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- 2025-12-23 07:50:53
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- 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.
- Company
- Dong-A and Pfizer win Industry Ad-PR Awards
- by Kim, Jin-Gu Dec 07, 2023 05:47am
- Dong-A Pharmaceutical's ‘Bacchus’ and Pfizer Korea's 'Green Move Campaign' won the grand award in the advertising and PR categories of the 2023 Korea Pharmaceutical and Bio-Industry Advertising and PR Awards. On the 6th, Dailypharm (CEO: Jeong Seok Lee) held the ‘2023 Korea Pharmaceutical and Bio-Industry Advertising and PR Awards Ceremony’ at the K-room of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association heqdquarters. Now celebrating its 11th year, the competition for the award had been stronger than ever, with 77 entries from 39 pharmaceutical companies. The awards were divided into advertising and PR categories. In the advertising category, 1 grand prize, 1 best excellence prize, and 1-3 excellence prizes were given in each of the 3 areas: ▲TV-CF, ▲print-radio, and ▲Internet-SNS. In the PR category, one grand prize, 1 best excellence prize, and 2 excellence prizes were awarded given in 2 areas: ▲social contribution and disease promotion campaigns, and ▲corporate and product promotion. Dong-A Pharmaceutical's ‘Bacchus’ seized the grand prize in the advertisement category. Among the 49 entries that were made in the category, Dong-A’s advertisement received the highest scores for message clarity, novelty, and consumer trust. The grand prize awardee received a trophy and a cash prize of KRW 5 million. Sang-Hyun Han, Advertisement Team Lead at Dong-A Pharmaceutical, said, “This year marks the 60th anniversary of Bacchus’s launch. We prepared an ad that looked back on the past 60 years of Korea with Bacchus and is pleased that our ad received good reviews as a result.” Han said, “We plan to release a more youthful and dynamic ad next year that celebrates Bacchus’s 60 years to come. We are planning an innovative and fresh advertisement that can lift the public's fatigue like our product.” In the TV-CF field, Dong Wha Pharm’s ‘Pancol’ received the best excellence prize, and was awarded a trophy and a cash prize of KRW 3 million. Boryung Consumer Healthcare’s ‘Younggaksan Cool,’ Johnson & Johnson Korea’s ‘Tylenol,’ and Samjin Pharm’s ‘Anjung Sol’ received excellence prizes and a cash prize of KRW 2 million. In the Internet and SNS field, Yuhan Corp’s ‘Contac Gold’ received the best excellence prize. Ahn-gook Pharm’s ‘Tobicom’ and Daewon Pharm’s ‘Newbein’ received excellence prizes. In the Print-Radio field, Daewoong Pharmaceuticals ‘Impactamin’ received the best excellence prize, and Kukje Pharm’s ‘Company PR ad’ received the excellence prize. In the PR category, 28 entries on the company’s CSR activities and company promotion were submitted by companies. Among the 28, Pfizer won the grand prize in the PR category with its ‘Green Move Campaign.’ As the grand prize awardee, Pfizer received a trophy and a cash prize of KRW 5 million. Oh Hye-min, Policy & Public Affairs Lead at Pfizer Korea, said, “Corporate ESG activities are no longer an option – it is an obligation. As our company is already engaged in various ESG activities at the headquarters level, we decided to start the Green Move campaign after long discussions on what Pfizer Korea could additionally provide to society. We want to make it a mid-to-long-term project rather than just a one-time event. We look forward to your interest." In the CSR and disease awareness campaign, area Sinsin Pharm’s ‘Shinshin H2O Life’ won the best excellence prize. The runners-up were Withus Pharmaceutical's ‘Sponsorship of the Korea Ssireum Association’ and Korea United Pharm’s ‘Global Talent Development Program.’ In Company PR and product promotion area, Hanmi Pharm’s ‘50th Anniversary History Discovery Campaign’ won the best excellence prize, while Geo-Young’s " Zyrtec 10mg for Allergic Rhinitis" and Boehringer Ingelheim's ‘Trajenta’ received excellence prizes. Dae-Chun Ahn, former president of the Korea Advertising Society (Inha University) served as the head of the judging panel for this year’s event, and Jae-Hoon Cheong, professor of Pharmacy at Sahmyook University, and Jae-Kook Lee, executive director of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association served as expert judges. Ahn said, "In the Advertising category, the judges focused on the delivery and clarity of the theme and message, how novel and original the ideas and expressions were, and how credible the message was beneficial to the consumers’ public interests." He added, "In the corporate PR category, we focused on how timely the message was from a long-term perspective and how it contributed to the consumers’ public interest. For CSR activities, an area that was newly introduced this year, we focused on the authenticity of the message, the degree of reflection into society, and the continuity and consistency of the campaign activities." The Korea Pharma & Bio Industry Advertising-PR Award was launched in 2013 to encourage advertisers to add new value to the pharmaceutical industry and drugs, and to encourage the creation of advertisements that resonate with pharmacists, the primary consumers of pharmaceutical advertisements." Jeong Seok Lee, CEO of Dailypharm, said, "I would like to congratulate the 17 pharmaceutical company officials that won today's awards. The awards are one recognition of the hard promoting and marketing work and efforts companies made throughout the year. We look forward to seeing more great work next year."
- Company
- Jemperli becomes 1st immunotherapy for endometrial cancer
- by Eo, Yun-Ho Dec 06, 2023 06:00am
- The first reimbursed immunotherapy option has been introduced to the field of endometrial cancer in Korea. According to industry sources, GSK Korea’s PD-1 inhibitor Jemperli (dostarlimab) has been listed for reimbursement in Korea from December 1st. Since receiving marketing authorization from the Ministry of Food and Drug Safety in December last year, the company moved relatively quickly through the reimbursement process, passing HIRA’s Drug Reimbursement Evaluation Committee deliberation in August, and recently completed drug price negotiations with the NHIS and received approval from the Health Insurance Policy Review Committee. GSK has been carrying out an Expanded Access Program (EAP) in 15 major medical institutions in Korea even before filing for reimbursement to provide access to patients in need of treatment for endometrial cancer. The program has now been closed and Jemperli is being reimbursed through the NHIS as of this month. Jemperli’s approval was based on the cohort A1 analysis results of the Phase I multicohort GARNET trial that demonstrated the efficacy of Jemperli in a cohort of patients with relapsed or advanced dMMR/MSI-H endometrial cancer who progressed on or following prior treatment with a platinum-containing regimen. In particular, this study had the largest cohort among PD-1 inhibitor monotherapy studies for dMMR/MSI-H endometrial cancer patients among those that have been conducted so far. The major efficacy outcome measures of the study were Objective Response Rate (ORR) and Duration Of Response (DOR) as determined by a Blinded Independent Central Review (BICR) according to (Response Evaluation Criteria Solid Tumors) RECIST v 1.1. As a result of analyzing a total of 108 patients with a median follow-up of 16.3 months, Jemperli demonstrated durable antitumor activity with a manageable safety profile. In the cohort, the ORR was 43.5% (95% CI, 34.0-53.4) and the median DOR was not yet reached. Disease Control Rate (DCR) was 55.6%, and the proportions of responses lasting 6 and 12 months were 97.9% and 90.9%, respectively. Endometrial cancer develops in the endometrium, the inner lining of the uterus, and accounts for the majority of cervical cancer. Roughly, 1 out of 4 endometrial cancer patients are diagnosed to be in the advanced stage or experience recurrence, and patients whose disease recurs after platinum-based chemotherapy have limited treatment options.
- Company
- Erleada chases leader Xtandi in prostate cancer mkt
- by Kim, Jin-Gu Dec 06, 2023 06:00am
- Pic of Astella Astellas Pharm Korea ‘Xtandi (enzalutamide)’ took the lead among oral androgen receptor targeted agents (ARTAs) used to treat prostate cancer. In comparison to declining sales of Janssen's ‘Zytiga (Abiraterone),’ sales of Janssen's other prostate cancer drug ‘Erleada (Apalutamide)’ has been rapidly increasing since being released just 6 months ago, chasing Xtandi in the market. Xtandi's Q3 sales KRW 11.7 billion…top among ARTAs for prostate cancer The ARTA-type prostate cancer treatment, Xtandi, posted KRW 11.7 billion in sales in Q3. According to IQVIA, a pharmaceutical industry research institute, this represents a 53% increase from the KRW 7.6 billion it had raised in the same quarter last year. Xtandi is approved for ▲the treatment of asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC), ▲mCRPC previously treated with docetaxel, ▲high-risk non-metastatic castration-resistant prostate cancer, and ▲hormone-sensitive metastatic prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT). It was approved in Korea in June 2013 and received reimbursement in November following year. Recently, Xtandi's sales have increased sharply, especially since Q3 last year. Previously, its sales ranged around KRW 6 billion, but this significantly increased to KRW 7.6 billion in Q3 last year, then to KRW 8.7 billion in tQ4, KRW 10.5 billion in Q1 this year, and KRW 11 billion in Q2. The increase in sales last year is attributed to the expanded reimbursement. In August, selective reimbursement was granted for the use of ADT as combination therapy for patients with progressive prostate cancer accompanied by distant metastasis. Starting this November, reimbursement for ADTs were extended and is applied regardless of the use of other androgen-production-suppressing drugs. Despite a 3% reduction in the insurance price due to its increased usage, its increase in prescriptions is said to have offset this decrease. Quarterly sales of major ARTA prostate cancer treatments (Unit: KRW 100 mil, Data: IQVIA) Zytiga sales 'slow down'...Erleada sales reach KRW 4.8 billion in only half a year ' Zytiga, a previous competitor of Xtandi, has recently shown a decline in sales. Zytiga's sales in the last quarter were KRW 4.8 billion, a 14% decrease from KRW 5.6 billion of the previous year. Since 2021, Zytiga had closely chased Xtandi in terms of sales. In Q1 2021, sales of Xtandi and Zytiga were KRW 7.6 billion and KRW 2.9 billion, respectively, which is a 2.7 times difference. By Q1 2022, this gap narrowed to 1.2 times, with sales reaching KRW 6.4 billion for Xtandi and KRW 5.2 billion for Zytiga. The sales difference between the 2 drugs further decreased to less than KRW 1 billion in Q2 that year. However, Zytiga's sales have continued to remain in the range of KRW 5 billion since then. Meanwhile, Xtandi's sales increased rapidly. From Q2 his year, the sales difference between the two drugs doubled. Pic of JanssenJanssen's new ATRA-type prostate cancer treatment, Erleada, has rapidly increased its sales since its introduction. In December 2020, Erleada was approved as Janssen's third ATRA prostate cancer therapy. It was added to the reimbursement listing in April this year. Following the listing, Erleada generated sales of KRW 2.7 billion in the second quarter and increased to KRW 4.8 billion in the third quarter, marginally surpassing the sales of Zytiga. Therefore, Janssen plans to focus on Erleada as a latecomer follow-on drugs to Zytiga, aiming to challenge the market leader Xtandi. The market stirrer would be the change in the patient co-payment rates for Xtandi and Zytiga, and the generics development by domestic pharmaceutical companies. Last month, the co-payment rates for Xtandi and Zytiga were adjusted from 30% to 5%. This change occurred following the listing of Erleada, the third ARTA prostate cancer therapy, at a 5% co-payment rate. The maximum reimbursement amount (listed price) for Xtandi was adjusted in the process. Xtandi was registered as a subject to essential reimbursement through a risk-sharing agreement (RSA). With expanded reimbursement, the listed price per tablet was reduced from KRW 28,820 to KRW 14,170. This will be reflected after the fourth quarter of this year. The release of a Zytiga generic by a domestic pharmaceutical company is also anticipated to significantly influence the competitive ground. Hanmi Pharm launched Abiraterone, a generic of Zytiga, under reimbursement in October. As a result, the price of Zytiga was reduced by 30%, from KRW 16,780 to KRW 11,746 per tablet. This price reduction is expected to be reflected in sales after the fourth quarter of this year, potentially resulting steeper decline in Zytiga's sales.
- Company
- AbbVie Korea strengthens its autoimmune disease pipeline
- by Eo, Yun-Ho Dec 05, 2023 05:48am
- AbbVie Korea is actively working to advance its position in the field of autoimmune diseases. According to industry sources, AbbVie Korea successfully expanded the indications for its Interleukin-23(IL-23) inhibitor 'SKYRIZI (Risankizumab)’ and JAK inhibitor ‘RINVOQ (Upadacitinib).’ On November 15th, an indication was added for SKYRIZI to treat adult patients with moderately to severely active Crohn's disease who had responded inadequately or were intolerant to biologic therapy and/or existing therapies. The approval was based on a multicenter, randomized, double-blind, placebo-controlled Phase III trial that demonstrated the efficacy, safety, and tolerability of SKYRIZI in adult patients with moderate-to-severe active Crohn’s disease. In the ADVANCE and MOTIVATE induction trials, 1,419 patients were randomly assigned to receive 6000 mg intravenously, 1,200 mg intravenously, or placebo at week 0, week 4, and week 8. Clinical remissions and endoscopic responses were measured by stool frequency (SF) and abdominal pain score (APS) at 12 weeks. The FORTIFY trial evaluated 462 patients who showed clinical response to 12 weeks of intravenous induction therapy in the ADVANCE and MOTIVATE trials. Patients were randomly assigned to receive either subcutaneous risankizumab 180 mg, subcutaneous risankizumab 360 mg, or withdrawal from risankizumab to receive subcutaneous placebo every 8 weeks for up to 52 weeks. The primary endpoints were clinical remission and endoscopic response at week 52. SKYRIZI is currently approved and reimbursed in Korea to treat moderate-to-severe plaque psoriasis in adults who are candidates for phototherapy and systemic therapy (including biologic treatment), as well as to treat active psoriatic arthritis in adults who are non-responsive to DMARDs (disease-modifying anti-rheumatic drug). As for RINVOQ, its reimbursement has been expanded to the treatment of severe active ankylosing spondylitis from December. Accordingly, patients with severe active ankylosing spondylitis who have stopped receiving treatment due to poor response to one or more types of tumor necrosis factor-alpha inhibitor (TNF-α inhibitor) or IL-17A inhibitor will be able to receive reimbursement for once daily treatment of 15mg of RINVOQ. The reimbursed price of RINVOQ is KRW 19,831 for once-daily dose of 15 mg, and patients covered by special exemption of calculations provisions only have to pay 10% of the drug price. RINVOQ proved efficacy in patients with severe active ankylosing spondylitis who were enrolled in the Phase 2/3 SELECT-AXIS1 and the Phase 3 SELECT-AXIS2 clinical trials. In both SELECT-AXIS 1 and 2 clinical studies, the ASAS40 (Assessment of Spondyloarthritis International Society response standard improvement of 40% or more) response rate for patients treated with RINVOQ 15 mg was 52.0% and 45.0%, respectively, at 14 weeks. This was significantly higher than that of the placebo group (26.0% and 18.0%, respectively.) In addition, the ASAS40 response was observed from Week 2 in SELECT-AXIS1 and from @eek 4 in SELECT-AXIS 2, confirming quicker effect of the drug. In the SELECT-AXIS 2 clinical trial, the average reduction in back pain in the Rinvoq 15mg treatment group was -3.00, which is a significant decrease compared to the placebo group (-1.47), and the intensity of morning stiffness also decreased by -3.08 compared to the baseline value compared to the placebo group (-1.67). Lee Sin Suk, Chairman of Korean College of Rheumatology, said, “RINVOQ has significantly improved the pain, inflammation, and joint damage in patients with severe active ankylosing spondylitis, and also helped improve the quality of life in patients as well as reaching treatment goals. The reimbursement expansion is likely to address the unmet need and alleviate the financial burden of patients who had been unable to receive benefits, and is expected to offer an effective oral treatment option for the patients."
