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- 2026-05-04 16:26:39
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- Reimb at a halt for one-shot IRD drug Luxturna
- by Eo, Yun-Ho Dec 12, 2023 05:38am
- Reimbursement discussions for the one-shot retinal disease treatment Luxturna is being delayed in Korea. According to Dailypharm coverage, Novartis Korea failed to reach an agreement with the National Health Insurance Service on the drug price of uxturna (voretigene neparvovec) for inherited retinal dystrophy (IRD) within the 60-day deadline and will enter into extended negotiations. This suggests that the two parties involved (government-pharmaceutical company) were unable to reach an opinion regarding finances for the drug. Although the company had applied for reimbursement of the drug in September 2021, no progress had been made on its listing for a while and was finally presented as an agenda for deliberation by HIRA’s Drug Reimbursement Evaluation Committee in March this year. However, the drug failed to pass DREC review and receive reimbursement standards at the time. The company supplemented and reapplied for the drug’s reimbursement thereafter, thanks to which the company was able to start reimbursement negotiations. As disagreements over the terms of the risk-sharing agreement (RSA), including the refund rate, had previously stalled DREC deliberations, this may have played a role in stalling the pricing negotiations between NHIS and Novartis Korea as well. An official from Novartis said, “Luxturna is the only treatment option available for patients with IRD. As both the company and the government are well aware of this, we will do our best to overcome our differences within the extended negotiation period." Meanwhile, the efficacy of Luxturna was demonstrated through a Phase III trial that was conducted on IRD patients with confirmed biallelic RPE65 mutations. Study results showed that the group of patients that received Luxturna demonstrated statistically significant improvements in their functional vision compared to the control group at one year of treatment. Using the mean score of the multi-luminance mobility test (MLMT), which evaluates the ability to complete the obstacle course at low light levels by recreating the daily walking environment, as the primary endpoint at one year of treatment, the MLMT score change in the Luxturna treatment group was 1.8 points, 1.6 points higher than the 0.2 points in the control group.
- Company
- Taked’a new CMV drug Livtencity passes DREC review in 1 yr
- by Eo, Yun-Ho Dec 11, 2023 05:02am
- The reimbursement adequacy evaluation for the cytomegalovirus (CMV) treatment ‘Livtencity’ has been completed in 1 year since the drug received approval in Korea. According to industry sources, Takeda Pharmaceuticals Korea submitted its reimbursement application for Liventity (maribavir) in Q3, and the agenda has passed the review of the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee on the 7th of this month. Therefore, the company will now proceed to drug pricing negotiations with the NHIS if the Ministry of Health and Welfare gives the negotiation order. Whether negotiations will be successful, and a new treatment option will be introduced and rise as an alternative for patients who are resistant to existing drugs, remains to be seen. CMV is a type of herpes virus that's extremely common worldwide. Over 60% of all adults are infected with CMV within their lifetime and typically develops in patients who use immunosuppressants after hematopoietic stem cell transplantation (HSCT). Around 30-70% of HSCT patients experience CMV viremia. In HSCT patients, CMV causes multisystemic diseases such as pneumonia, hepatitis, gastroenteritis, retinitis, and encephalitis. Among these, pneumonia’s mortality rate is near 60%. Because CMV in immunocompromised patients is fatal, patients had generally received preemptive treatment mainly with ganciclovir, valganciclovir, foscarnet, and cidofovir, and hospitalization had been essential. Additionally, because these drugs have similar mechanisms of action, if resistance to one drug develops, likely, that the patient will not respond to other treatments as well. However, the introduction of Livtencity brings hope to these patients for secondary treatment. Livtencity has almost no side effects compared to existing drugs and offers an alternative if resistance to the existing treatments develops. Livtencity’s antiviral activity inhibits CMV multiplication and migration through a differentiated multi-modal mechanism of action that inhibits the protein kinase of the HCMV enzyme UL97. It not only inhibits DNA from coming out of cells, but also interferes with viral DNA replication, encapsidation, and nuclear egress. Meanwhile, Livtencity was first approved in November 2021 by the US FDA as the first treatment for patients with post-transplant CMV infection/disease and was approved in Korea in December last year. Also, Livtencity has passed the Drug Committees (DCs) of tertiary hospitals in Korea including Samsung Medical Center, Saint Mary's Hospital, Asan Medical Center, and Sinchon Severance Hospital, as well as other medical institutions such as the Kyungpook National University Hospital, Jeonbuk National University Hospital, and Chonnam National University Hwasun Hospital.
- Company
- Trulicity sales fall 30%...affected by supply shortage
- by Kim, Jin-Gu Dec 11, 2023 05:02am
- Sales of the GLP-1 receptor antagonist class treatment Trulicity had fallen 30% in 1 year. This is estimated to have been due to the prolonged domestic supply disruptions. Major insulin products that experienced sporadic supply shortages have experienced a sharp decrease in sales. In the case of Xultophy, its sales, which had surged to KRW 4.8 billion in Q2 fell to KRW 3.1 billion in Q3. In the case of Soliqua, its sales, which had remained at the KRW 2 billion level, sur soared to KRW 4 billion in Q3. On the other hand, the two other insulins that have been experiencing shortages – Tresiba and Ryzodeg - saw stable sales in Q3 this year. Trulicity posts record high sales in Q2→sales drop in Q3 due to prolonged supply disruption Pic of TrulicityAccording to the market research institution IQVIA on the 11th, Eli Lilly’s Trulicity’s sales in Q3 were KRW 11 billion. This is a 30% drop from the KRW 15.8 billion it posted in Q3 last year. Trulicity is a GLP-1 receptor antagonist class diabetes drug. GLP-1 analogs are developed using the hormone glucagon-like peptide-1 (GLP-1), which is involved in the regulation of blood sugar in the body. GLP-1 hormone stimulates insulin secretion immediately after a meal to lower blood sugar and reduces insulin secretion when blood sugar falls below a certain level to help prevent hypoglycemia. The drug’s performance this quarter is in stark contrast to last quarter's record quarterly revenue. Trulicity's revenue had been growing rapidly until Q2 this year. It crossed the KRW 15 billion mark for the first time in Q3 last year and soared to USD 18 billion in Q2 this year. However, sales fell sharply in Q3. The industry analysis is that its performance is finally experiencing the aftermath of the domestic supply disruption that has been in full swing since Q3, which led to a sharp drop in sales. Trulicity's supply issues began to surface in Q2 this year. In late June, Lilly notified its sales and marketing partner, Boryung, of its difficulties in supplying Trulicity 0.75mg/0.5ml in Korea. Quarterly sales of Trulicity (Unit: KRW 100 million Data: IQVIA) Then, the company started to have difficulties supplying the 1.5mg/0.5ml dosages as well. Initially, Lilly estimated that it would be able to resume domestic supply in mid-October, but in mid-October, the company pushed back the estimate to November. And this was only for the 1.5mg/0.5ml dose, with no exact timeline set still for the 0.75mg/0.5ml dosages. The industry expectation is that if the disruption continues beyond Q4, Trulicity's sales will decline further. Xultophy’s sales fall, Soliqua’s sales rise… Major insulin sales fluctuate due to shortages Sales of major insulin injections, which have been in short supply for most of the year, are also showing fluctuations in sales. In Korea, Novo Nordisk’s Tresiba, Ryzodeg, Xultophy, Sanofi-Aventis’s Xultophy, Tuojeo, and Lilly’s Humalog have been experiencing shortages one after another since Q2 this year. Sales of major products have fluctuated greatly in the process. For example, Xultophy’s sales plummeted from KRW 4.8 billion in Q2 this year to KRW 3.1 billion in Q3. In the case of Xultophy, its domestic supply began to be disrupted around August. Novo Nordisk initially predicted that it would be able to resume supply in September, but pushed back its prediction to November. On the other hand, Sanofi-Aventis' Soliqua saw a significant increase in sales in Q3. The company reported sales of KRW 4 billion in Q3, up 63% from KRW 2.4 billion in Q3 last year. Since Q2 2021, Soliqua has consistently generated sales of KRW 2 billion to 2.4 billion every quarter. However, in Q3 this year, the company first marked sales of KRW 4 billion with Soliqua since its launch in Korea. The industry analysis shows that the demand for Soliqua’s sales rose due to the unstable supply of other insulin products. Quarterly sales of major insulin products (Unit: KRW 100 million, Data: IQVIA) However, sales of products saw little change. Novo Nordisk's Tresiba, Ryzodeg, and Lilly's Humalog have been experiencing sporadic shortages, but on the surface, their sales have remained stable. Tresiba sold KRW 10.9 billion in Q3 this year, flat YoY. Tresiba has been consistently generating sales in the high KRW 10 billion to low KRW 11 billion range since Q3 last year, after posting sales of KRW 10.9 billion. In the case of Ryzodeg, the company recorded sales of KRW 8.8 billion in Q3 this year. This is a 4% increase from KRW 8.4 billion in Q3 last year. Humalog posted sales of KRW 5.2 billion in Q3. This is a 4% decrease compared to the KRW 5.4 billion it posted in Q3 last year The industry analyzed that Tresiba, Ryzodeg’s sales remained level due to the spread of the stock shortage issue in the market, which led to an increase in temporary demand for stockpiling.
- Company
- Double-dose Trelegy Ellipta in reimb process for asthma
- by Eo, Yun-Ho Dec 11, 2023 05:02am
- The double dose of Trelegy Ellipta, which was approved for asthma, not COPD, is making rapid progress for reimbursement listing in korea. According to the pharmaceutical industry, GSK Korea has recently started reimbursement pricing negotiations with the National Health Insurance Service for its Trelegy 200 Ellipta (fluticasone furoate ·umeclidinium ·vilanterol). On the 9th, Trelegy 200 Ellipta has successfully passed the Health Insurance Review and Assessment Service (HIRA)'s Drug Reimbursement Committee. Therefore, industry eyes are on whether Trelegy Ellipta's reimbursement would be expanded to asthma in addition to its COPD indication. Trelegy 200 Ellipta has demonstrated its efficacy through the Phase 3 CAPTAIN study, which compared Trelegy Ellipta and dual combination therapy FF/VI(fluticasone furoate / vilanterol) in 2436 adult asthma patients who are age 18 and over and whose asthma is uncontrolled despite treatment with dual combined therapy ICS/LABA. As the primary endpoint, each cohort’s Forced Expiratory Volume in 1 second (FEV1) changes at Week 24 were evaluated. The results demonstrated statistical significance as the Trelegy Ellipta treated cohort showed 110mL improvement in FEV1 compared with the FF/VI treated cohort. The safety profile of Trelegy Ellipta for asthma treatment in the CAPTAIN study was also consistent with the known profile of the individual drug components and their combinations. The common side effects were nasopharyngitis v(13-15%), headache (5-9%), upper respiratory tract infection (3-6%), and the adverse reactions were comparable in all treatment cohorts. Trelegy Ellipta was the first triple combination therapy for COPD to be approved in Korea in May 2018. Its specific indication for COPD is as a maintenance therapy for patients with moderate to severe cases that are inadequately controlled by a combination of a long-acting beta2-agonist (LABA) and an inhaled corticosteroid, or a LABA and a long-acting muscarinic antagonist (LAMA). Currently, patients who use Trelegy Ellipta are granted reimbursement when they meet one of the following three standards: ▲patients whose FEV1 values are less than 60% of the predicted normal value despite combination therapy with LABA and LAMA or those who have experienced acute exacerbations more than twice a year, ▲patients whose symptoms such as dyspnea are not adequately controlled despite combination therapy with LABA and inhaled corticosteroids, ▲patients receiving a combination of vilanterol trifenatate /fluticasone furoate inhaler, which has the same dosage as Trelegy Ellipta, and umeclidinium inhaler, as well as those on a combination of ICS/LABA and LAMA monotherapy with the same dosage as Trelegy, who wish to switch to Trelegy in compliance with its approved indications.
- Company
- Chong Kun Dang receives attention for its 'R&D potential'
- by Chon, Seung-Hyun Dec 08, 2023 05:28pm
- Chong Kun Dang Pharmaceutical (CKD Pharm) has reported over 10 billion won of its R&D costs as assets for the first time. The cost includes increased clinical trial costs for the commercialization of its biosimilars and incrementally modified drugs (IMD). The company has gained recognition for its R&D potential following a major technology export recently, which has drawn significant attention to its drug development pipeline. Chong Kun Dang Headquarters According to the Financial Supervisory Service (FSS) on 8th, the CKD’s development costs that were accounted for as intangible assets at the end of Q3 amounted to 11.6 billion won, up 2.3 billion won from 9.3 billion won reported at the end of the first half of the year, marking over 10 billion won for the first time. In 2019, the FSS issued a guideline that only R&D projects with technical feasibility such as new drugs could be accounted for as assets. FSS’s R&D cost capitalization guideline set was the initiation of Phase 3 clinical trials for new drugs and approval of Phase 1 clinical trials for biosimilars. As for generics, approval of bioequivalence test plans. CKD’s intangible R&D assets were only 3.8 billion won at the end of last year. This year, it has rose to 6.6 billion won, increasing by 2.8 billion won in Q1 and 2.8 billion and 2.2 billion won in Q2 and Q3, respectively. With its drug development pipeline nearing commercialization, more R&D costs were reported as assests. The company's combination drugs contribute to a big part of the CKD’s R&D costs recognized as intangible assets. As of the end of Q3, the hypertension combination drug CKD-828's clinical costs were capitalized at 3.2 billion won. The development costs of 2.6 billion won and 1.8 billion won, for the dyslipidemia combination drug CKD-391 and the diabetes combination drug CKD-371 were recognized as intangible assets, respectively. The biosimilar CKD-701, which is a biosimilar of the macular degeneration treatment Lucentis, has capitalized R&D costs of 600 million Korean won. CKD received approval from the Ministry of Food and Drug Safety in October last year for Lucent-BS, and launched it in Korea in January after receiving health insurance coverage. Lucent-BS is the second biosimilar released by CKD. In Nov. 2018, the company received domestic approval for Nesbell, a biosimilar to the anemia treatment NESP. CKD developed Nesbell after securing a differentiated raw material manufacturing technology in 2008 and establishing biopharmaceutical production infrastructure in 2012. The amount of R&D costs capitalized by CKD had not been extensive, but its drug pipeline has attracted attention following a recent major technology export deal. On the 6th of last month, CKD signed a technology export contract with Novartis for the drug candidate CKD-510. The deal includes a non-refundable upfront payment of US 80 million (106.1 billion won) dollars. CKD is set to receive milestone payments up to US 1.225 billion (1.6241 trillion won) dollars dependent on development and regulatory approvals. This was the first major technology export contract the company had signed that exceeded 100 billion won. CKD-510, which is a new drug candidate developed by CKD, is a highly selective non-hydroxamic acid (NHA) platform technology-based HDAC6 inhibitor. It has shown efficacy in preclinical studies for various HDAC6 related diseases, including cardiovascular diseases. It has demonstrated safety and tolerability in Phase 1 clinical trials in Europe and the USA. CKD has completed a European Phase 1 trial of CKD-510 for Charcot-Marie-Tooth disease (CMT). CMT is a rare hereditary peripheral neuropathy where genetic mutations lead to motor and sensory nerves damages, complicating normal walking and daily activities. There is currently no definitive cure for CMT. CKD’s strategy is to derive optimal drugs for various diseases based on the basic structure of HDAC6 inhibitors. Currently, CKD is developing new drugs, with a platform technology for CMT, Huntington's disease, Alzheimer's disease, blood cancer, and autoimmune diseases. Chong Kun Dang CKD is also developing a new bio-drug in the oncology field. CKD-702 is an anti-cancer bispecific antibody that inhibits both hepatocyte growth factor receptor (c-Met) and epidermal growth factor receptor (EGFR), which are essential for cancer growth. CKD-702 binds to each receptor to block cancer cell proliferation signals and decrease receptor numbers, making it a first-in-class bio new drug from CKD. A domestic Phase 1 clinical trial is currently underway. To verify the efficacy and mechanism of action of CKD-702, CKD conducted research on its use as monotherapy, using non-small cell lung cancer animal models. The study has shown that CKD-702 exhibits anti-tumor effects by simultaneously inhibiting the hepatocyte growth factor receptor and the epidermal growth factor receptor. It was also found to be highly effective in animal models that had developed resistance to existing c-Met and EGFR targeted cancer drugs. Currently, phase 1 trials evaluating its indications for non-small-cell lung cancer are underway, and there are plans to expand the indications to stomach cancer, colon cancer, and liver cancer for global clinical trials. CKD's new drug, CKD-508, which is being developed as dyslipidemia treatment, has been undergoing Phase 1 clinical trials in the UK since 2020. The drug is expected to lower LDL cholesterol and increase HDL cholesterol by inhibiting the CETP enzyme. It is regarded as the most effective CETP inhibitor developed to date, having improved upon the drawbacks of first-generation CETP inhibitors. CKD aims to complete the Phase 1 clinical trials within the year.
- Company
- Gardasil dominates HPV vaccine mkt in KOR
- by Kim, Jin-Gu Dec 08, 2023 05:55am
- The human papillomavirus (HPV) vaccines Gardasil and Gardasil 9 have established dominance in the cervical cancer vaccine market. As of Q3, their market share has reached 99.9%. Following the expanded vaccination age limit and increase in domestic supply price, the quarterly sales of these vaccines increased to 35.3 billion won. Gardasil 9’s sales may increase even further if President Yoon Suk Yeol include it into the National Immunization Program (NIP), as pledged. Q3 Gardasil and Gardasil 9 sales 35.3 bil…Market share of 99.9% According to clinical research firm IQVIA, the sales of MSD's Gardasil and Gardasil 9 in Q3 were 35.3 billion won, a 5% increase from 33.6 billion won in the same quarter last year. Gardasil and Gardasil 9 are vaccines for preventing HPV, which causes cervical cancer. Gardasil prevents four types of HPV, and Gardasil 9 prevents nine. Gardasil and Gardasil 9 were approved in 2007 and 2016, respectively. As the company's more recent vaccine, Gardasil 9, is leading the market. Its sales increased from 40.5 billion won in 2019 to 42.5 billion won in 2020, and to 72.6 billion won in 2021. Last year, it posted 117 billion won, and it has already accumulated 80.2 billion won in sales by Q3 this year, making it likely to surpass 100 billion won in sales for the second consecutive year. Gardasil also had shown good performance with sales of 20.6 billion won in 2019, 20.4 billion won in 2020, 21.3 billion won in 2021, and 26.7 billion won in 2022. During these periods, Gardasil and Gardasil 9 have overtaken the competing drug GSK’s Cervarix, and established a lead. As of the last quarter, their market share has reached 99.9%. Since Q4 2021, their share has exceeded 99.0% and has been getting closer to 100%. Cervarix managed to maintain quarterlsy sales of over 300 million won until Q4 of 2021, but this dropped to less than 100 million won from Q2 of last year. Since the Q4 of last year, its quarterly sales have shrunk further to below 50 million won. The pharmaceutical industry perceives it as discontinued sales-wise in the domestic market. With expanded vaccination age limit and increased supply price….NIP inclusion likely to increase sales The surge in the Gardasil and Gardasil 9 usage is attributed to the expansion of the vaccination age limit and increased supply price. As of July 2020, the vaccination age limit for Gardasil was extended from 9-26 years to 9-45 years. At the same time, the awareness that not only women but also men should be vaccinated has become widespread. MSD has consecutively raised the domestic supply price of Gardasil 9 in 2021 and 2022. The Gardasil 9 price, which was 106,300 won (excluding VAT) in 2021, increased to 122,245 won in April of the same year. In July of last year, it rose again to 132,636 won. The price increase over two years amounts to 25%. Inclusion of Gardasil 9 in the NIP is expected to significantly boost sales. President Yoon Suk Yeol, during his presidential candidacy, pledged to include Gardasil 9 to the NIP. As a follow-up, Korea Disease Control and Prevention Agency (KDCA) is currently reorderd research services for Gardasil 9. Previous research service had concluded that Gardasil 9 lacked cost-effectiveness. However, the KDCA has decided to conduct additional research to analyze the cost-benefit. The KDCA re-ordered the related research service in May. After obtaining results within this year, the KDCA plans to include Gardasil 9 in the NIP in Q1 next year. With Gardasil 9’s NIP inclusion, the supply price may decrease because of the bidding process. However, the widespread forecast is that the substantial increase in the number of vaccinated people will ultimately lead to related sales increase.
- Company
- Former Janssen Korea President Cherry Huang goes to China
- by Eo, Yun-Ho Dec 08, 2023 05:55am
- Cherry Huang, former President of Janssen Korea It has been confirmed that the position of President at Janssen Korea is currently vacant. According to Dailypharm's coverage, former CEO Cherry Huang recently left the company to serve as President of the Chinese subsidiary. As a result, Janssen Korea is now in the search for a new president. Since being appointed president in May 2021, Huang has led Janssen Korea for more than 2 years. She was the second foreign lead to head the Korean subsidiary, following her predecessor Jenny Chung. Since appointing Jung-Hoon Jang as president in 1983, the company has appointed Koreans to head the subsidiary, appointing Tae-Hong Choi, the current CEO of Hana Pharm in 2007, then Sangjin Kim, current President/Co-CEO at Samil Pharmaceutical, in 2011, then Oak-yeon Kim in 2012. In 2018, the company switched to a foreign president when Oak-yeon Kim transferred to the Asia-Pacific division. Whether Janssen Korea will switch back to a local leader remains to be seen. Meanwhile, Johnson & Johnson's pharmaceutical division, Janssen Korea, was a powerhouse in the central nervous system (CNS) field until the early 2000s. Currently, the company has established a reputation for itself in the autoimmune disease space, after entering the market with ‘Remicade (infliximab),’ and has been offering a variety of treatment options including ‘Stelara (ustekinumab),’ ‘Tremfya (guselkumab),’ and ‘Simponi (golimumab).’
- Company
- Jemperli reimbursed as immunotherapy for endometrial cancer
- by Dec 08, 2023 05:55am
- GSK Korea holds a press conference celebrating the launch of its immunotherapy Jemperli’s reimbursement A new immuno-oncology drug has been added to the sparse list of treatments available for endometrial cancer. GSK Korea succeeded in obtaining insurance reimbursement for its Jemperli in a year since obtaining approval in Korea in December last year. GSK Korea held a press conference on Sunday at Lotte Hotel Seoul to celebrate the launch of its immuno-oncology drug Jemperli (dostarlimab) in Korea. The drug is a PD-1 inhibitor class immuno-oncology drug. It was approved in Korea as a treatment for patients with recurrent or advanced deficient mismatch repair (dMMR) or high microsatellite instability (MSI-H) endometrial cancer that has progressed on or following prior systemic treatment with a platinum-containing chemotherapy regimen who are in December last year. The drug was approved for reimbursement in 1 year since then. Jemperli has been listed on the reimbursement list as of December 1. Jemerli demonstrated efficacy in the GARNET trial that enrolled 143 patients with recurrent or advanced dMMR/MSI-H endometrial cancer. After a median follow-up period of 27.6 months, Jemperli achieved an objective response rate (ORR) of 45.5%. The complete response rate was 16.1%, and the partial response rate was 29.4%. Among patients who showed treatment response, 93.3% and 83.7% of the patients showed continued treatment response at 12 months and 24 months, respectively. Most of the reported adverse events were mild, and included diarrhea (16.3%), asthenia (15.7%), and fatigue (13.7%). Jae-Weon Kim, Professor of Obstetrics and Gynecology at Seoul National University Hospital, said, “A limitation existed in the field due to lack of treatments available for use in case of recurrence after platinum-based chemotherapy. Jemperli’s reimbursement holds significance as being the first immuno-oncology drug to be granted reimbursement in the field.” Jemperli attempts to expand its reimbursement as first-line therapy in endometrial cancer… an area that lacks treatment options At the conference, GSK also indicated the possibility of extending Jemperli’s marketing authorization to the first line in endometrial cancer. Currently, the 5-year survival rate for recurrent endometrial cancer is reported to be less than 20%. For recurrent patients who have failed first-line treatment, the survival rate falls further to less than 1 year. The current first-line standard of care for endometrial cancer was the cytotoxic agent combination of paclitaxel and carboplatin. Second-line treatment options are even more limited. Old drugs such as paclitaxel, Avastin (bevacizumab), and docetaxel are being used as second-line treatment, but have not had a significant impact on improving survival. Therefore, the company plans to expand Jemperli’s indication to the first line in endometrial cancer based on its clinical results while seeking approval for other cancers. Yoo-jin Yang, managing director of GSK Korea’s Oncology BU, said, “We are working to secure more indications for Jemperli in other areas, in addition to endometrial cancer. In endometrial cancer, we will work to receive approval for Jemperli as a first-line treatment."
- Company
- JW Pharm Hemlibra's sales tops KRW 10 bil for the 1st time
- by Chon, Seung-Hyun Dec 07, 2023 05:47am
- Annual sales of JW Pharmaceutical's Hemlibra has surpassed the 10 billion won mark for the first time since its launch in Korea. The expanded reimbursement significantly boosted sales, by threefold. According to the pharmaceutical research agency IQVIA, Hemlibra's Q3 sales reached 6.8 billion won, a 261.3% increase from 1.9 billion won in the same period last year. Hemlibra is a prophylactic treatment for Type A hemophilia, which is caused by the deficiency of blood clotting Factor VIII. It utilizes a dual-specific antibody technology that binds simultaneously to clotting Factors IX and X. Unlike traditional Factor VIII treatments, Hemlibra is the first non-Factor VIII medication that can be administered subcutaneously at intervals of up to four weeks. Hemlibra was developed by Chugai Pharmaceutical, a subsidiary of Roche. JW Pharmaceutical secured the domestic development and sales rights for Hemlibra in 2017 and received approval from the Ministry of Food and Drug Safety in 2019. Hemlibra had been released with reimbursement in 2020, and its sales remained at mere 2.1 billion won range in Q1. However, its sales rose to 3.6 billion won in Q2, up by 68.4% from the previous quarter, and showed an even steeper increase in Q3. The surge in Hemlibra's Q2 sales was due to the expanded reimbursement. Since May, Hemlibra has been reimbursed for patients over the age of one with Type A hemophilia who do not have Factor VIII antibodies. In May 2020, Hemlibra was initially reimbursed for severe Type A hemophilia patients with inhibitors. Three years later, the reimbursement was expanded to non-antibody patients. JW Pharmaceutical reports that there are approximately 1,700 Type A hemophilia patients in Korea, with about 70% being severe cases. Among them, a significant majority are non-antibody patients. Over 60% of Type A hemophilia patients in Korea fall under Hemlibra reimbursement group. Hemlibra's sales last year reached 7.6 billion won. The quarterly sales alone nearly matched the previous year's annual sales, marking significant growth due to the reimbursement expansion. For the first time since its launch in Korea, Hemlibra topped the annual sales of 10 billion won, amounting to 12.5 billion won in Q3 sales. JW Pharmaceutical expects Hemlibra to provide substantial treatment benefits to patients based on its efficacy and safety proven through large-scale clinical trials. In the HAVEN 1 trial that was conducted on patients with inhibitors, Hemlibra showed a 79% reduction in annualized bleeding rate (ABR) to 3.3 compared to prior prophylaxis with a bypassing agent. or patients without inhibitors, the HAVEN3 trial demonstrated a 68% reduction in ABR to 1.5 compared to factor VIII prophylaxis. Research comparing the effects of Hemlibra on both inhibitor and non-inhibitor patients yielded similar results and confirmed long-term efficacy. The goal of prophylaxis (bypassing therapy) for hemophilia patients is to maintain a certain level of factor VIII activity to prevent bleeds. Hemlibra has shown sustained plasma concentrations. According to the company, the clinical trial demonstrated a favorable safety profile. Results from HAVEN 1 - 4 trials had shown that side-effects observed in patients treated with Hemlibra were minor injection site reactions. Hemlibra’s global sales last year were 3.823 billion Swiss francs (approx. 5.7 trillion won), up 27% from the 3.022 billion Swiss francs YoY. Currently, over 20,000 patients in 144 countries worldwide are using Hemlibra.
- Company
- Bemarituzumab is granted ODD status in Korea
- by Eo, Yun-Ho Dec 07, 2023 05:47am
- The new gastric cancer drug bemarituzumab received an orphan drug status in Korea. The Ministry of Food and Drug Safety (MFDS) recently announced so through the orphan drug designation notice. Specifically, the drug is indicated to treat patients with fibroblast growth factor receptor 2b (FGFR2b) overexpression and unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma. Amgen’s bemarituzumab is a first-in-class investigational FGFR2b targeted antibody. And, Amgen gained access to the drug as part of its acquisition of Five Prime Therapeutics in 2021. In the same year, the FDA has granted bermarituzumab a Breakthrough Therapy designation (BTD). Bermarituzumab is a humanized IgG1 monoclonal antibody that targets the binding of FGFR2b. It blocks FGFR2b activation and slows cancer progression. The data from the its Phase 2 FIGHT clinical trial was been released in October 2022. For patients with HER2-negative FGFR2b-overexpressing tumor, bemarituzumab plus combination chemotherapy demonstrated clinically significant results in progression free survival (9.5 months vs 7.4 months), overall survival (19.2 months vs 13.5 months), and response rate (53% vs 40%). Based on the previous results, the company has been conducting FORTITUDE-101 and FORTITUDE-102 Phase 3 trials to further evaluate bemarituzumab in FGFR2b overexpression gastric cancer patients. In the Phase 1 trial, bemarituzumab showed no dose-limiting toxicities and a had confirmed objective response rate (ORR) of 18% in patients with refractory FGFR2b-positive gastric cancer.
