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- 2026-05-09 09:58:29
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- Same ‘one-shot’ but different? Zolgensma reimb slow
- by Eo, Yun-Ho Mar 17, 2022 05:59am
- Although both drugs are from the same pharmaceutical company and are both one-shot, high-priced drugs, the two drugs are showing a stark difference in their results. Discussions on the reimbursement listing for Novartis Korea’s Zolgensma (onasemnogene abeparvovec) is not progressing so smoothly. The company had applied for the reimbursement listing of its Spinal Muscular Atrophy (SMA) treatment Zolgensma in May last year through the approval-benefit appraisal linkage system, but the agenda has not been deliberated by the National Health Insurance Service DREC until now. As it is a rare disease drug, the Drug Reimbursement Standard Subcommittee must set reimbursement standards, and the drug pass DREC deliberations to receive reimbursement. According to industry sources, the government had numerously requested data supplementation to the company, upon which the company repeatedly submitted additional data. Originally, drugs should receive DREC deliberations within 150 days of submitting an application under the National Health Insurance Act, but this period has long been exceeded. This is different from the results made for the company’s new CAR-T therapy ‘Kymriah (tisagenlecleucel).’ Kymriah has passed DREC deliberations last January. Last month, Yong-Myung Jang, HIRA’s Director of Development at the Health Insurance Review and Assessment Service (HIRA) mentioned Zolgensma at a press meeting with the Special Press Corp last month, raising hopes on the progress to be made for Zolgensma. Director Jang said, “We have collected opinions from the society, experts, and held an expert advisory meeting to discuss its clinical use. DREC deliberations are in the way for the drug.” However, Zolgensma was not on the list for deliberations in February. Meanwhile, Zolgensma is a gene therapy that contains a genetic material that functionally substitutes defective genes. The Ministry of Food and Drug Safety approved Zolgensma as the second advanced biologic product after Kymriah. Advanced biopharmaceuticals are cell therapies or gene therapies that use live cells, tissues, or genetic material as ingredients. Under the ‘Safety and Support Act for Advanced Regenerative Medicine and Advanced Biopharmaceuticals,’ advanced biopharmaceuticals can receive differentiated safety management including long-term follow-up studies and support for R&D and product commercialization. Despite being a one-shot treatment, the price of the single shot costs 2.5 billion won in the U.S. and 1.89 billion won in Japan. Due to the high price, the listing process for Zolgensma in Korea is also expected to walk a rocky road However, expectations for its efficacy are very high. The Phase III SPR1NT and STR1VE-EU results for Zolgensma that was presented recently gained much attention. In the SPR1NT study, all pediatric SMA patients with two SMN Type 2 gene copies (Cohort 1) that were treated presymptomatically survived without requiring ventilatory or nutritional assistance and achieved sitting independently for 30 seconds or more. Most (11/14) patients achieved age-appropriate motor milestones within the World Health Organization (WHO) window of normal development. In the STR1VE-EU study, most pediatric patients (82%) that were treated with Zolgensma, including those with severe SMA, achieved motor milestones unseen in the natural history of SMA Type 1. An official from the company said, “Patients and their families are longing for the prompt reimbursement of Zolgensma. We are working closely with relevant ministries so that we can receive reimbursement as soon as possible and not deprive the opportunity for patients desperately waiting to be treated with Zolgensma.”
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- Molnupiravir can be supplied on the day of approval
- by Mar 17, 2022 05:58am
- MSD is trying to contribute a lot to overcoming the COVID-19 pandemic. Molnupiravir is fully prepared to be supplied on the same day as soon as it is approved. Kevin Peters, CEO of MSD Korea, made the remarks at a press conference held on the 16th. MSD developed the COVID-19 treatment Molnupiravir last year and received the U.S. Food and Drug Administration (FDA) EUA in December of that year. This is the second COVID-19 treatment after Pfizer's Paxlovid. 13 countries, including the UK, Japan, Australia and Taiwan, approved the use of Molnupiravir. The WHO has included Molnupiravir as a treatment option in the revised COVID-19 treatment guidelines. In November last year, MSD also applied for EUA of Molnupiravir to the MFDS. However, it has not been approved even after about three months. This is in contrast to the approval of Paxlovid, which filed an application at the same time, in about a month. Some point out that Molnupiravir's effectiveness fell short of expectations as a result of clinical trials. In phase 2/3 conducted by MSD, Molnupiravir reduced hospitalization and death risk by about 30%. Paxlovid had up to 89% effect in its own clinical practice. For this reason, the FDA advisory committee also considered whether to approve Molnupiravir. Although they managed to recommend approval, 10 people, or 40%, opposed it. Regarding the progress of approval of Molnupiravir, CEO Peters said, "I think both vaccines and treatments should provide as many options as possible to effectively overcome the pandemic." Molnupiravir is used in many countries around the world, contributing a lot to treatment, he said. He then said, "MSD is cooperating as much as possible so that Molnupiravir can be used quickly," adding, "What I can promise is that it can be supplied immediately as soon as approval is given. We are fully prepared to supply it from the day of approval."
- Company
- Verzenio makes "bid with verified data” against Ibrance
- by Mar 17, 2022 05:58am
- The breast cancer treatment ‘Verzenio’ is working hard to expand its market. Although it is a latecomer in the CDK 4/6 inhibitor market, Lilly is showing confidence that it can bring different results from other previous treatments. In fact, Verzenio is pioneering the base of use of CDK4/6 inhibitors from metastatic breast cancer to early breast cancer based on its powerful data. The cyclin-dependent kinases (CDK) 4/6 inhibitors that control cell division and growth selectively inhibit the proliferation of cancer cells. The drugs target human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, which accounts for 60% of all breast cancers. The drug that had opened the door to the CDK 4/6 inhibitor market was ‘Ibrance (Palbociclib).’ After it was introduced in August 2016, the drug became namely ‘the' breast cancer treatment. In this sense, the market was formidable for the latecomer Verzenio (abemaciclib), which was approved in May 2019, because of the solid position established by Ibrance during the past three years. Also, the misconception that “all CDK4/6 inhibitors are same” and the introduction of the third CDK4/6 inhibitor,‘ Kisqali (ribociclib),' had intensified competition in the market. However, Lilly is showing extreme confidence in Verzenio. In an interview with Dailypharm, Jihee Kim, a Sr. Brand Manager for Verzenio at Lilly Korea, said, “Verzenio has shown consistent effect regardless of the patient's menopausal status, and extended overall survival (OS) in patients who were known to have a relatively poor prognosis. Its molecular structure is slightly different from the other two drugs, which makes differences in efficacy, side effects, and administration period. This is why Verzenio is preferred in treating patients with poor prognosis." Results of the MONARCH-2 trial that allowed for the approval of Verzenio showed that the use of the Verzenio+fulvestrant combination demonstrated a significantly longer median overall survival (OS) of 46.7 months compared to the median OS of 37.3 months with fulvestrant monotherapy. The primary endpoint, median progression-free survival (PFS) was 16.4 months vs 9.3 months. Significant results were also obtained from its sub-analysis. Verzenio had shown consistent prolongation effects in breast cancer patients with poor prognosis such as those with liver metastasis or high-grade tumors, progesterone receptor-negative patients, and those with metastasis in other areas than the bone. These study data were also positively received by the clinical field and are making an impact. Sales of Verzenio had surged after its reimbursement listing in June 2020 (based on IQVIA), raising ₩11.2 billion last year. This is a 136% rise YoY. Its sales are still far below Iblance’s sales of ₩65.6 billion, but is considered to be a smooth start. Also, the hidden efforts of the marketing team had shone through. Sr. Manager Kim said, “Not many doctors were aware of the latecomer Verzenio at the time, and it was difficult to change the prescription pattern of the doctors as the doctors regarded all CDK4/6 inhibitors the same. To overcome this, we have actively conducted symposiums and product briefings. Among the healthcare professionals who attended our briefings, some hed given feedback that they would consider prescribing our drug to eligible patients and prescribed them. I felt proud that we were able to deliver the value of Verzenio all the way to the patient." Also, another characteristic of Verzenio is that it is the only CDK 4/6 inhibitor that does not require a "treatment holiday." CDK 4/6 inhibitors are taken for 2 years at the longest, and therefore the management of its side effects in the early stages is very important. Also, regular toxicity monitoring is essential in the early stages of administration is also essential. Other drugs have a 1-week break period after 3 weeks of administration, therefore when these drugs are discontinued due to side effects, this period is extended, causing difficulties in toxicity management. On the other hand, management of the daily-taken Verzenio is much simpler. If a side effect arises, the patient may temporarily discontinue taking the drug and restart use after dose adjustments or the same dose as needed. Verzenio can also expand the field covered by CDK4/6 inhibitors, as it has acquired positive data in early breast cancer. Verzenio achieved its primary endpoint in an average follow-up period of 15.5 months as adjuvant therapy in patients with early HR+/HER2- breast cancer. Although its indication has not been extended to breast cancer in Korea yet, expectations are high among HCPs in the field on the use of CDK4/6 inhibitor in early breast cancer. Until then, it is most important for HCPs to use Verzenio in metastatic breast cancer and learn for themselves the characteristics of the drug and establish trust in the drug.
- Company
- Drug-resistant TB drug Dovprela applies for reimbursement
- by Eo, Yun-Ho Mar 16, 2022 05:57am
- ‘Dovprela,’ the first new drug introduced in the field of tuberculosis in 50 years, is attempting reimbursement listing in Korea. According to industry sources, Viatris Korea has submitted an application for the reimbursement listing of its multi-drug resistant tuberculosis treatment, Dovprela (pretomanid). Dovprela, which was first approved in September in the US and in October in Korea, is indicated in combination with bedaquiline and linezolid to treat adult patients with extensively drug-resistant (XDR), or treatment-intolerant or nonresponsive multidrug-resistant (MDR) pulmonary tuberculosis (TB). Pretomanid is the first new drug introduced in the field in 50 years. The field of TB has been neglected by front-line pharmaceutical companies due to its lack of economic feasibility. Pretomanid was also developed by a non-profit organization, ‘TB Alliance,’ rather than by general pharmaceutical companies. The drug demonstrated its efficacy in the Phase III Nix-TB trial. Dovprela in combination with bedaquiline and linezolid (BPaL) demonstrated 92% effect in patients with treatment-intolerant or nonresponsive multidrug-resistant TB and an 89% effect in patients with extensively drug-resistant TB within 6 months and identified its potential as a new short-term combination therapy in the field. Also, it reduced the treatment period from 18-24 months to 6 months, and almost all patients with treatment-intolerant or nonresponsive multidrug-resistant TB and extensively drug-resistant TB were found to be sputum culture-negative within 16 weeks. As the first ready-to-use combination that consists solely of oral treatments, the BPaL regimen reported a 90% cure rate in patients with extensively drug-resistant tuberculosis when used for 6 months compared to the standard treatment that recommends the use of at least 4 drugs in the initial intensive phase. Meanwhile, multi-drug resistant tuberculosis is a type of tuberculosis that cannot be treated with two or more TB treatments including isoniazid and rifampicin, the two most effective anti-TB treatments due to intolerance. Its cause can be divided into primary resistance and acquired resistance. Primary resistance develops when a patient is infected with drug-resistant MTB or during the course of treatment due to arbitrary discontinuation of treatment or irregular administration, etc. The treatment success rate of multi-drug resistant tuberculosis is around 50%. In addition to this low treatment efficiency, more side effects arise with the use of second-line drugs than first-line drugs. Moreover, due to its longer treatment period of 18 to 24 months, the cost burden is high, and may even require surgical operations.
- Company
- Whether companies give up developing COVID-19 vaccines
- by Kim, Jin-Gu Mar 16, 2022 05:57am
- Domestic pharmaceutical companies are divided over the development of the COVID-19 vaccine. After the introduction of Pfizer, Moderna Vaccine, some companies stopped developing due to reduced commerciality and difficulties in recruiting clinical participants. Companies that are newly developing in preparation of the coronavirus are steadily appearing, creating conflicting scenes. ◆ Three new clinical trials after approval of Pfizer vaccine According to the pharmaceutical industry on the 14th, Genematrix applied for a patent for a candidate substance for the next-generation COVID-19 vaccine. The company confirmed its effectiveness on various mutations such as delta and omikron, and explained that it is expected to be used universally. In addition to Genematrix, at least three companies are believed to have challenged themselves to develop a new coronavirus vaccine in the past year. Quratis and HK inno.N were approved for phase I clinical trials in Korea in July last year. In August last year, Aijin was approved for the 1/2a clinical trial. They have entered clinical trials or began development in earnest since the domestic approval of the Pfizer vaccine (March 2021). ◆Genexine discontinued clinical trials, delaying Cellid's subsequent clinical approval Some of the companies that had previously conducted clinical trials stopped clinical trials. Genexine announced on the 11th that it will stop developing 'GX-19N'. Genexine plans to withdraw its Phase 2 and Phase 3 clinical trials approved in Indonesia. Genexine received approval for Phase 1/2a in Korea in June 2020 and began developing a coronavirus vaccine using a DNA platform. However, with the release of the Pfizer and Moderna vaccines first, the vaccination rate at home and abroad increased, and it was difficult to recruit patients and eventually gave up development. It is the same for other companies that have started to develop COVID-19 vaccines. In the case of Cellid, phase 1/2a, which began in December 2020, has been completed, but approval of phase 2b/3 is being delayed. Cellid applied to the Ministry of Food and Drug Safety for a phase 2b/3 in November last year. Geneone also went on phase 1/2a in December 2020, but it is confirmed that patients are still being recruited. ◆SK Bioscience and EuBiologics entered phase 3, and what they have in common is that they are synthetic antigen platforms It is understood that only SK Bioscience and EuBiologics are in progress among domestic coronavirus vaccine developers. SK Bioscience is conducting phase 3 of GBP510. SK Bioscience plans to commercialize its products within the first half of this year. EuBiologics also entered the final stage with the approval of Phase III clinical trials in January this year. SK Bioscience and EuBiologics have something in common that they have adopted a synthetic antigen platform. The pharmaceutical industry analyzes that synthetic antigen platforms, a traditional vaccine manufacturing method, have advantages in measuring safety and efficacy.
- Company
- Exon 20 insertion targeting Exkivity comes to Korea
- by Eo, Yun-Ho Mar 15, 2022 05:58am
- Takeda’s new lung cancer drug ‘Exkivity’ is coming to Korea. According to industry sources, Takeda Pharmaceuticals Korea recently submitted an application for the marketing authorization of ‘Exkivity (mobocertinib).’ The drug is expected to be approved within the year at the earliest. Exkivity was approved in the US in September last year as a non-small cell lung cancer (NSCLC) treatment that targets EGFR Exon20 insertion mutations like Janssen’s ‘Ryvrevant (amivantamab)’ that was approved last month. Unlike Exkivity, Ryvrevant has the strength of being an oral tablet. Exkivity was granted priority review and received Breakthrough Therapy Designation, Fast Track Designation, and Orphan Drug Designation by the FDA. EGFR Exon20 insertion mutation is a new biomarker that is newly receiving attention in the field of NSCLC. Targeted anticancer therapies that are currently available for prescriptions include those that target the Exon19 deletion or Exon21 L858R substitution mutations that are commonly found in EGFR mutations, but an unmet need existed for EGFR Exon20 insertion mutations. In this context, the introduction of targeted therapies like Exkivity is expected to play an important role in managing NSCLC in the future. Meanwhile, Exkivity demonstrated its efficacy through the Phase I/II trial. In the study, Exkivity demonstrated an ORR of 35% as well as a median progression-free survival (PFS) of 7.3 months. The Phase 1/2 trial of EXKIVITY consisted of 114 patients with EGFR Exon20 insertion-positive NSCLC who received prior platinum-based therapy and were treated with a 160 mg dose of Exkivity. The most common adverse reactions were diarrhea, rash, nausea, stomatitis, vomiting, decreased appetite, paronychia, fatigue, dry skin, and musculoskeletal pain.
- Company
- Samsung·Celltrion speeds up dev of follow-on similars
- by Ji Yong Jun Mar 15, 2022 05:58am
- (Pic of Samsung Bioepis and Celltrion) Celltrion and Samsung Bioepis’s follow-on biosimilars are gaining momentum in the global market. A total of 11 biosimilars from the two companies are being prepared for their launch into the global market. According to the industry on the 14th, Celltrion’s Avastin biosimilar is awaiting approval in the US and European market this year. Also, Samsung Bioepis’s Lucentis biosimilar eye drug, ‘Byooviz’ is preparing its release in the US market. Also, 9 other biosimilars from the two companies that target trillion-won market items such as the psoriasis treatment ‘Stelara,’ macular degeneration treatment ‘Eylea,’ SKE treatment ‘Prolia’ are awaiting release into the global market. Both companies are working to create new growth engines in addition to their existing flagship biosimilars. Celltrion’s pipeline as of December 31st last year (Data=Celltrion)◆CT-P16 expected to be approved this year… clinical trials for 5 of biosimilars to start this year In the case of Celltrion, its 6th biosimilar following Remsima, Remsima SC, Truxima, Herzuma, and Yuflyma, CT-P16, is expected to be approved within the year. Celltrion applied for the approval of CT-P16 in September and October in the US and Europe. In general, since the approval process takes around a year in the two regions, T-P16 is likely to be approved this year. Also, since Avastin’s patent has already expired in the US and Europe, CT-P16 can be released immediately upon approval. Avastin was developed by Roche for the treatment of metastatic colorectal cancer, metastatic breast cancer, NSCLC, and glioblastoma. According to IQVIA, Avastin’s global market size is around 8 trillion won. As CT-P16 has the same indication as Avastin, the company plans to grow the drug into its next flagship biosimilar. Pfizer’s Zirabev, Amgen’s Mvasi, Samsung Bioepis’s Aybintio are currently competing in the Avastin market. Celltrion is also working to expand its biosimilar portfolio. Celltrion is currently conducting global Phase III trials for its Stelara biosimilar ‘CT-P43,’ Xolair biosimilar ‘CT-P39,’ Eylea biosimilar ‘CT-P42,’ and Prolia biosimilar ‘CT-P41,’ among others. Celltrion started the development of its Actemra biosimilar ‘CT-P47’ in December last year. Also, the company may enjoy a market preoccupation effect if it succeeds in commercializing its Zolair and Stelara biosimilars, as the two products are being developed at a faster pace than the biosimilars of competitors. Samsung Bioepis’s pipeline as of December 31st last year (Data=Samsung)◆ Byooviz to be released in the US in the first half of the year … 4 Phase III trials underway Samsung Bioepis’s ‘Byooviz’ is awaiting entry into the US market. Byooviz respectively received marketing approval in the EU and the US in July and September last year. Its release in Europe is being coordinated with the company’s partner, Biogen, and is set to be released in the US in the first half of this year. With the release, a total of 6 biosimilars including its 5 existing biosimilars Benepali, Flixabi, Ontruzant, Imraldi, Aybintio will be penetrating the global market. Lucentis, which was developed by Genentech, is used to treat ophthalmologic diseases such as macular degeneration and macular edema. Its annual sales have recorded approximately 4 trillion won. As the first Lucentis biosimilar, Byooviz is expected to greatly enjoy a market preoccupation effect when released in the US. Samsung Bioepis is diversifying its pipeline from eye diseases to rare diseases. The company has completed Phase III trials for its Soliris biosimilar ‘SB12.’ With the completion, it is expected that the company may apply for the approval of SB12 in Europe and the US within the year. Also, Phase III trials for its 3 other pipelines - Eylea biosimilar ‘SB15,’ Prolia biosimilar ‘SB16,’ Stelara biosimilar ‘SB17’ – are underway.
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- Pharma·Biopharmas make or break COVID-19 CMO deals
- by Ji Yong Jun Mar 14, 2022 05:51am
- Domestic pharmaceutical companies are experiencing mixed results regarding their CMO businesses for COVID-19 vaccines. Samsung Biologics and SK Bioscience are already in the process of manufacturing COVID-19 vaccines. On the other hand, GC Pharma and Huons Global gave up their COVID-19 vaccine CMO business. In addition, uncertainties continue in Hanmi Pharmaceutical and Hankook Korus Pharm’s COVID-19 CMO businesses. ◆Korea-US CMO likely to dismantle due to discontinuation of Genexine’s COVID-19 vaccine development According to industry sources on the 12th, Genexine applied to discontinue its ongoing Phase II/III trial for its COVID-19 vaccine, GX-19N, on the 11th. In other words, Genexine is virtually letting go of its COVID-19 vaccine development business. (From the left) Genexine CEO Young-Chul Sung, Hanmi Pharmaceutical President & CEO Se-Chang Kwon Accordingly, Hanmi Pharmaceutical’s plan to CMO Genexine’s vaccine has been disrupted. Hanmi Pharmaceutical has signed a CMO agreement with Genexine for Genexine's vaccine candidate in May last year. An official from Genexine said, “With the trial withdrawal, it seems that the CMO deal the company made with Hanmi Pharmaceuticals for the COVID-19 vaccine would also be terminated." With the CMO deal virtually dismantled, the only card left in Hanmi’s hand is the CMO deal for the Indian Zydus Cadila’s COVID-19 vaccine, ZyCoV-D. Hanmi Pharmaceutical had signed a CMO agreement with Enzychem Lifesciences and Zydus for the COVID-19 vaccine ZyCoV-D in January. Hanmi Pharmaceutical expects to sign the formal deal in the second quarter of this year. Once the contract is signed, Hanmi Pharmaceutical will be in charge of the global supply of ZyCoV-D. ◆GC Pharma and Huons gives up… Korus lot release of ‘Sputnik’ delayed indefinitely The CMO decisions for companies other than Hanmi Pharmaceutical have already been finalized. Huons Global had closed its CMO business for the Sputnik V vaccine due to the Russia-Ukraine war. Huons Global said, “In consideration of the unstable international situation, we have decided that it will be impossible to maintain the contract and decided to discontinue the business.” Previously, GC Pharm had also been continuing discussions with CMO Janssen's COVID-19 vaccine since August last year. The discussions went on for 4 months until GC Pharm discontinued the discussions in December of the same year. Hankook Korus Pharm’s CMO deal on Russia’s COVID-19 Sputnik V vaccine has also not been finalized yet. The uncertainty around its CMO business is growing with the international and social direction set to impose financial and logistics sanctions on Russia. The company is currently waiting for a supply request from Russia. Pic. of Samsung Biologics’ Plant 3, SK Bioscience◆Samsung Biologics·SK Bioscience enters second year into CMO deals for their COVID-19 vaccine businesses In Korea, three types of COVID-19 vaccines - vaccines developed by Moderna, AstraZeneca, and Novavax - have been approved and are being produced. in Korea. Moderna’s COVID-19 vaccine is being supplied in Korea and abroad by Samsung Biologics under the CMO agreement that was made in May last year. SK Bioscience is in sole charge of the CMO of Novavax’s vaccine to supply in Korea and abroad. SK Bioscience’s CMO deal for AstraZeneca’s vaccine has been terminated in December last year. Samsung Biologics plans to sign additional CMO deals for other mRNA vaccines in addition to the one made for Moderna. The company has already signed a CMO deal to produce the API for US company GreenLight Bioscience's COVID-19 mRNA vaccine and is set to manufacture the product in the second quarter of this year. SK Bioscience plans to concentrate on manufacturing Novavax’s COVID-19 vaccine. SK Bioscience secured three Novavax vaccine consignment production lines at L House in Andong. The company will be in charge of direct sales of Novavax’s vaccine in Korea, Thailand, and Vietnam.
- Company
- Roche,set to establish a Korean precision medical ecosystem
- by jung, sae-im Mar 13, 2022 08:01pm
- Roche Korea announced on the 7th that it has signed term sheet with the KSMO to form a partnership with four organizations, including the KCSG, NCC, and the KHIDI, to establish a Korean precision medical ecosystem. Turnsheet is the process of specifying and agreeing on major contract conditions such as goals, scope of cooperation, roles and responsibilities by institution prior to partnership contracts. It is an extension of the Memorandum of Understanding (MOU) signed by these institutions and companies earlier. With the signing of termsheet, they plan to conduct KOSMOS II, an expanded study of the KOSMOS Study on genomic mutation-based customized drug therapy for patients with advanced solid cancer, which began in 2020. KOSMOS II is a study for the development of personalized cancer treatment, and aims to evaluate the effectiveness and stability of drugs and create a treatment platform tailored to genetic mutations by collecting NGS-based genetic test results and real world data for mid- to long-term clinical studies. Through this study, the government plans to improve patient access to genome-based customized treatment, collect and integrate genetic data and clinical data of 1,000 cancer patients to establish a national "public clinical genome database" that can be used for new drug development. The KSMO and the KCSG design KOSMOS II studies, provide customized treatment according to the results of the "Molecular Oncology Board (MTB)" and establish an actual clinical genome database. MTB is a multidisciplinary expert consultative body that recommends optimal customized treatment policies for patients by interpreting genetic test results. Society and research associations have already issued MTB treatment recommendations in December and provided customized treatment to about 100 patients in accordance with the guidelines. As a national cancer data center designated by the MOHW, the NCC provides the technology and infrastructure necessary for the development of the first clinical genome database. The KHIDI promotes cooperation with the MOHW and supports the recruitment of domestic and foreign pharmaceutical companies to participate in clinical research partnerships. Multinational pharmaceutical companies, including Roche Korea, provide research medicines and other services for patients registered in the KOSMOS II study. Meanwhile, the KSMO, the KCSG and Roche Korea signed an MOU to establish a Korean precision medical ecosystem in November 2019, strengthening the experience and expertise of domestic medical staff based on ▲ comprehensive genetic profiling and genetic tumor boards, ▲ deriving a plan to provide customized treatment for cancer patients who no longer have standard treatment options, ▲ establishment of a database within the scope of related laws and regulations in Korea, ▲ the government, academia, and pharmaceutical companies have cooperated to expand partnerships to establish a precision medical ecosystem.
- Company
- Dong-A ST submitted an appeal against patent dispute
- by Kim, Jin-Gu Mar 13, 2022 07:59pm
- AstraZeneca SGLT-2 inhibitor-based diabetes treatment ForxigaThe battle over material patent of Forxiga (Dapagliflozin Propanediol Hydrate), an SGLT-2 inhibitor-based diabetes treatment, will head to the third round. The opportunity for Dong-A ST's generic for Forxiga to release is also expected to vary depending on when and how the Supreme Court decides. ◆ Dong-A ST, a letter of appeal was submitted According to the pharmaceutical industry on the 7th, Dong-A ST objected to the patent court's ruling on material patent of Forxiga and filed an appeal on the 4th. Battle over the patent is now finalized by the Supreme Court. The key is whether the Supreme Court ruling will be made before April next year, the expiration date of this material patent. From Dong-A ST's point of view, the generic for Forxiga can only be released a day earlier than other generic companies only if it is ruled in favor of the Supreme Court before April next year. If the Supreme Court loses or a ruling is made after April next year, the opportunity for Dong-A ST's exclusive early launch of the generic product will disappear. At this time, the remaining 14 companies that succeeded in overcoming another material patent and received general for excellence will have an opportunity to release the generic early. ◆ According to the Supreme Court's ruling, 14 generic companies may dominate the market The reason why the number of cases is so complicated is that AstraZeneca has double-registered Forxiga material patents. AstraZeneca has registered two material patents: "C-aryl glucoside SGLT2 inhibitor (expired on April 7, 2023)" and "C-aryl glucoside SGLT2 inhibitor and inhibition method (expired on January 8, 2024). Generics first challenged patents that expire in January 2024, which are relatively easy to overcome. 14 companies, including Kyungdong Pharmaceutical, Kukje Pharmaceutical, Daewon Pharmaceutical, Donghwa Pharmaceutical, Boryung Pharmaceutical, Samjin Pharmaceutical, Shinil Pharmaceutical, Alvogen Korea, Youngjin Pharmaceutical, Ildong, Jeil, Jong Kun Dang, and Hanwha Pharmaceutical, won all the first and won the generic for exclusivity. This patent awaits the Supreme Court ruling with AstraZeneca's appeal. Unless a reversal ruling is made by the Supreme Court, they can sell generic products when their first substance patent expires in April 2023. ◆ Dong-A ST which brought up the prodrug strategy, mixed judgment in the first and second trials In April 2018, Dong-A ST filed a passive trial against AstraZeneca to confirm the scope of rights in Forxiga's first material patent. Dong-A ST is the first in Korea to try to overcome Forxiga's material patent using the "Prodrug" strategy. Prodrug is evaluated as a different drug, such as an original drug. The original drug and chemical structure differ in some parts of the substituent until immediately before taking it after the drug is produced. However, when a patient enters the body after taking it, it has the same effect as the original drug. The salt can be converted into a simple ionic bond. The chemical structure of the substance itself does not change. Prodrug has to change the substituent in a more demanding way called covalent bonds. The chemical structure is different from the original drug. There were mixed judgments in the first and second trials on whether prodrucg could be viewed as a completely new substance. Dong-A ST won the first trial and AstraZeneca won the second trial, respectively.
