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- 2026-05-01 00:25:42
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- Jardiance generics prepare for final launch in Korea
- by Kim, Jin-Gu Sep 30, 2024 05:47am
- Generic companies are in the midst of last-minute preparations to enter the market for the SGLT inhibitor diabetes drug Jardiance (empagliflozin), which is set to expire in just about half a year. With Forxiga’s market withdrawal expected to leave an annual sales gap of KRW 50 billion, the race to fill this gap is expected to intensify among the generic companies. Generic companies seek to avoid Jardiance’s crystalline form patent 8 years later…are they eyeing Forxiga’s gap? According to industry sources on the 26th, Hanmi Pharmacuetical and KyungDong Pharm recently won the passive trial to confirm the scope of Jardiance’s crystalline form patent (10-1249711). In the case of Hanmi Pharmaceutical, it succeeded in avoiding Jardiance’s crystalline patent a step later than other companies. More than 50 companies, including Chong Kun Dang, have challenged Jardiance’s crystalline form patent since 2018 and won their first trial between 2019 to 2021. Hanmi Pharmacuetical had also filed to invalidate the same Jardiance’s patent in 2015 but hadn’t made much action since losing the first trial the following year. Even when the other companies filed a series of challenges to avoid the crystalline patent, Hanmi Pharmaceutical chose not to join in the race. However, in March this year, the company changed its course and again filed to avoid the crystalline patent. The company’s challenge comes 8 years later than the other companies. Like the other companies, Hanmi Pharmaceutical plans to launch its generic early, when the patent for Jadian expires in March next year. Some speculate that AstraZeneca’s decision to withdraw another SGLT-2 inhibitor, Forxiga, from South Korea, may have played a role in this. AstraZeneca Korea decided to withdraw Forxiga from the Korean market last December. Forxiga was the leading SGLT-2 inhibitor in the market until recently. With the market leader withdrawing from the market, industry insiders believe that the generic companies are seeking to target this void created by the withdrawal. In fact, prior to Hanmi Pharmaceutical, Daehwa Pharmaceutical, Medica Korea, Korea Prime Pharmaceutical, and Aprogen Biologics filed challenges to avoid the crystalline patent and launch their generic versions of Jardiance in March this year. All of these challenges were filed after AstraZeneca decided to withdraw Forxiga from South Korea. According to the market research institution UBIST, Forxiga’s prescription sales amounted to KRW 51 billion in 2022. Last year, its prescriptions grew 9% to KRW 55.5 billion, despite the launch of its generics upon Forxiga’s patent expiry. The rise in prescription sales was slightly slower this year, earning KRW 21.7 billion in the first half of the year. In Q2, the drug’s sales were overtaken by the combined prescription volume of its generics. As a result, the drug’s prescriptions are expected to decline in earnest in the second half of this year. AstraZeneca Korea plans to supply Forxiga domestically only until the first half of this year, and then distribute only the stockpiled amount. This means that from next year, a KRW 50 billion gap will remain unfilled in the market in earnest. Last-minute generic approvals also in full swing...companies expected to push ahead with launch despite unregistered patent risk Due to such circumstances, the domestic pharmaceutical companies' expectations for Jardiance’s generic market have also been growing ahead of the expiration of the product patent. Companies that have previously succeeded in avoiding Jardiance’s crystalline patent are in the midst of last-minute preparations, including receiving authorizations for their generics one after another. Only this month, GC Cross and Dongkwang Pharm received approval for their generic versions of Jardiance and Jardiance Duo. Including the two, there are now 53 companies that have authorized generic versions of Jardiance and Jardiance Duo. If Hanmi Pharmaceutical and Daehwa Pharmaceutical, which succeeded in avoiding Jardiance’s crystalline patent, also receive approval for their respective generic versions, the number of approved generic companies is expected to increase to 60. In other words, fierce competition among Jardiance generics is expected from March next year. The product patent for Jardiance will expire in March next year. Other than the product patent, the crystalline patent is the only patent registered in MFDS’s green list. Generic companies plan to avoid the crystalline patent and release generics early in line with the date of Jardiance’s substance patent expiry. Although there are still patents that have not been registered in Korea’s green list, most companies are expected to push ahead and launch their respective generics. In the case of Trajenta generics, most companies pushed ahead with their generic launches without fully addressing the risk of its unlisted patents.
- Company
- New myelodysplastic syndrome drug 'Reblozyl' lands Big 5 DC
- by Eo, Yun-Ho Sep 30, 2024 05:46am
- Product photo of Reblozyl. The treatment for myelodysplastic syndrome (MDS), 'Reblozyl,' is available for prescription at tertiary general hospitals. Sources said that Bristol Myers Squibb (BMS) Pharmaceutical Korea's Reblozyl (luspatercept) has passed all drug committees (DC) of the 'Big 5' medical centers, including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Seoul Asan Medical Center, and Sinchon Severance Hospital. However, Reblozyl is still non-reimbursable. The drug was not approved for reimbursement appropriateness at the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA), held August last year. It has not been updated since then. Reblozyl can be prescribed to treating ▲patients with very-low risk, low-to intermediate-risk MDS or myelodysplastic/myeloproliferative neoplasms with ring sideroblasts and thrombocytosis ▲anemia in adult patients with myeloproliferative neoplasms ▲patients with Beta Thalassemia who may need RBC transfusions. Reblozyl is for adults who have not responded well to an Erythropoiesis-Stimulation Agent (ESA) or may need red blood cell (RBC) transfusions. Reblozyl can be administered once every 3 weeks in patients with MDS or Beta Thalassemia at an initial dosage of 1.0 mg/kg. Reblozyl's mechanism works by binding to TGF-β superfamily ligands, thereby diminishing the overactivation of the Smad 2/3 pathway. The drug promotes erythroid maturation. The efficacy of Reblozyl was demonstrated through the Phase 3 MEDALIST study. During the 24-week follow-up period, the study results showed that 13% of the placebo group reached consecutive transfusion-free periods, whereas 38% reported in the Reblozyl group. During the same period, the percentages of patients who reached a transfusion-free period over 12 weeks were 8% for the placebo group and 28% for the Reblozyl group. Those for over 16 weeks were 4% for the placebo group and 19% for the Reblozyl group. Extending the follow-up period to 48 weeks, the percentages of patients who reached a transfusion-free period over 16 weeks were 7% for the patient group, whereas 28% for the Reblozyl group. Meanwhile, MDS is a type of malignant disease affecting blood stem cells in the bone marrow. It is a disease of the elderly, with higher occurrence in elderly over 60 years of age. MDS is characterized by immature blood cells and low counts of healthy white blood cells, red blood cells, or platelets in the peripheral blood. The most common adverse reactions are fatigue from anemia, systemic weakness, and loss of motor ability. Worsened anemia could cause palpitation, trouble breathing, chest pain, and the possibility of advancing to acute myeloid leukemia (AML). The clinical outcomes and the progress were found to be categorically diverse. There were cases of a stable life with slight anemia, but a case of death within a few months from complications associated with low counts of red blood cells or acute leukemia was reported.
- Company
- Phesgo can be prescribed in Korea with reimbursement
- by Eo, Yun-Ho Sep 30, 2024 05:46am
- Breast cancer biobetter ‘Phesgo’ can now be prescribed in general hospitals in Korea with insurance reimbursement. According to industry sources, Phesgo (pertuzumab/trastuzumab), which is a subcutaneous injection combination of Roche's Perjeta and Herceptin, has passed drug committees (DC) reviews of tertiary hospitals in Korea, including Samsung Medical Center and Seoul National University Hospital. As a biobetter drug, the drug has been reimbursed since August, being applied to the preferential drug pricing plan. Phesgo is a combination of Herceptin and Perjeta, drugs that were previously administered intravenously, into a single subcutaneous injection. The primary benefit of the change from an intravenous to a subcutaneous formulation is its reduced administration time. When treating HER2-positive breast cancer, the existing intravenous regimen required a total of 270 minutes (4.5 hours) for a single dose administration and observation. In the case of Phesgo, the treatment can be completed within 20 minutes as it requires 5 minutes of administration and 15 minutes of observation time, reducing the time by up to 90% compared to traditional therapy. The coinsurance rate of Phesgo was set at the same as for Perjeta: ▲30% when administered in combination with chemotherapy as neo-adjuvant therapy for patients with locally advanced inflammatory or early-stage (>2 cm in diameter) HER2-positive breast cancer; ▲100% when administered in combination as adjuvant therapy for patients who are HER2-positive and have lymph node-positive breast cancer (up to 18 cycles of trastuzumab and pertuzumab combination therapy); and▲5% when administered in combination for patients with metastatic or unresectable locally advanced recurrent breast cancer who are HER2-positive and have not received prior HER2 therapy or chemotherapy. In the Phase III FeDeriCa study that studied 500 patients with HER2-positive early-stage breast cancer, the Phesgo subcutaneous arm was found to be non-inferior to the trastuzumab and pertuzumab intravenous arms. In general, because intravenous and subcutaneous injections have different routes of administration, their anticancer effect is identified based on the trough level and the probability of being cancer-free at the time of surgery. In the case of Phesgo, there was no difference in the trough level according to the route of administration, and the anti-cancer effect and survival period of the two therapies were the same, offering added strength of convenience to the existing advantages. “In the FeDeriCa study, Phesgo subcutaneous injection demonstrated equivalent trough levels as intravenous trastuzumab and pertuzumab,” said Seock-Ah Im, Professor of hematology-oncology at Seoul National University Hospital. ”It provides convenience to both patients and healthcare providers by reducing treatment time while maintaining the effectiveness and safety of intravenous trastuzumab and pertuzumab.” Meanwhile, the insurance authorities have also decided to reimburse Phesgo through the risk-sharing agreement scheme, to save health insurance finances. This is because Phesgo’s development target product, Perjeta, is also currently covered by the risk-sharing agreement scheme.
- Company
- K-Phama companies are targeting Southeast Asia
- by Heo, sung-kyu Sep 27, 2024 05:53am
- Korean pharmaceutical companies target Indonesia to establish a bridgehead for Southeast Asia market entry. Companies have invested in Indonesia by buidling manufacturing plants. The government and associations are also in support. According to pharmaceutical companies on September 20th, pharmaceutical companies, the government, and organizations are quickly establishing collaborative partnerships with Indonesia. Recently, public-private representatives, including KPBMA, Ministry of Food and Drug Safety (MFDS), KIMCo, and 15 Korean pharmaceutical and biotech companies, have visited Jakarta, Indonesia, to seek collaborative business opportunities with Indonesian Food and Drug Authority (BPOM) and local companies. The collaboration between pharmaceutical companies and the government is critical because the industry has shown interest in entering the Indonesian market. Korean pharmaceuticals are showing intersts due the growth in Indonesia market and government's support for in-house pharmaceutical development. Indonesia's pharmaceutical and biotech market is expected to grow quickly from KRW 13 trillion in 2022 to KRW 18 trillion in 2026. The analysis suggests that population growth and increased intractable diseases, including cancer and degenerative brain diseases, from an aging society will contribute to such development. Furthermore, Indonesia is considered a hub for pharmaceutical R&D·production·consumption. It is the biggest pharmaceutical consumption market among the countries in the Association of Southeast Nations (ASEAN). Additionally, to target the "Halal Belt," which consists of approximately 1.9 billion people worldwide due to population growth in Muslim countries, the Indonesian market is considered as a bridgehead in response to the increasing demand for "Halal certification" for pharmaceuticals. For these reasons, Korean pharmaceutical companies are currently establishing joint-subsidiaries with local companies, building manufacturing plants, and out-licensing technologies, in addition to exports. In particular, countries that have already entered the market are experiencing the results. Korean pharmaceutical companies that have entered the market include Daewoong Pharmaceutical, Chong Kun Dang, GC Biopharma, SK Plasma, HK inno.N, Il Dong Pharmaceutical, and Daewon Pharm. For Daewoong Pharmaceutical, the stem cell factory in the Cikarang Javabeka Industrial Complex of Daewoong Biologics Indonesia, an Indonesian subsidiary, obtained GMP certification from the Indonesian BPOM and began full-scale operation. Since establishing a branch in Jakarta in 2005, Daewoong Pharmaceutical has steadily strengthened cooperation, including establishing a joint venture with Infion, Daewoong Infion, in 2012. These efforts are bearing fruit. Chong Kun Dang established Indonesia's first halal-certified anticancer drug production plant in 2019 after establishing a joint venture, 'CKD-OTTO,' with the Indonesian pharmaceutical company OTTO in 2015. In addition, the Indonesian joint venture is achieving success by exporting products from Indonesia to Algeria and other countries. GC Biopharma received final approval for the business license for blood product plant construction and technology transfer from the Indonesian BPOM, on June 1, 2023. The company works with the Indonesian Red Cross and local pharmaceutical company P.T. Triman to supply plasma for blood product processing and plant business. A three-party business agreement has been signed concerning this. GC Cell, an affiliate of GC Biopharma, has signed a partnership agreement with the Indonesian company 'Kalbe Farma' and entered into a technology transfer and out-licensing agreement for 'Immune Cell LCD', a patient blood-derived immune anti-cancer cell therapy. The launch is aimed for next year. SK Plasma received approval from the Indonesian BPOM in March last year to build a plasma fractionation plant that can process 1 million liters of raw plasma annually. The company plans to establish a factory in collaboration with the 'Indonesia Investment Authority (INA)' and take charge of factory operations, business rights, production, and sales. In addition to companies establishing factories, HK inno.N exports K-CAB, Daewon Pharm exports Pelubi CR tab, and Boryung exports Kanarb tab. The government also continues to provide support. On September 11th, the MFDS dispatched a pharmaceutical entry support team through a public-private partnership. The MFDS visited Korean pharmaceutical companies operating in Indonesia to discuss the current status and outlook of the Indonesian market, learn about their experience in the local market, and collect information on other difficulties. The effort to enter the Indonesian market will continue through collaboration among government bodies, such as the MFDS, organizations, and pharmaceutical companies.
- Company
- 'Treatment options for psoriasis are evolving'
- by Son, Hyung Min Sep 27, 2024 05:53am
- Dr. April W. Armstrong, Professor and Chief of Dermatology at the University of California Los Angeles (UCLA) David Geffen School of Medicine “In the field of psoriasis, the development of many biologics has been largely abandoned due to the lack of convincing data showing similar efficacy to marketed drugs. On the other hand, in the field of oral drugs, interest in the TYK2 mechanism has increased upon the introduction of Sotyktu, increasing the industry’s R&D on such oral drugs. I expect to see an active oral psoriasis treatment option development in the coming years.” Dr. April Armstrong, a professor at the David Geffen School of Medicine at UCLA, recently spoke to Dailypharm about her rising expectations in the future of psoriasis treatment upon the introduction of various psoriasis treatment options. Professor Armstrong is an expert in the field of psoriasis, having served as chair of the Medical Board at the National Psoriasis Foundation and co-president of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA). Psoriasis is a chronic, non-contagious skin condition with flare-ups and remissions, with an estimated prevalence of 3% in Korea and an estimated 1.5 million patients. It is characterized by narrow, rice-like red patches on the skin, covered with white dead skin cells, which can grow from the size of a coin to the size of the palm of your hand when the rash becomes aggravated. Psoriasis is categorized by clinical type, and in “plaque psoriasis, which accounts for 80 to 90 percent of all cases, the rash is shaped like a plaque. Psoriasis is not just a skin disease, but a systemic and persistent immunologic abnormality that is difficult to cure and requires long-term management. The goal of treatment for psoriasis is to improve the quality of life by improving skin lesions and controlling flare-ups and exacerbations while minimizing the side effects of medications and preventing the many systemic complications caused by chronic inflammation. A variety of treatment options have already emerged for psoriasis, including TNF-α inhibitors and interleukin (IL)-inhibitors. In addition, new oral therapies, such as BMS' Sotyktu, have emerged to target both therapeutic efficacy and patient convenience. Sotyktu is the first TYK2 inhibitor approved for moderate-to-severe plaque psoriasis in adults. Sotyktu is taken orally once daily, regardless of meals, with no dosage adjustments, expanding the patients’ options in a setting where biologics were the only treatment option available outside of the existing universal treatment. Professor Armstrong emphasized that Sotyktu brought the psoriasis treatment environment a step forward and that oral formulations could be the next big R&D trend. Introductino of Sotyktu...first oral treatment option to target TKY2 Sotyktu is a TYK2 inhibitor. TYK2 is an important link in the signaling pathway of IL-23, a cytokine known to play a key role in the pathogenesis of psoriasis. TYK2 mediates multiple cytokine pathways, such as IL-23, which in turn triggers the production of pro-inflammatory cytokines including IL-17 that promote keratinocyte proliferation and epidermal overgrowth, resulting in psoriasis. As a TYK2 inhibitor, Sotyktu selectively binds to the regulatory domain of TYK2 and blocks IL-23 signaling, thereby reducing the production of IL-23 and IL-17, which in turn reduces keratinocyte proliferation. “Patients with psoriasis have long suffered from a lack of adequate treatments, and only recently have started gaining access to moderately effective treatments,” said Professor Armstrong. However, there is still an unmet need. Healthcare providers need to ensure that patients have access to treatments that fit their preferences and lifestyle. Some patients may be uncomfortable with the idea of injections. Some patients avoid Injectable medications due to significant anxiety, such as fear of needles, in which case oral medications can be an alternative.” The introduction of Sotyktu expanded options for patients who have primarily been prescribed injectables. In addition to the clinical trial that became the basis of its approval, Sotyktu’s efficacy and safety were confirmed in recently published 4-year patient follow-up results. The study, named POETYK PSO-1,2, LTE, looked at the Psoriasis Area and Severity Index (PASI) 75 response rate and static Physician's Global Assessment (sPGA) 0/1 response rate from 52 weeks to 4 years in 513 patients who continuously received Sotyktu for 4 years. Results showed that 71% of patients treated with Sotyktu maintained PASI 75 over the 4 years, and 57% of patients achieved and maintained a high standard of “clear” and “almost clear” skin. “No new adverse events or signals were identified in the safety data collected over the 4 years,” said Professor Armstrong. The safety profile and tolerability seen in the parent study were well maintained in the Sotyktu arm.” “In terms of safety, Sotyktu was free of serious or major adverse events, including major adverse cardiovascular events, cancer, and venous thromboembolism. Also, the serious adverse events that may arise with the Janus kinase (JAK) 1/2/3 inhibitors, such as serious infections and psoriatic arthritis, were not reported with the use of Sotyktu.” Another strength of Sotyktu is that it is effective in Asian patients. In the PSO-3 study, which focused on Asian patients from Korea, China, and Taiwan, the PASI response rate was approximately 10% higher than that identified in the global study. “The superior data of Sotyktu identified in the Asian study may be due to the fact that Asians tend to weigh less than Westerners, as well as genetic differences,” explained Professor Armstrong. “The PSO-4 clinical data in Japanese patients showed a 76% PASI 75 rate and 83% sPGA 0/1 rate at Week 16.” “However, it should be noted that both PSO-3 and 4 trials were relatively small studies compared to global studies, and PSO-4 was a single-arm study in Japanese patients. Single-arm studies without control arms tend to show higher rates,” added Professor Armstrong. Increased psoriasis treatment options... broaden choices for patients Treatment options for psoriasis have expanded with the introduction of a variety of new drugs, including injectable and oral therapies. Various treatment options, which include IL-17, IL-23, TNF-α inhibitors, and Sotyktu, are all improving the quality of life for patients with psoriasis. However, Professor Armstrong suggests that the future trend in R&D for psoriasis treatments will likely shift toward oral agents. “With the introduction of Sotyktu, the development of biologics (injectables) in the treatment of psoriasis has gradually faded away,” said Professor Armstrong, ”Fewer new biologics are being developed, except for those that are nearing the end of development or have already been launched in other countries and are expected to be introduced to Korea.” According to Professor Armstrong, some biologics are under clinical trials in the U.S., but many of them have been discontinued due to the lack of convincing data, showing similar efficacy to drugs already on the market. In the case of IL-17 inhibitors, concerns have been raised about the exacerbation of inflammatory bowel diseases such as ulcerative colitis and Crohn's disease, as well as oral candidiasis. IL-23 inhibitors have not been associated with any significant adverse events, but there have been concerns about pain or discomfort at the injection site and upper respiratory tract infections. On the other hand, the safety of oral Sotyktu is considered to be well-established with 4 years of data. While other oral therapies have been associated with higher rates of adverse events such as nausea and vomiting than placebo, Sotyktu has been well tolerated, with rates of these events not significantly different from placebo, said Professor Armstrong. “This is an exciting time for patients with psoriasis, due to the increasing treatment options available. Contrary to how patients had to choose between safety or efficacy when opting to use oral treatment options, oral therapies have evolved since then. New oral drugs such as Sotyktu have demonstrated long-term efficacy and safety comparable to first-generation biologics such as TNF-α inhibitors and IL-12/23 inhibitors,” said Professor Armstrong. ”The treatment options have significantly improved than in the past.”
- Company
- KRPIA expresses concerns over drug approval fee hike
- by Eo, Yun-Ho Sep 27, 2024 05:53am
- “The pharmaceutical industry is bound to feel burdened by the sudden decision. We hope that the new drug approval system will be adjusted through discussions with the industry.” The Korean Research-based Pharmaceutical Industry Association (KRPIA) expressed the pharmaceutical industry's stance regarding the amendment to the 'Fee Regulations for Approval of Drugs, etc.' that was announced by the Ministry of Food and Drug Safety (MFDS) on the 9th. As part of the ‘Measure for Innovation in New Drug Approval', the MFDS is expected to dramatically increase the fee for new drug approval from KRW 8.83 million to KRW 410 million, which is a nearly a 50-fold increase, by fully applying the benefit principle. In essence, KRPIA agrees with the MFDS’s proposal, including the need to realize new drug approval fees, strengthen review capabilities, and shorten the approval period. KRPIA saw that the MFDS’ decision to significantly increase the approval fee reflects the authorities’ intention to innovate the new drug approval process to respond more quickly and flexibly to environmental changes and meet new industrial demand. However, it added the industry’s concerns regarding the fee burden, which rose significantly - over 50 times - with the sudden announcement of the revision without a grace period or phased application. As this is an unprecedented increase in the fee, the KRPIA’s position is that an approval system and administrative services should be prepared at a level that everyone can agree on through sufficient discussions with the industry. “The license fee of KRW 410 million is very high compared to almost all developed countries except the U.S. and Europe,” KRPIA said, noting that Korea's market size is only one-fourth and drug prices are only 60% of Japan's, which also has a similar fee level. With many countries racing to introduce new drugs quickly to improve patient access to treatment, Korea's pharmaceutical market size, challenging drug price environment, and Korea-specific approval requirements suggest that an excessive approval fee hike could be another factor that can slow the introduction of innovative new drugs with low prevalence or small market size. “Its implementation in January 2025 may be too soon for pharmaceutical companies to prepare for changes, and seems to be an insufficient time for the MFDS to recruit specialized personnel and overhaul the system,” said KRPIA. “In order for the intention of the system to be well realized, the fee hike must be accompanied by an overhaul of the new drug approval system and the introduction of fast and advanced administrative services," emphasized KRPIA.
- Company
- Switching between JAKis for RA yet to be reimbursed
- by Eo, Yun-Ho Sep 27, 2024 05:52am
- 국내 처방되고 있는 JAK억제제들The plan to allow insurance reimbursement when switching between JAK inhibitors in rheumatoid arthritis, which was expected to take effect in October, has been postponed. According to Dailypharm coverage, the health authorities have recently put on hold the notification of the proposed revision that allows switching between JAK inhibitors in rheumatoid arthritis. The tentative timeline for the notification was set as the end of the year, but this is not confirmed yet. The delay was reportedly caused by problems with the final approval of the budget bill. Currently, 4 drugs are prescribed for rheumatoid arthritis in Korea, including Pfizer Korea’s Xeljanz (tofacitinib), Lilly's Olumiant (baricitinib), AbbVie's Rinvoq (upadacitinib), and Eisai Korea’s Jyseleca (filgotinib). Until now, the government has been adhering to the position that it is difficult to reimburse switching JAK inhibitors due to the lack of clinical evidence. However, after continuous statements submitted by the Korean College of Rheumatology and other organizations, as well as prescription experience on cross-dosing, the government reconsidered its position and came to a positive conclusion. The industry expected the change to be applied in October, but the notification of the amendment has been delayed. As a result, it remains to be seen if patients will be able to freely switch between JAK inhibitors before the end of the year. If reimbursement for switching between the drugs is allowed, such use is expected to further activate the JAK inhibitor market. According to drug market research firm UBIST, the outpatient prescription market for JAK inhibitors was KRW 27.5 billion in the first half of last year. This is a 54% increase in one year compared to the KRW 17.8 billion in the first half of last year. The market for JAK inhibitors has been expanding at a rapid pace. The market, which had been around KRW 12.5 billion in 2019, had expanded to KRW 18.7 billion in 2020, KRW 25.5 billion in 2021, KRW 33.5 billion in 2022, and KRW 40 billion last year. This year, the market reached KRW 27.5 billion in the first half of the year alone and is expected to exceed KRW 50 billion by the end of the year.
- Company
- Minjung Jung to head Corporate Affairs at Sanofi KR, NZ, AU
- by Eo, Yun-Ho Sep 26, 2024 05:51am
- Sanofi’s Executive Director Minjung Jung (48) has been named head of Corporate Affairs for the Sanofi Group's 3 subsidiaries - Korea, New Zealand, and Australia. The appointment follows the appointment of Kyungeun Bae (53) as the General Manager of Pharma MCO South Korea and Australia/New Zealand & MCO Lead in the first half of last year, raising the stature of Sanofi Korea. With this promotion, Jung will now lead Corporate Affairs for the three countries, effective September 9th. The Corporate Affairs department is responsible for Public Affairs, Communications, CSR, Government, and Affairs. Jung is a seasoned public affairs professional who joined Sanofi in September last year. Since starting her career at MSD Korea in 2007, Jung has served various marketing roles at Boehringer Ingelheim Korea, Merck Korea, and Amgen Korea. Sanofi has been executing a Play To Win strategy, which focuses on building innovation platforms to develop first-in or best-in-class therapies and vaccines from 2020. The plan is to drive long-term growth through a virtuous cycle of efficiently redeploying resources to accelerate innovation and maximize R&D productivity. As a key part of this strategy, Sanofi has been operating its Korea and Australia & New Zealand subsidiaries as one integrated organization.
- Company
- "Bird flu: a new emerging pandemic risk factor"
- by Son, Hyung Min Sep 25, 2024 05:49am
- Jacob Lee, Professor of the Division of Infectious Disease at Hallym University Kangnam Sacred Heart Hospital.The industry is preparing against avian influenza, which can be transmitted from animal to human, as it is predicted to be the next pandemic risk factor. Experts suggest that an improved vaccine technology development and manufacturing system are required ahead of the emerging pandemic following COVID-19. CSL Seqirus Korea held a press conference on September 24th at Hotel President in Seoul to share the recent advances in avian influenza. During the meeting, Jacob Lee, Professor of the Division of Infectious Disease at Hallym University Kangnam Sacred Heart Hospital, emphasized strengthening Korea's response measure strategy for avian influenza. Avian influenza is an infectious respiratory disease that commonly occurs in wild birds. Recently, there have been cases of animal and human infections in addition to poultry and wild birds. In March, a death case was reported in Vietnam related to avian influenza human infection. The highly pathogenic H5N1 strain of avian flu, which emerged from a type of influenza A and is spreading world-wide, has infected over 300 species of birds and over 40 species of animals. 14 cases related to H5N1 human infection transmitted from cows and birds were reported in the United States alone. Several duck farms in South Korea have recently reported H5N1 infection cases. The Korea Disease Control and Prevention Agency (KDCA) is preparing responses to potential influenza pandemic, such as holding a symposium to discuss response plans. Lee said, "Although continual human-to-human infection has not been reported, there are increasing cases of animal-to-human infection. The academics consider avian influenza as the risk factor for causing the next pandemic." And added, "We could use vaccine technologies developed for COVID-19, such as the messenger RNA (mRNA) platform, for influenza. Establishing these platforms can reduce development time once an antigen is chosen." mRNA vaccines are composed of mRNA molecules and lipid nanoparticles surrounding it. mRNA contains a genetic material that can synthesize target proteins, and lipid nanoparticles protect mRNA, working as a transporter to deliver mRNA into the body. Recent studies showed that lipid nanoparticles can function as not only an mRNA transporter but also an 'immune enhancer,' increasing immune responses to vaccines. Lee says that Korea needs to secure vaccines that can enhance immunity since technology is still lacking. CSL Seqirus is known to manufacture vaccines rapidly through its platform. The company can readily shift from manufacturing seasonal vaccine influenza to pandemic influenza vaccine using its global manufacturing network. Moreover, the company manufactures and supplies vaccines for viral variations and zoonotic viruses. Marc Lacey, CSL Seqirus Global Pandemic Head, said, "We have built vaccine technologies through years of vaccine development experiences. For example, MF59 can enhance immune responses with a small antigen dosage. For H5N1 avian influenza variant, it only took 79 days until the vaccine developed. Our company can readily respond to global pandemic influenza." Lee said, "Vaccines that can be produced domestically in South Korea are egg-based and cell-based. Korea needs to develop the mRNA vaccine platform and immune enhancers. If the development is difficult, we must establish a system to introduce vaccines from overseas."
- Company
- ‘Link the processes to improve access to orphan drugs'
- by Kim, Jin-Gu Sep 25, 2024 05:49am
- A claim has been raised that the approval, evaluation, and negotiation linkage system should be introduced to strengthen access to rare disease drugs. Also, the claim that the pharmacoeconomic evaluation system should be flexibly applied to rare disease drugs and that the scope of the risk-sharing agreement system be expanded was raised at the time. Seung-Rae Yu, a professor at Dongduk Women's University College of Pharmacy, made the arguments above at the ‘Roundtable on Improving Access to Rare Disease Drugs' that was hosted by NA Representative Youngseok Seo (NA Welfare and Health Committee) that was held on the 24th. While introducing a study that was conducted on rare disease patients in Korea, Professor Yu said that 8 out of 10 patients feel a financial burden in the process of treating rare diseases without reimbursement. He pointed out that even though the government has continuously strengthened coverage, the number of cases for which treatments were not introduced to Korea or had not been listed for reimbursement in the long term has been increasing. In response, Yu emphasized the need to introduce a system that combines approval, evaluation, and negotiation to further speed up the reimbursement coverage process in Korea. In this regard, the government is currently conducting a pilot project that conducts reimbursement evaluations at the same time as the marketing authorization application. Yu argued that the pilot project should be expanded into a full-scale project. He also stressed the need to flexibly apply the pharmacoeconomic evaluation to rare disease treatments. He said, “The ICER threshold for the pharmacoeconomic evaluation should be flexibly applied to diseases that irreversibly worsen patients’ lives and cause disease burden, and the application of the risk-sharing system should be expanded to improve Korea’s reimbursement rate.” Yu added that priorities for strengthening coverage should be determined through public discussion in the mid-to-long term. “Given the status of new drugs introduced in Korea compared to major countries and the disparity in the proportion of new drug expenditure within the total drug expenditure, we need to prioritize reimbursement for diseases that have a high disease burden.” The government gave a generally positive evaluation to the approval-evaluation-negotiation linkage pilot project. However, the government announced plans to address the issues identified in the 1st pilot project and proceed with the 2nd pilot project. Eun-Joo Lee, an official from the Ministry of Health and Welfare’s Division of Pharmaceutical Benefits, explained, “The pilot project linking the approval-evaluation-negotiation system is underway. Two drugs were selected for the first pilot project, and we are now preparing to launch the 2nd pilot project.” Lee added, “We had difficulties during the first pilot project,” he said, ”In the case of one drug, it was difficult to objectively measure the drug’s cost-effectiveness due to problems with the evaluation tool in the process of deciding whether to reimburse the drug. We plan to reflect this in the second project.”
