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- 2026-04-08 03:35:27
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- Hanmi files phase 1 FDA IND for their next-gen obesity drug
- by Son, Hyung-Min Apr 03, 2024 05:50am
- Hanmi Obesity Pipeline. Hanmi Pharmaceutical announced on the 1st that it submitted an investigational new drug (IND) to the U.S. FDA on March 29 for its triple-agonist (HM15275), a next-generation obesity drug. Its IND includes a trial goal to assess drug tolerance, pharmacokinetics, and pharmacodynamics of HM15275 in healthy adults and patients with obesity. Hanmi aims to commercialize HM15275 by 2030. On February 29, Hanmi submitted an IND to the Ministry of Food and Drug Safety (MFDS) in Korea and is actively pursuing clinical development. HM15275 is optimized to bind to glucagon-like peptide-1 (GLP-1), gastric inhibitory peptide (GIP), and glucagon (GCG). It is anticipated that HM15275 will have an ‘effect of weight loss of 25% weight loss with minimal muscle loss.' Hanmi plans to present several accounts of their major research results at the 2024 American Diabetes Association (ADA) conference, which is scheduled for June in the United States. At the conference, Hanmi will present the best-in-class potential and the mechanisms of action (MOA) of HM15275 in effective weight loss in obese model. Additionally, the company will present results demonstrating the efficacy of HM15275 in various cardiovascular diseases model, which is known as one of the major causes of obesity. Choi In-young, head of Hanmi Pharmaceutical's R&D Center, emphasized, “Hanmi has been continuously building innovative potential in the field of ‘obesity,’ a globally recognized social issue, based on our R&D capacity in the metabolic syndrome sector for a long period.” And added, “Hanmi is committed to pursuing R&D innovations with passion and tenacity to enhance the pharmaceutical power.” According to the WHO report published in the international research paper Lancet, as of 2022, the world's obese population is over 1 billion, more than double the number since 1990. If current trends continue, it's estimated that the world's obese population will reach 1.9 billion by 2035.
- Company
- Pharmas face sales challenges and rebate monitoring
- by Son, Hyung-Min Apr 03, 2024 05:50am
- As the ongoing feud between the medical community and the government over the medical school quota continues, the pharmaceutical industry faces the full impact. In addition to major hospitals, outpatient clinics have shortened working hours, making it difficult for some pharmaceutical company employees even to meet medical professionals. Sales and marketing department employees express concerns about the immediate impact on performance. Industry sources reported on April 2 that the Korean Medical Association (KMA) has decided to shorten doctors’ working hours in outpatient clinics to 40 hours per week. Starting April 1, outpatient clinics will voluntarily shorten their working hours for late nights and weekend visits. Starting April 1, professors at 20 medical schools nationwide will begin a 24-hour continuous shift followed by a day off for daytime work the next day. This is a follow-up measure after the Medical School Professors Association of Korea sent a letter to the heads of major hospitals nationwide, urging them to adhere to the 52-hour workweek for professors. The pharmaceutical industry anticipates a decrease in sales and revenue…”Events have been cancelled...Challenges in detailing marketing” With medical professionals' working hours shortened, the pharmaceutical industry is expected to face significant disruptions. Asan Medical Center in Seoul is reported to have banned pharmaceutical company employees from entering to prevent disruptions, and there is speculation that other major hospitals may follow. Even if hospital entry is permitted, it is said to be extremely difficult for pharmaceutical employees to meet with medical professionals. “Since the medical feud began, we have been unable to meet with medical professionals at university hospitals. Even outpatient clinics are asking us not to make visits,” a sales employee in the Korean pharmaceutical industry said. “Not only finding new clients but maintaining sales with existing clients has become challenging,” he added. “The impact on sales will be lessened for large pharmaceutical companies as they have original products and are conducting co-promotions. Currently, only the big pharmaceutical companies can conduct detailing marketing targeting medical professionals,” he added. “Smaller pharmaceutical companies need to sell generic drugs to improve profitability, but it is challenging to schedule appointments with medical professionals to conduct detailing marketing.” “I’m uncertain about the second quarter, but it’s possible that some companies may experience a decrease in sales profits by the second half of the year,” he said. In addition to domestic pharmaceutical companies, global pharmaceutical companies that have entered the Korean market also express concerns about the medical gap. As they supply medications such as anticancer drugs, orphan drugs, and biologics needed for severely ill patients, consulting with medical professionals is essential. However, those companies are also experiencing difficulty in arranging meetings. The analysis suggests that especially with the cancellation of conferences and subcommittee meetings scheduled for February and March, opportunities for product promotion have diminished. “Scheduled meetings related to clinical trials are moving forward, but the majority of symposiums and conferences are being cancelled,” a sales employee of the global pharmaceutical company said. “We are concerned about the cancellations of scheduled events. It is a difficult time for everyone, but we hope that agreements can be reached between the medical community and the government,” he added. Medical device and therapeutic material companies are also in crisis. With a decrease in the number of surgeries due to medical gaps, a decline in revenue is inevitable. “With delayed payments and a significant decrease in the number of surgeries in major hospitals, we have observed a significant drop in revenue compared to the same period last year. The discontinuation of surgeries is the biggest issue," an employee of the medical device company said. "The impact on consumable sales is greater than on equipment sales. With fewer surgeries, the usage of therapeutic materials has decreased by more than half. If this situation continues for a month or two, the company's future will be concerning," he added. The government is conducting intensified tax audits…Pharmaceutical industry faces ‘triple hardships’ with having to submit expenditure reports Analysis suggests that pharmaceutical companies will face increased pressure due to intensified rebate monitoring and the requirement to submit expenditure reports. The government has announced intensified monitorings on pharmaceutical company rebates until May. The Ministry of Health and Welfare (MOHW) is operating a focused reporting period for pharmaceuticals and medical device rebates until May 20. Through this focused reporting period, the MOHW aims to encourage voluntary reporting and uncover rebates. The government is reportedly implementing a focused reporting period for illegal rebates in response to suspicions of pharmaceutical company employees being recruited for doctor rallies. However, there is a prevailing view that it primarily targets pharmaceutical companies. Currently, the government is conducting intensified tax audits targeting some domestic pharmaceutical companies. Additionally, the government also discloses economic benefit expenditure reports from pharmaceutical and medical device suppliers for academic conference support and participation in product briefings. Last month, the MOHW announced guidelines for disclosing expenditure reports and conducting investigations. The economic benefit expenditure report includes details of financial benefits provided by pharmaceutical and medical device industries to medical professionals to enhance transparency in drug and medical device transactions. The economic benefit expenditure report for the previous fiscal year will be published in December of this year. “Amid the intensifying conflict between the medical community and the government, we are facing a triple hardships of intensified tax audits, declining sales and operating profits, as well as disclosure of expenditure reports,” a domestic pharmaceutical industry employee said. “While the government is pressuring the medical sector to gain advantageous positions in negotiations, the adverse effects are impacting the pharmaceutical industry,” he added. "While a decline in sales is anticipated, there should be no issues with expenditure reports or rebate problems unless they are fabricated or illegal," another domestic pharmaceutical company employee stated. “We hope hospitals and the pharmaceutical industry can overcome this crisis together.”
- Company
- Pfizer expands co-marketing partnership deals
- by Son, Hyung-Min Apr 03, 2024 05:50am
- Pfizer Korea will co-market 2 blockbuster autoimmune disease drugs with a local drug distributor Hanlim MS. Pfizer has signed copromotion deals with Jeil Pharmaceutical, Donghwa Pharm, and Chong Ku Dang, but this is the first time the company has signed a co-marketing partnership deal with Hanlim MS. The company explained that it decided to partner with Hanlim MS because it owns various capabilities in distribution and supply in the field of autoimmune disease treatment. Autoimmune disease treatment Enbrel According to industry sources on the 3rd, Pfizer announced that it will co-market its autoimmune disease drug Enbrel with Hanlim MS. This is the second agreement the companies have made, following the co-marketing agreement of Janus kinase (JAK) inhibitor Xeljanz in January. Previously, Pfizer distributed and marketed both drugs directly, and this is the first time the company decided to comarket the two drugs. Pfizer has continuously been forging co-promotion partnerships with domestic pharmaceutical companies. It is comarketing the antidepressant Pristiq Donghwa Pharm, and the pneumococcal vaccine Prevenar with Chong Kun Dang. Viatris, which was spun off from Pfizer in 2020, is selling Lipitor, Celebrex, and Lyrica with Jeil Pharm. However, 2 autoimmune disease drugs will be sold by Hanlim MS, a subsidiary of Hanlim Pharm. Pfizer is said to have positively evaluated the synergies in terms of business strategy with Hanlim MS's nationwide distribution network. Hallim MS is a direct pharmaceutical distributor Hanlim Pharm established through a spin-off in 2008. Hallim MS generates 100% of its revenue from product sales. The company has been recognized for having a nationwide distribution network with many years of accumulated know-how since establishing an internal sales organization in 2010. This year, Hanlim MS has upscaled its rheumatology business unit to a division level and started to expand its business in earnest. Pfizer Korea had signed a comarketing agreement with Hanlim MS for Xeljanz in January last year Hanlim MS has been expanding its business in various other sectors in addition to pharmaceuticals. In 2022, Hanlim MS signed a memorandum of understanding with OpenM, a medical device company, and FNA Medical, a medical device wholesaler, for ‘OpenCast (cast).’ In 2021, Hanlim Pharm also secured the domestic sales rights for an Eylea biosimilar, a macular degeneration treatment, with Altos Biologics, a subsidiary of domestic biotech company Alteogen. Alteogen is currently conducting a global Phase III clinical trial for its candidate drug. Pfizer Korea said, “Hanlim MS owns a broad range of capabilities and know-how in distribution and supply of pharmaceuticals including immune-mediated inflammatory disease therapies, and has a long-standing partnership with rheumatologists, so we expect our partnership to bring great synergies.”Sales of Enbrel-Xeljanz on a decline...will the partnership with Hanlim MS bring synergistic effect Pfizer Korea plans to expand sales through the co-marketing agreement with Hanlim MS. Currently, sales of Enbrel and Xeljanz are declining due to the emergence of competing products. Enbrel, which was approved in Korea in 2003, has 6 indications - adult rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis, radiographically unidentified axial spondyloarthritis), psoriasis, and juvenile idiopathic arthritis. However, its sales have been on a decline due to the rise of biosimilars and additional biologics. According to market research firm IQVIA, Enbrel's sales have declined for 5 consecutive years after posting sales of KRW 12.9 billion in 2019. Last year, the drug failed to reach the KRW 10 billion sales mark and posted KRW 9 billion in sales. Companies that have launched biosimilars have been steadily gaining a bigger slice of the market pie. LG Chem's Eucept posted sales of KRW 4.4 billion last year, up 8.8% year-on-year. Its sales volume has been gradually increasing since posting KRW 1.2 billion in 2019. Samsung Bioepis' Etoloce’s sales dropped 13.8% from KRW 4 billion in 2022 to KRW 3.5 billion last year. Etoloce has consistently recorded sales of more than KRW 3 billion since 2019. In addition to Enbrel, sales of Xeljanz, which is being jointly sold by Pfizer Korea and Hanlim MS, have also been on a decline. Xeljanz was the first oral JAK inhibitor approved for the treatment of rheumatoid arthritis and was approved in South Korea in 2014. It is currently approved for the treatment of rheumatoid arthritis, ulcerative colitis, psoriatic arthritis, ankylosing spondylitis, polyarthritis, juvenile idiopathic arthritis, and juvenile psoriatic arthritis. However, sales of Xeljanz have been declining due to the emergence of competitors such as Rinvoq, Olumiant, and Jyseleca. Last year, Xeljanz generated sales of KRW 12.9 billion, down 4.4% from 2022. This is the third consecutive year of declining sales for Xeljanz, after posting KRW 16.2 billion in 2020.
- Company
- Kukje Pharm and Celltrion will comarket Eylea biosimilar
- by Nho, Byung Chul Apr 03, 2024 05:50am
- Celltrion CEO Young-ho Yoo (left) and Kukje Pharm CEO Tae-hoon Nam is posing for a commemorative photo after signing the MOU. By taking in Celltrion's Eylea biosimilar, Kukje Pharm has further strengthened its position in the domestic ophthalmic disease treatment market. On the 2nd, Kukje Pharm announced that it has entered into a strategic marketing partnership agreement with Celltrion to commercialize CT-P42 (Eylea biosimilar, aflibercept), an ophthalmic retinal disease treatment developed by Celltrion, in Korea. Under the agreement, Celltrion will exclusively distribute CT-P42 in Korea to Kukje Pharm, and Kukje Pham will provide patients with access to the high-quality biologic drug in Korea by taking charge of its domestic sales and distribution as soon as CT-P42 is approved by the Ministry of Food and Drug Safety in Korea. Eylea, which was developed by the US company Regeneron, binds to vascular endothelial growth factor (VEGF) receptors and inhibits neovascularization. It is used to treat ophthalmic retinal diseases such as neovascular (wet) age-related macular degeneration, diabetic macular edema, macular edema following retinal vein occlusion, and vision impairment due to choroidal neovascularization by Among them, wet macular degeneration causes abnormal new blood vessels to grow underneath the macula, which expands and can produce hemorrhage, edema, and damage to the retina and macula, leading to decreased vision and even blindness. It has recently been recognized as one of the top 3 causes of blindness in people over 65 years of age. Eylea’s annual global market sales amount to approximately USD 1.3 billion and is about KRW 97 billion in Korea and sales with the growing number of patients with macular degeneration. Kukje Pharm already has a diverse product lineup in the field of ophthalmic disease treatments and has recently established itself as a strong player in the ophthalmic disease market with the successful launch of its new and improved drug ‘Reba-eye Eye Drops'. The partnership is expected to enhance the company's competitiveness in the market by adding the Eylea biosimilar to its existing lineup of various ophthalmic disease treatments, including Reba-eye Eye Dropgs, Cualone Eye Drops, and Retium Tab. Both companies expect the partnership to provide patients with broader treatment options in the domestic ophthalmic disease therapeutics market. A Kukje Pharm official said, "This agreement further strengthens our position in the ophthalmic therapeutic area and enables us to provide patients with more effective treatment options through the domestic sales of CT-P42. We plan to leverage our company’s existing marketing and distribution network to ensure the successful launch of CT-P42."
- Policy
- Novartis’ 'Ilaris' will be reconsidered for the DREC review
- by Lee, Tak-Sun Apr 03, 2024 05:50am
- Novartis The rare disease drug 'Ilaris Injection (canakinumab, Novartis Korea)' will be reconsidered for review by the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA) after two months. Ilaris is a drug used to treat a rare disease called 'periodic fever syndromes (PFS)' for which there are ten patients in South Korea. The drug received domestic approval in August 2018 but has not cleared the reimbursement hurdle. According to industry sources on the 2nd, Ilrais is anticipated to be reconsidered for review by the DREC, which is scheduled for April 4th. According to industry sources on the 2nd, Ilaris will be reconsidered for review by the DREC. In the DREC held in February, the drug was recognized for appropriateness of reimbursement under the condition of submitting additional documents. The DREC decided Ilaris has reimbursement appropriateness for indications in ▲Cryopyrin-Associated Periodic Syndromes (CAPS) ▲Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) ▲Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) ▲Familial Mediterranean Fever (FMF) ▲Active Systemic Juvenile Idiopathic Arthritis (SJIA). However, the DREC required the submission of CAPS, TRAPS, and FMF documents. Yet, Novartis failed to submit related documents within the deadline, so the decision on the appropriateness of reimbursement was postponed. Novartis has requested reevaluation and will be reviewed by the DREC again after two months. Ilaris is an IL-1 inhibitor recommended for the treatment of periodic fever syndromes (PFS) by international guidelines. It is the only drug to receive approval for this treatment from South Korea, the U.S. FDA, and the European EMA. With clinically proven treatment effectiveness and safety, Ilaris is covered by reimbursement in 30 countries. However, Ilaris faced challenges in acquiring reimbursement coverage in South Korea. Its attempts to secure reimbursement were unsuccessful in 2017 and 2022. Now, Ilrais is being considered for the third time. Patients strongly demand reimbursement coverage for the drug, which is highly priced at KRW 20 million per administration. The patients’ families have posted a petition for Ilaris reimbursement listing on the government’s online petition website called, Cheongwon24. Attention is focused on whether the drug will receive the reimbursement appropriateness decision from this DREC review and proceed to the drug price negotiations with the National Health Insurance Service (NHIS). If negotiations for drug pricing succeed, Ilaris will be covered by reimbursement.
- Company
- K-Bio accelerates solid cancer trials with ‘new MOA’ CAR-T
- by Son, Hyung-Min Apr 02, 2024 05:54am
- The Korean pharmaceutical and biotechnology industry aim to introduce solid cancer-targeting CAR-T with new mechanisms of action (MOA). Chimeric antigen receptor T (CAR-T) cell therapy is an immune cell therapy for cancer treatment designed to deliver genetic material to T cells to produce the CAR in patients. CAR-T has not been approved for indications in solid cancer because the tumor microenvironment, such as fibroblasts in tumor tissues, limits T-cell modifying CAR-T from T-cell infiltration, posing barriers to discovering target antigens. All of the commercialized treatments, including Novartis’ Kymriah, Gilead Science’s Yescarta, and BMS’ Breyanzi, have been approved for blood cancers. To overcome these challenges, Korean companies are developing differentiated strategies, such as targeting mesothelin that can adhere to the cells and aid in signaling or new technology platforms. According to industry sources on the 29th, HK inno.N, GC Cell, AbClon, and Vaxcell-Bio are conducting clinical trials for CAR-T therapy to treat solid cancer. HK inno.N. HK inno.N and CellabMED, a Korean biotechnology company, are developing CAR-T therapy for treating solid cancer. Earlier this month, these companies signed a joint-research agreement to collaborate on new drug development throughout all phases, including research, production, and business development. CellabMED, a biotechnology company, specializes in developing innovative anticancer drugs based on antibody therapy and CAR-T therapy. The company’s CLM-103, a candidate CAR-T targeting glioblastoma, has received IND approval to target solid cancer for the first time in South Korea. HK inno.N is developing CAR-T therapy using T-cells expressing an antibody that inhibits the immune gateway factor ‘HLA-G’ as their inhouse research. HLA-G overexpression on certain cancer cells can disrupt the immune system in the body. HK inno.N’s CAR-T therapy has been selected as a national drug development support project, and it aims to start clinical trials. GC Cell. GC Cell is developing a CAR-T therapy targeting MSLN (mesothelin), primarily overexpressed in solid tumors. Mesothelin is gaining attention as a target for cancer antigen, with expression rates of 85-90% in mesothelioma, 80-85% in pancreatic cancer, and 60-65% in ovarian cancer and lung cancer. In preclinical studies, GC Cell confirmed the anticancer activity in experiments targeting pancreatic cancer tissue transplanted animals. Additionally, no side effects related to the target or non-tumor toxicity were observed. AbClon. AbClon is developing a candidate CAR-T therapy, AT501, for patients with solid tumors. AT501 is a switchable CAR-T therapy candidate targeting HER2-positive solid tumors. AbClon's in-house research has developed this therapy by applying existing CAR-T technology to a switch molecule that combines an artificial protein binding to HER2-responsive specific targets and cotinine. AbClon has developed the switchable CAR-T platform (zCAR-T). It is a next-generation technology that uses cotinine switch molecules to regulate CAR-T activity, addressing issues found in conventional therapies, such as toxicity, resistance, and disease expansion. According to the company, the zCAR-T platform is an improved technology that requires switch molecules to attack cancer cells rather than developing CAR-T cells that directly target specific proteins on the surface of cancer cells. This approach has the advantage of activating and proliferating CAR-T cells and altering target molecules using switch molecules. Vaxcell-bio. Vaxcell-bio is developing ‘VaxCAR2301.’ It is a novel candidate CAR-T therapy that simultaneously targets PD-L1 and EphA2. According to the company, when using the single-chain antibody fragment (scFv) of the immune checkpoint inhibitors avelumab and atezolizumab, which target PD-L1, in immune cell production, either non-dissociation or slow dissociation after cancer cell death can occur, resulting in excessive cytokine storms. The company addressed this issue by reducing the affinity of the antigen-binding site, which binds to antibodies, to a moderate level. In preclinical studies, VaxCAR2301 demonstrated a CAR expression rate reaching 78% in CD8-positive cytotoxic T cells. This is significantly higher than the 58% for avelumab CAR-T and 45% for atezolizumab CAR-T. Additionally, treatment with VaxCAR2301 led to controlled tumor size, rapid weight recovery, and an extended survival period until the end of the experimental observation.
- Policy
- 3 more successful Zolgensma treatment cases reported…
- by Lee, Tak-Sun Apr 02, 2024 05:54am
- Zolgensma, a one-shot treatment for spinal muscular atrophy (SMA), is demonstrating a high effect post-reimbursement. The government has been conducting a post-marketing performance evaluation on the drug since its reimbursement in August 2022, and so far, there has been only 1 case of failure reported after its use. The drug costs about KRW 2 billion per dose off-label, but the patient's out-of-pocket cost for the single dose has been lowered to a maximum of KRW 5.98 million (applied the 10% co-payment rate) with insurance reimbursement. According to the performance evaluation results on Zolgensma Inj that were released by the Health Insurance Review and Assessment Service on Sept. 29, all the 3 patient cases reported showed significant improvement. A 20-month-old boy, a 2-month-old girl, and a 2-month-old boy who received treatment with Zolgensma all showed an increase in motor function test scores. As a result, HIRA concluded that a significant improvement occurred after the drug’s administration. Patients who receive Zolgensma are required to be clinically evaluated before administration and every 6 months thereafter for up to 5 years. Objective data such as medical records on the patient need to be submitted to HIRA for clinical evaluations. Failure is defined as a) use of permanent ventilation or death; b) when the CHOP-INTEND score does not improve by at least 4 points from the pre-dose baseline; or c) even if the improvement stated in b) is achieved, the CHOP-INTEND score decreases by at least 4 points or HFMSE decreases by at least 3 points in 2 consecutive response evaluations. However, there has only been 1 case of failure among the performance evaluations disclosed by HIRA so far. The single treatment failure case of a 2-year-old girl was released in the first evaluation data that was disclosed in June of last year. At the time, the patient had respiratory problems due to SMA and died of acute respiratory failure. Other than the single case, patients in all of the other presented outcomes have shown significant improvement. 19 of the 20 cases in the 4 published reports to date have shown meaningful improvement. Zolgensma is evaluated to be superior to its alternative – the intrathecal injection alternative Spinraza (nusinersen) - in terms of administration method, and superior in event-free survival and motor function achievement when indirectly compared to its alternative in patients with rapidly progressive SMY Type 1 patients. Despite its very high price of KRW 2 billion, the drug is proving to be effective, justifying its reimbursement coverage.
- Policy
- Oppo parties also promise 'drug price system reform'
- by Lee, Jeong-Hwan Apr 02, 2024 05:54am
- Following the ruling party’s pledge, the opposition parties also announced their general election pledges to promote Korea’s growth into a pharma-bio powerhouse, by investing in research and development (R&D) and preparing customized drug pricing systems for the global entry of Korea’s new drugs, heralding their intent to foster and develop Korea’s domestic industries. Both the ruling and opposition parties largely accepted most of the policy proposals submitted by the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, therefore, changes in the pharmaceutical and bio-regulatory administrations and drug pricing policies are expected after the 22nd general election. The following is a summary of the pharmaceutical and bio sector-related policy pledges made by the Democratic Party of Korea in its general election policy manifesto on the 29th. First, in response to KPBMA’s request for the government to strengthen Korea’s R&D environment to become a global key player, the DPK promised to expand national investment and lay the foundation for Korea’s rise into a pharmaceutical bio powerhouse. However, unlike the People Power Party, DPK’s vision is to create a national investment system linked to strengthening the social responsibility of pharmaceutical companies. The DPK also promised to establish a strategic R&D investment system and strengthen outcome-based support, and this is in line with the KPBMA’s request to expand government R&D investment and support the development of blockbuster new drugs. In particular, the DPK also promised to reform the drug pricing system suitable to new drugs seeking to enter the global market. They also pledged to establish a drug price compensation system connected to innovative pharmaceutical companies and their R&D investment rates. It is also expected to affect the drug pricing system for incrementally modified new drugs and generic drugs that serve as a cash cow for new drug development. To address the issue of drugs that have long-term unstable supply, the DPK pledged to establish a public pharmaceutical company and drug distribution corporation, and the opinion on the pledge remains controversial. Proponents argue that the policy would increase the level of state control over out-of-stock drugs, while opponents argue that it would be inefficient and impractical to establish a separate public pharmaceutical company instead of using existing pharmaceutical companies that own the infrastructure. The DPK plans to improve the supply stability of essential medicines and improve the production and investment environment by stockpiling and supporting the establishment of drug production facilities that manufacture essential medicines and drug shortage prevention drugs. The KPBMA called for the establishment of a national measure to realize self-sufficiency of drug substances, and the DPK pledged to expand incentives for drugs using domestic raw materials and support the development of technology for the localization and self-sufficiency of essential medicines and vaccines. Lastly, the DPK’s pledge to build a public big data platform for new drug development and support the utilization of AI is also regarded to be in the same line with the KPBMA’s policy proposal on fostering a digital innovation ecosystem for the pharmaceutical and bio-industry, including the utilization of advanced AI and big data.
- Company
- PharmaEssentia reattempts reimb of BESREMi in Korea
- by Eo, Yun-Ho Apr 02, 2024 05:53am
- PharmaEssentia is again attempting to list BESREMi, its new drug for polycythemia vera (PV), for reimbursement in Korea. Dailypharm’s coverage found that the Taiwanese pharmaceutical company PharmaEssentia has recently resubmitted an application for the reimbursement of BESREMi (Ropeginterferon alfa-2b) in Korea. The company had submitted an application for the reimbursement of its drug in March last year as a treatment for patients with polycythemia vera resistant or intolerant to hydroxyurea but failed to clear the hurdle of Korea’s Health Insurance Review and Assessment Service’s Cancer Disease Review Committee in July of the same year. At the time, the CDDC determined that there was insufficient evidence to determine the clinical usefulness of BESREMi as a second-line treatment. This time, PharmaEssentia included additional domestic clinical data on BESREMi to supplement the drug’s evidence of efficacy as a second-line treatment. As 50,000 people signed the National Assembly’s public petition requesting the ‘reimbursement of BESREMi’ in February, whether the drug will be reimbursed this time is gaining more attention. BESREMi is a next-generation interferon treatment that selectively removes JAK2 mutations that cause polycythemia vera. It offers an improved purity and tolerability over existing interferons so that it can be administered every 2 weeks for the first 1.5 years and every 4 weeks thereafter. Currently, BESREMi is recommended for the treatment of PV in the National Comprehensive Cancer Network (NCCN) and European Leukemia Network (ELN) guidelines, regardless of prior treatment history. Polycythemia vera is a rare blood disorder where a somatic cell mutation in the bone marrow abnormally activates bone marrow function and produces excessive red blood cells. According to HIRA data, around 5,000 patients are affected with PV, and hydroxyurea is used for the majority of patients. However, the current reimbursed drugs cannot cure PV, and no new alternatives exist for patients who fail treatment with hydroxyurea, leaving the patients with a high unmet need.
- Policy
- Price reduction dilemma for 'Forxiga' set for withdrawal
- by Lee, Tak-Sun Apr 02, 2024 05:53am
- 'Forxiga tab (dapagliflozin, AstraZeneca),' a diabetes treatment that was announced to be withdrawn from the Korean market in the second quarter of this year, has failed to reach an agreement in the price-volume agreement (PVA). Initial negotiations fell apart, so the company is likely to attempt renegotiation. The company hopes to maintain a high drug price before withdrawing Forxiga from the Korean market because other countries reference drug pricing in Korea. According to the industry on the 1st, AstraZeneca Korea negotiated with the National Health Insurance Service (NHIS) for Forxiga’s price-volume agreement (PVA), but they failed to reach an agreement. As a result, AstraZeneca has requested renegotiation. When a pharmaceutical company requests renegotiation for a drug that has not met prior negotiations, it can seek approval for reimbursement by the Drug Reimbursement Evaluation Committee (DREC). Based on the DREC decision, the drug is excluded from subjecting to the reimbursement coverage, or the Ministry of Health and Welfare (MOHW) can mandate a renegotiation once. Forxiga is expected to be considered by the DREC review scheduled for the 4th. Depending on the DREC decision, it may either be excluded from reimbursement or start renegotiations with the NHIS. It seems highly probable that there will be a renegotiation. Forxiga’s upper limit price remained the same before generics entered the market. With generics entering the market last May, the price was expected to reduce by 30%. Due to the court’s suspension of execution, the Forxiga price is maintained at 734 won per tablet. The drug pricing reduction execution is suspended until June 30. It appears that the company may have objected to reducing drug prices through the PVA program. “As other countries reference drug prices in South Korea, it may be necessary to maintain high drug prices in South Korea to continue sales in other countries despite withdrawing from the Korean market,” the industry official explained. As Forxiga would be excluded from reimbursement coverage if an agreement for the upper limit price is not reached during the PVA renegotiation, it is to be watched what decision AstraZeneca makes. Depending on the outcome, Forxiga may be withdrawn in the first half of the year. Despite generics entering the market following the patent expiry of Forxiga last year, Forxiga has recorded an outpatient prescription amount of KRW 55.5 billion, according to UBIST. About 60 generic companies have introduced blockbuster drugs following Forxiga’s patent expiration last April. Affected by generic market entries, AstraZeneca Korea has decided to withdraw from the Korean market in the second half of the year.
