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- 2026-05-02 10:21:17
- Company
- 4 of 5 listed pharma companies expand investments
- by Chon, Seung-Hyun Nov 26, 2024 05:54am
- Pharmaceutical companies have significantly expanded their research and development (R&D) investments to discover their next item. Five out of five major pharma and biotech companies increased their R&D spending this year compared to the previous year. The top pharmaceutical companies in terms of sales have been investing heavily in R&D to develop new drugs. Yuhan Crop, Celltrion, and Dong-A ST showed a significant increase in R&D expenditures. According to the Financial Supervisory Service on the 25th, the cumulative R&D investments of 20 major pharmaceutical and biotech companies totaled to KRW 1.867 trillion in Q3, up 14.5% from the KRW 1.6387 trillion in the same period last year. The data was compiled from 20 listed pharmaceutical companies with the highest sales of main drug products. Ildong Pharmaceutical, which spun off its R&D subsidiary last year, was not included in the survey. Sixteen of the 20 major pharmaceutical companies increased their R&D investment this year compared to the same period last year. Celltrion, Samsung Biologics, Yuhan Corp, Daewoong Pharmaceutical, Hanmi Pharmaceutical, SK Biopharmaceuticals, Chong Kun Dang, Dong-A ST, HK Inno.N, JW Pharmaceutical, Boryung Pharmaceutical, Daewon Pharm, Huons, Dongkook Pharmaceutical, Dongwha Pharmaceutical, and Celltrion Pharmaceutical showed an increase in R&D expenditures through the third quarter compared to last year. Yuhan Corp showed the largest increase in R&D expenditure this year. The company invested KRW 201.1 billion in R&D through the third quarter, up 48.5% from KRW 135.4 billion it had invested in the same period last year. The increase was largely due to the reallocation of technology fees it accrued from its anti-cancer drug Leclaza. In August, the U.S. Food and Drug Administration (FDA) approved Leclaza in combination with Rybrevant for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a confirmed epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutation. Yuhan Corp received a USD 60 million technology fee from Janssen Biotech for the FDA approval of Leclaza. Of the total Leclaza royalties received, 40% was paid to the original developer, Oscotec. In 2016, the company acquired the preclinical development rights to Leclaza from Oscotec and its subsidiary Genosco. The technology fees redistributed to Oscotec were recognized as R&D expenses. This significantly increased the company’s R&D expenses as Yuhan paid more than KRW 30 billion to Oscotec out of the royalties it had received for Leclaza. In the first half of the year, Yuhan’s R&D expenses were high due to the introduction of promising technologies from bioventures. In March, the company paid KRW 6 billion to acquire the technology of SOS1-inhibiting anti-cancer drug candidates from Cyrus Therapeutics and Kanap Therapeutics. In the second quarter, the bank paid KRW 3 billion in technology fees to a biotech company, J Ints Bio. Celltrion reported cumulative R&D expenses of KRW 312.8 billion in the third quarter, up 34.0% YoY. Celltrion has received approval for 2 biosimilars in Europe so far this year. In May, the company received marketing authorization from the European Commission for its first biosimilar of Xolair, Omlyclo. Xolair is an antibody-based biological drug used to treat allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic idiopathic urticaria. In August, the company received approval for SteQeyma, a biosimilar to the autoimmune disease treatment Stelara, received European marketing authorization. Stella Stelara is a Janssen-developed autoimmune disease treatment for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Celltrion has acquired 8 and 6 approvals in Europe and the U.S., respectively. Celltrion is developing follow-on biosimilars for Keytruda, Prolia, Actemra, Cosentyx, and Ocrevus. Dong-A S&T's R&D expenditure through the third quarter was KRW 103 billion, up 25.5% YoY. Its clinical expenses for new drug development increased significantly. DA-4505, an immuno-oncology drug, was approved for Phase I/IIa clinical trials in Korea in November last year. DA-4505 showed improved tumor suppression through preclinical studies compared to AhR antagonists being developed by global pharmaceutical companies. A Phase III clinical trial for DA-8010, a treatment for overactive bladder, was completed in Korea in May. However, DA-8010 did not show a statistically significant difference. In October, Dong-A ST’s Stelara biosimilar Imuldosa received final approval from the FDA, marking the company's entry into the U.S. market. The company passed the U.S. market gateway 11 years after starting the development of Imuldosa in 2013. SK Biopharmaceuticals, Boryung, Samsung Biologics, Daewoong Pharmaceuticals, Hanmi Pharmaceuticals, and HK Inno.N have expanded their R&D expenditures by more than 10% YoY through the third quarter of this year. The increase in R&D expenditures was larger among pharmaceutical companies with larger sales. Samsung Biologics, Celltrion, Yuhan Corp, GC Biopharma, Chong Kun Dang, Hanmi Pharmaceutical, Daewoong Pharmaceutical, Boryung Pharmaceutical, and HK Inno.N have invested KRW 1.49 trillion in R&D this year, up 16.8% from the previous year. Of the top 10 companies by revenue, nine, except for GC Biopharma, increased their investment from last year. It is analyzed that large pharmaceutical companies, which have accumulated experience in developing new drugs and are actively seeking to expand globally, have been actively investing in R&D to discover new items. SK Biopharmaceuticals had the highest R&D investment-to-sales ratio, at 30.7%. Dong-A ST and Daewoong Pharmaceutical followed with 19.9% and 18.3%, respectively, while Hanmi Pharmaceutical, Yuhan Corp, Celltrion, and JW Pharmaceutical also invested more than 10% of their sales in R&D.
- Company
- Will Imfinzi and Imjudo be reimbursed in Korea?
- by Eo, Yun-Ho Nov 26, 2024 05:54am
- Whether the immuno-oncology drug combination of Imfinzi and Imjudo will gain a place as a treatment option for liver cancer in Korea is gaining attention. AstraZeneca Korea's combination therapy of PD-L1 inhibitor Imfinzi (durvalumab) and CTLA-4 inhibitor Imjudo (tremelimumab) recently passed the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee review and is headed towards a Drug Reimbursement Evaluation Committee review. Given that the application was submitted in June, this is a relatively fast track reaching coverage in Korea, which is why the industry’s eyes are on how quickly the combination therapy will be approved for reimbursement. The immunotherapy combo will first target liver cancer, as the combination was approved as a first-line treatment for adult patients with advanced or unresectable hepatocellular carcinoma (liver cancer). More specifically, the approved STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab) includes an initial single dose of Imjudo 300mg added to Imfinzi 1500mg, followed by Imfinzi every 4 weeks. At the recent European Society for Medical Oncology (ESMO) Congress 2024, the 5-year overall survival data from the Phase III HIMALAYA trial that demonstrated the efficacy of the Imfinzi and Imjudo combination in hepatocellular carcinoma was presented. In the HIMALAYA trial, patients with inoperable HCC were treated with STRIDE (single dose of Imjudo followed by Imfinzi maintenance therapy), Imfinzi monotherapy, and sorafenib monotherapy. When comparing the results of the Imfinzi and Imjudo combination with sorafenib combination therapy in patients with unresectable HCC, patients who received the STRIDE regimen had a 5-year overall survival (OS) rate of 19.6%, compared with the 9.4% for patients who received sorafenib. The median overall survival was 16.43 months and 13.77 months, respectively, showing a 24% lower risk of death in the Imfinzi-Imjudo combination arm. “ The Imfinzi-Imjudo combination therapy has significant advantages in that it has a much lower risk of bleeding than conventional therapies and does not worsen liver function," said Hong Jae Chon, Professor of Hemato-Oncology at CHA Bundang Medical Center. “In particular, the combination shows potential for longer survival than existing therapies."
- Company
- ‘Oral drugs can address the unmet PNH treatment needs’
- by Son, Hyung Min Nov 26, 2024 05:54am
- Dr. Jun Ho Jang, Professor of Medicine, Department of Hematology-Oncology, Samsung Medical Center The paroxysmal nocturnal hemoglobinuria (PNH) market, which has been dominated by AstraZeneca's Soliris and Ultomiris, has seen the introduction of the oral drug Fabhalta. Experts believe that Fabhalta’s use will increase in the future as it has been shown to reduce anemia and blood transfusions compared to existing treatments. On the 25th, Novartis Korea held a press conference for specialized journalists in Samseong-dong, Seoul, to celebrate the approval of Fabhalta in Korea. Fabhalta was approved in August as the first oral treatment for PNH. PNH is a rare and life-threatening disease caused by the destruction of red blood cells in the blood vessels, leading to symptoms of bloody urine and complications such as acute kidney failure. The disease is estimated to affect approximately 1.5 people per million worldwide. Its incidence is higher in East Asian countries such as Korea, China, and Japan than in Western countries. The number of PNH patients in Korea is expected to have approximately doubled from 260 in 2010 to 504 in 2023, with the number still on the rise. Fabhalta is a factor B inhibitor that acts proximally in the immune system's alternative complement pathway and has a comprehensive mechanism of action that controls red blood cell destruction. Previously, PNH has been treated with C5 inhibitor drugs, including Soliris and Ultomiris. However, while C5 inhibitors reduce the risk of thromboembolism by controlling intravascular hemolysis, they may not completely inhibit extravascular hemolysis. Up to 50% of patients on C5 inhibitors experience extravascular hemolysis, which is a major contributor to the development of persistent anemia. In addition, approximately 80% of PNH patients treated with C5 inhibitors have had an incomplete response to treatment, to the extent that they required transfusions or experienced anemia. Fabhalta has been shown to be effective in patients both on and off C5 inhibitors. The drug’s efficacy was confirmed through the Phase III APPLY-PNH trial in patients with residual anemia despite prior anti-C5 treatment who switched to Fabhalta and the Phase III APPOINT-PNH study in complement inhibitor-naïve patients. Trial results showed that 82.3% of anti-C5-experienced Fabhalta patients, 0% of anti-C5-treated patients, and 77.5% of complement inhibitor-naïve patients showed a sustained increase of hemoglobin levels of 2 g/dLa or higher from baseline in the absence of transfusions. The patients’ hemoglobin level was maintained in the 48-week extension study. The study showed that patients who continued to take C5 inhibitors had hemoglobin levels similar to those of the initial switch group when they switched to Fabhalta at Week 24, and the fatigue score returned to those of healthy individuals in the Fabhalta arm. In terms of safety, there were no treatment-related adverse events with Fabhalta that required treatment discontinuation. The incidence of clinical breakthrough hemolysis was significantly lower with Fabhalta compared to C5 inhibitors, and headache, nausea, and diarrhea occurred but were resolved within 1 week. An advantage of Fabhalta is its formulation. As an oral formulation, the drug offers better dosing convenience over existing intravenous formulations like Soliris and Ultomiris. Currently, Soliris (a 4-hour infusion once every 2 weeks) and Ultomiris (a 5.5-hour visit once every 8 weeks) require an in-person visit for their administration in the hospital. The introduction of C5 inhibitors has significantly improved the treatment of PNH, but there is an unmet need amongst patients who are unable to benefit from the use of C5 inhibitors or experience side effects,” said Dr. Jun Ho Jang, Professor of Medicine, Department of Hematology-Oncology, Samsung Medical Center. ”Up to 82% of patients do not achieve normal hemoglobin levels with C5 inhibitors, which can lead to anemia and blood clots. “ “Fabhalta targets both intravascular and extravascular hemolysis. Its strength lies in its ability to normalize hemoglobin and LDH levels,” added Jang. “In addition, switching from existing therapies to Fabhalta can improve patients’ quality of life by reducing fatigue, and can help patients overcome transfusion dependency.”
- Opinion
- [Reporter's View] what 'AI-driven drug discovery' requires
- by Kim, Jin-Gu Nov 26, 2024 05:54am
- This year’s Nobel Prize in Chemistry was jointly awarded to David Baker, a professor at the University of Washington, Demis Hassabis, CEO of Google DeepMind, and John Jumper, Director at DeepMind. Professor Baker was recognized for his contribution to creating protein design models. The DeepMind team was honored for developing 'AlphaFold,' which reduced the time required for protein structure prediction from years to mere hours using AI. The potential of AI in drug development has once again been recognized following the winning of the Nobel Prize. At the same time, it has alleviated concerns that AI-driven drug discovery is just chasing a mirage. In South Korea, various AI-driven drug discovery projects are being conducted. The chief project is the 'K-MELLODDY (Machine Learning Ledger Orchestration for Drug Discovery)' project. It is a Korean version of the MELLODDY project, in which 10 global pharmaceutical companies such as Amgen, key European universities, and biotech startups participated in 2020. The core of this project is federated learning. This method gathers data from individual pharmaceutical companies and research institutions to train AI models. To maintain data privacy, it encrypts gathered data. The goal is to shorten the lengthy drug development process significantly. In South Korea, eight pharmaceutical companies, including Daewoong Pharmaceutical·Dong Wha Pharm·Samjin Pharmaceutical·Yuhan Corporation·Jeil Pharmaceutical·Hanmi Pharmaceutical·Huons·JW Pharmaceutical, are participating. The project includes five universities and hospitals, such as Seoul National University Hospital, and four research institutes, including the Korea Research Institute of Bioscience and Biotechnology (KRIBB). AI drug development companies Simplex and Aifase are also part of the project. Experts in AI-driven drug development unanimously emphasize the importance of 'high-quality data' for AI training. A large volume of data is not sufficient. They explain that pharmaceutical companies or research institutions must utilize detailed clinical and preclinical data to accelerate drug discovery. The challenge lies in gathering clinical and preclinical data from individual pharmaceutical companies into one. These data are the intellectual property of each company and the culmination of extensive efforts by numerous research and development teams. While federated learning employs heavily encrypted processes to protect this data, companies remain hesitant and concerned about the potential external leakage of their core proprietary information. The same applies to clinical failure data. Experts stress that failure data is just as important as success data for AI training. Some explain that failure data is more effective in teaching AI systems. However, from the perspective of pharmaceutical companies, systematically recording and managing clinical failure data is a cumbersome task. The pharmaceutical companies participating in the K-MELLODDY project likely have overcome these concerns and challenges to unite around meeting the goal of AI-driven drug development. They deserve recognition. However, it is crucial to encourage more companies to participate. Only then can Korean pharmaceutical companies compete with global pharmaceutical companies that train AI systems on larger datasets worldwide. The government's involvement is crucial to encouraging more Korean companies to participate. The Ministry of Health and Welfare (MOHW) and the Ministry of Science and ICT (MSIT) have agreed to support KRW 34.8 billion in the K-MELLODDY project by 2028. Some argue that while the budget is significant, it may be insufficient to attract greater participation from pharmaceutical companies. In addition to establishing the federated learning platform, direct support for participating companies is essential. The current vision, which promises to reduce the considerable time and costs of drug development alone, is insufficient to give incentive. The government must take a more proactive role so that the goal of creating effective AI models for drug discovery can be closer.
- Company
- "Pharmaceutical companies using CSOs must renew contracts
- by Kim, Jin-Gu Nov 26, 2024 05:53am
- Based on the Contract Sales Organization (CSO) reporting system implemented last month, pharmaceutical companies must be aware of potential legal risks. Pharmaceutical companies using CSOs must sign contracts with companies that have completed registration and renew existing contracts to align with the timeline following reporting. The Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) hosted the On November 22, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) hosted the 'Ethical Management Workshop for the Second Half of 2024' at the Mondrian Seoul Itaewon. During the workshop, Attorney Park Jong-cheol from the law firm Hwawoo advised as such. Over 300 compliance officers (CP) from the pharmaceutical industry, in-person and online, have participated. Park presented strategies for minimizing legal risks for pharmaceutical companies using CSOs. According to him, these companies face various legal risks, including violations related to illegal rebates, labor laws, fair trade laws, and pharmaceutical laws. To minimize risks, Park emphasized the necessity of continuous management and oversight of CSOs and maintaining detailed records as evidence. Park also advised that promotional activities conducted by in-house sales teams and those belonging to CSOs should not overlap. To minimize risks, He said, "Companies must select larger, established firms capable of independently fulfilling contractual obligations." Park gave examples of practices that could constitute violations of the Fair Trade Act. He explained that these include cases where a CSO provides excessively high or low compensation to healthcare professionals, guarantees fixed margins, or continues transactions despite repeated unfair practices. Park also emphasized the importance of compliance with the CSO Reporting System, which has been effective since October 19. Under this system, pharmaceutical companies are permitted to contract only with CSO companies that have completed registration with local governments. Any existing contracts must be renewed following the registration date to ensure compliance. Contracts must include the following details: ▲The name of the pharmaceutical promotion agent ▲The name of the representative, the location of the business office, registration number, and business registration number ▲Details of the promotional activities entrusted, including the names of the delegated pharmaceutical products and the commission rates for each item ▲Duration of the contract ▲Obligations and compliance requirements for the entrusted party, including training provisions. The mandatory retention period for these contracts is five years, and they must be submitted to the MOHW upon request. Park advised, "If an existing contracted company fails to register, the termination of the contract should be considered." He added, "During subcontracting, oversight may become less stringent. It is advisable to diversify CSO transactions and standardize transaction terms to better align with industry standards." "Increasingly rigorous tax audits on pharmaceutical companies…must prepare by conducting diagnostics assessment" Suseok Ryu, an accountant at KPMG Samjong Accounting, explained ways to respond to the high-intensity investigation of the pharmaceutical industry by the National Tax Service. Ryu said the pharmaceutical and biotech industries have faced increasingly rigorous tax audits. These audits are characterized by extended or suspended timelines and comprehensive requests for access to companies’ IT systems. Both planned and unplanned investigations have become more frequent, while the intensity of regular audits has also increased. The documents requested during these audits cover a wide range, including internal company policies on sales incentives, discounts, and employee welfare expenses, domestic and international bank account details showing cash and cash-equivalent assets, expenditure reports and corporate card usage records, gift card purchase records, distributor lists and related contracts, employee travel logs, and VAT non-deductible purchase details and data backups. In particular, the National Tax Service primarily focuses on illegal rebates, activities related to the Fair Competition Code, such as product briefings·academic conferences, costs incurred from returns or complaints by healthcare providers, sales discounts, sales incentives, and business travel expenses. "For pharmaceutical companies, tax audits heavily focus on identifying a history of rebates. Therefore, they must identify potential issues and prepare accordingly through tax diagnostics assessments," Ryu emphasized. "As tax investigators are authorized to review financial transactions without the taxpayer's consent, it is crucial to meticulously prepare supporting documentation to account for cash flow and ensure compliance." "For expenses related to academic conference funds, it is essential to secure documentation that can prove the advertising effects, such as booth operation photos and journal advertisement placement records." Ryu added, "Returns of unsellable pharmaceutical inventory should also be justified with detailed evidence, as they could otherwise be misconstrued as entertainment expenses." "Expenditure report will be disclosed at the end of year…must be thoroughly cross-checked for omission·errors" Han-Cheol Kang, an attorney at Kim & Chang's Corporate Compliance, introduced strategies to respond to potential disputes before releasing the first expenditure report at the end of the year. According to the revised Pharmaceutical Affairs Act, the government will disclose expenditure reports submitted by pharmaceutical companies and CSOs for the first time at the end of the year. Kang stressed the importance of accurate data entry. "Even in the U.S., which implemented its disclosure system after years of preparation, 31% of transaction records contained errors," Kang said. "The American Medical Association's findings attributed these issues to a lack of review opportunities and data inaccuracies." "Once expenditure reports are disclosed, they are difficult to amend and may lead to violations of the Pharmaceutical Affairs Act. Therefore, it is crucial to ensure no omissions or errors, such as incorrect attendee records," Kang stated. "It is also essential to cross-check the provided amounts and categories with supporting documentation to ensure accuracy." "Companies must prepare for potential disputes by securing evidence, establishing systems to verify facts, and implementing error-checking procedures," Kang emphasized. "The persistent practices of providing unjust economic benefits, practical challenges due to excessive regulations, and negative public opinion present significant risk factors both within and outside the industry," Jae-Kook Lee, Senior Vice President of KPBMA, said. "The pharmaceutical and biotech industries must not forget their responsibility to meet the era's·public's expectations. In collaboration with its 297 member companies, the KPBMA will continue to make every effort to promote ethical management practices."
- Company
- K-Bio to showcase at the ASH 2024
- by Son, Hyung Min Nov 25, 2024 05:54am
- Development accomplishments of the Korean pharmaceutical industry's blood cancer treatments will be showcased at an international conference. Hanmi Pharmaceutical, PharosiBio, LigaChem Biosciences, and Aptamer Sciences will present their promising clinical study results, and they are set to join the global stage. PharosiBio and Hanmi Pharmaceutical will present their clinical accomplishment of new drug candidates for acute myeloid leukemia (AML). Aptamer Sciences and LigaChem Biosciences will unveil the competitiveness of their antibody-drug candidate (ADC) platforms. Clinical results of AML will be showcased…new drug discovery platform competitiveness ↑ According to sources on November 23, the American Society of Hematology Annual Meeting and Exposition (ASH 2024) will take place from December 7 to 10 in San Diego, U.S. The American Society of Hematology, the world's largest blood cancer-related academic conference, commences its 66th meeting this year. Hanmi Pharmaceutical will showcase the clinical result of its innovative new drug candidate for AML, 'tuspetinib,' confirming the potential of the drug as a triple combination drug therapy at the ASH 2024. The results will be presented by Hanmi Pharmaceutical's U.S. partnering company, Aptose Biosciences. In 2021, Hanmi Pharmaceutical outlicensed tuspetinib to Canadian pharmaceutical company Aptose Biosciences. Tuspetinib is a new innovative drug targeting key kinases involved in myeloid malignancies. Tuspetinib works in a differentiated pattern. It has been developed as a once-daily administration. It received the fast-track designation pharmaceutical from the U.S. Food and Drug Administration (FDA) last year. Aptose Biosciences is currently investigating the potential of tuspetinib in combination with hypomethylating agents such as BCL2 inhibitor Venetoclax (product name: Venclexta) and azacitidine. Previously, Aptose Biosciences has reported that the combination therapy of tuspetinib and venetoclax in patients with relapsed or refractory AML demonstrated favorable safety profiles and positive drug responses, regardless of prior venetoclax treatment experience. In particular, with tuspetinib administration, no noticeable side effects or typical toxicity responses were observed in medications of the same class. It showed broad activity in all patients with AML who have genetic mutations. Aptose Biosciences will decide on the volume of the triple combination therapy and finish the pilot study by presenting it in the European Hematology Association (EHA) meeting next year. PharosiBio will showcase the Phase 1 trial results of its new drug candidate, 'PHI-101,' for AML. Along with the clinical Phase1b results conducted with PHI-101 160 mg monotherapy, this company is expected to unveil comprehensive clinical data after completing the recruitment of patients. PHI-101 is a targeted cancer agent being developed for treating patients with AML not responding to previous medications or who relapsed due to FLT3 mutation. This new drug candidate product targets the FLT3 gene mutation that occurs in 35% of all patients with AML, inhibiting the growth of cancer cells. In addition to the study of PHI-101 monotherapy, PharosiBio is also conducting clinical trials of combination therapy. The company confirmed the effects of triple combination drug therapy containing PHI-101, Venetoclax, and azacytidine. Venetoclax and azacytidine are used as a first-line treatment for adult patients with AML. In a xenograft animal model, PHI-101 showed a 95% tumor growth inhibition (TGI) when used in combination with Venetoclax. Additionally, when azacitidine was added to the PHI-101+Venetoclax combination therapy, the reported survival period was 53 days. This figure is longer than the 30 days of the control group. PharosiBio plans to investigate the potential of both monotherapy and combination therapy and aim to target all treatment phases. ASH 2023 photo (source=ASH). Development of ADC for blood cancer is actively conducted LigaChem Biosciences and Aptamer Sciences will report on competitiveness of their ADC platform. ADC is a novel anticancer drug that connects an antibody, which binds to specific antigens on the surface of cancer cells, with a cytotoxic drug linked by a linker. ADCs take advantage of antibodies' selectivity for their targets and the drug's cytotoxic activity to selectively target cancer cells, thereby increasing therapeutic efficacy while minimizing side effects. LigaChem Biosciences will unveil Phase 1 results of CS5001, an ROR1 targeting ADC candidate product under co-development with ABL. ROR1 is a protein that is strongly expressed during fetal development. The clinical trial analyzed the efficacy, pharmacokinetics (PK), and antitumor activity of CS5001 in patients with solid cancer and lymphoma. Based on the presented clinical results, in the first eight dose groups of CS5001, no dose-limiting toxicities (DLT) were observed. Superior safety and expected pharmacokinetics properties were reported, with the maximum tolerated dose (MTD) not being reached. Aptamer Sciences will showcase the study data of 'AST-202,' a new drug candidate product that was selected from utilizing ApDC (Aptamer-Drug Conjugates) in patients with blood cancer. ApDC is a next-generation ADC new drug development platform with its proprietary branched linker-payload technology. Aptamer Sciences has conducted a comparison study comparing ACD Adcetris and AST-202, which are used as conventional blood cancer treatment, and acquired a significant result in tumor-suppressing effects. In a lymphoma model, AST-202 demonstrated superior tumor-suppressing effects than Adcetris, and more than 80% of the AST-202-treated group survived.
- Policy
- Limiting new drug patent term extensions would be beneficial
- by Lee, Jeong-Hwan Nov 25, 2024 05:53am
- The domestic pharmaceutical industry's attention is focused on whether the proposed amendment to the Patent Act, which would limit the drug patent term to 14 years and stipulate the number of patent rights that can be extended to one (singular), will pass the Bill Review Subcommittee of the National Assembly's Standing Committee review. The proposed amendment to the bill aims to address the issue of how pharmaceutical companies with new drugs have been operating a de facto “market monopoly” on new drug patents by 'overlapping' the patent term extension system, delaying the timing of generic launches, infringing on the public's right to choose medicines, and causing losses to health insurance finances. The legislation, which institutionalizes the drug patent system that is being used by a number of countries overseas including the United States, Europe, and China, is expected to harmonize domestic standards with patent laws deemed as world standards while strengthening the foundation for fostering the domestic generic industry. On the 24th, the Trade, Industry, Energy, SMEs, and Startups Committee announced that it would review the Patent Act amendment bill introduced by Rep Dong-Jin Koh of the People Power Party at a bill subcommittee scheduled for the 26th. A similar bill had been introduced during the 21st National Assembly by Representative Il-Young Jung of the Democratic Party of Korea but was abandoned upon the NA term expiry. 14-year cap set for patent extensions in the US, Europe…Extension limited to 1 patent The main amendments to Rep Koh’s bill, which will soon be reviewed, are ▲ establishing a 14-year cap on the patent term, and ▲ limiting the number of patents that can be extended to a single drug. The reasoning behind the bill is that the patent term extension system prescribed by Korea’s Patent Act is different from that of developed countries such as the United States and Europe, which may cause reverse discrimination against the domestic pharmaceutical industry. Specifically, the United States, Europe, and China limit the number of patents that can be extended for a single drug to a singular patent - just one. Korea and Japan, on the other hand, allow an unlimited number of patents to be extended for a single drug. For example, if a drug has a product patent, a use patent, and a formulation patent, the U.S., Europe, and China only allow extensions for the product patent, while Korea and Japan allow extensions for each of the substance, use, and formulation patents. Korea also does not stipulate a separate cap period for patent extensions. This differs from the U.S., which allows patents to be extended for up to 14 years from the date of approval, and Europe, which allows patents to be extended up to 15 years. If Koh’s bill passes review, it is expected that Korea's domestic law on drug patent extension will be harmonized with those in the U.S. and Europe, and an environment will be fostered where patients can opt to use cheaper and high-quality generic versions quickly. If Korea trims Korea’s excessive drug patent protection laws being granted to global pharmaceutical companies in Korea to the global level, patients will have greater rights and access to generics without having the need to pay for expensive original drugs. Korea’s pharmaceutical industry “New drug patents cause market monopoly side effects...a legislation is needed” The Korean pharmaceutical industry is concerned that the current patent law in Korea grants too wide a right for new drugs patent term extensions, which has caused the unexpected side effect of guaranteeing market monopoly. The industry has been arguing that legislation should be enacted as soon as possible to limit the new drug patent term extension period to no more than 14 years from the date of approval, and to stipulate the number of patent rights that can be extended for a single new drug as a singular number in order to eradicate the side effects of market monopoly and foster the domestic health and pharmaceutical industries. In particular, their logic is that if the regulations to protect unreasonable patent extension rights for new drugs are improved, the launch of quality generics will be accelerated, expanding the public's choice of medicines while saving healthcare finances. The domestic pharmaceutical industry's position is that international harmonization of the regulations with those of the U.S. and Europe is also needed to allow only a singular patent extension for a single new drug. The current system that allows multiple patent extensions puts too much pressure on pharmaceutical companies that seek to launch generics early by forcing them to bear litigation costs and long litigation periods until the final invalidation ruling. A Korean pharmaceutical industry official said, “Korea’s patent law has strongly protected the patent extension rights of new drug patent holders. This is the reason why the launch of generics is unreasonably delayed in reaching the market. We should adopt the U.S. and European regulations that limit the duration of the patent to 14 years, including the extension period, and limit the allowed number of extensions to a single patent.” “If the launch of generics by domestic pharmaceutical companies are delayed due to Korea’s stronger new drug patent protection laws than in developed countries, there is a greater risk of deteriorating public health finances,” the official said, adding, ” To invalidate multiple patent extensions, pharmaceutical companies bear the burden of litigation costs and endure a long time until the final invalidation ruling, which in result lacks practicality.”
- Policy
- Once-weekly Icodec nears approval in Korea
- by Lee, Hye-Kyung Nov 25, 2024 05:53am
- A once-weekly insulin drug for diabetics is close to being approved in Korea. According to the minutes of the Central Pharmaceutical Affairs Council meeting released by the Ministry of Food and Drug Safety (MFDS) on the 21st, the safety and efficacy feasibility of the basal insulin preparation was discussed. As a result of the deliberation, the council recognized the safety and efficacy of the preparations, based on which a risk management plan for hypoglycemia management will now be required. The drug being discussed was Novo Nordisk's Icodec, a fixed-dose combination of a once-weekly GLP-1 RA Ozempic (semaglutide, Novo Nordisk) contained in a pen at a ratio of 1 unit to 0.0029 mg. Icodec was developed as the first once-weekly formulation of basal insulin with potent hypoglycemic effects and had demonstrated non-inferiority to the existing once-daily formulation of basal insulin. The CPAC members noted that although Icodec’s clinical results in patients with type 1 diabetes were positive, there was a need for management to reduce hypoglycemic episodes. Patients whose blood glucose is not controlled with insulin and require insulin intensification therapy, which involves the addition of mealtime bolus doses of insulin, are at increased risk of increased injection frequency, hypoglycemia, and weight gain. Regarding such concern, a council member said, “Although the incidence of hypoglycemic episodes tended to be higher than in the control group, the safety profile was as expected for the basal insulin and there was no increase in hypoglycemic episodes over the entire study period. The management of hypoglycemic episodes with existing once-daily long-acting insulin formulations in practice is not a major concern and is manageable for the item under review.” In other words, as the drug’s clinical results showed that all patients did not have recurrent hypoglycemic episodes, the CPAC deemed the risk as manageable. There were also mentions about the convenience of once-weekly dosing versus lifelong injections. “A long-acting formulation would be very helpful in terms of patient convenience and adherence,” said another member, explaining that “This is similar to the use of long-acting osteoporosis medications that have extended dosing intervals.” In terms of improving adherence, some pointed out that the once-weekly injections would be of great benefit to patients. “While we agree with the safety and efficacy rationale, the risk of hypoglycemic episodes with this drug should be emphasized in the patient information leaflet to ensure that the risk of hypoglycemic episodes and risk mitigation measures are not overlooked in practice,” said an official. Regarding the same concern, another committee member commented “Fatty acid-binding long-acting peptide formulations are already available in the form of once-daily Tresiba, which has been used as basal insulin for about 10 years without any major issues.” “Overall, all members of the committee agree on the item’s safety and efficacy,” the CPAC chairman concluded, ”However, we would like to emphasize the need for caution for hypoglycemic episodes in the instructions for use submitted by the company.” Meanwhile, in July, the U.S. Food and Drug Administration (FDA) put Icodec's approval on hold, stating the need to address issues with the manufacturing process and labeling related to its type 1 diabetes indication.
- Company
- 'Altuviiio' for hemophilia A expected to be marketed in KOR
- by Eo, Yun-Ho Nov 25, 2024 05:53am
- 'Altuviiio,' a new once-weekly administered hemophilia A drug, is expected to be marketed in South Korea. According to industry sources, Sanofi-Aventis has recently submitted an application for approval of Altuviiio (efanesoctocog alfa). The Ministry of Food and Drug Safety (MFDS) granted this drug an Orphan Drug Designation (ODD) in May. Altuviiio recently received the 'Global Innovative products on Fast Track (GIFT)' designation. Altuviiio is the first hemophilia therapy to receive an orphan drug designation from the MFDS in South Korea other than a non-factor agent, which received the designation three years ago. Altuviiio is a first-in-class high sustained factor (HSF) therapy for hemophilia A. With once-weekly treatment, Altuviiio keeps hemophilia factor activity levels at over 40% and helps provide patients with a near to normal life. Following approval in the United States and Japan last year, it was approved in Europe this year. Benefits such as accelerated approval review and exemption from GMP facility inspection are granted when designated as an orphan drug. Additionally, drugs designated as a GIFT item undergo rolling review and receive an expert consulting through 1:1 support between the reviewer and the developer, allowing them to be marketed more quickly. Meanwhile, the efficacy of Altuviiio was demonstrated through the XTEND-1 global Phase 3 study. The study results demonstrated that the Altuviiio-administered group had a significant reduction of 77% in annualized bleeding rates (ABR) compared to a group with prior factor VIII prophylaxis. The average weekly factor VIII activity for the Altuviiio-administered group was over 40 IU/dL and they had shown levels of 15 IU/dL at 7 days. Also, Altuviiio demonstrated superior drug tolerance and antibody occurrence was not reported in the Altuviiio-administered group. The most common side effects of Altuviiio were headache, arthralgia, falling, and backache.
- Policy
- Academia requests reimb expansion for Perjeta, Verzenio
- by Lee, Tak-Sun Nov 25, 2024 05:53am
- Lymph node-positive patients will now be reimbursed for their use of the breast cancer drug Perjeta inj (pertuzumab, Roche). The reimbursement extension was requested by the relevant medical societies and will take effect in December. It is interesting to note that the new criteria for reimbursement of anticancer drugs were established based on the opinions of academic societies rather than pharmaceutical companies. The Health Insurance Review and Assessment Service recently issued a notice for the opinion inquiry on the amendment to the 'Details on the Application Criteria and Methods of Medical Reimbursement Benefits for Drugs Prescribed and Administered to Cancer Patients' notice. The amendment is set to take effect on December 1. The most notable change in the amendment is that the expansion of reimbursement benefits was being made at the request of academic societies rather than pharmaceutical companies. One such example is the breast cancer drug ‘Perjeta inj.’ Currently, the Perjeta-based combination as neoadjuvant combination therapy is being reimbursed for “locally advanced, inflammatory, or early-stage (>2 cm in diameter) HER2-positive breast cancer. However, in other countries, its use is also covered for lymph node-positive patients. In other countries such as the United States (FDA) and Australia (TGA), lymph node-positive patients are included in the indication, and the NCCN guideline recommends the regimen subject to the application as category 2A for cN1 or higher, and ESMO recommends the regimen as [I,A] for lymph node-positive patients. As a result, HIRA decided to set the reimbursement standard to include lymph node-positive patients because HER2-positive lymph node-positive breast cancer patients are at high risk of recurrence and need to improve survival with neoadjuvant chemotherapy, and pertuzumab-based neoadjuvant chemotherapy for lymph node-positive patients is a therapy with proven clinical benefit, being recommended in major guidelines such as NCCN and ESMO. The application for this reimbursement expansion was made at the request of the relevant academic societies. Perjeta is not the only drug to benefit from reimbursement expansions at the request of a medical society this time. Verzenio Tab will also be added reimbursement standards for use in combination with endocrine therapy. It, in combination with endocrine therapy, will be approved as adjuvant treatment for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, lymph node-positive, early-stage breast cancer at high risk of recurrence. This regimen was mentioned in the textbook as an effective agent for hormone receptor-positive, HER2-negative, lymph node-positive, high-risk recurrent early breast cancer and is recommended as category 1 in the NCCN guidelines (2024. v.1.). As the combination demonstrated a significant difference in IDFS (invasive disease-free survival) compared to the group that received an alternative, endocrine monotherapy, HIRA set its reimbursement standard to grant 'Anastrozole, Letrozole, Exemestane, Tamoxifen ± LHRH agonist' partial co-insurance (5/100) and ‘Verzenio’ no co-insurance (100/100, full out-of-pocket cost) within the scope of Verzenio’s indication.. In addition, the new drugs ‘Qarziba Inj’ and ‘Vyxeos liposomal Inj’ have been added to the reimbursement list among anticancer drugs. In addition, a benefit expansion for ‘Trisenox Inj’ (induction of remission and consolidation in patients with newly diagnosed low-risk (white blood cell count ≤10×109/L) acute promyelocytic leukemia) was added. In addition, for the ‘Braftovi+Erbitux’ combination therapy, reimbursement was additionally approved as a biweekly treatment for previously untreated patients with BRAF V600E-mutant metastatic colorectal cancer. Currently, only the weekly regimen was granted reimbursement.
