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- 2026-05-04 14:01:10
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- Keytruda posts KRW 100 bil in quarterly sales
- by Chon, Seung-Hyun May 24, 2024 05:48am
- The immuno-oncology drug Keytruda has strengthened its dominance in the domestic drug market, maintaining quarterly sales in the KRW 100 billion range. After being granted reimbursement expansion as a first-line treatment, Keytruda’s sales surged even greater, tripling the sales gap with the runner-up in the market. Also, other new anticancer drugs from multinational pharmaceutical companies like Tagrisso and Imfinzi showed strong growth. According to the market research institution IQVIA on the 24th, sales of MSD Korea’s Keytruda led the market with sales of KRW 116.8 billion in Q1, up 33.1% YoY. This marks the 17th consecutive quarter that Keytruda has held the top spot in the domestic drug market since taking the top spot in Q1 2020. Keytruda, which was introduced to Korea in 2015, is an immune checkpoint inhibitor that inhibits PD-1 (programmed death 1) proteins expressed at the surface of activated T cells, thereby inhibiting its binding to PD-L1 and activates the immune system to treat cancer. The drug is currently approved for 16 cancers: ▲Lung cancer, ▲head and neck cancer, ▲ Hodgkin’s lymphoma, ▲urothelial carcinoma (bladder cancer), ▲esophageal cancer, ▲ melanoma, ▲renal cell cancer (kidney cancer), ▲endometrial cancer, ▲stomach cancer, ▲small intestine cancer, ▲ovarian cancer, ▲pancreatic cancer, ▲biliary tract cancer, ▲colorectal cancer ▲triple negative breast cancer, and ▲cervical cancer. It is indicated for the largest number of cancer types among cancer immunotherapies approved in Korea. It is reimbursed for 7 indications in 4 types of cancer – non-small-cell lung cancer, melanoma, urothelial carcinoma, and Hodgkin’s lymphoma. It is also reimbursed as a first-line treatment for melanoma and non-small-cell lung cancer. It has shown accelerated performance since its reimbursement was extended to the first line in 2022. In March 2022, Keytruda’s reimbursement was extended to cover first-line treatment for non-small cell lung cancer. Keytruda’s sales jumped 117.1% in one year, from KRW 40.4 billion in Q1 2022 to KRW 87.8 billion in Q1 last year. Its Q1 sales this year tripled compared to 2 years ago. Since exceeding sales of KRW 100 billion in Q3 last year, the drug has posted sales of over KRW 100 billion for 3 consecutive quarters. This is the first time a drug’s quarterly sales have surpassed KRW 100 billion in the domestic pharmaceutical market. Keytruda’s sales are nearly three times higher than the second place, Prolia. Keytruda's insurance ceiling price was lowered by 25.6% with the reimbursement expansion. Considering how sales had increased by twofold in Q1 compared to Q4 2021, before the reimbursement expansion, it is calculated that Keytruda’s prescriptions increased by over threefold during the period. Also, AstraZeneca’s anticancer drug Tagrisso has benefited from the reimbursement expansions this year. Q1 sales of Tagrisso were KRW 39.9 billion, up 46.0% YoY. Tagrisso is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). EGFR-TKIs are targeted anticancer drugs prescribed to patients with metastatic non-small cell lung cancer (NSCLC) with EGFR mutations. Tagrisso’s quarterly sales surpassed KRW 20 billion in Q1 2020 and remained in the KRW 20 billion range until Q4 last year. Beginning this year, Tagrisso, along with Yuhan Corp’s Leclaza, were granted reimbursement expansions as were covered as a first-line treatment for locally advanced or metastatic NSCLC with certain genetic mutations.’ Tagrisso reported sales of KRW 26.9 billion in Q4 last year, and sales jumped 47.9% in a single quarter after the reimbursement expansion. Health authorities estimate that Tagrisso's coverage as a first-line treatment will cost an additional KRW 92 billion, according to the Ministry of Health and Welfare. Yuhan Corp’s Leclaza’s sales more than tripled to KRW 18.9 billion in Q1 from KRW 6.2 billion in sales in Q4 last year. The MOHW analyzed that the reimbursement coverage of Leclaza as a first-line treatment will cost the nation an additional KRW 88.1 billion. New products recently launched by multinational pharmaceutical companies have also risen to prominence at the top of the domestic drug market. Amgen's Prolia ranked second overall with Q1 sales of KRW 41.2 billion, up 16.2% from the previous year. This is a 64.7% increase in 2 years from KRW 25 billion in Q1 2022. Launched in Korea in November 2016, Prolia is a biological osteoporosis treatment that targets the RANKL protein essential for the formation, activation, and survival of osteoclasts that destroy the bone. Its sales started to rise after it was applied reimbursement as a second-line treatment in 2017. After additionally being approved for reimbursement in the first line from April 2019, Prolia’s sales rose explosively. Prolia is copromoted by Chong Kun Dang in Korea. Sales of Sanofi’s atopic dermatitis treatment Dupixent rose 30.9% YoY to record KRW 40.5 billion in Q1. Dupixent is the first targeted biologic for the treatment of moderate-to-severe atopic dermatitis that is not well controlled with topical therapies or who cannot use topical therapies. Sales of Dupixent, which was approved in March 2018, increased rapidly after it was approved for reimbursement for severe atopic dermatitis in January 2020. Sales of the immuno-oncology drug Imfinzi increased 107.1% YoY to reach KRW 31.5 billion in Q1 this year. Imfinzi is a PD-1-targeted immuno-oncology drug developed by AstraZeneca. Imfinzi was the first immuno-oncology drug to demonstrate efficacy in biliary tract cancer. In 2022, AstraZeneca received approval for the combination of Imfinzi+gemcitabine+cisplatin in South Korea. The combination became the new standard of care for biliary tract cancer in 12 years. AstraZeneca is currently in the process of expanding reimbursement to the biliary tract cancer indication. Among domestically developed new drugs, HK Inno.N’s gastroesophageal reflux disease treatment K-CAB’s sales had risen 21.6% YoY in 1H to record KRW 32.2 billion, and rose to 6th place. K-CAB, was released in March 2019. It has a new mechanism of action that inhibits gastric acid secretion by competitively binding to the proton pump and potassium ion located in the final stage of acid secretion. Hanmi Pharmaceutical's hyperlipidemia combination drug Rosuzet ranked 10th overall with sales of KRW 29.3 billion in Q1. Rosuzet is a combination drug that contains rosuvastatin and ezetimibe.
- Company
- Pharmas face a heavy burden from high-interest loans
- by Kim, Jin-Gu May 24, 2024 05:48am
- Pharmaceutical and biotech companies’ bank loan interest rates have been set high for over two years. A high-interest rate, up to 8%, has been maintained, and key companies face a heavy burden from this. The pharmaceutical industry raises concerns that an extended financial burden due to high interest rates may decrease investment. Most big pharmaceutical companies with high loan ratios are currently focused on repaying loans while reducing thier investment sizes. Samsung Biologics’ Q1 interest expenses amount to KRW 16.1 billion…4-5% interest rate has been maintained for over 2 years According to the Financial Supervisory Service on May 23rd, Samsung Biologics’ loan amount by the end of Q1 amounts to KRW 16.1 billion. This amount decreased compared to KRW 21.7 billion in Q1 last year, but the company may be facing a heavy burden. Samsung Biologics borrowed KRW 572 billion in 1-year short-term loan from six banks, including Kookmin Bank. The interest rate is around 4.66-5.38%. The company also borrowed a long-term loan of KRW 425.4 billion, with KRW 350.4 billion due within a year. The interest rate for long-term loans is 1.55-5.74%. Furthermore, the amount of money that Samsung Biologics must repay KRW 1.3024 trillion within a year, including private loans. It appears that the company spent KRW 1.61 billion just on interest in Q1. The loan burden due to the high interest rate has continued for two consecutive years. Last year, Samsung Biologics spent KRW 81.6 billion on interest, and in 2022, the company had to pay KRW 64.1 billion in interest. These amounts are strikingly different from the previous years. In 2020 and 2021, the company paid KRW 16.1 billion and KRW 14.7 billion in interest, respectively. The recent increase in interest amount may be due to expanding the loan size for building of the new 4·5 manufacturing plant, but the analysis suggests that a higher interest rate may have played a part. In fact, the short-term and long-term loan interest rates were 1.50-2.70% until 2021. However, the interest rate significantly increased in 2022, up to 5%. After that, the high-interest rate has been maintained for over two years. Major pharmaceutical companies’ interest rates are up to 7%...due to the expanded interest amount burden, concerns arise about investment decline Other pharmaceutical and biotech companies are currently facing similar challenges. The companies are struggling to procure funds and investments due to accumulating burden of a high-interest rate, which can reach a maximum 7%. As of the end of Q1 last year, Yuhan’s short-term loan interest rate was 3.93-5.67%, and long-term loan interest rate was 3.00-6.30%. Last year’s short-term and long-term loan interest rates were around 2.20-7.70%. However, Yuhan’s loan interest rate was around 1.30-3.40% until 2021. GC Pharma had a short-term loan of KRW 248.3 billion with an interest rate of 4.47-6.46% as of the end of Q1 last year. This rate is similar to the 4.54%-6.45% of 2022. In 2021, GC Pharma’s loan interest rate was merely 1.60-3.80%. In Q1 this year, GC Pharma spent KRW 7.1 billion on interest. Its interest amount was KRW 10.6 billion in 2021 but significantly increased to KRW 15.6 billion and KRW 23.9 billion in 2022 and 2023, respectively. Hanmi Pharm’s short-term loan interest rate was 1.70-2.80% in 2021 but has increased to 2.70-6.3% in 2022. Its interest rate for last year and Q1 this year was 4.20-5.40%. Hanmi Pharm’s expense for interest amount has significantly increased from KRW 16.8 billion in 2021, KRW 28.5 billion in 2022, and KRW 22.6 billion in 2023. In Q1 this year, Hanmi Pharm spent KRW 7.3 billion just for the interest amount. Furthermore, other companies, including Daewoong Pharmaceutical, HK inno.N, Boryung, Dongkook, Ildong Pharmaceutical, Dong-A ST, and JW Pharmaceutical, have been burdened by a high-interest rate of 5-8% for more than two years. Ildong Pharmaceutical has up to 8% of short-term loan interest rate. Changes in loan interest rates of major pharmaceutical companies. Yuhan, GC Pharma, Hanmi, Daewoong Pharmaceutical, HK inno.N, Boryung, Jeil Pharm, JW Pharmaceutical, Ildong Pharmaceutical, and Dong-A ST (source: Financial Supervisory Service). The pharmaceutical companies say that more than two years of accumulating interest burden may lead to a decline in investment. For instance, Samsung Biologics has focused on repaying loans while cutting back on investment. The analysis suggests that this may be due to the company’s larger loan size, but the accumulated burden from the high interest rate may have played a role in part. The company's cash flow statement shows that the cash flow from investment activities decreased in size, from KRW 3.1065 trillion spent in 2022 to KRW 1.5663 trillion spent last year. This indicates that the investment spending decreased by almost half. On the other hand, the cash flow from financing activities amounted to an inflow of KRW 3 trillion in 2022, but it showed an outflow of KRW 635 billion last year. It indicates that while the company borrowed KRW 3 trillion from banks in 2022, it focused on repaying loans last year, resulting in an expenditure of KRW 635 billion. Other pharmaceutical and biotech companies have also been cautious about expanding investments recently. The industry anticipates this trend to persist for some time, partly due to the low probability of interest rate cuts by the Bank of Korea. As a result, the burden on pharmaceutical and biotech companies from high interest rates is expected to be extended.
- Company
- Enhertu gets expanded indications for NSCLC·breast cancer
- by Son, Hyung-Min May 23, 2024 05:49am
- Enhertu (trastuzumab deruxtecan) Daiichi-Sankyo Korea and AstraZeneca Korea announced that Enhertu (trastuzumab deruxtecan) received expanded indication for HER2-low metastatic breat cancer and metastatic non-small cell lung cancer (NSCLC) on May 20. Enhertu is now approved for treating ▲patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have previously undergone systemic therapy in the metastatic setting or relapsed within 6 months of completing adjuvant chemotherapy and hormone receptor-positive (HR+) patients who have received or are unsuitable for endocrine therapy ▲patients with unresectable or metastatic NSCLC with activated HER2 (ERBB2) mutations who have previously received systemic therapy, including platinum-based chemotherapy. The basis for this Enhertu’s expanded indication is DESTINY-Breast04 and DESTINY-Lung02 clinical trials DESTINY-Breast04 clinical trial compared the efficacy and safety of Enhertu and chemotherapy (capecitabine, Gemcitabine Paclitaxel, Nab-paclitaxel) chosen by physicians in 557 patients with unresectable or metastatic HER2-low breast cancer who had previously undergone 1-2 chemotherapy sessions. The trial also demonstarted that the Enhertu treatment group of HR+ cohort had a significant improvement in median progression-free survival (mPFS), with 10.1 months compared to 5.4 months in the control group. Enhertu also reduced the mortality risk by 50% in all patient cohort, including HR+ and HR- patients, compared to the control group. Furthermore, Enhertu demonstrated an anti-tumor response for the second-line treatment of HER2-mutant metastatic NSCLC through the DESTINY-Lung02 study. This study evaluated the efficacy and safety in patients with advanced, unresectable, or metastatic NSCLC who have previously been treated with systemic therapy, including platinum-based chemotherapy, more than once. The clinical results demonstrated that Enhertu had Blinded Independent Central Review (BICR)-assessed confirmed ORR of 49%, complete response (CR) of 1%, and partial response (PR) of 48%. "Enhertu’s expanded indication will provide an opportunity for patients with HER2-mutant lung cancer who had limited treatments options. It also provides HER2-targeting treatment options for over 60% of all breast cancer patients. Enhertu will be a meaningful treatment option for many patients from now," Daiichi Sankyo Korea’s Oncology Business Franchise Head Lee Hyun-ju said. "We are pleased to provide the new treatment option, Enhertu, to patients with HER-2 low metastatic breast cancer and HER2-mutant metastatic NSCLC. We will continue our efforts to improve cancer treatment settings based on our various oncology portfolio," AstraZeneca Korea’s Oncology Business Unit Director Yang Mi-sun said.
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- 'China approves new drugs after completing trials in China'
- by Lee, Tak-Sun May 23, 2024 05:48am
- The Korea-China Bio Innovation Forum is being held in Hangzhou, China, from the 20th to the 22nd, with 25 Korean bio venture companies participating and meeting with more than 50 Chinese biotech and pharmaceutical companies China's drug approval authorities grant first-in-class drug approvals to drugs as soon as their multi-regional clinical trials (MRCTs) in China are complete, regardless of whether they are approved by the U.S. Food and Drug Administration (FDA) or other national drug regulatory agencies. Tigermed’s Senior Consultant Jessica Liu responded so to a domestic pharmaceutical company's observation that Korea's Ministry of Food and Drug Safety (MFDS) tends to approve new drugs after referencing the situation of advanced countries, such as whether the U.S. FDA or European EMA approves them. At the Korea-China Bio Innovation Forum hosted by Tigermed and Dream CIS in Xiaoshan, Hangzhou, China, on March 21, Senior Consultant Jessica Liu introduced China's drug approval regulatory policy. According to Liu, China's regulatory authorities have begun working to optimize the new drug IND approval system in 2027. The plan was to shorten the review period for the clinical trial plan from preclinical trials and optimize the review period for new drug approval applications, dividing the required period into 70 days, 130 days, and 200 days according to the approval track for each drug. In particular, China has been operating priority review, breakthrough review, and conditional approval systems for new drugs for which available treatments have been identified that meet the 'unmet medical needs' by targeting serious or life-threatening rare diseases. Korean pharmacuetical and biotech companies attending the forum asked for more details on the Chinese regulatory environment after the presentation. In Korea, first-in-class new drug approvals are granted after the authorities examine the drug’s situation in advanced countries such as the US FDA, and the question of whether the same applies in China attracted the attention of the participants. There were also questions about whether China has an orphan drug designation system like Korea and the United States. Domestic companies want to know if they can take advantage of an incentivized track in the licensing process when introducing treatment for a disease with a very small number of patients into the Chinese market. Jessica Liu, Senior Consultant, Tigermed Liu replied that China approves new drugs based on clinical data regardless of their US FDA approval status. While China does not have an orphan drug designation system, it does have criteria for rare disease drugs and an accelerated approval policy. Liu explained, "In China, a new drug application can be submitted and approved as soon as a large-scale multiregional clinical trial is completed in China without the need for FDA or other country’s drug regulatory authorization. In 2017, the regulations were updated to allow imported drugs to conduct Phase I MRCTs, removing the requirement that drugs need registered overseas trials or enter Phase II or Phase III trials.” Liu added, "Although China does not have an orphan drug designation track like in the US, it has published a list of rare diseases in 2018 and 2023, which currently has 207 rare diseases. Although there is no specific patient count threshold like the orphan drug system, rare disease treatments are subject to accelerated approval in China as well.” Meanwhile, the Korea-China Bio Innovation Forum is part of DreamScience's licensed-out new business program, Dream Science, which invites Korean biotech companies and ventures that want to enter China to China for partnership and networking meetings with Chinese pharmaceutical and biotech companies. From the 20th to the 22nd, 25 domestic bio venture companies will participate in the forum and meet with more than 50 local biotech and pharmaceutical companies in China, and will return with information and business information necessary for their expansion into China.
- Company
- Clinical trial failures…novel PD drugs face challenges
- by Son, Hyung-Min May 23, 2024 05:48am
- Novel candidates for Parkinson’s disease that have gathered the industry’s attention are repeatedly failing to prove effectiveness in clinical trials. Bukwang Pharmaceutical was developing novel drugs for Parkinson’s disease but failed to prove its efficacy in Europe phase 2 clinical trials. D&D Pharmatech and Peptron also failed in phase 2 clinical trials. U.S. Amneal Pharmaceuticals and AbbVie also faced hurdles from the U.S. FDA. Despite of these circumstances, pharmaceutical companies continue to develop novel drugs for Parkinson’s disease and work to turn around failing history. Contera Pharma, Bukwang Pharmaceutical’s subsidiary According to industry sources on the 22nd, Denmark’s Contera Pharma, Bukwang Pharmaceutical’s subsidiary, announced that the phase 2 trial to confirm the efficacy of JM-010, a novel candidate for Parkinson’s disease, failed to meet the primary endpoint. Contera Pharma specializes in developing neurological disease treatments and was acquired by Bukwang Pharmaceutical in 2014. JM-010 targets Parkinson’s disease’s dyskinesia treatment. It has been developed to lessen involuntary movements of arms, legs, and face in Parkinson’s disease patients. This clinical trial, named Astoria, evaluated the efficacy and safety of JM-010 by administering either JM-010 or placebo in patients with Parkinson’s disease experiencing dyskinesia. The study was conducted at 38 clinical sites across Europe and Asia, including Germany, France, Italy, Spain, Slovakia, and South Korea, and involved 38 patients with Parkinson's disease. The clinical trial included patients who experienced dyskinesia as a side effect of levodopa, which is approved for the treatment of Parkinson's disease. The primary endpoint was the result of dyskinesia reduction, which was evaluated by the Unified Dyskinesia Rating Scale (UDysRS) at 12 weeks. The clinical results demonstrated that the total scores of UDysRS in the low-dose and high-dose groups of JM-010 were reduced by 0.3 points and 4.2 points, respectively, but the values were not statistically significant. For the safety profile, two doses of JM-010 have shown good tolerability, and no adverse reactions have been found in the clinical trial. Contera Pharma is also conducting additional analysis of Astoria’s complete clinical data, including secondary endpoints. The company will disclose the complete clinical results at a major conference. D&D Pharmatech·Peptron fail at phase 2 trials…AbbVie rejected by FDA Clinical trials for Parkinson's disease treatment have failed before. Korean biotech ventures like D&D Pharmatech and Peptron have also experienced challenges in proving efficacy in clinical trials. D&D Pharmatech's NLY01, a glucagon-like peptide-1 (GLP-1) agonist mechanism, failed to demonstrate efficacy in a phase 2 clinical trial in 2020. After 36 weeks of administration, it did not show statistically significant improvement in symptom alleviation compared to the placebo group which was set as the primary endpoint parameter. In detail, at 24 weeks of administration, a significant difference was found between the NLY01 treatment group and the placebo group. However, between 24-36 weeks, the placebo group’s symptoms showed more improvements than those of the NLY01 group. Peptron also failed to secure the efficacy of ‘PT320,’ a Parkinson’s disease candidate drug, in a phase 2 trial in South Korea, which was disclosed in 2022. The PT320 2.0 mg group’s UPDRS part 3 score, which evaluated Parkinson’s disease movement symptoms and was used as the primary endpoint, was not different from the placebo group’s. The PT320 2.5㎎ treatment group showed symptom improvements but failed to demonstrate statistical significance. AbbVie failed to receive FDA approval last year. ABBV-951, under development by AbbVie, has shown significant improvement in the onset time of efficacy compared to Duodopa (active ingredients: carbidopa·levodopa) used as a treatment for Parkinson's disease in phase 3 clinical trials, without exhibiting persistent dyskinesia. When taken once daily, this medication's effects can last 24 hours. However, the FDA has requested further clarification on using the adjunctive exercise device with ABBV-951 and has thus rejected approval. Novel drugs for Parkinson’s disease have failed multiple times in the past…development continues Despite past failures, global pharmaceutical and pharmaceutical and biotech companies in South Korea continue to conduct clinical trials. Amneal Pharmaceuticals’s IPX203 is an oral formulation of levodopa and carbidopa extended-release capsules. Levodopa addresses dopamine shortage, which has been pointed out as the primary cause of Parkinson’s disease. Carbidopa is used as a combination therapy because it can inhibit the conversion of levodopa to dopamine in peripheral nerves. Last year, the FDA found scientific evidence of levodopa’s safety based on pharmacokinetics research last year. However, the FDA requested additional information on Carbidopa due to inadequate proof. The company plans to develop IPX203, which offers longer treatment effects with a lower dose than the conventional formulation. AbbVie plans to receive approval through an additional novel drug candidate in addition to ABB-951. AbbVie is conducting a phase 3 trial through Cerevel Therapeutics, which recently disclosed the top-line results of Tavapadon’s phase 3 trials. Tavapadon is a novel drug candidate for Parkinson’s disease. It is designed as a dopamine D1/D5 receptor partial agonist taken orally once daily to balance motor control activity and drug efficacy. The clinical trial evaluated the efficacy and safety of Tavapadon as a levodopa adjuvant therapy in 507 Parkinson’s patients. Clinical results showed that during the 27-week trial period, the Tavapadon treatment group had a longer duration of Parkinson’s disease remission than the placebo group. AbbVie plans to share additional data from monotherapy trials of TEMPO-1 and TEMPO-2 by the end of this year. The novel drug development for Parkinson's disease continues in the pharmaceutical and biotech industry in South Korea. S.Biomedics is working on stem cell therapy TED-A9, Mthera Pharma is developing the natural drug MT-101, and Kainos Medicine is targeting the Fas Associated Factor 1 (FAF1) protein with KM-819. Additionally, ABL Bio is working on a dual antibody, ABL-301. Pipelines of pharmaceutical and biotech industry in Korea: Bukwang Pharmaceutical, S.Biomedics, Mthera Pharma, Kainos Medicine, ABL Bio, Hanall Biopharma, and Ildong Pharmaceutical.
- Company
- Leclaza’s sales soar with reimbursement expansion
- by Chon, Seung-Hyun May 23, 2024 05:48am
- The sales of Yuhan Corp’s new anti-cancer drug 'Leclaza' have jumped significantly. Sales have more than tripled in one year since the drug has been granted reimbursement as a first-line treatment for lung cancer this year. Leclaza’s sales quickly reached the KRW 20 billion mark in quarterly sales, paving the way for the drug to achieve the KRW 100 billion mark in annual sales. According to the drug research institution IQVIA on Wednesday, Leclaza reported sales of KRW 18.9 billion in Q1, up 269.9% from the KRW 5.1 billion in Q1 last year. Leclaza’s first-quarter sales more than tripled from the previous quarter. Quarterly Leclaza sales (Unit: KRW 100 million, Source: IQVIA) Leclaza is a treatment for non-small cell lung cancer that was approved in January 2021 as the 31st new drug developed in Korea. It entered the prescription market in July 2021 with its reimbursement listing. Leclaza’s quarterly sales last year were in the KRW 5 billion to 6 billion range, but its sales have more than tripled this year. The surge in prescriptions is likely due to Leclaza’s reimbursement expansion as a first-line treatment. Leclaza was first approved as a second-line treatment for patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) who developed a resistance to a specific gene (T790M) after being previously treated with 1st generation or 2nd generation EGFR-TKIs. In June last year, the Ministry of Food and Drug Safety approved Leclaza’s indication expansion to ‘first-line treatment of NSCLC.’ Yuhan Corp applied for the reimbursement of Leclaza as a first-line treatment to health authorities in Korea, and the Ministry of Health and Welfare approved its reimbursement expansion to first-line treatment last month. Starting this year, Leclaza will be reimbursed by health insurance as a ‘first-line treatment of locally advanced or metastatic NSCLC with certain gene mutations.’ The Ministry of Health and Welfare analyzed that Leclaza’s first-line reimbursement will cost the country an additional KRW 88.1 billion. Combined with Leclaza’s Q1 sales and the reimbursement expansion, this means that Leclaza’s sales could exceed 100 billion won this year. Leclaza is the first homegrown drug to exceed KRW 10 billion in quarterly sales. Other homegrown new anticancer drugs that were approved before Leclaza include Il-Yang Pharmaceuticals’ Supect, Dongwha Pharm’s Milican, Chong Kun Dang’s Camtobell, Sam Sung Pharmaceutical’s Riavax, Hanmi Pharmaceutical’s Olita. None of the products posted annual sales that exceeded KRW 10 billion. Sales of Leclaza surged in Q1 this year, bringing its cumulative sales since its launch up to KRW 61.7 billion. Leclaza is also on track to enter the U.S. market. Late last year, Johnson & Johnson (J&J) submitted an Investigational New Drug (IND) application and a supplemental biologics license application to the U.S. Food and Drug Administration (FDA) for a combination of its EGFR-positive non-small cell lung cancer drug Rybrevant and Leclaza. In November 2018, Yuhan Corp licensed out its technology for Leclaza to Janssen Biotech for a non-refundable upfront payment of USD 50 million. Johnson & Johnson's application is based on the results of the Phase III MARIPOSA trial, which evaluated the efficacy of the combination of Rybrevant plus Leclaza. The interim analysis data from the trial were presented at the European Society for Medical Oncology Annual Congress (ESMO Congress 2023) in October. Trial results showed that the combination of Rybrevant plus Leclaza improved progression-free survival (PFS), the primary endpoint, compared to Tagrisso (osimertinib) alone. Median PFS was 23.7 months for the Rybrevant plus Leclaza combination arm versus 16.6 months for Tagrisso alone. The Rybrevant plus Leclaza combination was associated with a 30% lower risk of disease progression and death compared with Tagrisso alone.
- Company
- Oral renal anemia drug meets reimb listing terms
- by Nho, Byung Chul May 22, 2024 05:47am
- Mitsubishi Tanabe Pharma and JW Pharmaceutical have filed an application to the Health Insurance Review and Assessment Service (HIRA) for drug pricing of licensed renal anemia drugs, Vadanem and Enaroy. An application for drug pricing has been filed for two items of renal anemia drugs that are equivalent in efficacy to conventional EPO injections but cost much less. New treatment options are expected to become available. According to industry sources, Mitsubishi Tanabe Pharma and JW Pharmaceutical have filed an application to the Health Insurance Review and Assessment Service (HIRA) for drug pricing of licensed renal anemia drugs, Vadanem and Enaroy. The insurance pricing of these drugs is about KRW 1.2 million, which is about KRW 300,000-500,000 lower annually than EPO injections. It is expected to significantly save the finances of the National Health Insurance. Furthermore, the efficacy of these drugs demonstrated equivalence (non-inferiority) to a comparator drug through clinical trials. The adverse reactions are similar to or less than those of the existing drugs. It is considered to be the new treatment option. If these two drugs were to secure indications for nondialysis patients, it was expected that they would quickly gain market share due to the improvements in administration convenience compared to injectables. However, it is a disappointing that they were only approved for indications for dialysis patients. However, for over the past 30 years, the market has been virtually monopolized by three first-generation erythropoiesis-stimulating agents (ESAs), which are Epoetin alfa, Darbepoetin alfa, and Methoxy polyethylene glycol, and epoetin beta. These have seen annual growth rates exceeding 10%. Consequently, the introduction of an oral formulation is seen as a response to the demands of the current era. Under these circumstances, AstraZeneca voluntarily withdrew its Evrenzo Tab (roxadustat), approved by the Ministry of Food and Drug Safety (MFDS) in 2021, due to various complications, including drug pricing issues. Anemia is caused by decreased kidney function and EPO production capacity, followed by lowered hematopoiesis. Renal anemia is accompanied by oxygen depletion due to decreased red blood cells, and it is commonly accompanied by in tiredness, decreased appetite, insomnia, and depression. It reduces the quality of life and impacts the mortality rate of patients. There are over 700 million patients with chronic renal kidney disease worldwide, and 1 out of 7 patients experience anemic symptoms. The remaining available drugs are Enaroy Tab (Enarodustat) and Vadanem Tab (vadadustat), which were approved in Korea in 2022 and 2023, respectively. If these drugs fail to be listed for reimbursement, Korean patients who suffer from renal anemia and doctors will permanently have no options for oral treatments. Considering that these drugs are priced 30% less than injectable formulations and have improved convenience of administration, with equivalent effectiveness, it would be a major loss as a nation. According to the National Health Insurance Service (NHIS) data, the number of patients with chronic kidney disease in Korea increased 36.9%, from 206,061 patients in 2017 to 282,169 patients in 2021. The increase was particularly steep in patients in their 80s, up 82.8%. Dialysis patients are also on the rise exponentially. Listing of competitive and new drugs may be justified as the National Health Insurance finance spent on approximately 100,000 patients amounts to KRW 3 trillion. “We expect the progress will be made soon because the initiation of negotiations related to listing was centered on whether Mitsubishi Tanabe Pharma’s Vadanem will be granted U.S. FDA approval and the direction of insurance pricing of the drug in European regions,” an industry expert said. Vadanem received FDA approval in March and is expected to receive a pricing decision in Europe between May and June. In August last year, Vadanem made a second attempt for the U.S. FDA approval for indication in 'anemia treatment (hemodialysis plus peritoneal dialysis) in adult patients with chronic kidney disease under hemodialysis,' and the FDA granted approval based on the absence of safety issues. Vadanem and Enaroy are hypoxia-inducible factor (HIF) prolyl hydroxylase (PH) enzyme (HIF-PH) inhibitors. These inhibitors have mechanisms of improving hemoglobin levels by activating 'erythropoietin (EPO)' and reducing 'hepcidin,' a hormone responsible for iron metabolism. Meanwhile, the EPO formulation, developed 30 years ago, is the only available treatment for renal anemia. Third generation injectables with extended intervals of administration have been launched recently. However, many patients do not respond to these treatments, experience changes in blood pressure, and have adverse reactions, such as nausea and vomiting. Thefore, there is a need for treatments with new mechanism.
- Company
- MSD applies for Welireg’s reimbursement in Korea
- by Eo, Yun-Ho May 22, 2024 05:47am
- The rare anti-cancer drug ‘Welireg’is seeking insurance coverage in Korea. According to industry sources, MSD Korea recently submitted an application for the reimbursement of its oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor Welireg (belzutifan). The drug is beginning its reimbursement voyage a year after its approval in Korea. Welireg was designated an orphan drug in Korea for the treatment of Von Hippel-Lindau disease in January last year, then formally approved in May of the same year. Specifically, the drug is indicated for the treatment of adult patients with VHL disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. As a HIF-2α inhibitor, Welireg reduces transcription and expression of HIF-2α target genes associated with cellular proliferation, angiogenesis, and tumor growth. The drug’s efficacy was demonstrated in the open-label Study 004 trial, which investigated 61 patients with VHL-associated RCC who were diagnosed with at least one measurable solid tumor localized to the kidney. Patients enrolled in the trial had other VHL-associated tumors including CNS hemangioblastomas and pNET. The major efficacy endpoint of the clinical trial was the overall response rate (ORR) in patients with VHL-associated RCC as measured by radiology assessment using RECIST v1.1 as assessed by an independent review committee (IRC). Additional efficacy endpoints included duration of response (DoR) and time to response (TTR). In the study, Welireg showed an ORR of 49% in patients with VHL-associated RCC. All responses were partial responses. The median DoR had not yet been reached, and the DoR among responders who were still responding after at least 12 months was 56%. Median TTR was 8 months. Also, in patients with VHL-associated CNS hemangioblastomas, Welireg showed an ORR of 63%, with a complete response rate of 4% and a partial response rate of 58%. Recently, Welireg was additionally approved for a kidney cancer indication in the US. Its efficacy for the indication was confirmed in LITESPARK-005, a trial conducted on patients with unresectable locally advanced or metastatic clear cell renal cell carcinoma (RCC) that had progressed following both a PD-1 or PD-L1 checkpoint inhibitor and a VEGF-TKI. Results showed that Welireg improved progression-free survival (PFS) and reduced the risk of disease progression or death by 25% compared to everolimus in patients with advanced renal cell carcinoma who received a PD-1 or PD-L1 immune checkpoint inhibitor and a VEGF receptor-targeted therapy, either sequentially or in combination. Although it is yet to be reimbursed, Welireg is being approved and prescribed at various medical institutions in Korea, passing drug committee reviews at the National Cancer Center, Samsung Medical Center, and Asan Medical Center. The first prescription was issued at Samsung Medical Center in December last year.
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- FDA approves Samsung and Biocon’s Eylea biosimilars
- by Son, Hyung-Min May 22, 2024 05:47am
- Samsung Bioepis’s Opuviz became the first Eylea biosimilar to be approved in the US. In particular, due to its interchangeability designation, Opuviz can be administered interchangeably with Eylea, increasing its chances of gaining an advantage in the market over its competitors. According to KoreaBIO on the 21st, the US FDA approved Samsung Bioepis’s Opuviz and the Indian Biocon Biologics's Yesafili as interchangeable biosimilars that can substitute the original macular degeneration treatment Eylea. The approval will allow pharmacies in the US to make substitutions of Eylea at the pharmacy level without an additional physician’s prescription. The FDA began designating interchangeable biosimilars in July 2021. This was the FDA's recognition that a biosimilar can be prescribed to any patient and produce the same clinical outcomes as the original drug. Unlike generic drugs, which must demonstrate bioequivalence, biosimilars demonstrate biosimilarity at the time of approval. This is because the cells used in manufacturing, the manufacturing process, among others cannot be the same as the original drug. As a result, ensuring interchangeability is considered a key to expanding sales. In fact, in the Humira biosimilar market, Samsung Bioepis and Celltrion, in addition to Boehringer Ingelheim and Pfizer, are conducting Phase IV clinical trials to confirm the possibility of its biosimilar’s interchangeability. #SBBiosimilars and new drugs heat up market competition#EB #I2The competition in the macular degeneration treatment market is expected to intensify with the entry of Eylea biosimilars. Currently, not only Samsung Bioepis and Biocon, but also later entrants such as Sam Chun Dang Pharm and Celltrion have jumped into biosimilar development. Eylea is a vascular endothelial growth factor-A (VEGF-A) inhibitor for macular degeneration that was developed by Bayer and Regeneron. The drug, which remains a strong market leader since its approval, generated global sales of USD 9.148 billion (KRW 12.58 trillion) last year. It works by inhibiting vascular endothelial growth factor (VEGF) to prevent abnormal blood vessel growth in the eye. By blocking VEGF, Eylea can help slow or reduce retinal damage and preserve vision. Eylea has an advantage in terms of dosing interval over its competitors. Eylea can be dosed every 2 months compared to Novartis' Lucentis (once a month), demonstrating its longer duration of effect. Eylea was also shown to be superior to Lucentis in diabetic macular degeneration, which results in a severe form of vision loss. In preparation for the inflow of Eylea biosimilars, Bayer and Regeneron developed a high-dose version of Eylea to defend the market. Their plan was to launch a higher-dose formulation and further increase dosing intervals. Bayer and Regeneron are aiming to get approval for Eylea high-dose for all of the indications they have secured, including diabetic macular edema, age-related macular degeneration, and retinal vein occlusion. The variable is Roche’s Vabysmo, which emerged as a formidable competitor to Eylea. Vabysmo is a macular degeneration treatment that was developed by Roche. The drug not only inhibits VEGF but also blocks the angiopoietin-2 (Ang-2) pathway to inhibit neovascularization. Blocking both pathways independently has been shown to be more effective than blocking VEGF alone in reducing inflammation, leakage, and abnormal blood vessel growth. Vabysmo improved visual acuity at a level non-inferior to that of Eylea in the TENAYA and LUCERNE trials that compared its safety and efficacy with Eylea. Its duration of response lasted 24 months. In other words, Vabysmo achieved comparable efficacy to other treatments with once every 4 months dosing compared to the once every 1-2 month dosing required for other treatments.
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- FDA approval delayed and retry…what’s 'Rivoceranib'?
- by Son, Hyung-Min May 21, 2024 05:56am
- HLB’s rivoceranib, which was expected to be an FDA-approved new drug candidate, failed to receive final approval. Although HLB confirmed that Rivoceranib combined with immunotherapy camrelizumab extended overall survival in the first-line treatment for liver cancer, they received request for supplementary documents. The current request for supplementation is not related to the drug’s effectiveness but rather to an issue concerning the monitoring of Jiangsu Hengrui Pharmaceuticals’ Chemistry, Manufacturing and Controls (CMC) process. Therefore, HLB plans to cooperate and reapply for approval soon. HLB announced on the 17th that they received a complete response letter (CRL) request from the US FDA regarding the application for Rivoceranib plus camrelizumab combination therapy as the first-line treatment for liver cancer. HLB aims to work on the supplementary documentation and reapply for approval promptly. FDA must notify the approval state within the 6 months of receiving a developer’s CRL. “We cannot be certain, but there were some points during the CMC monitoring process of Jiangsu Hengrui Pharmaceuticals. In response to the request, we provided supplementary documents, but it seems our reply may not have been adequate,” HLB Chairman Jin Yang-gon said. “In my opinion, Jiangsu Hengrui Pharmaceuticals, which owns 17 pharmaceutical items, can solve any problem,” He added. “We will closely cooperate with Jiangsu Hengrui Pharmaceuticals and will try to get FDA approval soon. We will also speed up for global phase 3 clinical trials for the next indication.” Rivoceranib, acquired from Bukwang Pharm, closer to be a new FDA-approved drug Rivoceranib is an oral anticancer drug that selectively inhibits vascular endothelial growth factor receptor-2 (VEGFR2), which is involved in angiogenesis. The development of Rivoceranib started after Elevar Therapeutics of the US acquired global licensing rights of the drug from Advenchen Laboratories. Bukwang Pharm recognized Rivoceranib’s potential and secured licensing rights of Korea, Europe, and Japan from Elevar Therapeutics in 2009. Subsequently, HLB paid KRW 40 billion to acquire Rivoceranib’s development right from Bukwang Pharm in 2018. Then, HLB incorporated Elevar Therapeutics as its subsidiary and secured Rivoceranib’s global rights, excluding China. HLB also acquired the substance patent of Rivoceranib and made it its asset. HLB and Jiangsu Hengrui Pharmaceuticals have been developing Rivoceranib plus camrelizumab combination therapy for the treatment of liver cancer and stomach cancer. Jiangsu Hengrui Pharmaceuticals’ camrelizumab inhibits PD-1 protein expressed on the surface of immune cells (T cells), preventing the binding to PD-L1 receptors on cancer cell surfaces, thereby activating immune cells. HLB obtained positive results for the combination therapy in the first-line treatment of liver cancer and submitted a New Drug Application (NDA) to the FDA in May last year. The approval was based on the results of the CARES-310 Phase 3 trials, disclosed at 2022 ESMO by HLB and Jiangsu Hengrui Pharmaceuticals. The clinical trials compared the efficacy and safety of Rivoceranib plus camrelizumab to Bayer’s Nexabar, which is used as a standard therapy for liver cancer. In clinical trials, Rivoceranib plus camrelizumab recorded a median overall survival (OS) of 22.1 months, demonstrating an improvement compared to Nexabar’s 15.4 months. This result was more extended than the OS of 19.2 months recorded by Roche’s combination therapy of Tecentriq, an immunotherapy for cancer, plus Avastin, a targeted anticancer agent. Furthermore, it is also extended than the OS of 16.4 months of AstraZeneca’s Imfinzi plus Imjudo combination therapy. These drugs were compared with Nexabar alone. Furthermore, Rivoceranib plus camrelizumab secured statistical significance, with a progression-free survival (PFS) of 5.6 months and an overall response rate (ORR) of 33.1%. Currently, HLB and Jiangsu Hengrui Pharmaceuticals are also conducting clinical trials of the drug for stomach cancer, in addition to liver cancer. At the 2023 ESMO of last year, Jiangsu Hengrui Pharmaceuticals disclosed the DRAGON IV Phase 3 clinical trial’s first interim results of triple combination therapy of Rivoceranib plus camrelizumab plus chemotherapy in localized, resectable stomach or gastroesophageal adenocarcinoma. The clinical results have shown that the combination therapy recorded a pathophysiological complete remission rate of 18.3%, which is an improvement compared to the chemotherapy group’s 13.7%.
