) of Cibinqo monotherapy in patients 12 years of age and older with moderate-to-severe AD for 12 weeks. Results showed that 63% of the Cibinqo 200 mg administered group had achieved EASI-75 (improvement of at least 75% in lesion extent and severity) at week 12, which was a significant improvement compared to the 12% in the placebo group. Also, the rate of patients that achieved EASI-90 at week 12 had been 39% in the Cibinqo group, 5% higher than the placebo group.
- Company
- GSK has signed a sales contract with GC Pharma & Kwang Dong
- by Eo, Yun-Ho Oct 25, 2022 05:46am
- GSK has signed a joint sales contract with two domestic companies, GC Pharma and Kwang Dong, to sell the shingles vaccine Shingrix. GSK Korea announced on the 24th that it signed a Co-Promotion and Distribution Partnership for Shingrix's domestic sales and marketing on the 21st. Through this partnership, GC Pharma and Kwang Dong will jointly promote GSK's new shingles vaccine Shingrix on all distribution channels, including hospitals. GSK subsidiary is expected to strengthen its expertise in the distribution of shingles vaccines by selecting GC Pharma and Kwang Dong, which have domestic sales networks and marketing know-how accumulated in the shingles vaccine sector. "We are pleased to introduce a shingles prevention vaccine for adults over 50 and those over 18 years of age through a strategic partnership with GC Pharma and Kwang Dong, which have expertise in vaccine distribution," GSK President Rob Kempton said. Heo Eun-cheol, CEO of GC Pharma, said, "We are very happy to partner with GSK, a leading global healthcare company. Based on GC Pharma's accumulated vaccine know-how and understanding of distribution, we will work closely with GSK to provide better shingles prevention options to more people, he said. Choi Sung-won, CEO of Kwang Dong, said, "Kwang Dong has achieved various achievements for a wide range of patients and medical staff through partnerships with various domestic and foreign companies." "We will contribute to the health of the people by focusing on Shingrix the professional capabilities that GSK has developed as a vaccine distribution and marketing partner since 2015," he stressed. Meanwhile, Shingrix is scheduled to be released in Korea in December.
- Company
- Lyumjev can be prescribed in general hospitals
- by Eo, Yun-Ho Oct 24, 2022 06:08am
- The new fast-acting insulin ‘Lyumjev’ can now be prescribed at general hospitals in Korea. According to industry sources, Lilly Korea’s ‘Lyumjev (insulin lispro)’ has passed the drug committee (DC) reviews of various medical institutions including the Samsung Medical Center. Lyumjev, which was approved in Korea in December last year, has been approved for reimbursement since September this year. Its prescriptions are expected to begin in earnest after landing in more general hospitals. As mealtime insulin, Lyumjev contains the active ingredient ‘insulin lispro-aabt,’ and is used to help reduce blood sugar levels in adults with type 1 or type 2 diabetes who have difficulty managing target blood glucose levels or whose blood glucose level increases after meals. The domestic approval was made based on results from the PRONTO clinical trial program that was conducted on adult patients with Type 1 and Type 2 diabetes. PRONTO-T1D and PRONTO-T2D are treat-to-target, multicenter, parallel studies Phase III clinical trials in which patients in each treatment arm were first treated to reach the same blood sugar level, and then compared for their main therapeutic effects, including the rate of hypoglycemia, postprandial glucose (PPG) control, and period of proper blood sugar maintenance. Study results showed that Lyumjev demonstrated non-inferiority to Humalog (lispro 100U)’ in the primary endpoint, which was the change in glycated hemoglobin (HbA1c) from baseline to 26 weeks. Also, Lyumjev demonstrated superiority over Humalog in reducing 1-hour and 2-hour postprandial glucose excursions. Meanwhile, Phase I trial results on Type 1 diabetes patients have also shown that Lyumjev’s absorption of insulin into the bloodstream was faster than that of ‘Humalog,’ ‘Insulin Aspart,’ and ‘fast-acting Insulin Aspart.’ The blood glucose results of patients up to 3 hours following injection of Lyumjev were similar to those of participants without diabetes.
- Company
- Will Onureg, an acute leukemia maintenance drug be listed?
- by Eo, Yun-Ho Oct 24, 2022 06:08am
- Attention is focusing on whether Onureg will be able to be listed on the insurance benefit list. According to related industries, Onureg of BMS Pharmaceutical Korea is expected to be submitted to the HIRA Cancer Disease Review Committee on the 2nd of next month. Onureg is the only oral maintenance of acute myeloid leukemia. It was approved in Korea in March as a treatment for adult patients with acute myeloid leukemia who achieved CRi or incomplete hematological recovery after induction therapy and were not suitable for hematopoietic stem cell transplantation (HSCT). Acute myeloid leukemia is also fatal among leukemia. Without treatment, 90% of people die within a year. Even if it becomes CR, the risk of recurrence is also high because up to 100 million residual leukemia cells may remain. If proper treatment is not accompanied after CR, the recurrence rate reaches up to 50% within a year, and the median OS value is only 8 months in case of recurrence. Maintenance therapy that can prevent recurrence and maintain CR condition as stable as possible is drawing attention. Onureg proved its validity through a phase 3 study of QUAZAR AML-001 in 472 patients with acute myeloid leukemia. As a result of the study, the mOS of the patient group who took Onureg was 24.7 months, extending the survival period by 10 months from 14.8 months in the placebo group and lowering the risk of death by 31%. At the time of 1 and 2 years of treatment, the proportion of patients who survived in the Onureg group was 73% (56% in the placebo group) and 51% (37% in the placebo group), respectively, which were higher than in the placebo group. RFS also confirmed the effect of reducing the risk of recurrence as Onureg reached 10.2 months, which is 5.3 months longer than the placebo group. The proportion of patients who did not recur after 6 months of treatment was 67% in the Onureg group, higher than 45% in the placebo group, and even at one year, the proportion of patients who did not recur was higher in the Onureg group.
- Company
- Lucentis biosimilar of Chong Kun Dang gets domestic approval
- by Chon, Seung-Hyun Oct 24, 2022 06:08am
- Chong Kun Dang succeeded in commercializing its second biosimilar. Chong Kun Dang announced on the 20th that it has received approval from the Ministry of Food and Drug Safety for domestic items of the "Lucentis" biosimilar. The indication for "treatment of neovascular (habitual) age-related macular degeneration" has been approved. Lucentis, sold by Roche and Novartis, is a drug used to treat eye diseases such as macular degeneration diabetes, and macular edema. Lucentis is a large product with global sales of 4.4 trillion won last year. Chong Kun Dang proved that the therapeutic effects of CKD-701 and Lucentis were equal through phase 3 clinical trials of 312 neovascular age-related macular degeneration patients at 25 hospitals, including Seoul National University Hospital, from September 2018 to March last year. According to IQVIA, a pharmaceutical research institute, Lucentis recorded 35.1 billion won in sales in Korea last year. Chong Kun Dang is the second Korean company to succeed in commercializing Lucentis biosimilars after Samsung Bioepis. Samsung Bioepis received an item license from Lucentis biosimilar Amelivu in May. Chong Kun Dang said, "We expect CKD-701 to provide patients with various treatment drug choices and expand treatment opportunities." Chong Kun Dang said, "It will be released after going through the health insurance registration process." As a result, Chong Kun Dang produced its own second biosimilar. Chong Kun Dang received domestic permission from biosimilar Nesbell for the anemia treatment NESP in November 2018. After securing differentiated raw material manufacturing technology in 2008, Chong Kun Dang established a biopharmaceutical production infrastructure in 2012 and developed Nesbell.
- Company
- Tumor-agnostic Vitrakvi lands in Big 5 tertiary hospitals
- by Eo, Yun-Ho Oct 21, 2022 05:47am
- The tumor-agnostic drug ‘Vitrakvi’ has landed in the Big 5 tertiary hospitals in Korea. According to industry sources, Bayer Korea’s neurotrophic tyrosine receptor kinase targeted anticancer drug Vitrakvi (larotrectinib) has passed the drug committees of major hospitals in Korea, including general hospitals like the Samsung Medical Center, Seoul National University Hospital, Seoul St.Mary’s Hospital, Asan Medical Center, and Sinchon Severance Hospital and major medical institutions such as Gangnam Severance Hospital, National Cancer Center, and Seoul National University Bundang Hospital. The drug is seemingly settling quickly in the prescription market after it was listed for reimbursement in April. Vitrakvi, which received marketing approval in Korea in May last year, underwent the reimbursement listing process through the pharmacoeconomic evaluation exemption track and passed HIRA’s Drug Reimbursement Evaluation Committee review in November. Its competitor which has the same mechanism of action, Roche’s ‘Rozyltrek’ is also undergoing pricing negotiations with the NHIS. Vitrakvi is indicated for use in adult and pediatric patients with solid cancer who have progressed after using conventional treatment options or have no suitable treatment options available that have NTRK gene fusions without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to result in severe morbidity. In other words, it may be used in virtually most cancer types with an identified NTRK gene. Vitrakvi’s approval was based on data from a Phase I trial on adults 18 years and older, the Phase II NAVIGATE study on pediatric and adult patients over the age of 12, and the Phase I/II SCOUT study on pediatric patients aged 1 month to 21 years that includes those with primary CNS tumor. According to an efficacy review that was conducted on 55 patients with identified NTRK fusion in the 3 studies above, Vitrakvi’s overall response rate (ORR) was 75% and partial response 53% in various cancer types (including soft tissue sarcoma, infantile fibrosarcoma, salivary gland tumors, thyroid cancer, lung cancer, melanoma, colon cancer, gastrointestinal stromal tumor, cholangiocarcinoma, appendiceal carcinoma, breast cancer, and pancreatic cancer) Vitrakvi showed an effect not only in adults but also in pediatric patients. Twenty-four patients aged 1 year or less participated in the studies above, and the drug showed the same efficacy in these patients as in adult patients. As a result, Vitrakvi was approved for use in both pediatric and adult patients.
- Company
- Celltrion develops anticancer drugs using ADC platform
- by Oct 21, 2022 05:47am
- Celltrion announced on the 17th that it has signed a contract with domestic bio company Pinotbio to introduce options for implementing ADC Linker-Payload platform technology. With this contract, Celltrion paid advance payments and secured the right to utilize Pinotbio's ADC Linker-PINOT-ADC for up to 15 targets. Celltrion plans to develop ADC anticancer drugs targeting solid cancer by applying PINOT-ADC technology to pipeline candidate materials under development. For a total of 15 target options secured this time, Celltrion can use the technology for one target for each option event, and advance payments, milestones, and royalties for each option event are set separately. ADC Linker-PBD technology is a technology that combines payloads with excellent therapeutic effects with antibodies that react only to specific antigens so that drugs can selectively act on cells expressing antigens. The maximum therapeutic effect can be expected with the minimum drug administration, and the drug can be selectively delivered to the target cell. Celltrion has secured anticancer drugs such as blood cancer treatment Truxima, breast and gastric cancer treatment Herzuma, metastatic direct bowel cancer, non-small cell lung cancer, and ovarian cancer treatment Begzelma. The contract is expected to enable the development of more diverse anticancer drugs by securing options for implementing ADC platform technology. Celltrion signed a contract with Pinotbio to introduce platform technology implementation options, as well as a stake investment and joint research contract. The two companies decided to focus their development capabilities as much as possible to achieve the joint goal of developing ADC treatments while establishing a long-term partnership through equity investment and joint research contracts. An official from Celltrion said, "The introduction of Linker-Payload platform technology has added momentum to the development of ADC anticancer drugs as a future growth engine project. We will actively expand new growth engines through continuous cooperation with promising biotech such as Pinotbio."
- Company
- LG Chem acquires US pharma company for KRW 800 billion
- by Chon, Seung-Hyun Oct 19, 2022 05:49am
- LG Chem will invest KRW 800 billion to acquire a US bio-company. With the acquisition, the company will also be securing an anticancer drug that is being sold in the US. On the 18th, LG Chem announced that it would acquire AVEO Pharmaceuticals for $566 million (approx. KRW 800 billion). LG Chem will be acquiring a 100% stake in AVEO Pharmaceuticals, a company known for its FDA-approved renal cell carcinoma treatment ‘Fotivda.’ This will be the first time a Korean company acquires a company that owns an FDA-approved new drug. AVEO Pharmaceuticals was established in Boston, MA in 2002. It owns full capabilities ranging from clinical development, approval, sales, and marketing in the oncology market. Listed on the Nasdaq in 2010, the company received FDA approval for its targeted therapy Fotivda for the treatment of renal cell carcinoma in 2021. AVEO Pharmaceuticals is expected to record sales of KRW 150 billion this year, which will abe a threefold year-on-year growth. If the ongoing clinical trial that is evaluating Fotivda in combination with an immuno-oncology drug becomes successful, Fotivda’s indication will expand, raising expectations for its further growth. LG Chem will use its assets to finance the funds for the acquisition to LG Chem Life Science Innovation Center (LG CBL), which is based in Boston, US. LG CBL will then establish a special purpose corporation (SPC) to proceed with the M&A of AVEO Pharmaceuticals. The overall deal is expected to be completed in around 3-6 months, after receiving majority approval from AVEO’s general shareholders' meeting and undergoing deliberation by the Committee on Foreign Investment in the United States. LG Chem said, “With the acquisition, we will be able to secure anticancer commercialization capabilities in the US in a short period of time while establishing a bridgehead to launch various in-house new drugs to the US, the world’s largest pharmaceutical market.” LG Chem made the decision to acquire AVEO Pharmaceuticals, a company that has successfully entered the commercialization stage, as it is possible to operate a business in oncology with a sales organization that focuses around on a small number of medical institutions specializing in cancer. Fotivda received a Category 1 Recommendation in the NCCN Guidelines in August and was evaluated to have settled in the renal cell carcinoma treatment market. In addition to Fotivda, AVEO Pharmaceuticals also owns 3 oncology pipelines including the head-and-neck cancer treatment that is undergoing a Phase III clinical trial, etc. LG Chem has a total of 20 new drug pipelines in the development stage, which includes 9 oncology pipelines including cell therapies in solid cancer, as well as treatments for gout, NASH, and obesity. LG Chem plans to accelerate market entry from the beginning of the launch of its new drugs by securing U.S. commercialization capabilities early on. LG Chem aims to record KRW 2 trillion in sales in Life Sciences by 2027 by internalizing AVEO’s commercialization and clinical capabilities. Ahk Cheol Shin, Vice Chairman & Chief Executive Officer at LG Chem, said, “This acquisition decision is the most important milestone in the 40-year history of LG Chem’s biology business. It will lay the foundation for the business to take the global leap forward. We will continue to strengthen commercialization capabilities in the US and actively expand local sales while further enhancing our clinical and licensing capabilities in the US to accelerate our advance into a global innovative pharmaceutical company.”
- Company
- Novo Nordisk appoints Sasha Semienchuk as new GM
- by Eo, Yun-Ho Oct 19, 2022 05:48am
- Sasha Semienchuk, VP & General Manager, Novo Nordisk Korea On the 18th, Novo Nordisk announced that it has appointed Sasha Semienchuk as the VP and General Manager of its Korean subsidiary effective in October. Sasha Semienchuk owns over 20 years of experience in healthcare across sales, marketing, research, and management at multinational pharmaceutical companies and startups in 7 countries on three continents. After joining Novo Nordisk in 2012, Semienchuk was engaged in various diseases and therapeutic areas. From 2015, Semienchuk served as a Senior Director of Global Marketing in the obesity disease area at Novo Nordisk in Denmark and led communication and commercial activity between global exepert organizations. From 2018, Semienchuk worked as the Senior Marketing Director at Novo Nordisk Japan and led the launch of various new insulin products in its Insulin team. Meanwhile, his predecessor, Rana Azfar Zafar, has been appointed as Vice President of Novo Nordisk's CEM (Commonwealth Independent States Emerging Market) cluster and will be overseeing business in Kazakhstan, Azerbaijan, Georgia, Armenia, Uzbekistan, Turkmenistan, Tajikistan, Kyrgyzstan, and Mongolia.
- Company
- Forxiga & Jardiance are expected to surpass 100 billion won
- by Nho, Byung Chul Oct 19, 2022 05:48am
- The SGLT-2-inhibited original diabetes treatment market recorded 53 billion won in the first half of this year, which is expected to surpass 100 billion won by the end of this year. The SGLT-2 original drug market was divided into Forxiga and Beringer Ingelheim Jardiance, and sales of 22.1 billion won and 30.9 billion won in the first half, respectively. The total sales of both Forxiga and Jardiance products last year were 91.6 billion won, up 94% from 47.1 billion won in 2018. From 2018 to 2021, Jardiance's sales were 19.8 billion won, 26.1 billion won, 29.4 billion won, and 32.3 billion won. During the same period, Jardiance Duo recorded 2.5 billion, 6.5 billion, 13.8 billion, and 21.1 billion won. Compared to the pace of growth between 2018 and 2021, Jardiance Duo increased by 63% (19.8 billion → 32.3 billion) and 744% (2.5 billion → 21.1 billion). Jardiance Duo's overall sales last year were 53.4 billion won, 15.3 billion more than Posh's 38.1 billion won. Jardiance Duo's sales in the first half of this year were 17.5 billion won and 13.3 billion won, respectively, and if such an elastic curve is maintained, it is expected to grow by 8.26% compared to the previous year. Forxiga's growth rate over the past four years is 54%, and its appearance between 2018 and 2021 recorded 24.7 billion won, 27.9 billion won, 32 billion won, and 38.1 billion won. Forxiga 10mg, which was approved in Korea in 2013, maintained 784 won at the beginning of its launch but was cut by 24 won to 760 won in May this year. This drug is used in type 2 diabetes monotherapy and is effective in reducing the risk of chronic heart failure and chronic kidney disease hospitalization and death. In particular, Forxiga is expected to compete fiercely in the market between original and generic due to the expiration of material patents in the first half of next year. When the patent expires, the original drug Forxiga will be recognized for 70% (532 won) of the existing drug price, 68% (516 won) of the generic released by innovative pharmaceutical companies, and 59.5% (452 won) of the generic. Jardiance, which was approved in 2014, is also used as a single and combination therapy for blood sugar control in type 2 diabetic patients, just like Forxiga. Jardiance 10 and Jardiance 25mg prices are 660 won and 852 won, respectively. Jardiance Duo 5/500, 5/850, 5/1000, 12.5/500, 12.5/850, and 12.5/1000 mg receive insurance drug prices of around 330 won to 469 won. New diabetes drugs with SGLT-2 inhibition mechanism have advantages of more advanced efficacy and low side effects, such as less strain on the kidneys while showing excellent blood sugar drop effects compared to existing treatments.
