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- 2025-12-24 05:40:03
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- Nubeqa, approval for a combination therapy indication
- by Eo, Yun-Ho Dec 23, 2022 06:06am
- It is expected that the prescription of the combination therapy of the prostate cancer treatment Nubeqa will be possible in Korea. According to related industries, Bayer Korea recently submitted an application to the Ministry of Food and Drug Safety to expand the Taxotere combination therapy indication of an oral androgen receptor inhibitor (ARi) Nubeqa for treating vision nmCRPC. Nubeqa is an androgen receptor inhibitor with a unique chemical structure that binds to androgen receptors to inhibit the growth of prostate cancer cells through strong antagonism. The corresponding indication of this drug has been validated through an ARASENS phase 3 study. The metastatic hormone-sensitive prostate cancer patient group with Nubeqa and ADT and Taxotere on ARASENS 3 demonstrated a statistically significant improvement in total survival compared to the control group with ADT and Taxotere. The patient group using Nubeqa, ADT, and Taxotere showed a statistically significant delay in the period required for the pain to progress. The clinical results were announced at the 2022 Urology Cancer Symposium (ASCO GU) of the American Society for Clinical Oncology held in February, and were published in the medical journal "New England Journal of Medicine." Nubeqa has not yet applied for insurance benefits in Korea, so it is expected to take time to lead to actual prescription activation. The drug has not been registered since the HIRA Cancer Disease Review Committee ruled it unsuitable in February 2021.
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- 1 of 2 patent suits filed this year proceed to the 2nd round
- by Kim, Jin-Gu Dec 23, 2022 06:06am
- It seems that the patent disputes in the pharma and bio industry will continue on in the long term. Among the 20 major rulings made during the first trial, 11, over 50% are being retried in a second trial by the Patent Court of Korea. Both the winning and losing parties of the patent suit that had been filed against Boryung Pharmaceutical’s fixed-dose combination for hypertension, ‘Dukarb (fimasartan and amlodipine),’ opted to continue their dispute in a second trial. In the case of the patent dispute over Novartis’s heart failure treatment ‘Entresto (valsartan+sacubitril),’ the original company appealed after the generic drug companies won the first trial. In the case of the dispute over the DPP-4 inhibitor class antidiabetic ‘Galvus (vildagliptin),’ the agenda is being fiercely tried again from square one after the Supreme Court's ruling of remand after reversal, and Novartis is also further countering by filing a trial for the active confirmation of the scope of rights. ◆Generics companies win first trial on Entresto... Novartis appeals According to industry sources on the 23rd, 21 major trial rulings and judgments have been made this year for patents in the industry. The number excludes cases where the company voluntarily withdrew its suit after requesting judgment. 20 of the cases received a ruling from the Intellectual Property Trial and Appeal Board (first trial), and 1 received a ruling from the Patent Court of Korea (second trial). Of the 20 cases that received a ruling in the first trial, 11 cases chose to continue on to the second trial. This means that more than half of the parties of major disputes did not accept the decision of the first trial. Pic of EntrestoEntresto’s patent dispute is one representative example. The dispute was sparked after its generic companies simultaneously filed suits to invalidate and confirm the passive scope of rights on Entresto’s 6 patents. Starting with Elyson Pharm, 13 companies challenged ▲1 use·composition patent ▲ 1 salt·hydrate patent (un-listed in the patent register) ▲1 use patent ▲1 crystalline form patent ▲2 substance patents for Entresto. The first trial was concluded in favor of the generic companies. Generic companies succeeded in challenging 1 use·substance patent, 1 crystalline form patent, and 2 substance patents. The remaining trials for the use patent and salt·hydrate patent have not been concluded yet. The company of the original drug, Novartis, decided to continue on the fight to the second trial for the crystalline form patent and the use·composition patent in March and July of this year. The company has given up the trials for its other 2 substance patents. Entresto has no drug substance patent, and the role is replaced by the use·composition patent and crystalline form patent. Therefore, Novartis plans to focus its defense strategy around these two patents. ◆Both the winning and loser parties appeal to ruling for Dukarb... long-term dispute inevitable Pic of Dukarb Two conflicting rulings were made in the first trial for Boryung’s Dukarb patent. Among 40 generic companies that challenged Dukarb’s patent, 2 won against Boryung, while the others lost. 29 of the companies filed a new trial on the same patent at the same time. If the first trial they attempted was made to avoid the patent by confirming the passive scope of rights, the companies added a patent invalidation strategy after losing the first trial. From the generic company’s perspective, whether it receives a winning decision from the Patent Court of Korea or a new ruling from the Intellectual Property Trial and Appeal Board, the company will be eligible to release its generic early. This is why companies that challenge the patent are mobilizing all available strategies. Boryung Pharmaceutical also filed a lawsuit against the two pharmaceutical companies that won against the company in the first trial to annul the trial decision. As a result, the Dukarb patent dispute, which began in March last year, is expected to be prolonged to even after the substance patent for Kanarb expires in February next year. ◆Galvus dispute to continue to the end...Novartis files active confirmation of the scope of rights # i3 The patent dispute around Galvus was also inconclusive this year. The analysis is that the conflict has been prolonged for more than 5 years due to the sharp differences in the position of the two parties. The situation had also intensified with Novartis' counteract, filing a trial for the active confirmation of the scope of rights. The conflict began in 2017 when Ahn-Gook Pharmaceuticals and Hanmi Pharmaceuticals claimed part of the term extended for the substance patent of Galvus invalid. The generic companies won the first trial. In the second trial, the court overruled the first court’s decision and ruled in favor of the original company. In the third trial, the Supreme court questioned the qualifications of the original company that filed the appeal and remanded it back to the first trial. With the remandment, the dispute resumed in the first instance court. Unlike in the previous first trial, the Intellectual Property Trial and Appeal Board ruled in favor of the original company, and generic companies appealed once again. Currently, Ahn-Gook Pharmaceuticals and Hanmi Pharmaceuticals are waiting for the second trial ruling. Apart from the dispute, Novartis had filed a trial for the active confirmation of the scope of rights against Kyongbo Pharmaceutical, Ahn-Gook Pharmaceuticals, and Korea United Pharm. The active confirmation of the scope of rights is filed by the original companies to protect their patent rights from generic companies. The suit is rarely filed in the domestic pharmaceutical and bio-industry. Kyongbo and the others have already released their generic versions after they won the first trial. The substance patent for Galvus expired in March of this year. However still, Novartis plans to see the dispute to the end and be recognized for the generic companies’ patent infringement. If Novartis wins, it will be possible to claim damages due to patent infringement. All companies that released Galvus generics will be subject to claims for damages. Also, Roche and Alvogen Korea received mixed results over the 3 use patents for Avastin. Alvogen Korea won 2 trials and Roche succeeded in defending 1 claim. Both companies decided to appeal and take the dispute to the second trial. However, Roche withdrew the lawsuit it had filed for cancellation of the trial decision in September and plans to focus on the case appealed by Alvogen Korea. In the patent dispute over Monterizine Cap, Hanmi Pharmaceuticals filed an appeal for the cacellation of the trial decision against 20 pharmaceutical companies after losing the first trial.
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- New HCV drug Epclusa lands in hospitals with reimb
- by Eo, Yun-Ho Dec 22, 2022 05:52am
- The Hepatitis C treatment ‘Epclusa’ is rapidly landing in hospitals for prescriptions after being granted reimbursement in Korea. According to industry sources, Gilead Science Korea’s oral chronic hepatitis C treatment Epclusa (sofosbuvir/velpatasvir) has passed the Drug Committees (DCs) of the Big-5s including the Seoul National University Hospital, Seoul St. Mary’s Hospital, Asan Medical Center, and Shinchon Severance Hospital, as well as other major medical institutions including Ajou University Hospital, Hallym University Sacred Heart Hospital, Pusan National University Hospital, Kyungpook National University Hospital, Chonnam National University Hospital, Chonbuk National University Hospital, Chungnam National University Hospital, and Chungbuk National University Hospital. When considering how the drug has only been listed for reimbursement on the 1st of last month, the drug is quickly landing at hospitals for prescriptions in Korea. Epclusa can be administered with reimbursement in adult and pediatric patients 23 years or older, weighing at least 30 kg, with any genotype of the chronic hepatitis C virus, regardless of the stage of cirrhosis or previous treatment experience. With the approval, Epclusa became the only treatment in Korea that can be prescribed with reimbursement regardless of HCV genotype or stage of fibrosis from November. Epclusa is a fixed-dose combination of sofosbuvir, a nucleotide analog NS5B polymerase inhibitor, and velpatasvir, an NS5A replication complex inhibitor. The drug demonstrated a 99% treatment success rate (SVR12) in the ASTRAL-1 study conducted on patients with chronic HCV infection genotypes 1, 2, 4, 5, and 6 , without cirrhosis or with compensated cirrhosis. Also, in the ASTRAL-4 study, the treatment success rate was 94% in patients with decompensated cirrhosis using Epclusa. Meanwhile, according to the HCV treatment guidelines issued by the Korea Association for the Study of the Liver, Epclusa is recommended for patients with all HCV genotypes, with or without compensated cirrhosis, with or without treatment experience. Also, Vosevi is recommended as a retreatment for patients with chronic hepatitis C that have previously failed DAA treatment.
- Company
- Dong-A ST introduces candidate substance technology
- by Kim, Jin-Gu Dec 22, 2022 05:52am
- Global joint development of immuno-cancer drugs under the mechanism of double fusion antibodies and acquisition of exclusive sales rights Dong-A ST announced on the 21st that it has signed a license agreement with Kanaph Therapeutics to license candidate substances for immuno-cancer drugs under the dual fusion antibody mechanism. Dong-AST will introduce global joint research and development and exclusive sales rights of preclinical immuno-cancer drug candidates held by Kanaph Therapeutics, a domestic pharmaceutical bio-venture. Dong-AST will pay Kanaph 5 billion won in advance and up to 18 billion won in additional payments depending on the development milestone. It also plans to pay up to 180 billion won more depending on sales if it succeeds in commercialization. Royalty is separate and will be paid at a certain rate according to the sales profit after the product is released. According to Dong-AST, the substance is an antibody and cytokine fusion protein. It is a mechanism to activate immunity by transferring cytokines specifically to tumors using antibodies to proteins expressed in the tumor microenvironment. At this time, cytokines are not delivered to normal tissues, so side effects of systemic immune activity can be prevented.
- Company
- PO SMA tx Indication of Evrysdi expands
- by Eo, Yun-Ho Dec 21, 2022 06:05am
- Evrysdi, a PO SMA treatment, can be used for infants under 2 months in Korea. According to related industries, Evrysdi recently obtained approval from the Ministry of Food and Drug Safety to expand the indication. Accordingly, Evrysdi can be administered to newborns before symptoms appear in Korea. The expansion of neonatal indications was based on the results of phase 2 clinical RAINBOWFISH. In the study, the efficacy, safety, pharmacokinetics, and pharmacokinetics of Evrysdi were evaluated for asymptomatic SMA patients who were genetically diagnosed up to 6 weeks of age regardless of the number of SMN2 genes. The primary target point was set as the proportion of patients who could sit without assistance or support for 5 seconds. By the time of the data cutoff, a total of 26 patients were registered. Their age was 28.5 days (central value), and they were diagnosed with SMA based on genetic testing but had no symptoms. Evrysdi, the first PO option as an SMA treatment, has the advantage of being able to be customized according to age and weight. The process of registering insurance benefits is still slow. It is not on the HIRA's public list of any committees. It remains to be seen whether Evrysdi will be able to expand its coverage in 2023 along with the expansion of the indication. Meanwhile, Biogen's Spinraza and Novartis' Zolgensma are currently listed in the SMA area in Korea.
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- Organon sold 3 types of infertility & contraceptives
- by Dec 21, 2022 06:05am
- Organon announced on the 19th that it will conduct direct sales and marketing of infertility and contraceptive products. According to Organon, the company will directly sell and market the infertility treatments Puregon and Organutran, and the implantable contraceptive Impranon in the body from next year. The company explained that it is a strategic business decision to realize the promotion of women's health. The goal is to strengthen competitiveness in infertility and contraception markets, including existing women's health products. Impranon will start direct marketing on January 1, 2023. Puregon and Orgalutran will be in charge of Organon Korea after the co-promotion contract with Han Wha, scheduled for the first half of next year. The three products that are converted to direct sales are representative infertility and contraceptive drugs sold in Korea over the past 20 years. Puregon has established himself as a representative of follicle-stimulating hormone, an ovulation-inducing agent. Orgalutran is a GnRH antagonist and has been used to prevent early ovulation spikes in women undergoing hyperovulation induction for assisted reproduction.Impranon is a long-term persistent reversible contraceptive inserted under the skin, with a 99% contraceptive effect lasting up to three years. CEO Kim So-eun said, "We will make significant progress in promoting women's health by strengthening expertise and differentiating based on various women's health product portfolios."
- Company
- Verzenio attempts reimb in early breast cancer in Korea
- by Eo, Yun-Ho Dec 20, 2022 06:06am
- The anticancer drug ‘Verzenio’ is attempting reimbursement listing for early breast cancer in Korea. According to industry sources, Lilly Korea has recently submitted an application for the reimbursement listing of its CDK4/6 inhibitor ‘Verzenio (abemaciclib)’ as a treatment for early-stage breast cancer with a high risk of recurrence. The company has been rapidly progressing its reimbursement procedure since the drug’s indication was expanded last month. The drug was approved by the Ministry of Food and Drug Safety as an adjuvant treatment for adult patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-), node-positive, early breast cancer (EBC) at high risk of recurrence, in combination with endocrine therapy. Verzenio’s efficacy in early breast cancer was demonstrated through the monarchE trial. The Phase III monarchE trial was the only trial to confirm successful results in 20 years as an adjuvant treatment for HR+/HER2- early breast cancer in combination with endocrine therapy in 20 years. The results from Cohort 1 of the monarchE trial, which became the basis for the indication expansion last month, showed that Verzenio+endocrine therapy not only demonstrated a reduction in the risk of recurrence compared to endocrine therapy alone through an improvement in invasive disease-free survival (IDFS), but it also confirmed a reduction in risk of remote recurrence through an improvement in distant relapse-free survival (DRFS). Joohyuk Sohn, Professor of Medical Oncology at Severance Hospital said, “Early breast cancer patients mainly experience recurrence after primary treatment in their first 1-2 years. This is why these patients need a more effective adjuvant treatment to reduce the risk of recurrence and death. An unmet medical continued to exist in the field due to a lack of new treatment options for patients with HR+/HER2- early breast cancer after the introduction of aromatase inhibitors in the early 2000s." Verzenio is currently reimbursed in Korea for the treatment of HR+, HER2- advanced or metastatic breast cancer ▴ in combination with an aromatase inhibitor for postmenopausal women as initial endocrine-based therapy; ▴in combination with Faslodex for women with disease progression following first-line therapy.
- Company
- MSD-Boryung Bio will copromote Prodiax 23 in Korea
- by Dec 20, 2022 06:05am
- On the 19th, MSD Korea announced it has selected Boryung Biopharma as its new distributor and supplier for its pneumococcal vaccine, ‘Prodiax 23.’ Under the agreement, Boryung Biopharma will be distributing and supplying both the private and contract Prodiax 23 products under the National Immunization Program starting January 1, 2023. MSD Korea’s copromotion agreement with its previous supplier, HK.Inno.N, is set to end at the end of this year. MSD Korea explained that the agreement had been made after reviewing the company’s vaccine product portfolio and long-term strategy from various angles. Boryung Biopharma’s main portfolio consists of vaccines and biological agents and owns a stable cold chain system. MSD Korea believed that Boruyng Biopharma’s experience in directly supplying flu vaccines for the NIP will create a synergy effect. MSD’s 23-valent pneumococcal polysaccharide vaccine, Prodiax23, was approved in 2000. The vaccine covers the widest spectrum of serotypes among pneumococcal vaccines available in Korea. People aged 65 or older may receive pneumococcal vaccines for free under the NIP. Jaeyong Cho, Executive Business Unit Director of Vaccines at MSD Korea, explained, “The interest and demand for our pneumococcal vaccine has been rising in line with the rising public interest in infectious respiratory diseases. Our agreement with Boryung Biopharma was made to instantly and actively respond to this rise in demand.”
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- Shingrix presents a new paradigm for shingles prevention
- by Eo, Yun-Ho Dec 20, 2022 06:05am
- Professor YoonKorea GSK's herpes zoster vaccine "Shingrix" announced its official launch. GSK held a press conference at InterContinental Seoul COEX on the 15th to commemorate the launch of Shingrix, a shingles-prevention vaccine, in Korea. At the meeting, Yoon Kyung-young, an infectious medicine professor at Korea University Anam Hospital, introduced the epidemiology of shingles, the risk of diseases and complications, and strategies to prevent shingles through unmet needs and vaccines. Shingles occur when the varicella-zoster virus, a chickenpox-causing virus, is reactivated. Shingles are accompanied by unbearable pain, and some patients may experience neuralgia (post-shingles neuralgia) that lasts for months to years even after the shingles rash disappears. Professor Yoon said, "The risk of shingles is increasing in the elderly, where the immune system is strong and cannot maintain an effective immune response due to aging. "In the elderly and immunodeficiency cases, chronic pain caused by neuralgia after shingles, as well as complications such as invasion of eye nerves, facial paralysis, and damage to the auditory nerve are often leading," he explained. In addition, "Sherpas zoster complications lower the quality of life of patients, so it is important to prevent it in advance as a shingles vaccine." Shingrix emphasized that it will present a new paradigm for preventing herpes zoster in Korea as the first and only recombinant inactivation vaccine in Korea that has proven its preventive effect and safety profile through global clinical research. Under the theme of "Major Clinical Research Results of R&D and Shingrix in Recombinant Shingles Vaccine (RZV)," Kim Hyung-woo, managing director of GSK Medical Department, explained the implications of Shingrix's innovative mechanism and development. Shingrix, a Recombinant Zoster vaccine, is the first shingles vaccine in Korea approved by combining GSK's immune enhancer with a non-live antigen. It can help prevent the risk of developing shingles in adults over the age of 50 due to naturally weakened immunity due to aging. Shingrix showed 97.2% preventive effect in two global phases 3 clinical trials (ZOE-50, ZOE-70) conducted on 15,411 adults over the age of 50, and more than 90% preventive effect in all age groups over the age of 70. Significant adverse reactions were similar in the Shingrix administration group and the placebo administration group. An interim analysis of ZOSTER-049 (ZOE-LTFU) conducted by an extensive study of ZOE-50 and ZOE-70 confirmed that the shingles-prevention effect of Shingrix persists for at least 10 years after initial inoculation. In addition, Shingrix confirmed the safety profile through five clinical trials targeting immunocompromised people aged 18 or older. Based on this, Singrix can be vaccinated even in immunosuppressive diseases such as autologous hematopoietic stem cell transplant patients, solid cancer, blood cancer, and solid organ transplant patients, which have a higher risk of shingles than the general public. "Based on a number of clinical results, Shingrix is an innovative vaccine that is recommended to prevent shingles in adults over 50 years of age, not only in the United States but also in Canada, Germany, and the Netherlands, so it can be an effective alternative to prevent shingles in Korea," Kim said. Meanwhile, Shingrix was approved by the Ministry of Food and Drug Safety in September last year. It can be used for the purpose of preventing shingles in adults over 50 years of age or over 18 years of age who are at high or expected to have an increased risk of shingles due to immunodeficiency or immunosuppression due to disease or treatment. It is available in more than 20 countries worldwide, including the United States, Canada, Germany, Belgium, Australia, and Japan. In Korea, vaccinations are expected to be available at major general hospitals, hospitals, and clinics across the country starting this week.
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- Reimb for Revlimid as maintenance therapy near after 4 yrs
- by Eo, Yun-Ho Dec 19, 2022 04:35am
- After 4 long years of await, Revlimid as maintenance therapy is nearing reimbursement listing in Korea. According to industry sources, the agenda of reimbursing Revlimid as maintenance therapy that has passed deliberations by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee in June will be deliberated at this year’s final Health Insurance Policy Deliberation Committee meeting. If this last procedure progresses and is completed without issues, the drug’s reimbursement is expected to be expanded from 2023. The agenda of using Revlimid as maintenance therapy had undergone various twists and turns in Korea. Since 2019, BMS Korea had actively sought to list the drug for reimbursement, but made no progress. The agenda has also been listed for deliberation by the CDDC in September 2019, June 2020, then again in September last year at the CDDC meeting that gained attention due to its deliberation of the CAR-T therapy ‘Kymriah (tisagenlecleucel),’ but to no avail. “A drug that prevents or delays recurrence of cancer” This is an extraordinary concept. All cancer survivors would jump to take that option. Revlimid has presented such an option for the first time in the field of multiple myeloma, a type of blood cancer that has a recurrence rate of 70-80%. The National Comprehensive Cancer Network made a Category 1 recommendation for the Revlimid maintenance therapy as the only option allowed for in all patients, regardless of eligibility for transplant. The European Society for Medical Oncology guidelines also recommends Revlimid as the only maintenance therapy to be used after autologous stem-cell transplantation. The significance of Revlimid, which has settled as the global standard of care as a maintenance therapy, has been demonstrated through a meta-analysis of 3 clinical trials (CALGB 100104, IFM 2005-02, GIMEMA RV-MM-PI-209). In a median follow-up of 79.5 months on 1,209 patients, PFS (progression-free survival) of patients that used Revlimid maintenance as monotherapy was 52.8 months, which was a significant improvement from the 23.5 months observed in the control arm that did not use maintenance therapy. the study demonstrated Revlimid’s clinical efficacy with more than double extension in PFS. In the follow-up study that was conducted for 88.8 months, the OS (overall survival) of the control group that did not receive maintenance therapy was 86.9 months. On the other hand, the Revlimid maintenance therapy arm’s OS was 111 months, demonstrating a significant improvement. The study showed that maintenance therapy can be a solution to prevent recurrence and improve the quality of life in multiple myeloma patients that experience frequent recurrence. Since patients with multiple myeloma experience worse symptoms when their cancer recurs, it is most important to prevent or delay recurrence after transplantation. Ki-Hyun Kim, Professor of Hemato-oncology at the Samsung Medical Center (Chair of the Multiple Myeloma Research Committee of the Korean Society of Hematology), said, “The prognosis for multiple myeloma deteriorates significantly and the treatment options narrow greatly with every recurrence, therefore using good treatments at the start of treatment is important. It is a shame that we cannot actively recommend maintenance therapy to patients despite their proven clinical efficacy due to the realistic issue of ‘non-reimbursement’.” “If the maintenance therapy is also approved for reimbursement in addition to RVD therapy, it will greatly improve the long-term quality of life in patients in Korea.”
