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- 2026-03-17 19:30:54
- Company
- Losartan products are about to be withdrawn from the market
- by Kim, Jin-Gu Dec 20, 2021 06:12am
- With the recovery of Losartan with excessively detected impurities, pharmaceutical companies are considering strategies after recovery measures are completed. Many pharmaceutical companies that did not have a very high market share in the Losartan market are reportedly considering gradually withdrawing from the market after the recovery is completed. It is predicted that the pace of market reorganization will accelerate after the recovery measures are completed. According to the pharmaceutical industry on the 20th, a large Korean pharmaceutical company A is discussing ways to stop selling the product line after the recovery of Losartan is completed. Company A has five Losartan items, and some or all of these products are subject to collection. According to UBIST, a pharmaceutical market research firm, the amount of outpatient prescriptions for company A's five Losartan items last year was more than 7 billion won. It is confirmed that more than 5 billion won was prescribed cumulatively by the third quarter of this year. The pharmaceutical industry interprets the reason why Company A is considering withdrawing the market as to resolve uncertainties. Since NDMA impurities were first discovered in Valsartan in 2018, the pharmaceutical industry has struggled with the impurity crisis every year. In particular, since all impurity incidents occurred in unexpected situations, it was difficult for companies as sales suspension and recovery were repeated after detecting impurities. Moreover, in the case of Company A, it is considered the background of considering withdrawal from the market since it has various ARB drugs such as Telmisartan, Candesartan, Valsartan and and Irbesartan. An official from Company A said, "Nothing has been accurately decided yet. Losartan's prescription performance is not bad, but other ARB-based drugs are larger in terms of the total amount of prescription," he said. The pharmaceutical industry predicts that pharmaceutical companies, including Company A, will withdraw from the market after the recovery of the Losartan hypertension treatment is completed. As of last year, the amount of outpatient prescriptions in the hypertension treatment market, including Losartan, was 320.8 billion won, with two companies, Hanmi and Organon accounting for more than half (53.9%). Hanmi's five types of Losartan recorded 122.4 billion won in prescriptions last year, accounting for 38.1% of the market share. Organon accounts for 15.8%. It was followed by 3.9% per Chong Kun Dang, 3.0% of SK Chemicals, 2.9% of Samik, 2.4% of Kyung Dong, 2.2% of HK inno.N, and 2.0% of Daewoong Bio. In addition, 91 companies are competing for the remaining 27.5%. Most pharmaceutical companies' annual prescriptions are less than 500 million won. The MFDS announced on the 7th that all or some manufacturing number products of 295 items from 98 companies that were detected or feared to exceed the daily intake allowance will be voluntarily recovered. The pharmaceutical industry is in the process of recovering the product.
- Company
- EMA designated Hanmi's HM15211 as ODD
- by Kim, Jin-Gu Dec 20, 2021 06:12am
- Hanmi Pharmaceutical's LAPSTriple Agonist, HM15211 announced on the 17th that it has been designated as ODD by the European Medicines Agency (EMA). According to Hanmi Pharmaceutical, EMA recently designated it as ODD for the treatment of primary sclerosing cholangitis, PSC. The LAPSTriple Agonist has previously been designated as ODD by the FDA. It was designated as a rare drug in March last year, and was once again designated as ODD in May this year. With this designation, LAPSTriple Agonist has become a new drug that has received a total of four rare drug designations, including three from the FDA and one from the EMA. Including this, Hanmi Pharmaceutical will hold a total of 18 ODD designated records (9 FDA cases, 6 EMA cases, and 3 MFDS cases) with 10 indications from 6 pipelines. At this point, it is the highest record among domestic pharmaceutical companies. LAPSTriple Agonist is a triple agonist that acts as a simultaneous activation of GLP-1 receptors, glucagon receptors, and GIP receptors. Based on multiple pharmacological effects, it is expected that excessive accumulation of bile acids in the liver will be reduced and liver inflammation and fibrosis will be suppressed to dramatically improve the quality of life of patients. Hanmi Pharmaceutical confirmed the effects of LAPSTriple Agonist on reducing bile acid accumulation and anti-inflammatory and anti-fibrotic effects. Primary sclerosing cholangitis is a chronic progressive bile identity liver disease caused by unknown intrahepatic biliary tract inflammation and fibrosis. The FDA and the EMA's designation of ODD is a system that supports the smooth development and permission of treatments for rare and intractable diseases or life-threatening diseases. In Europe, the cost of applying for permission will be reduced, and various benefits such as exclusive rights for 10 years will be granted when approving the first marketing permit among products of the same affiliate.
- Company
- Myung In’s Parkinson’s Tx demonstrates efficacy
- by Dec 20, 2021 06:12am
- A Parkinson’s disease treatment that Myung In Pharm has acquired an exclusive licensing agreement from an Israeli pharmaceutical company - 'P2B001 (Fixed-dose combination of pramipexole+rasagiline)’ – has demonstrated its safety and efficacy at a global Phase III clinical trial. According to the topline results announced by the Israeli pharmaceutical company Pharma Two B Ltd. (P2B), P2B001 successfully met its primary and key secondary endpoints and demonstrated statistically significant benefit over existing treatments. A total of 544 patients with early-stage Parkinson's disease in 70 centers in the US, Europe, and Canada were randomized to four treatment arms: P2B001 (pramipexole 0.6mg + rasagiline 0.75mg combination); pramipexole ER capsule (pramipexole 0.6 mg); rasagiline ER capsule (rasagiline 0.75mg); and the currently marketed pramipexole ER capsules titrated to an optimal dose for each individual. Patients in each treatment arm were administered their respective dose once a day for 12 weeks. The primary endpoint was the change in the total Unified Parkinson's Disease Rating Scale (UPDRS, defined as the sum of parts II and III) for P2B001 as compared to each of its components over 12 weeks. Results showed that P2B001 improved the total UPDRS score by 2.66 points compared to the pramipexole 0.6mg-treated arm (p=0.0018) and by 3.30 points compared to the rasagiline-treated arm (p=0.0001). Also, P2B001 showed significant improvement over its comparators in the secondary endpoint, Epworth Sleepiness Scale (ESS) score. From a safety prospect, P2B001 significantly reduced adverse events including sleepiness and orthostatic hypotension compared to the pramipexole ER capsule. The company explained that the trial results support the use of P2B001 as first-line treatment in patients with early-stage Parkinson's disease, once a day, without the need for titration. Hang Myung Lee, CEO/President of Myung In Pharm, said, “With the Phase III clinical trial results, we have now secured data that P2B001 has superior efficacy and a more significant safety profile over each of its individual components as well as the currently marketed pramipexole ER capsules. We believe that P2B001 could become an important new option when considering the long-term care plan that needs to be set for early-stage Parkinson's disease and the superior efficacy demonstrated in the trial.” P2B plans to submit a New Drug Application to the FDA next year. Myung In Pharm also plans to apply for marketing authorization of P2B001 to the Ministry of Food and Drug Safety in 2022 and release the drug in Korea in 2023. Myung In Pharm had acquired the exclusive license for the commercialization of P2B001 in Korea through an equity investment in P2B in November this year.
- Company
- Expectations rise for Lilly’s Alzheimer drug
- by Eo, Yun-Ho Dec 20, 2021 06:11am
- Expectations have been rising for the commercialization of Lilly’s new drug candidate for Alzheimer’s. On the 15th (local time), Eli Lilly announced that it will complete filing for approval of its new Alzheimer’s candidate ‘donanemab’ within the first quarter of 2022. The news was announced at an investor meeting while introducing plans for five new drugs that will be launched within the next two years. Lilly had previously said that an application for approval of donanemab would be made sometime next year. if Lilly’s donanemab is approved, the addition of donanemab to the market following Biogen’s accelerated approval of Aduhelm in June is expected to intensify competition. Although the information available on donanemab is limited, a head-to-head study against Aduhelm is ongoing, and initial data from the study is expected to roll out in the second half of next year. Based on the initial data from a Phase II trial announced earlier this year, the FDA granted Breakthrough Therapy designation for donanemab in June. Results of Lilly’s Phase II TRAILBLAZER-ALZ trial on donanemab is a monoclonal antibody that targets a modified form of beta-amyloid called N3pG that was released in July demonstrated that the reduced beta-amyloid deposits slowed the decline of cognitive function in Alzheimer patients. Donanemab Patients with early symptoms of Alzheimer’s who were administered donanemab in the trial showed a rapid reduction in amyloid plaque at 24 weeks and showed the most rapid amyloid plaque removal in patients who had the most severe plaque burden at baseline. At the meeting, Lilly also announced its release plans for its antidiabetic tirzepatide, mantle cell lymphoma treatment pirtobrutinib, ulcerative colitis treatment mirikizumab, and atopic dermatitis treatment lebrikizumab.
- Company
- Ildong signed for Nexium worth ₩50 billion
- by Dec 20, 2021 06:11am
- AstraZeneca Korea announced on the 14th that it has signed a partnership contract with Ildong for gastroesophageal reflux disease treatment "Nexium (Esomeprazole)" and type 2 diabetes treatment "Qtern (Dapagliflozin/Saxagliptin Monohydrate)." Through this, Ildong Pharmaceutical will jointly sell Nexium and Qtern with AstraZeneca Korea from January 1 next year. In 2014, the two companies promoted Onglyza and Komblyze XR (Metformin HCl/Saxaglipin Monohydrate). Ildong Pharmaceutical has succeeded in marketing H2 receptor antagonists, PPI drugs, and functional dyspepsia treatments. Ildong Pharmaceutical plans to grow Nexium into an item with annual sales of more than 50 billion won in the future. Last year, Nexium's domestic sales were estimated at about 49.4 billion won. Nexium was jointly sold by Daewoong Pharmaceutical, and the contract ends on December 31. Daewoong Pharmaceutical plans to focus on selling its own P-CAB-based gastroesophageal reflux disease treatments Fexuprazan and Nexium. Kim Sang-pyo, CEO of AstraZeneca Korea, said, "We are happy that the two companies, which have been maximizing each other's strengths in the diabetes treatment field for the past eight years, are seeking opportunities for a new leap forward in the digestive field." He said, "We hope to provide differentiated treatment benefits of 'Nexium' and 'Qtern' to more medical staff and patients." Yoon Woong-seop, vice chairman of Ildong Pharmaceutical, said, "We are looking forward to strengthening our partnership with AstraZeneca Korea through Nexium and Qtern following Onglyza and Kombiglyze XR." He said, "We plan to do our best not only for the health of patients but also for the smooth medical activities of medical staff, but also to create synergy between the two companies and expand market performance."
- Company
- New depression drug Spravato lands in the 'Big 5' Hospitals
- by Eo, Yun-Ho Dec 16, 2021 05:52am
- Janssen’s new drug for depression, ‘Spravato,’ can now be prescribed at general hospitals in Korea. According to industry sources, Spravato (esketamine) that is used in combination with an oral antidepressant, has passed the review of drug committees (DC) of 80 medical institutions in the nation including the 'Big-5' general hospitals - Samsung Medical Center (SMC), Seoul National University Hospital (SNUH), Seoul St. Mary’s Hospital, and Severance Hospital - as well as the Kyung Hee University Medical Center, Kyungpook National University Hospital, Inje University Paik Hospital, Seoul National University Bundang Hospital, Chung-Ang University Hospital, Jeju National University Hospital, Inje University Haeundae Paik Hospital. Spravato, which was approved in June last year in Korea, was the first-ever prescription nasal spray with a new mechanism of action that was introduced in the field of treatment-resistant depression (TRD) and the first in 30 years introduced in the field of major depressive disorder. Spravato’s esketamine modulates the glutamate receptor called an N-methyl D-aspartate (NMDA) receptor in the brain and restores synaptic function and increases neurotrophic signaling to improve depression symptoms. Last year, the drug added an indication for the treatment of major depressive disorder with suicidal thoughts or actions. The approval of the depression with suicidal ideation indication was based on results of the global Phase III ASPIRE I and ASPIRE II study. In both ASPIRE I and ASPIRE II, Spravato met the primary endpoint as defined as the reduction in depressive symptoms from baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) at 24 hours after the first dose when taken in conjunction with standard of care therapy (including oral antidepressants and hospitalization). Efficacy for the initial indication of treatment-resistant depression was demonstrated through a Phase 3 clinical trial consisting of short- and long-term trials that were conducted on 1,700 adult patients with treatment-resistant depression. In the short-term clinical trial on patients aged 18 to 65 years with treatment-resistant depression, the MADRS score of patients who were administered Spravato in combination with oral antidepressants was lowered by 19.8 points during the 4-week treatment period. Patients who were administered a placebo showed a 15.8 point reduction in the MADRS score, demonstrating a statistically significant improvement in symptoms of patients who used Spravato with an oral antidepressant. In the long-term trial, the probability of recurrent depressive symptoms was 51% percent lower in the Spravato +oral antidepressant-treated group that achieved stable remission than that of the placebo+oral antidepressant-treated group. Jong-woo Paik, Professor of Mental Health and Medicine at Kyunghee University, said, “Unlike other antidepressants that take several days for symptoms to improve after intake, Spravato showed immediate improvement in depressive symptoms. Such a characteristic is particularly effective in treating and managing patients in emergencies such as those who had attempted suicides.”
- Company
- Dupixent can be used by all age groups
- by Dec 16, 2021 05:51am
- Dupixent, atopic dermatitis (Eczema) treatment that marks its third anniversary, is becoming the only biological agent available for all ages. Doctors agreed, "It is time to show flexibility in applying Dupixent benefits that have secured long-term effectiveness and safety." At an online seminar held by Sanofi to mark the 3rd anniversary of its launch in Korea on the 13th, Ahn Ji-young, a dermatologist at the National Medical Center, and Na Chan-ho, a dermatologist at Chosun University Hospital, shared their long-term Dupixent administration experience in 52 weeks (1 year) in domestic adult atopic dermatitis patients. Professor Ahn's 52-week long-term data is a study that analyzed the medical records of patients treated with Dupixent from September 2018 to December 2020, targeting 99 adult patients with moderate-severe symptoms. In the 52nd week of administration, EASI improved 88.1% compared to 30.02 points in the baseline. 89.9% of the administered group achieved EASI-75, and the itching NRS score also improved by 76.6% compared to the baseline of 8.37 points. The POEM score also improved 67.21% compared to the baseline (23.73 points) in week 52, and DLQI improved 69.02% compared to the baseline (22.37 points). Even in long-term administration for 52 weeks, it was consistent with the safety profile shown in phase 3 clinical trials. The main adverse reactions improved as both symptoms were treated, including facial erythema (19.9%) and conjunctivitis (17.17%). Professor Ahn said, "Atopic dermatitis is a chronic disease, and long-term symptom improvement requires safe and continuous treatment," and added, "Dupixent was able to confirm the long-term effectiveness and safety profile up to 52 weeks consistent with clinical trials in domestic patients." Professor Na then announced the results of an analysis of moderate-severe youth patients treated with Dupixent for one year from October last year. He explains that children and adolescents suffering from severe atopic dermatitis are burdened with serious diseases such as study, sleep, and outdoor activities. Until Dupixent received indications for children and adolescents, treatment options such as systemic immunosuppressants were limited. Dupixent improved the EASI score by 82.9% compared to the baseline (25.1 points) in the 16th week of administration, and the CDLQI related to childhood skin also increased by 57.2% compared to the baseline (13.1 points). POEM scores and itching NRS scores improved 54.4% and 53%, respectively, compared to baseline. Like adults, it showed similar effects in domestic youth patients in the actual clinical environment. Furthermore, the EASI-75 achievement rate was 77.8%, which was better than that of phase 3 (41.5%). Recently, Sanofi also confirmed the effectiveness and safety of Dupixent in phase 3 clinical trials for infants and toddlers aged 6 months to 5 years. If the indications expand to that age, Dupixent is expected to be the only biological agent available to patients of all ages suffering from moderate-severe atopic dermatitis. Experts said it was time to give flexibility to Dupixent's conditions, which secured a variety of data. Professor Ahn said, "It is necessary to study whether patients undergoing long-term administration maintain their effectiveness even if the administration interval is increased. At the same time, it would be nice to expand benefits to patients who are initially administered by reflecting subjective indicators in addition to objective indicators, she said. Professor Na also added, "As the guidelines of the Association of Atopic Dermatitis have recently been revised to reflect subjective indicators such as DLQI, it seems necessary to refer to the standards."
- Company
- Pfizer’s NSCLC drug Vizimpro to be prescribed at GHs
- by Eo, Yun-Ho Dec 14, 2021 05:57am
- Pfizer’s EGFR TKI Vizimpro may now be prescribed at general hospitals. According to industry sources, Pfizer Korea’s Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor (TKI) Vizimpro (dacomitinib) passed the Drug Committees (DCs) of four of the Big-5s - Samsung Medical Center (SMC), Seoul National University Hospital (SNUH), Seoul St. Mary’s Hospital, Asan Medical Center (AMC) – and many other major medical institutions including the National Cancer Center, Seoul National University Bundang Hospital, Pusan National University Hospital, Chungbuk National University Hospital, and Chungnam National University Hospital, etc. Vizimpro, which was listed for reimbursement in Korea in December last year, was granted priority review by the US FDA in January 2018 and approved in September of the same year. The drug is currently approved in the US, EU, and Japan among other countries. In Korea, Vizimpro was approved as a first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC). The drug is indicated to treat EGFR-positive advanced NSCLC patients diagnosed with exon 19 deletion or exon 21 L858R substitution mutations. Currently, 1st generation EGFR TKIs AstraZeneca’s Iressa (gefitinib) and AstraZeneca’s Iressa (gefitinib); 2nd generation EGFR TKI Giotrif (afatinib); and 3rd generation EGFR TKI AstraZeneca’s Tagrisso (osimertinib) are being prescribed in Korea. Among these drugs, competition between Vizimpro and the other 2nd generation EGFR TKI Giotrif for prescriptions is expected to intensify. Vizimpro’s efficacy was demonstrated through the Phase III ARCHER 1050 study. The study directly compared Vizimpro with Iressa (gefitinib) and registered a total of 452 NSCLC patients. Results showed that by progression-free survival, (PFS) Vizimpro reduced the hazard ratio by 41% compared to Iressa, and the median PFS of Vizimpro was 14.7 months, an improvement to the 9.2 months in the Gefitinib group.
- Company
- Sang Wook Kang, CEO of GSK consumer healthcare, resigned
- by Eo, Yun-Ho Dec 14, 2021 05:57am
- The CEO of GSK and Novartis' OTC joint venture "GSK Consumer Healthcare" is expected to be replaced. According to related industries, Kang Sang-wook (45) CEO of GSK Consumer Healthcare Korea recently resigned. As a result, CEO Kang will leave the company about three years after taking office in January 2019. He entered the pharmaceutical industry through BAT Korea and L'Oreal Korea. The exact reason for resignation is unknown, and it has been confirmed that Kang's successor has not yet. For the time being, GSK Consumer Healthcare will be operated as a temporary representative system. Meanwhile, GSK Consumer Healthcare was launched in 2015 as a Novartis joint venture as a company that sells items such as GSK's OTC and consumer goods. Since then, it has maintained its corporation so far after integrating the US pharmaceutical company Pfizer and Consumer Healthcare business in 2018. The company is selling more than 50 products in Korea, including oral care brands such as Sensodyne, Parodontax, and Polydent, as well as OTC and medical device brands such as Theraflu and Otrivin.
- Company
- Boehringer loses another ‘Trajenta’ trademark dispute
- by Kim, Jin-Gu Dec 13, 2021 05:57am
- Boehringer Ingelheim once again tasted defeat in a trademark dispute over its DPP-4 inhibitor antidiabetic ‘Trajenta (linagliptin).' In addition to the trademark dispute against Kwangdong Pharmaceutical in 2019, the company recently lost once more in a suit against Daewoong Pharmaceutical. According to the industry on the 13th, the Intellectual Property Trial and Appeal Board dismissed the trademark invalidation trial field by Boehringer Ingelheim against Daewoong Pharmaceutical. Boehringer Ingelheim had filed a trademark invalidation trial against Daewoong Pharmaceutical claiming that Daewoong’s ‘Traceta’ is similar to Trajenta. Traceta is an Acetaminophen and Tramadol combination used to treat acute and chronic pain. The drug was approved in October 2019. In June 2019, four months before gaining approval, the company had filed a trademark application for the trade name Traceta and registered the trademark in October 2019, immediately after the drug approval. On Boehringer Ingelheim’s claim of trademark infringement, Daewoong Pharmaceutical rebutted that the antidiabetic Trajenta and the analgesic Traceta have very different uses, and therefore have little risk of causing misunderstanding or confusion among general consumers. As a result, the IPTAB ruled in favor of Daewoong Pharmaceutical. This was the second trademark dispute defeat for Boehringer Ingelheim in Korea. The company had filed a similar trademark invalidation suit against Kwangdong Pharmaceutical in July 2019 but lost. At the time, Boehringer Ingelheim claimed the trademark of Kwangdong’s ‘Diagenta’ invalid due to their similar name and class of goods. Diagenta is a generic of Trajenta made by Kwangdong Pharmaceutical that was approved in February 2019. 24 companies including Kwangdong Pharmaceutical had received approval for their generics by succeeding in invalidating the crystalline form patent of Trajenta at the time, but Boehringer Ingelheim had only requested an invalidation trial against Kwangdong Pharmaceutical. The IPTAB said, “Trajenta is a coined trademark with no special meaning. Diagenta’s name nor appearance is similar to Trajenta and the contrast is clear in concept. Although both names contain ‘genta’, the difference between the first two letters is large, leaving little room for consumers to misunderstand or confuse them.” Trajenta is Boehringer Ingelheim’s DPP-4 inhibitor used to treat diabetes. According to the market research institution UBIST, prescription sales of Trajenta amounted to 64.5 billion won last year. The drug was prescribed 47.2 billion won’s worth by Q3 this year. Trajenta Duo, a Trajenta+metformin combination of Boehringer Ingelheim, sold an accumulated amount of 49.9 billion won by Q3 this year. 19 companies including Sinil Pharmaceutical had received generic exclusivity for Trajenta’s generic through a crystalline form invalidation patent and passive trials to confirm the scope of composition patent in 2016. The companies may release their generics after September 2023 when Trajenta’s substance patent and use patent expires.
