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- 2026-04-07 13:28:20
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- 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.
- Company
- 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.
- Policy
- Forxiga to maintain upper limit price until Korean mkt exit
- by Lee, Tak-Sun May 22, 2024 05:47am
- AstraZeneca Forxiga (dapagliflozin propanediol hydrate), an SGLT-2 class of diabetes treatment, will maintain its upper limit price until it leaves the South Korean market. It appears that AstraZeneca’s strategy for defending the upper limit price through the court’s suspension of execution has worked. The price-value agreement (PVA) negotiations, which were the last variable to determine the drug’s listing price, will likely end without any changes. According to industry sources on the 21st, Forxiga tab 10 mg will be deleted from the reimbursement listing as of June 1st as the company voluntarily withdrew approval on May 25th. A grace period is set until December 1st. Until this date, the drug can be reimbursed. When Forxiga tab is deleted from the reimbursement listing, the upper limit price will still be 734 won. The price of Forxiga tab was set to decrease by 30% from 734 won due to a mandatory adjustment following the generics listing. However, after the court accepted the company’s request for execution suspension, the upper limit price was maintained. At the end of last year, AstraZeneca officially announced the withdrawal of Forxiga tab from the Korean market. The drug’s withdrawal is set for the second half of this year. At the time of approval cancellation on April 25th, the Forxiga indications in chronic heart failure and chronic kidney disease, excluding diabetes, were transferred to HK inno.N’s generic ‘Dapa N tab.’ As reimbursement will be canceled due to approval cancellation, the drug’s upper limit price was expected to be maintained until it’s exit from the Korean market. However, the last remaining variable was the PVA negotiations with the National Health Insurance Service (NHIS). The company re-entered the negotiations after failing to reach an agreement in the initial negotiation, with the deadline set for the end of this month. If the company had agreed to decrease the upper limit price during the PVA negotiations, they could have reimbursement deleted at a lower price. However, AstraZeneca did not anticipate this situation. The company was hoping to maintain the drug’s upper limit price, considering the marketing of the drug in other countries that reference the Korean drug price. AstraZeneca received results as strategized. The PVA negotiations will likely conclude without changes to the upper limit price of the drug. The company may enter a separate contract with the government during the grace period for reimbursement, but that is not relevant now. The company has successfully maintained the drug’s upper limit price.
- Company
- 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%.
- Company
- Flu drug market enjoys rise for 6 consecutive quarters
- by Chon, Seung-Hyun May 21, 2024 05:56am
- The outpatient prescription market for flu drugs has recovered. Their prescription market, which had remained almost nonexistent for 3 years after the COVID-19 pandemic, has expanded significantly since then. With the flu epidemic lasting more than a year, the market for flu treatments has returned to pre-pandemic levels. According to the market research institution UBIST, the outpatient prescription market for influenza (flu) totaled KRW 6.8 billion in Q1, up 34.8% YoY. The prescription market for flu medications has grown more than 160 times in 2 years from just KRW 40 million in Q1 2022. The flu drug market has undergone significant changes throughout the COVID-19 pandemic and endemic. After recording KRW 8.2 billion in prescriptions in Q1 2020, the flu treatment market was virtually nonexistent until Q3 2022. Its prescription market was below KRW 100 million for 10 consecutive quarters since Q2 2020. This is due to the significant decline in other infectious disease outbreaks since the COVID-19 pandemic began in earnest, due to increased personal hygiene practices such as handwashing and mask-wearing. According to the Korea Disease Control and Prevention Agency, the number of suspected influenza patients per 1,000 outpatients never exceeded 5 until August 2022, since reaching 6.3 in the first week of March 2020, week 9. That means the flu had not even once spread and become an epidemic for 2 and a half years. The prescription market for flu treatments soared to KRW 10.4 billion in Q4 from just KRW 70 million in Q3 2022. On September 16, 2022, a flu epidemic warning was issued for the first time in 2 years and 6 months and then lasted for 2 years and 7 months until April this year. After the COVID-19 pandemic ended last year, the flu epidemic period has been lengthening due to fully lifted social distancing measures and an increase in outdoor activities. In Q4 last year, the amount of outpatient prescriptions for flu drugs exceeded KRW 20 billion. Number of suspected influenza patients per 1000 outpatients (Unit: people, Source: KDCA) In April, the number of suspected flu patients per 1,000 outpatients remained steady at around 10. The prescription market for flu medicines in Q1 of this year is similar to the KRW 6.7 billion in Q1 2019 before the pandemic. The prolonged flu pandemic has brought the market back to pre-pandemic levels. Oseltamivir accounts for most of the outpatient prescriptions in the flu treatment market. Oseltamivir is the main active ingredient in Tamiflu. The prescription market for oseltamivir was not able to surpass KRW 100 million until Q3 2022, after reaching KRW 8.2 billion in Q1 2020. However, it rebounded to KRW 10.4 billion in Q4 2022 and has continued to grow since then. In Q1 this year, oseltamivir-based prescriptions amounted to KRW 6.8 billion, up 34.8% year-on-year.
- Company
- Series of drug patent expiries change ₩250B DOAC mkt
- by Moon, sung-ho May 21, 2024 05:55am
- The direct oral anti-coagulant (DOAC) market is changing shape at an accelerated pace. This is due to the series of patent expiries of original drugs that had recorded high sales, mainly in the cardiology departments of university hospitals and clinic-level medical centers. #In particular, with the accelerated entry of generic drugs (generics), whether companies of original drugs will be restructuring their business units is also attracting attention. According to industry sources on the 18th, generic versions of original DOACs from major global pharmaceutical companies have recently been launched or announced one after another upon the originals’ patent expiry. DOACs that are currently prescribed in internal medicine hospitals and clinics and form the major market in Korea are Bayer’s Xarelto (rivaroxaban), Boehringer Ingelheim’s Pradaxa (dabigatran), BMS’s Eliquis (apixaban), and Daiichi Sankyo’s Lixiana (edoxaban). Among these, Xarelto’s decline in the prescription market has become more pronounced in recent years with its patent expiry in 2H 2022, and the bulk of domestic generics versions that followed. According to the drug research institution UBIST, Xarelto’s prescriptions plummeted 37% from KRW 49.4 billion in 2022 to KRW 31 billion in 2023. The downward trend has continued in Q1 this year, recording sales of KRW 7.6 billion. In addition, another blockbuster, BMS’s Eliquis, is also set to go off patent in 2H this year. As a result, generic versions of this drug are also expected to flood the market once the patent expires in September, which is expected to affect prescriptions. For reference, Eliquis has continued to dominate the clinical scene, with prescriptions totaling KRW 77.3 billion last year. In Q1 this year, its sales amounted to KRW 19.3 billion, but the general prospect is that this sales flow will change after the launch of its generics. In fact, major domestic companies are already preparing to launch generic versions of Eliquis. For example, Dongkook Pharmaceutical recently received approval from the Ministry of Food and Drug Safety for “Apigaban,” an apixaban generic. These changes are expected to solidify the sole lead of Daiichi Sankyo's Lixiana, which has been strengthening its market dominance in the field. Lixiana, which is marketed by Daewoong Pharmaceutical, has recently surpassed Eliquis in sales and solidified its dominance in the field. Last year, Lixiana's sales in Korea reached KRW 105.3 billion, and in Q1 this year, the drug posted 27.7 billion won in sales, continuing on its upward trend. "The sales of DOACs do not fluctuate much due to their need in clinical practice," said a professor of cardiology at A University Hospital, who requested anonymity. "But if generic versions are released, prescriptions will naturally be dispersed due to drug prices.” He added, "Due to rising interest in its utility after its reimbursement approval following transcatheter aortic valve implantation (TAVI) procedure, and due to the need for its continued use, pharmaceutical companies will essentially seek to own one product. It will be interesting to see how the global pharmaceutical companies that own the original products respond." The industry is watching BMS's moves following the patent expiration of Eliquis. BMS has recently undergone a major restructuring at its headquarters level. Last month, BMS reported Q1 earnings that beat expectations, with sales of multiple myeloma drugs ‘Revlimid’ and ‘Eliquis’ coming in higher than expected. However, one-time costs related to recently closed M&A deals turned the quarter into a loss, and the company said it would focus its resources on R&D programs that will provide the biggest return on investment going forward. In the process, the company announced that it would lay off 2,200 employees this year, discontinue some development programs, consolidate operations, and reduce management layers. In fact, after the BMS headquarters’ announcement, restructuring started in Japan and elsewhere. This is why there is a lot of industry speculation on whether the announcement will affect its Korean subsidiary as well. The series of generic Eliquis drugs that are set to be released upon the original drug’s expiry is also adding strength to the speculation. AstraZeneca also recently withdrew its diabetes drug Forxiga (dapagliflozin) from the Korean market after the launch of its generic versions, closed down the division, and offered voluntary retirement programs. In other words, some worry that global pharmaceutical companies will again launch early retirement programs following the patent expiry of their original drug and the launch of generics. However, BMS Korea denied any such plan. BMS Korea said, "We have no plans set following Eliquis’s patent expiry. We are alternating activities in the domestic market with Pfizer. Our plans at the headquarters level were implemented to strengthen our portfolio through recent M&A and intensive investment in R&D, and are independent of the Korean situation. At this time, we do not have any plans related to Eliquis’s patent expiry."
- Company
- Rolvedon's cumulative US sales surpasses ₩100B
- by Son, Hyung-Min May 21, 2024 05:55am
- Hanmi Pharmaceutical's neutropenia drug Rolvedon is cruising in the US market. Rolvedon has surpassed KRW 100 billion in cumulative sales in the US market. Hanmi Pharmaceutical's U.S. partner Assertio plans to further increase the drug’s market share by securing a same-day dosing indication. According to Assertio on the 18th, Rolvedon generated USD 14.5 million (about KRW 19.7 billion) in sales in Q1 this year, up 31.8% from the USD 11 million it generated in Q4 last year. Since its launch in the US in Q4 2022, Rolvedon has generated USD 80.2 million (KRW 110 billion) in cumulative sales. Rolvedon (Korean brand name: Rolontis) is a neutropenia treatment developed by Hanmi Pharmaceutical. In March 2021, it was approved as the 33rd homegrown new drug in Korea. Hanmi Pharmaceutical and its U.S. partner Spectrum (now Assertio) succeeded in obtaining U.S. Food and Drug Administration (FDA) approval for Rolvedon in September 2022. Quarterly Rolvedon Sales Hanmi Pharmaceutical licensed out Rolvedon to Spectrum Pharmaceuticals in 2012. Assertio acquired Spectrum in April last year and acquired the rights to market and develop Rolvedon and the lung cancer drug poziotinib. Assertio is a pharmaceutical company specializing in inflammation treatments like the non-steroidal anti-inflammatory drug Indocin and the orally disintegrating film Sympazan. After acquiring Rolvedon, Assertio braved the anticancer drug market. Since its release in October 2022, Rolvedon’s sales in the U.S. reached USD 10 million in Q4 sales. In December of the same year, Rolvedon was included in the National Comprehensive Cancer Network (NCCN) guidelines for prevention and treatment options for febrile neutropenia. Since then, Rolvedon's sales have continued to grow, to USD 15.6 million in Q1 and USD 21 million in Q2 last year. However, Rolvedon's growth has slowed since Assertio took over its sales. Rolvedon reported USD 8 million in revenue in Q3 last year, a 62.0% decrease from the previous quarter. Rolvedon has become reimbursable through the US’s public health insurance since April last year, but the terms are reportedly less favorable than the reimbursement system it had in place on its launch. Rolvedon’s sales rebounded in Q4 last year, recording KRW 10 million in revenue. Sales continued to grow in Q1 this year to KRW 14.5 million. Assertio attributed the rebound in sales to the new accounts it had signed using an updated commercialization strategy. Assertio has high hopes for its same-day dosing trial. Rolvedon is indicated for the treatment or prevention of neutropenia in cancer patients who receive myelosuppressive chemotherapy. As a granulocyte colony-stimulating factor (G-CSF) class that stimulates the granulocyte to increase neutrophil production, the drug has a similar mechanism of action with Amgen’s blockbuster drug ‘Neulasta (pegfilgrastim).’ However, neutropenia treatments like Neulasta cannot be administered until 24 hours after chemotherapy, which increases the number of hospitalization days for the patient hospitalized. Assertio is currently enrolling patients in a Phase I, same-day dosing trial with Rolvedon. Assertio CEO Heather Mason said, “Our goal is to have clinical data readout by the end of this year. We expect the new dosing regimen to serve as a differentiated strategy compared with competitors.”
- Company
- Dong-A, Ildong join hands…R&D synergy and resources
- by Chon, Seung-Hyun May 21, 2024 05:55am
- Dong-A ST and Idience sign a strategic equity investment and joint development agreement. Officials, (from left) Ildong Pharmaceutical President Lee Chae-joon, Idience CEO Lee Won-sik, Dong-A ST R&D President Park Jae-hong, and Dong-A ST President Kim Min-youn, taking photos. Dong-A ST and Idience join hands to develop novel anticancer drugs. Dong-A ST invested KRW 25 billion in Ildong’s subsidiary, Idience, and will co-develop novel anticancer drugs. Consequently, Dong-A ST has secured a pipeline of potential novel anticancer drugs, and Idience successfully contracted investment for its novel drug development. Dong-A ST invested KRW 25 billion in Idience…strengthens its novel oncology pipeline According to industry sources on the 20th, Dong-A ST signed a strategic equity investment and joint development agreement with Idience, Ildong’s company specializing in new drug development. Idience is delivering a third-party allocation capital increase of KRW 25 billion by issuing 19,142,420 new shares to Dong-A ST. Prior to the capital increase, Idience had 11,492,538 common shares and 10,985,074 preferred shares outstanding. Dong-A ST is expected to become Idience's second-largest shareholder after the capital increase. Founded in May 2019 as a subsidiary of Ildong Holdings, Ildong Pharmaceutical's holding company, Idience is a biopharmaceutical company specializing in new drug development. Idience is a development-centric (NRDO, No Research Development Only) biotech venture, focusing solely on drug development rather than direct drug discovery. Idience is under development of ‘Venadaparib.‘ Venadaparib is a novel targeted anticancer candidate with a mechanism focused on selective inhibition of Poly ADP-ribose polymerase (PARP), which is involved in cancer generation. Ildong Pharmaceutical developed Venadaparib as an in-house product and then transferred the rights to Idience. It is under development as an oral, targeted anticancer therapy for the treatment of gastric cancer, breast cancer, and ovarian cancer. The analysis indicates that Dong-A ST has strengthened the competitiveness of its oncology pipeline through this investment, obtaining rights for the use of Venadaparib in combination therapies. Dong-A ST continues to build its oncology pipeline by making R&D investments. In November last year, immunotherapy DA-4505 was approved for phase 1/2a trials in South Korea. Furthermore, the company presented preclinical results of SHP1(Src homology phosphatase-1) inhibitor ‘DA-4511’ at the AACR annual meeting 2024, held in April, and proved the candidate product’s potential for immunotherapy for cancer. In December, Dong-A ST invested KRW 31.4 billion in acquiring AbTis, a company specializing in antibody-drug conjugates (ADC). AbTis developed a third-generation ADC linker technology called ‘AbClick,‘ which site-selectively conjugates drugs to antibodies without antibody modification. In the second half of the year, AbTis plans to file an IND for AT-211, a Claudin 18.2 ADC candidate for gastric cancer and pancreatic cancer, in the U.S. and Korea. ”We plan to seek various measures to expand in a global market through this strategic collaboration. We will develop innovative novel anticancer drugs by joining Dong-A ST and Idience technology and products,” Dong-A ST President Kim Min-young said. Idience, secures financial resources for novel drug development…secured KRW 90 billion since its inception Idience has secured an additional financial resource for its novel drug development through Dong-A ST’s investment. Since its inception, Idience has received a total of KRW 65 billion in investment. When Idience was established, Ildong Holdings initially invested KRW 500 million and later added another KRW 4.5 billion. In 2021, Idience successfully secured an investment of KRW 40 billion. It also received a total investment of KRW 40 billion from various firms, including Yuanta Investment, TS Investment, Mirae Asset Capital, and Seoul Investment Partners. In 2022, Idience raised additional investment through a third-party allocation capital increase of KRW 15 billion from Ildong Holdings and others. With the completion of Dong-A ST's capital increase, Idience is set to secure a total of KRW 90 billion in investment capital since its inception. Dong-A ST's cash and cash equivalents in the first quarter amounted to KRW 267.3 billion. With this ample funding, Dong-A ST aims to secure a new drug pipeline while Idience secures funding for drug development. Idience is currently working on the commercialization of Venadaparib, including clinical development for targeting various cancer types, such as gastric cancer, breast cancer, and PARP inhibitor-resistant cancer. In gastric cancer, Venadaparib received orphan drug designation from the U.S. FDA in 2022 and is currently undergoing clinical trials. Earlier this year, at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, interim results from Phase 1 clinical trials were presented. These results demonstrated a broad range of applications and superior therapeutic effects compared to standard treatments, showcasing Venadaparib's competitive edge. In addition to their previous relationship in the Korean market, Dong-A ST and Ildong Pharmaceutical also built a collaborative partnership for developing novel drugs. Dong-A ST and Ildong Pharmaceutical are co-marketing a natural medicine Motilitone since 2019. Motilitone is a product utilizing natural substances extracted from the seeds of the morning glory flower and the stems of the fucus brown algae. Since 2019, Dong-A ST has been selling the antiulcer drug Gaster, produced by Ildong Pharmaceutical. Gaster is indicated for various conditions, such as gastric and duodenal ulcers, upper gastrointestinal bleeding, reflux esophagitis, Zollinger-Ellison syndrome, acute gastritis, and improvement of gastric mucosal lesions due to acute exacerbation of chronic gastritis. “It is significant to have partnered with Dong-A ST and successfully received investment. Idience’s R&D capacity and pipeline values are recognized through this deal,” Idience CEO Lee Won-sik said.
- Company
- Global RSV vaccines emerge…K-pharma enters clinical trials
- by Son, Hyung-Min May 20, 2024 05:42am
- The RSV vaccine Beyfortus, developed by Sanofi and AstraZeneca, GSK’s Arexvy, and Pfizer’s Abrysvo. Competition is expected to intensify as new drugs emerge in the respiratory syncytial virus (RSV) market. Sanofi received approval for its RSV vaccine and is the third company to acquire the approval, following GSK and Pfizer. Furthermore, Moderna’s messenger RNA (mRNA) vaccine awaits the FDA approval. In South Korea, EuBiologics has entered the Phase 1 trial. According to industry sources on the 20th, the RSV vaccine Beyfortus, developed by Sanofi and AstraZeneca, received approval in South Korea on April 30th. Consequently, Beyfortus has become the first preventative RSV vaccine targeting young children to obtain domestic approval from the regulatory institution. Last year, GSK’s Arexvy and Pfizer’s Abrysvo were launched overseas, but they have yet to start acquiring domestic approval. RSV is a virus that causes pneumonia and bronchiolitis. Although RSV can be infected at any age, young children are particularly prone to infection. It is the common cause of hospitalization for young children, with a high disease incidence, and 90% of young children worldwide are infected before 2 years. When infected, the symptoms are similar to the common cold. Certain young children experience worsening symptoms, having lower respiratory symptoms such as pneumonia and bronchiolitis. In South Korea, RSV Synagis Inj, an antibody directed to RSV, is available. However, it has the disadvantage of multiple injections due to short-lasting in the body. Moreover, Synagis can only be administered to patients with certain diseases. With the long-lasting Beyfortus, healthy children less than 24 months can be vaccinated. The efficacy and safety of Beyfortus were confirmed in MELODY clinical trials against medically attended Lower Respiratory Tract Infection (LRTI) caused by RSV through 150 days after the treatment. In clinical trials, Beyfortus reduced the RSV LRTI infection rate to 74.5% in full-term infants and late preterm infants. The Beyfortus effect was 70.1% in preterm infants. Furthermore, the NIRSE-Gal interim analysis result, which was the basis for the European real-world evidence (RWE), has shown that the Beyfortus administration reduced the hospitalization rate by 82% in infants less than 6 months compared to non-vaccinated infants. RSV circulates between October and March every year. Sanofi and AstraZeneca are producing Beyfortus before the RSV season and plan to distribute most vaccine stocks before October. Moderna completes clinical trials and waits for FDA approval...EuBiologics enters clinical trials in South Korea as the first and only Moderna’s RSV vaccine will receive the decision for the FDA approval within this month. Moderna’s mRNA-1345 vaccine is developed to prevent RSV in adults over 60. When approved, it will be the third RSV vaccine that targets adults, following Arexvy and Abrysvo. The ConquerRSV trials, which evaluated the safety and efficacy of Moderna’s RSV vaccine, involved about 37,000 adults 60 years or older in 22 countries, including the United States. They were conducted as randomized, double-blind, and placebo-controlled studies. The interim analysis was based on two definitions of RSV-LRTD defined as either two or more symptoms, or three or more symptoms of disease. According to the clinical results, mRNA-1345 demonstrated vaccine efficacy of 83.7% in RSV-LRTD defined as two or more symptoms, and all primary endpoints were met. Adverse reactions of mRNA-1345 were mild or moderate, and the most common adverse reactions reported in the mRNA-1345 group were injection site pain, fatigue, headache, myalgia, and arthralgia. Moderna expects approval this month and plans to launch its first RSV vaccine to the market by the second half of the year. Additionally, EuBiologics has entered full-scale clinical trials in South Korea. EuBiologics’ euRSV vaccine under development has recently started administration in three RSV patients in Korea University Guro Hospital. The clinical trials involve patients randomly assigned to a placebo group, EuRSV low-dose group, or high-dose group, and tolerability and the safety will be evaluated. EuRSV is a recombinant protein subunit vaccine that combines an RSV F protein antigen with immunostimulants. In 2017, EuBiologics acquired immune modulation technology (EuIMT) from KIST. EuBiologics emphasizes that the manufacturing process of EuIMT is simple compared to GSK’s immunostimulant technology, MPL(monophosphoryl lipid). Consequently, the company expects that vaccine mass manufacturing will be possible at a low cost. After starting a phase 1 trial in South Korea, EuBiologics aims to enter global phase 2/3 trials through its U.S. subsidiary EUPOP Life sciences, which has North America and Europe licenses.
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- ‘Much work remains to be done for new drug access in Korea'
- by Eo, Yun-Ho May 20, 2024 05:42am
- Kyung-Eun Bae (Kay Bae ), Chair of the Korean Research-based Pharmaceutical Industry Association Kyung-Eun Bae (Kay Bae, 53) has risen to become the 'center' of the pharmaceutical industry. After being appointed as the general manager to lead subsidiaries including Korea, New Zealand, and Australia of the Sanofi Group, Bae was also appointed Chair of the Korean Research-based Pharmaceutical Industry Association (KRPIA) Being appointed to head the association representing multinational pharmaceutical companies in Korea along with Sanofi Group’s major Asia-Pacific countries, Bae has become a key figure in communicating with the industry and regulatory authorities, including Sanofi headquarters and the Korean government. Bae’s appointment came at the busiest time. Bae has received an offer every time the KRPIA Chair position became open, but she has turned down the offer up to now. And in a situation where her scope of work became broader than ever before, she accepted the long-declined offer. Serving as KRPIA Chair at the busiest time of her career, there had been concerns amid rising expectations about whether Bae would be able to do her part and perform both roles well. As a control tower, KRPIA has been working to make new drugs more affordable than ever before. Making proposals to reform the drug pricing system and engaging in government communications for its support has become a key role of the association. In her two roles, Bae will be overseeing two of Korea’s regular drug pricing reference countries - New Zealand and Australia – at Sanofi, and be determining KRPIA’s key message and strategy on behalf of the industry. In other words, Bae may be best positioned to make the most appropriate policy recommendations. Dailpharm met with Bae to find out more about her new roles. - Your appointment as KRPIA Chair came as a surprise because I thought you were going to turn down the position again. I became the head of Sanofi Australia and New Zealand and the Chair of KRPIA at the same time. I was hesitant at first because I didn't think I had the capability yet. However, I have always felt that I should contribute to the association's development because KRPIA's mission aligns with the values that global pharmaceutical companies deem important. I thought this year was the right time to take on the role. It seems to be that time of life for me when I’m destined to work. So I plan to dedicate myself to the work at hand while taking care of my physical health. I apologize for the unpredictability (laughs). - This is a very important time for multinational pharmaceutical companies. Looking at the government's policy direction, although there are still some policies that add pressure, there are also positive signals, such as the recent plan to compensate for the value of innovative new drugs. The phrase 'new drug value recognition' appeared for the first time in the 'Second Comprehensive National Health Insurance Plan' released by the government this year. It's a good start and an encouraging achievement as it lays the groundwork for improving patient access, including recognizing the innovativeness and value of new drugs and strengthening coverage for seriously ill patients. However, it is important to come up with concrete measures that are effective in practice so that new drugs can be supplied to patients quickly and lead to a virtuous cycle of R&D. -What are the KRPIA's recommendations to the government to address the practical issues you mentioned? There are two main areas I would like to point out. First, Korea is still too late in introducing new drugs. Statistics show that the percentage of new drugs introduced in Korea within 1 year of initial global (US, EU, etc.) approval is only 5%, which is very low compared to Japan and the US. Whether a new drug can actually be used by patients is most important. To address this issue, Korea has a Global Innovative Products on Fast Track (GIFT) system in place. However, we need to check whether the system is really shortening the review period and where the bottlenecks are. I think we first need to come up with a solution for drugs that are in urgent need of introduction. The second is in recognizing the value of new drugs. Companies are motivated when the value of new drugs is recognized, which in turn generates profits and creates a virtuous cycle of R&D. This ultimately requires a significant change in drug pricing policies, including a dramatic improvement in ICER values. When global pharmaceutical companies consider whether to invest in R&D in China, Japan, Southeast Asia, and Singapore, among other countries, they have to prioritize investing in countries with a strong R&D reputation. From an industrial perspective, this is why we need to move to reinforce Korea’s R&D competitiveness. Also, due to limited national health insurance finances, we need to take a look at the expenditure structure. In terms of the proportion of new drugs in drug expenditures, new drugs account for 60 to 70% of all drug expenditures abroad, but they account for less than 10% in Korea. We need to reorganize the inefficient systems that allow polypharmacy and clinic shopping. This way, we can budget for new drugs without putting a strain on insurance finances. -It was also surprising to see KRPIA voice the need to improve Korea’s expenditure structure. structure. Multinational pharmaceutical companies have been cautious in speaking out on the issue because the domestic market still has a strong tendency to look at new drugs as being from multinational companies, and generic drugs from domestic companies. Many were surprised that we released data on Korea’s drug expenditure structure (and the proportion of new drugs) last year. However, the government should be encouraging domestic companies to develop new drugs now. From the PE exemption system to ICER valuations, everything is connected, so KRPIA plans to communicate with the government on the issue whenever there is an opportunity. -It was also unexpected that KRPIA would request the government to disclose the discussions and results of committee reviews (such as those by the Pharmacoeconomic Evaluation Subcommittee) that new drugs undergo in the reimbursement process. Of course, securing the transparency of the reimbursement process may be a cautious matter for companies due to each company’s strategic secrets and so forth. But in the big picture of healthcare, patients are waiting. Information sharing is really important for decision-making. Transparency in that area is a win-win for the companies. I think this is why the government has been responding to many of the requests. -The government's efforts to strengthen post-listing control of drugs are also expected to be in full swing this year. Policies such as those that utilize real-world data (RWD) and switching the pharmacoeconomic evaluation exemption system to a temporary deferral of evaluation system may be of concern and dissatisfaction to KRPIA. I think post-listing control is necessary in part to manage the overall insurance finances. However, Korea’s post-management system is not integrated and is too fragmented, including the PVA (price-volume agreement), which often results in redundant drug price reduction mechanisms From the company's point of view, the system needs to be simplified to be predictable. Currently, the government operates a follow-up system that focuses only on drug prices, such as PVA, which creates a high administrative burden. I would like to see a system that takes into account the structural aspects, such as strengthening health insurance coverage for severe diseases over mild diseases. There seems to be too much focus on just reducing drug prices. Strengthening post-listing control without improving the system and policies for rapid new drug registration in Korea will eventually lead to another decline in access to new drugs. KRPIA is preparing a report on the problems of the post-listing control measures and suggestions for their improvement that we plan to propose to the government based on the views of professionals with extensive experience in the field.
