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- 2025-12-24 13:48:42
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- 2 new myelofibrosis drugs fail to extend coverage
- by Eo, Yun-Ho Nov 07, 2022 06:06am
- New drugs for the rare disease myelofibrosis are having difficulty expanding coverage in Korea. According to industry sources, after ‘Jakabi (ruxolitinib)’ failed to expand reimbursement in Korea in May, ‘Inrebic (pedratinib),’ the first new drug to be introduced to the field in one decade, also failed to pass the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee review in June this year. At the meeting, expanding reimbursement for Jakabi as a treatment for intermediate- or high-risk patients with myelofibrosis had been discussed. However, the applicant that applied for the reimbursement extension was the Korean Society of Hematology, not its supplier Novartis. Therefore, resuming or advancing discussions on its reimbursement may be unlikely. The case was more disappointing for Inrebic as it was the first new drug to be introduced to the field since Jakabi. Discussions had been made to extend the drug’s reimbursement as a treatment for patients with primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis, but the reimbursement standards had not been set. In the U.K., Inrebic is covered by the Cancer Drugs Fund (CDF). Although the drug’s reimbursement was rejected by the National Institute for Health and Care Excellence last year, this alternative has been prepared due to a consensus made on its need. Therefore, both the pharmaceutical company and the government needs to be willing to receive and grant reimbursement for Inrebic in Korea. Meanwhile, the once-daily oral treatment Inrebic has been for a broader indication that includes patients who have no treatment experience with Jakabi, but BMS had proposed a more limited patient population during the NICE evaluation process. As a JAK-2 inhibitor, Inrebic is receiving another level of expectations from the JAK1/2 inhibitor Jakabi. Inrebic was the first drug to obtain approval in Korea as a once-a-day oral medication that greatly reduces the burden from spleen volume and symptoms in treatment-naive patients with myelofibrosis.
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- Recobell can be prescribed at infertility centers
- by Eo, Yun-Ho Nov 03, 2022 05:54am
- The infertility treatment Recobell is available in general hospitals. According to related industries, Ferring Pharmaceutical's Recobell passed the Drug Committee of medical institutions with infertility centers such as Sinchon Severance Hospital, Bundang Seoul National University Hospital, and Bundang Cha Hospital. Along with the expansion of insurance benefit standards in May, the benefit is also expanding. Originally, the drug, which was only administered alone, is covered by Controlled Ovarian Stimulation to mature a number of oocytes in women undergoing auxiliary reproduction such as IVF or ICSI with hMG combination therapy. The expansion of Recobell's benefit criteria was based on the MARCS study, a multi-agency, open-label, and single-cohort clinical trial, which evaluated the efficacy and safety profile of Recobell's hMG combination therapy in 110 infertile patients with IVF/ICSI. According to the Gardner classification system, 3BB or higher is defined as a qualitative good-quality blastocyst. As a result of the MARCS study, it was confirmed that Recobell increased the possibility of collecting qualitatively good vesicles in combination therapy with hMG. The average number of qualitatively good distributions available on Day 5 or Day 6 of treatment, which is the primary evaluation variable, was 4.9, and the results were significantly higher than 2.0 in the ESTHER-1 study conducted with Recobell alone therapy. The number of mature oocyte collections, a major secondary evaluation variable, was also reported to be 11.3 on average, significantly higher than the ESTHER-1 study, which showed 7.4. In particular, it was confirmed that the proportion of appropriate oocyte (8-14 oocyte) collection was higher in patients aged 35 or older than those under 35, proving that combination therapy is more effective than single administration in elderly patients with relatively low pregnancy rates. Lee Won-don, director of Maria Hospital, said, "We expect that the use of Recobell and hMG combination therapy will be possible, greatly reducing the economic burden of patients who needed more effective treatment, and leading to a more improved pregnancy success rate."
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- Immuno-oncology drugs set out to conquer early stage cancer
- by Nov 03, 2022 05:54am
- Pic of Opdivo, Keytruda, Tecentriq, Imfinzi The use of immuno-oncology drugs has advanced to the frontline of early-stage cancers. This is because data has demonstrated that the use of immuno-oncology drugs in the early stages increases the possibility of surgery and reduces the possibility of metastasis and recurrence. Following their use in the field of non-small cell lung cancer (NSCLC), immuno-oncology drugs are evaluated to be paving the way for early treatment in difficult-to-treat cancer types such as melanoma, bladder cancer, esophageal cancer, and breast cancer. BMS and Ono Pharmaceutical’s anti-PD-1 immunotherapy Opdivo (nivolumab) has recently received approval for use in early-stage NSCLC. The Ministry of Food and Drug Safety approved the drug in combination with platinum-based chemotherapy for ‘resectable (tumor size larger than 4cm or benign lymph node) on the 26th of last month. With the approval, Opdivo became the first immuno-oncology drug allowed for use as adjuvant therapy in early-stage, resectable lung cancer patients. Even with the addition of targeted anticancer drugs, Opdivo is the only drug that can be used as neoadjuvant therapy. Previously, Tagrisso, an EGFR-targeted treatment, was approved as an adjuvant treatment in NSCLC. The Phase III CheckMate-816 trial(ONO-4538-55), which became the basis for the approval, enrolled patients with stage IB-IIIA NSCLC to compare Opdivo+chemotherapy with chemotherapy monotherapy. Its primary efficacy endpoint was event-free survival (EFS) and pathologic complete response (pCR) rate as assessed by the blinded independent central review (BICR). The secondary efficacy endpoint was overall survival (OS) and major pathologic response (MPR), and time to death or distant metastases. Results showed that in patients receiving Opdivo+chemotherapy, the median EFS was 31.6 months, decreasing the risk of relapse or death by 37% compared to 20.8 months of patients treated with chemotherapy alone. The pCR was 24% in the Opdivo group, and 2.2% in the control group. While the data are still immature, favorable early overall survival (OS) results were observed with Opdivo in combination with chemotherapy. In the interim analysis, Opdivo+chemotherapy reduced the risk of death by 43%. Further analysis will be conducted in the future as the data is yet to reach statistical significance. Compared to how 83% of the patients that received treatment with Opdivo+chemotherapy survived after 2 years, the survival rate of those that only received chemotherapy was 71%. Also, 83% of the patients who received Opdivo+chemotherapy received operations, compared with the 75% in chemotherapy-treated patients. Rates of Grade 3-4 treatment-related adverse events were similar even with the addition of Opdivo to chemotherapy versus chemotherapy alone (34% vs. 37%). Immuno-oncology competition extends to early-stage lung cancer In addition to Opdivo, other immuno-oncology drugs are also challenging the market. Companies are conducting trials on Keytruda, Imfinzi, and Tecentriq to verify their efficacy as adjuvant or neoadjuvant therapy. In October last year, the FDA approved Roche’s Tecentriq (atezolizumab) as adjuvant treatment in patients with stage II to IIIA NSCLC whose tumors have PD-L1 expression on ≥ 1% of tumor cells. In Europe, the indication was expanded for patients whose tumors have a PD-L1 expression ≥ 50% based on the interim analysis that showed a high effect in that patient group. Interim analysis results showed that adjuvant Tecentriq resulted in a 57% reduction in the risk of disease recurrence or death compared with best supportive care (BSC) in patients with stage II to IIIA NSCLC with PD-L1 expression of 50% or higher. Based on such findings, Roche is also planning to expand Tecentriq’s indication in Korea within the year. MSD’s Keytruda (pembrolizumab) is aiming to expand its indication as adjuvant therapy in patients with early-stage NSCLC (Stage IB-IIIA) regardless of PD-L1 expression. Interim analysis results of the Phase III KEYNOTE-091 study that was presented earlier this year showed that Keytruda significantly improved disease-free survival (DFS), which was one of the primary efficacy endpoints, and reduced risk of recurrence or death by 24% compared with placebo. The median progression-free survival [PFS] of the Keytruda-treated group was 53.6 months and 42.0 months for the placebo group. AstraZeneca’s Imfinzi (durvalumab) also presented positive results as a neoadjuvant therapy before surgery based on the interim results from the Phase III AEGEAN trial that was presented in July. The trial evaluated Imfinzi in combination with neoadjuvant chemotherapy as perioperative treatment for patients with resectable Stage IIA-IIIB NSCLC, and results showed that the combination therapy significantly improved pathologic complete response (pCR) compared to neoadjuvant chemotherapy alone. However, other primary and secondary efficacy endpoints of the trial, including event-free survival (EFS), disease-free survival, overall survival, etc. To esophageal cancer, bladder cancer, and melanoma... use as early treatment expanded to various cancer types The entry of immuno-oncology drugs to early-stage cancer is not limited to NSCLC. Opdivo demonstrated its efficacy as adjuvant therapy in melanoma, bladder cancer, and esophageal cancer as well. Its indications are: ▲as adjuvant therapy in patients with lymph node involvement or metastatic Stage IIIB/C or IIII melanoma who have undergone complete resection; ▲as adjuvant therapy in patients with non-muscle-invasive bladder cancer (NMIBC) at high risk of recurrence after radical surgical resection ▲as neoadjuvant therapy for completely resected esophageal or gastroesophageal junction cancer in patients with residual pathologic disease who have received neoadjuvant chemoradiotherapy. Moreover, study results that demonstrate Opdivo’s effect as adjuvant therapy in patients with Stage IIB-IIC melanoma, an earlier stage than the existing indications, were also presented recently. Interim analysis results of CheckMate-76K that was presented last month showed that Opdivo as adjuvant therapy reduced the risk of recurrence or death by 58% versus placebo in patients with completely resected Stage IIB or IIC melanoma. Opdivo’s 12-month recurrence-free survival (RFS) was 89% versus 79% for the placebo group. Keytruda also obtained an indication as adjuvant therapy in patients with Stage IIB or IIC melanoma who have undergone complete resection and renal cell carcinoma (RCC) with a high risk of recurrence following nephrectomy. In triple-negative breast cancer (TNBC), Keytruda was approved as both adjuvant and neoadjuvant therapy. In other words, in TNBC, Keytruda can be used in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
- Company
- Hanmi achieves record quarterly performance in 7 years
- by Chon, Seung-Hyun Nov 02, 2022 05:36am
- Hanmi Pharmaceutical recorded the highest performance in 7 years since 2015. Its sales and operating profit were the largest since Q4 2015 when it signed a series of mega technology export deals, thanks to the success of its new combination drug and Beijing Hanmi. On the 1st, Hanmi Pharmaceutical officially announced that its operating profit had increased 26.9% compared to the same period of the previous year to reach KRW 46.8 billion in Q3. Its sales revenue had also increased 12.9% to reach KRW 342.1 billion, and net profit by 11.5% to reach KRW 31.3 billion. The company’s cumulative operating profit had risen 44.2% compared to the same period of the previous year to reach KRW 119.2 billion, and its sales rose 15.0% in the same period to reach KRW 980.4 billion. The sales and operating profit made by Hanmi Pharmaceuticals in Q3 this year are the largest made since Q4 2015. In Q4 2015, Hanmi Pharmaceuticals signed a series of mega licensing-out deals and recorded sales of KRW 589.9 billion and an operating profit of KRW 171.5 billion. Quarterly Sales of Hanmi (left) operating profit (right) (Unit: KRW 1 million, data: FSS) Hanmi Pharmaceuticals said, “This is the first time since our establishment that our quarterly sales exceed KRW340 billion excluding technology fees from overseas.” The new combination drug developed by Hanmi Pharmaceuticals outperformed itself in the domestic market. According to the market research institution UBIST, outpatient prescription sales of its hyperlipidemia combination drug Rosuzet reached KRW 36.4 billion in Q3, which is a 13.5% increase from Q3 of the previous year. Its cumulative sales reached KRW 103 billion in Q3 this year. Launched at the end of 2015, Rosuzet is a combination drug that consists of two ingredients - rosuvastatin and ezetimibe – and is used to treat hyperlipidemia. Rosuzet is the first homegrown new drug to exceed outpatient prescription sales of KRW 100 billion in only 3 quarters. As Rosuzet’s sales exceeded KRW 100 billion in 2020 and the previous year, with the record, Rosuzet’s sales are set to exceed KRW 100 billion for three consecutive years. The company’s new fixed-dose drug combination, the Amosartan family, is also showing steady growth. Hanmi Pharmaceuticals has been selling the amlodipine and losartan combination Amosartan as well as Amosartan Plus, Amosartan Q, and Amosartan XQ. Amosartan Plus is a combination of three drugs, amlodipine, losartan, and chlorthalidone. Amosartan Q is a combination of Amosartan and the hyperlipidemia treatment rosuvastatin. Amosartan XQ is a combination of Amosartan, rosuvastatin, and ezetimibe that was released last year. Prescriptions of Amosartan in Q3 increased 1.1% from the same period of the previous year to record KRW 21.1 billion. Prescription of Amosartan Plus decreased 1.1% YoY to record KRW 7.1 billion, and Amosartan Q, Amosartan made KRW 2.9 billion and KRW 1.8 billion, respectively. Also, Hanmi Pharmaceutical’s Chinese subsidiary, Beijing Hanmi, showed improved performance. Beijing Hanmi recorded sales of KRW 93 billion in Q3 this year, making a 23.4% YoY increase. Its operating profit has also grown 25.5% to reach KRW 24.2 billion. Beijing Hanmi has been growing with the annual rise in demand for its key products including Mamiai (pediatric digestive supplement with lactic acid bacteria), Etanjing (cough medicine), and Leeddong (laxative), etc. An official from Hanmi Pharmaceutical said, “We have living up to our management slogan of ‘sustainable innovative management,' which was demonstrated through our excellent performance this year. We will do our best to present a management model for the Korean pharma-bio industry while endeavoring to support Korea's growth into a pharmaceutical powerhouse as a native Korean pharmaceutical company.”
- Company
- JW signs new anti-cancer drug R&D contract with KURE AI
- by Nho, Byung Chul Nov 02, 2022 05:35am
- Park Chan-hee, chief technology officer of JW Group (left) and David Ward, CEO of KURE AI Theraputics, are taking photosJW Group announced on the 1st that it has signed a joint research contract with U.S. bio venture company KURE AI Therapeutics to develop innovative anti-cancer drugs based on artificial intelligence (AI). Under this contract, JW Pharma and JW CreaGene will launch research and development of three new anticancer drugs using KURE AI's artificial intelligence and machine learning-based genetic analysis and biomarker search platform. JW Pharmaceutical will discover a new low-molecular anticancer drug task with KURE AI targeting patients with immune anticancer drug-resistant solid cancer. It will also establish a strategy to increase the clinical success rate of candidates for new anticancer drugs developed by JW Pharmaceutical. JW CreaGene, a research firm of JW, works with KURE AI to derive candidates for new CAR-NK cell therapy for solid cancer treatment. It plans to expand the pipeline of new immune cell treatments along with dendritic cell treatments and CAR-macrophage treatments that are currently being researched and developed. "We are very excited to promote an innovative joint research project with JW Group, which has competitiveness in developing new drugs tailored to patients," said David Wald, CEO of KURE AI. "We will strengthen cooperation to achieve the result of developing next-generation new drugs for precise cancer treatment." Park Chan-hee, CTO of JW Group, said, "We will expand the new drug pipeline through joint research with KURE AI, which has a global-level anti-cancer drug brokerage clinical research platform." CTO Park Chan-hee said, "We plan to further expand joint research with overseas companies that have specialized innovation R&D platforms." JW Pharma and JW CreaGene are actively promoting open innovation) to expand the new drug pipeline by combining their own R&D platform to discover new drug candidate materials and platforms of promising bio companies at home and abroad. Currently, in addition to KURE AI in the U.S., it is collaborating with seven domestic biotech companies, including Voronoi, Deargen, Iliasbio, Organoidsciences, Oncocross, SyntekaBio, Oncoinsight Since July, it has been looking for joint research partners with ARCH Venture Partners, the largest bio and healthcare venture capital in the United States, to expand its open innovation target overseas.
- Company
- RET-targeted Retevmo reattempts reimb listing in Korea
- by Eo, Yun-Ho Nov 01, 2022 06:02am
- The RET-targeted anticancer therapy ‘Retevmo’ will reattempt reimbursement listing in Korea. According to industry sources, Lilly Korea’s Retevmo (selpercatinib) will be deliberated by the Health Insurance Review and Assessment Service’s Cancer Disease Review Committee (CDRC) tomorrow on November 2nd. Retevmo received marketing authorization in March this year and was deliberated by CDDC for reimbursement in May. After deliberation, the CDDC decided not to set reimbursement standards for the drug. Whether a different conclusion will be made this time remains to be seen. The CDDC’s review process was raised as an issue at the recent NA Audit. Rep. Gi-Yoon Kang of the People Power Party pointed out the lack of rationale for the CDDC’s not setting reimbursement standards within HIRA’s reimbursement process. According to Rep. Kang, the CDDC made the decision not to set reimbursement standards for anticancer drugs that had applied for reimbursement with Phase II clinical trials due to their absence of Phase III trial data, but this undermines the purpose of drugs that received approval under the condition of conducting Phase III trials in the future. However, HIRA said what it requested was additional data, not Phase III trial data, that could explain the clinical efficacy of the drugs, as it lacks data comparing its efficacy with existing treatments (indirect comparative data with existing treatments, real-world data, reimbursement evaluation results abroad, etc.) In 2020, Retevmo was approved as the first treatment option for cancer patients with RET gene alternations in the US after the FDA reviewed the drug through the Accelerated Approval and Priority Review pathway and granted the Breakthrough Therapy & Orphan Drug Designation. The drug demonstrated its efficacy through the LIBRETTO-001 trial that was conducted on 702 patients with advanced or metastatic solid cancer with RET mutations. In the trial, the overall response rate (ORR) of patients with RET fusion-positive NSCLC without prior platinum-based treatment experience that was treated with Retevmo was 85%. Although the median duration of response (DoR) was not yet reached, 79% of the patients showed continued response during the follow-up period (median 7.4 months). In patients with platinum-based treatment experience, the ORR was 64%, and the median DoR was 17.5 months.
- Company
- Bukwang applies for approval of Lurasidone
- by Nov 01, 2022 06:02am
- Bukwang Pharmaceutical announced on the 31st that it has applied for an item permit for Lurasidone, a new drug for treating schizophrenia and bipolar depression, from the Ministry of Food and Drug Safety. Lurasidone is a treatment for depression with schizophrenia and bipolar disorder developed by Sumitomo Pharma, Japan. Bukwang Pharmaceutical has exclusive development rights and copyrights in Korea. Bukwang Pharmaceutical recently announced that Lurasidone proved non-differential compared to the existing schizophrenia treatment "Quetiapine" in the top-line results of phase 3 clinical trials for schizophrenia patients. Lurasidone has lower metabolic adverse reactions such as weight gain, prolactin gain, dyslipidemia, and hyperglycemia than conventional atypical antipsychotics, improving patients' social life and quality of life. Lurasidone can also be used as a treatment for bipolar disorder depression, where drug selection is very limited. Lurasidone is an antagonist that blocks dopamine D2, serotonin 5-HT2A, and 5-HT7 receptors, which also partially act on serotonin 5-HT1A receptors and show little affinity for histamine H1 and muscarinic M1 receptors. According to Bukwang Pharmaceutical, Lurasidone has been approved as a treatment for schizophrenia and bipolar depression in more than 45 countries, including the United States and the European Union. The largest sales in the North American market reached about 2.6 trillion won. Bukwang Pharmaceutical said, "Lurasidone is expected to improve the quality of life of patients with proven treatment effects and safety for depression with schizophrenia and bipolar disorder."
- Company
- MET-targeted anticancer drug Tabrecta reattempts reimb
- by Eo, Yun-Ho Oct 31, 2022 06:06am
- Once again, the MET-targeted anticancer drug Tabrecta is attempting to receive insurance reimbursement in Korea. According to industry sources, Novartis Korea has recently started the reimbursement process for Tabrecta (capmatinib in Korea. As the agenda was unable to pass deliberation by the Health Insurance Review and Assessment Service’s Cancer Disease Drug Committee deliberations in August, whether the company will succeed in its second attempt for reimbursement remains to be seen. MET mutation is a rare type of cancer that is present in approximately 3-4% of patients with non small-cell lung cancer (NSCLC). No treatment option had been available in the type until now. Tabrecta targets c-MET and was first approved as a treatment for MET exon 14 skipping mutation in NSCLC in May 2020. The drug’s efficacy was confirmed through the GEOMETRY mono-1 trial in 97 patients with METex14. In the pivotal GEOMETRY mono-1 trial, Tabrecta demonstrated a 68% objective response rate (ORR) and 41% ORR in treatment-naïve and previously treated patients, respectively. The duration of response (DoR) was 12.6 months and 9.7 months, respectively. Meanwhile, Novartis is also actively studying the combined use of Tabrecta respective drugs with other therapies. In particular, the combined use is expected to be able to address the issue of resistance that patients acquire after treatment with EGFR inhibitors. As such, combined use of Tabrecta with AstraZeneca’s 3rd generation EGFR TKI Tagrisso (osimerbinib) is also underway. More specifically, the study will evaluate the treatment effect of Tabrecta+Tagrisso in comparison to platinum- based chemotherapy in NSCLC patients with epidermal growth factor receptor (EGFR) mutation, T790M negative, MET-amplified who progressed following treatment with 1st/2nd generation EGFR tyrosine kinase inhibitors (TKIs) or Tagrisso.
- Company
- Samsung Biologics surpassed ₩2 trillion in sales
- by Kim, Jin-Gu Oct 31, 2022 06:06am
- Samsung BioLogics surpassed 2 trillion won in cumulative sales in the third quarter. It exceeded 1.568 trillion won in annual sales last year in three quarters. On the 26th, Samsung BioLogics announced that it achieved 873 billion won in sales and 324.7 billion won in operating profit in the third quarter. Both sales and operating profit rose 94% year-on-year. Cumulative sales are 2.358 trillion won on a consolidated basis. It is the first time since its foundation that Samsung BioLogics has surpassed 2 trillion won in sales. ◆ Samsung BioLogics exceeded sales last year in three quarters Samsung BioLogics explained that it recorded cumulative sales of 1.6896 trillion won and an operating profit of 659.5 billion won in the third quarter, exceeding its annual performance last year (sales of 1.568 trillion won and operating profit of 536.5 billion won). Samsung BioLogics incorporated Samsung Bioepis as a 100% subsidiary in April this year. Samsung BioLogics explained that this results from increased sales of raw material drug CMO (consignment production) and increased profits of CDO (consignment development). On top of that, it added that the rise in the exchange rate led to improved performance. Samsung BioLogics plans to strengthen its business by operating its fourth plant in earnest and expanding orders for CDMO. Samsung BioLogics' fourth plant has the world's largest production capacity with a total of 240,000 liters. It started partial operation this month and will be in full operation next year. When the fourth plant is operated next year, Samsung BioLogics' production capacity will be expanded to 604,000 liters. It is the largest in the global CDMO industry. In the CDO business sector, it has expanded its portfolio by launching a new dual antibody platform called 'S-dual'. The cumulative number of orders is 73 for CMO and 100 for CDO. Cumulative charges amount to $8.5 billion (about 12 trillion won). ◆ Samsung Bioepis' performance decreases Samsung Bioepis recorded 269.8 billion won in sales and 77.9 billion won in operating profit in the third quarter on a separate basis. Sales fell 0.5% year-on-year and operating profit fell 23%. In the third quarter of last year, it received licensed milestones for U.S. and European products. Although its performance declined due to the base effect, the company explained that sales and operating profit are steadily growing this year as product sales growth in the global market. Samsung Bioepis is selling a total of six biosimilars in the global market. In the third quarter of this year, it obtained U.S. permission for the "Humira" biosimilar (SB5) high-concentration formulation. It plans to complete phase 3 clinical trials of Prolia biosimilar (SB16) and Stella biosimilar (SB17) within this year.
- Company
- The commercialization of Camzyos is expected in Korea
- by Eo, Yun-Ho Oct 28, 2022 05:57am
- It is expected that the new HCM drug Camzyos will be commercialized in Korea. According to related industries, BMS Pharmaceutical Korea recently submitted an application to the Ministry of Food and Drug Safety for permission for the NYHA Class 2-3 (class II-III) HCM treatment Camzyos. Camzyos is acquired by BMS for $13.1 billion in 2020 and is a PO drug that targets and inhibits cardiac myosin for functional treatment and symptom improvement of HCM. Camzyos, which was approved by the U.S. FDA in April, is the first and only cardiac myosin inhibitor targeting the source of obstructive hypertrophic cardiomyopathy and has a mechanism to reduce heart muscle contractility and left ventricular hypertrophy by inhibiting the cross-binding formation of excessive myosin actin activity. This drug confirmed efficiency through a phase 3 clinical study of EXPLORER-HCM. As a result of the study, it was found that exercise ability, LVOT closure, NYHA function class, and health status were significantly improved in the Camzyos administration group. 37% of the Camzyos administration group achieved a complex primary evaluation variable defined by achieving pVO2 1.5mL/kg/min improvement, NYHA class improvement, or pVO2 3.0mL/kg/min improvement without NYHA class deterioration, compared to around 17% of these patients in the placebo group, and the most common side effects in the clinical case were dizziness and fainting. Meanwhile, BMS recently submitted an application to the FDA for approval to expand the indication to reduce the need for Camzyos' SRT (Septal Reduction Therapy).
