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- 2026-06-25 11:11:59
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- New drug Camzyos can be prescribed at hospitals
- by Eo, Yun-Ho Nov 17, 2023 06:00am
- The new drug Camzyos for obstructive hypersatic myocardial infarction is entering the general hospital prescription. According to the related industry, Camzyos of BMS Pharmaceutical Korea has passed the Drug Committee (DC) of medical institutions such as SMC and Sinchon Severance Hospital. Camzyos is the first and only treatment that selectively inhibits the excessive cross-bining of cardiac myosine and acttin, the cause of obstructive hypertrophic cardiomyopathy (oHCM). The drug has the mechanism of separating myosine from actin and relaxing the excessively contracted heart muscle, improving occlusion with an inflated left ventricle structure and left ventricle leaks. The clinical trial based on the Camzyos permit is the EXPLORER-HCM study. In the trial, Camzyos improved more than twice as much as the patient's symptoms (NYHA grade) and motor performance (maximal oxygen intake, pVO2), which is a primary evaluation variable. Of these, 20% of the Camzyos dosing group achieved both NYHA ratings and pVO2 improvements. After exercise, the left ventricle also reduced the occlusion index more than fourfold. Seven out of 10 people treated wit Camzyos had improved their indicators to such an extent that they did not consider surgery, maintaining a consistent effect for 30 weeks. oHCM is a rare heart disease in which the left Ventil muscle of the heart is abnormally thickened and blocks blood flow through the entire body through the aorta. Symptoms of oHCM vary, including shortness of breath, dizziness, chest pain, which can increase the risk of various cardiovascular complications such as heart failure and atrial fibrillation. Currently, oHCM treatment focuses on symptom relief and management rather than underlying treatment, so there was a high demand for unfulfilled treatment. Drug treatment options such as beta blockers and calcium channel blockers could reduce heart rate and myocardial contractility, but there were limitations that existing drug treatment options alone made it difficult to expect long-term improvement. Professor Lee Sang-cheol of the Department of Circulation at Samsung Seoul Hospital said, "OHCM is a rare disease that can cause sudden heart death without warning, and there has been many difficulties in treatment because there is no effective way to treat it non-invasively. Camzyos expects to be able to restore patients' quality of life by taking oral doses once a day, with excellent symptom-improving effects from the early days of treatment."
- Company
- GC Biopharma’s Hunterase approved after 11yrs
- by Chon, Seung-Hyun Nov 17, 2023 05:59am
- GC Biopharma’s rare disease treatment ‘Hunterase’ was granted official marketing authorization 11 years after receiving conditional approval. On the 16th, GC Biopharma announced that it had completed the Phase III trial for its Hunterase on the 14th and changed its license from conditional approval to final marketing authorization. Hunterase, which was approved in 2012 in Korea, is the world’s second treatment for developed Hunter syndrome, which is also known as ‘Mucopolysaccharidosis type II (MPS II),’ is a rare disease that is known to occur in roughly 1 in 100,000 to 150,000 male live births. As a congenital, hereditary metabolic disorder, Hunter syndrome shows various unpredictable symptoms such as skeletal abnormalities decreased intelligence, and even premature death around the age of 15 in severe cases. Less than 100 patients with Hunter syndrome exist in Korea. Hunterase had received conditional approval under the condition of conducting a Phase III trial in January 2012 GC Biopharma received approval for a Phase III trial in November 2016 and conducted a clinical trial to evaluate Hunterase’s efficacy and safety in patients with Hunter syndrome who have not previously received enzyme replacement therapy. The company completed its Phase III clinical trial results report in March of this year and submitted the Phase III clinical trial results to the Ministry of Food and Drug Safety in May. Afterward, the company completed a Good Clinical Practice (GCP) inspection and received the nod for the final change in its license. In the Phase III trial, patients who received Hunterase intravenously every week for 52 weeks showed statistically significant superior results compared with the past placebo control group. Due to the nature of the rare disease, it took a longer time to agree on a Phase III trial design, including patient recruitment. In the end, it took 6 years to prepare the Phase III clinical trial results report. However, the company explained that it met the required conditions 3+ years earlier than in the plans it discussed with the MFDS. A GC Biopharma official said, “Hunter syndrome is a serious and life-threatening rare disease, and based on the fact that it is realistically difficult to conduct confirmatory clinical trials, we have supplied it to patients under conditional approval. So just the fact that we completed the Phase III trial and met the conditions we were required to meet for its formal approval has significant meaning on its own.
- Policy
- Takeda Obizur accepts results of the drug rating
- by Lee, Tak-Sun Nov 17, 2023 05:59am
- If the alternative drug was accepted less than 90%, the drug price negotiation was omitted. It was confirmed which was conditionally approved by the Pharmaceutical benefit evaluation committee in October, accepted the results and moved to the stage of negotiation. This drug is used to treat bleeding in patients with adult acquired hemophilia A.l According to the industry on the 16th, Obizur was recognized for its salary suitability by accepting less than the evaluation amount of the weak level. The Pharmaceutical Review Committee, held on October 12, determined that there is a suitable salary for Obijour if it is accepted below the assessed amount. It is interpreted as a condition that the weighted average of alternative drugs is below. If Takeda accepts less than 90% of the weighted average price, drug price negotiations will be omitted, and only the expected amount of use will be negotiated, so it will be possible to make a faster registration. The drug has been undergoing a rapid payroll process since obtaining an item permit last March. Unlike conventional bypass drugs, it is a treatment that replaces the 8th person of blood clotting with AHA (accent hemophilia A) adaptation, and it has the advantage of being the only AHA treatment that can reliably monitor blood clotting factor 8 through standard analysis and treat individual doses. Takeda Pharmaceuticals Korea explained, "This drug is a gene recombinant made by removing B-domain from liver-like pig blood clotting 8 people, and it can replace inactivated human blood clotting 8 because it is not easily recognized by autoimmune antibodies to help blood clotting and help control bleeding." Good results were also found in clinical trials. An open-label phase 22/3 study evaluating the efficacy of Obijour in 28 patients with acquired hemophilia A found that all patients treated with Obzur had a positive response to all early episodes of bleeding at a 24-hour assessment after the first dose. Takeda are said to be preparing related materials before the full-scale negotiations.
- Company
- Will Keytruda’s receive reimb for TNBC in KOR?
- by Eo, Yun-Ho Nov 17, 2023 05:59am
- Whether MSD Korea will be able to make progress in extending reimbursement for its cancer immunotherapy Keytruda for the 13 additional indications it had applied for is receiving attention. According to industry sources, 3 indications of MSD Korea’s PD-1 inhibitor Keytruda (pembrolizumab) are expected to be deliberated by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee on the 22nd. Although the company applied for reimbursement of its 13 indications in bulk, the specific indications are expected to be deliberated separately. In October, its 3 applications for esophageal cancer, endometrial, and colorectal cancer were presented for deliberation by CDDC but received a ‘rediscussion’ decision. In the case of triple-negative breast cancer, although a new drug has received marketing authorization for the disease, no reimbursed option currently exists for TNBC as of now. Gilead Science Korea’s TNBC treatment ‘Trodelvy (sacituzumab govitecan)’ is also expected to be deliberated at the same meeting. Keytruda’s efficacy in TNBC was confirmed through 2 clinical trials. In KEYNOTE-522, a Phase III trial conducted on previously untreated patients with Stage II or III TNBC patients to evaluate the benefit of using Keytruda as neoadjuvant and adjuvant therapy, its use showed a significant 13.6% absolute increase in complete pathologic response compared with the control group. Event-free survival (EFS) rate was 84.5%, reducing the risk of disease progression and death by 37%. In KEYNOTE-355, Keytruda improved PFS regardless of the type of chemotherapy. The chemotherapy+ Keytruda arm in the study showed a PFS of 9.7 months, which was a 4.1-month improvement compared to the placebo arm, demonstrating statistical significance. MSD applied for 13 indications for Keytruda in June: ▲ early-stage triple-negative breast cancer; ▲locally recurrent or metastatic triple-negative breast cancer, ▲metastatic or with unresectable, recurrent head and neck squamous cell carcinoma, ▲ locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) carcinoma, ▲adjuvant treatment of patients with renal cell carcinoma, ▲non-muscle invasive bladder cancer,▲persistent, recurrent, or metastatic cervical cancer,▲ advanced endometrial carcinoma, ▲advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) ▲ unresectable or metastatic MSI-H or dMMR colorectal cancer ▲metastatic MSI-H or dMMR small bowel cancer, ▲ metastatic MSI-H or dMMR ovarian cancer, and ▲ metastatic MSI-H or dMMR pancreatic cancer
- Company
- Large companies more actively engage in patent challenges
- by Kim, Jin-Gu Nov 17, 2023 05:59am
- Pharmaceutical and bio companies with annual sales of more than KRW 300 billion were found to be most actively engaging in patent challenges. As of 2021, pharmaceutical companies with sales exceeding KRW 300 billion applied for an average of 7.7 generic exclusivity approvals per company. The average number of applications for generic exclusivity filed by each company was smaller for smaller companies. In Bum Kim, the expert consultant at Kim & Chang, introduced the above statistics at the ‘2023 Pharmaceutical Intellectual Property Policy Forum’ held at the intellectual Property Protection Agency in Seoul on the afternoon of the 16th. According to statistics, a total of 112 pharmaceutical companies applied for 792 generic exclusivity rights in 2021. Due to the strict requirements required when applying for generic exclusivity, it is used as an indicator of how actively generic companies have challenged original drug patents. To apply generic exclusivity, the company must be the first to request a trial or lawsuit to challenge the original drug’s patent, the first to apply for marketing authorization, and the first to win a trial or lawsuit. In general, the larger the pharmaceutical company, the more applications it had filed for generic exclusivity on average. 21 pharmaceutical companies with sales exceeding KRW 300 billion applied for 216 generic exclusivity rights in 2021. This renders the average number of applications for generic exclusivity filed by each company to become 7.7. The most number of applications filed by a single pharmaceutical company was 49. A total of 38 pharmaceutical companies with sales between KRW 100 billion to 300 billion field a total of 347 generic exclusivity applications. This renders the number of applications filed per company to 7.1. 27 pharmaceutical companies with sales between KRW 50 billion to 100 billion filed 142 generic exclusivity applications. This renders the number of applications filed per company to 4.6. In the case of small pharmaceutical companies with sales of less than KRW 50 billion, 26 companies filed 87 generic exclusivity applications. This renders the number of applications filed per these companies to 2.8. In terms of the total number of applications, mid-sized pharmaceutical companies with sales ranging from KRW 100 to 300 billion have most actively challenged the original drug’s patents, but the average number of applications per pharmaceutical company shows that large pharmaceutical companies with sales exceeding KRW 300 billion most actively engaged in patent challenges. Kim explained, “To receive first generic exclusivity, you have to make a lot of preparations to meet the strict conditions. So the statistics indicate that companies more actively engage in patent challenges when they are of a certain size.
- Opinion
- [Reporter’s View]Encouraging healthy competition in NSCLC
- by Son, Hyung-Min Nov 16, 2023 05:46am
- Although it might be frustrating for those competing against each other, healthy competition often leads to beneficial results on the whole. This is the case for the EGFR-mutated non-small-cell lung cancer treatments, Yuhan Corp’s Leclaza (lasertinib) and AstraZeneca’s ‘Tagrisso (osimiertinib).’ Both drugs are third-generation tyrosine kinase inhibitors (TKIs) targeting EGFR-mutated non-small cell lung cancer, and are currently used as first- and second-line treatment in the field. The two are same-generation drugs that own the same indications. Both have proven their effect in terms of brain metastasis, efficacy, and safety, which are important factors in treating cancer patients. Yuhan Corp and AstraZeneca, which developed the two drugs, have continued to engage in competition with combination therapies using their respective drugs. At the 2023 European Society for Oncology (ESMO) Congress that was held last month, results of Janssen’s main MARIPOSA study that evaluated the combined use of Janssen’s ‘Rybrevant (amivantamab)’ and Leclaza were disclosed. Results showed that Leclaza+Rybrevant improved the primary efficacy endpoint of progression-free survival (PFS). A favorable trend was also observed in overall survival (OS), the secondary endpoint. Also, results of the FLAURA2 study showed that Tagrisso extended PFS by pulling forward the use of platinum-based chemotherapy, which is currently used as a second-line treatment for EGFR-positive NSCLC. Due to the high interest in the 2 treatments, the results for the combination therapies received great attention, raising discussions on which treatment was more effective . The competition further intensified in Korea after Yuhan Corp announced that it would provide Leclaza for free until the drug was reimbursed. Although there was concern that AstraZeneca may object to the measure, the company did not, referring to how it would benefit patients. The movements to extend the patient's survival through the use of combination therapies, offering free treatment to patients, and not raising objections as the other company’s programs will benefit the patient, are all efforts on the companies’ part to put patients first. This deserves applause. Yuhan Corp and AstraZeneca are both separately in pricing negotiations with the National Health Insurance Service to receive reimbursement for Leclaza and Tagrisso as a first-line treatment for EGFRm NSCLC. It is difficult to say which treatment is superior. Ultimately, both drugs would need to be reimbursed if the patients and HCPs are to receive equal benefits in terms of choice. The cost of a single cycle of the two drugs when prescribed without reimbursement exceeds KRW 5 million. So it is this reporter’s wish that the two treatments will be approved for reimbursement so as to reduce the financial burden borne by patients with NSCLC. In this sense, we support the healthy competition between the two companies that can produce beneficial results for the patients.
- Company
- GI Innovation registers patent in US for its GI-101/GI-102
- by Nho, Byung Chul Nov 16, 2023 05:46am
- GI Innovation R&D center researchers are researching formulation and synthesis. GI Innovation announced on the 15th that it had registered patents for its immune-oncology drug GI-101/GI-102 in combination with various anticancer drugs. The company registered the patent for 101/GI-102 for broad application with global blockbuster anticancer drugs such as PARP inhibitors, CDK4/6 inhibitors, and VEGFR inhibitors, allowing it to enjoy exclusive rights as combination therapy with various anticancer drugs in the registered class. In May, the company had previously secured exclusive rights in the US for the use of GI-101 or GI-102 in combination with PD-1 antibodies like Keytruda, and PDL1 antibodies like atezolizumab by registering a patent for their combined use with these immunotherapies. The anticancer drug combination therapy patent registered this time includes exclusive rights for GI-101 or GI-102’s use as combination therapy with various anticancer drugs, including PARP inhibitors, CDK4/6 inhibitors, VEGFR inhibitors, and EGFR inhibitors. Therefore, the patent is expected to provide comprehensive protection. In addition, it can serve as a partner for blockbuster anticancer drugs seeking patent term extensions. According to the global market research institution Research Nester, the substance patent term for abemaciclib (patent set to expire in 2029), which owns the largest share of the KRW 2.5 trillion CDK 4/6 inhibitor market, and Olaparib (patent set to expire in 2028) that post the largest amount of sales in the PARP inhibitor market, is set to soon expire. In this context, GI Innovation secured a patent on their combined use with GI-101 and GI-102 that lasts until 2041. Therefore, based on this registered patent, the companies can adopt a drug approval strategy, developing a co-formulation with blockbuster anticancer drugs and conducting clinical trials on combination therapies for an evergreen effect. Myung-Ho Jang, CSO of New Drug Development and Clinical Trial and the inventor of the patent said, “The patent we recently registered in the US is as combination therapy with blockbuster anticancer drugs whose patents are about to expire, demonstrating sufficient value as a partner for use in combination with various anticancer drugs depending on the clinical results. We plan to discuss further plans with global pharmaceutical companies next year to license out our technology.”
- Policy
- Abbvie’s Skyrizi is approved for Crohn's disease in Korea
- by Lee, Hye-Kyung Nov 16, 2023 05:46am
- Abbvie’s ‘Skyrizi,’ which was first introduced to Korea as a psoriasis treatment, has received additional marketing authorization for its Crohn's disease indication The Ministry of Drug and Safety approved Abbvie Korea’s ‘Skyrizi Inj (risankizumab)’ and ‘Skyrizi Cartridge Inj (risankizumab)’ on the 15th. The products, which contain 600mg and 360mg doses of risankizumab, are indicated ’ for the treatment of moderately to severely active Crohn's disease in adults who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or biologic therapy. Skyrizi Cartridge Inj is a self-injectable product that contains a prefilled cartridge and an electric drug injection pump (on-body injector) as an administration device, improving the convenience of administration for patients. In Korea, Abbvie had received approval for different doses of its risankizumab ingredient as ‘Skyrizi Prefilled Syringe Inj,’ ‘Skyrizi Prefilled Syringe Inj 150mg/mL,’ and ‘Skyrizi Prefilled Pen Inj 150mg/mL.,’ for plaque psoriasis and psoriatic arthritis. The European Commission approved Skyrizi as a treatment for adult patients with moderately to severely active Crohn's disease in November 2022. Skyrizi is the first interleukin-23 (IL-23) inhibitor approved to treat moderately to severely active Crohn's disease. The European Commission’s approval of Skyrizi in Crohn's disease was supported by results from the 3 global Phase III programs. Interleukin inhibitors are biological agents and are mainly used to treat moderate to severe adult plaque psoriasis, and can largely be divided into IL-17 inhibitors and IL-23 inhibitors. The IL-17 inhibitors approved in Korea include Janssen’s ‘Stelara (ustekinumab),’ Lilly’s ‘Taltz (ixekizumab),’ and Novartis’s ‘Cosentyx (secukinumab).’ In the case of IL-23 inhibitors, they include Janssen’s ‘Tremfya (guselkumab),’ and Abbvie’s ‘Skyrizi.’ According to the market research institution IQVIA, the size interleukin inhibitor market rose 30% YoY to exceed KRW 100 billion last year. In particular, Janssen’s Stelara is the first interleukin inhibitor approved for Crohn's disease. Therefore, if Abbvie releases Skyrizi for Crohn's disease in Korea, it is expected to compete with Stelara.
- Company
- Poteligel can be prescribed at hospitals
- by Eo, Yun-Ho Nov 15, 2023 05:39am
- 'Mycobacterial Breed' and 'Poteligel', a treatment for 'siary syndrome', have entered the prescription of a general hospital. According to the relevant industry, Korea Kyowa Kirin's Poteligio (Mogamulijumab) has passed the Drug Committee (DC) of medical institutions such as Seoul Asan Hospital. Potelio passed the Cancer Disease Review Committee of the Health Insurance Review and Evaluation Agency last month and is waiting for the chairman of the Drug Payment Assessment Committee. If the registration is successful, it is judged that the prescription will be made immediately. This drug is a treatment for mycoid sarcoma and sia syndrome, which targets CCR4 (C-C chemokine receptor 4). It was designated as Breakthrough Therapy by the U.S. Food and Drug Administration (FDA) in August 2017. It has been rated as the first-in-class in the UK SMC and approved in the country in September last year. PORTRIDGEO HAS PROVEN VALIDITY THROUGH MAVORIC STUDIES. The study recruited 372 patients with recurrent, unresponsive fungal sarcoma or syndrome on the largest scale related to skin T-cell lymphoma (CTCL) systemic therapy to assess their effectiveness and safety. The study included patients with mycoccal sarcoma or syndrome who had previously received one or more (median 3 median) systemic therapy. 55% of patients had heterogeneous sarcoma, 45% had syndrome, and 77% had stage 3B or higher. 66% were accompanied by blood disease. As a result of the study, Poteligel showed a superior effect over the control group, Borinostat. Portelliggio has statistically significant improvements in non-progressive survival (PFS) compared to Vorinostat. The PFS median for Potelliggio was 7.7 months, while the control group was only 3.1 months.
- Company
- Korean bio companies intent on developing new AD drugs
- by Son, Hyung-Min Nov 15, 2023 05:39am
- Despite downturns, including the return of the rights for JW Pharmaceutical’s atopic dermatitis drug candidate, clinical trials for new drugs to treat atopic dermatitis are still ongoing in Korea. Last month, JW Pharmaceutical announced that its technology transfer agreement for its atopic dermatitis treatment JW1601 which it signed with the Denmark pharmaceutical company Leo Pharma has been terminated. JW1601 owns a dual-action mechanism that selectively acts on the histamine H4 receptors to suppress inflammation and itching. Histamine is a major mediator of allergic inflammation. However, the candidate was unable to satisfy its primary efficacy endpoint in a global Phase II trial. With no other atopic dermatitis treatment owning the same mechanism of action, the drug had the potential to become a First-in-class drug but was unable to reach the commercialization stage. However, JW Pharmaceutical plans to continue to review its direction of development and potential to acquire new indications. Clinical trials are being actively conducted on various mechanisms that suppress inflammation… stem cell treatment starts later phase trial In addition to the failed candidate that targets histamine H4 receptors, various new drug candidates that target atopic dermatitis are being developed in Korea right now. A Stem cell therapy, as well as new drug candidates targeting Bruton's tyrosine kinase (BTK), interleukin-2-inducible T-cell kinase (ITK), and Janus kinase (JAK) are also being studied for commercialization potential. One of the candidates that is evaluated to be close to commercialization is a stem cell treatment. Kangstem Biotech is a leader in the field of stem cell treatments for atopic dermatitis. The company recently completed patient administration of ‘FURESTEM-AD Injection,’ a new drug candidate being developed in a Phase III trial. FURESTEM-AD Inj is being developed as a treatment for patients with moderate-to-severe atopic dermatitis who have not responded to existing treatments. Kangstem Biotech plans to complete the Phase III trial by the first half of next year and apply for its marketing approval. Interim results of the Phase III long-term follow-up study disclosed by the company showed that in patients who were administered FURESTEM-AD Inj, 58% achieved Eczema Area and Severity Index-50 (EASI-50) in the first year, 66% in the second year, then 75% in the third year. EASI-50 refers to the percentage of patients whose dermatitis symptoms improved by more than 50% compared to the baseline. ‘SCM-AGH,’ a stem cell treatment for atopic dermatitis that is being developed by SCM Lifescience, has also secured positive results in a Phase II trial. In a clinical trial comparing the efficacy and safety of SCM-AGH compared with placebo, SCM-AGH met the primary endpoint. Also, the SCM-AGH arm saw significant results in the secondary endpoint achieving ESAI-90 at 24 weeks. Also, none of the 55 subjects who were administered SCM-AGH showed side effects. Due to safety issues that arose in some inflammation treatments the fact that no side effect occurred is considered positive. SCM Lifescience plans to conduct its Phase III clinical trial in Korea with Handok. In addition, Daewoong Pharmaceutical is conducting 2 clinical trials in the US. Its ‘DWP212525’, which targets JAK3 and TEC family kinase (TFK), is in a preclinical trial, and ‘DWP213388’, a BTK/ITK inhibitor, is in a Phase I clinical trial. Novacell, an affiliate of DongKoo Bio&Pharma, is developing NCP112, which targets G protein-coupled receptors (GPCRs) and formyl peptide receptor 2(FPR2), which are involved in the resolution of inflammation, as a treatment for mild-to-moderate atopic dermatitis. NuGel, a GPCR19-targeted inflammation modulator being developed by Chaperone in the US, has successfully entered Phase II trials.
