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- 2025-12-25 01:07:40
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- Heart failure guidelines revised for the first time in 6 yrs
- by Jul 25, 2022 05:57am
- The clinical practice guidelines for heart failure have been completely revised for the first time in 6 years. The new guideline contains all the latest drugs ranging from SGLT-2 inhibitors that demonstrated an effect in heart failure, angiotensin receptor-neprilysin inhibitors (ARNIs) that are represented by the Entresto, to the recently approved vericiguat. On the 22nd, the Korean Society of Heart Failure (KSHF) held an online press conference to celebrate the publication of the “Completely Revised Heart Failure Clinical Practice Guidelines 2022,” and announced the significance of the revision and the 10 important changes that were made. KSHF presents the “Completely Revised Heart Failure Clinical Practice Guidelines 2022,” The guideline had been completely revised for the first time in 6 years. The development of the Korean heart failure clinical practice guidelines started in 2016 when the KSHF first published a guideline for chronic heart failure, and then for acute heart failure in 2017. The guidelines underwent two partial updates in 2018 and 2020. Completely Revised Heart Failure Clinical Practice Guidelines 2022” consists of 64 chapters and 300 pages that reflect all the changes that were made over the past 5-6 years as well as the latest Korean and global research results. The major revisions include ▲the Definition and Classification of HF ▲HF diagnosis algorithm ▲Treatment of HF with reduced ejection fraction, ▲Changes in the roles of HF medicines (focusing on ARNI and SGLT2) ▲HF patients with improved ejection fraction ▲Treatment of HFmrEF and HFpEH ▲Treatment of comorbidities in HF patients ▲ Diagnosis and Treatment of cardiac amyloidosis ▲Period for transferring HF patients to tertiary hospitals or HF specialists ▲Treatment of acute HF patients and severe HF. The revision first made a more detailed classification and definition of HF. In the past, patients with an ejection fraction rate of 41-49% were considered to have a similar condition to “heart failure with preserved ejection fraction (HFpEF).” However, with studies reporting that the patient group shows similar drug treatment effects with the “Heart Failure with reduced EF (HFrEF)” group, the KSHF decided to classify the patient group as “Heart Failure with mildly reduced EF (HFmrEF)” The society also presented appropriate treatment methods in line with the newly set HF classification, as new treatments were introduced to treat HFpEF, a field that had high unmet needs with no suitable available treatment. While reflecting the international HF guidelines, such as those that were revised in the US in April 2022 and Europe in 2021, KSHF provided a standardized, optimal HF treatment guideline for Koreans whose recommendations align with the contents necessary and real to Korea. Source : KSHF In the guidelines, ARNI (angiotensin receptor-neprilysin inhibitors) or angiotensin-converting enzyme inhibitor (angiotensin receptor blocker for intolerant patients), beta blocker, saline corticoid receptor antagonist (aldosterone antagonist), and SGLT-2 inhibitors were recommended (Class I, Level of Evidence) as first-line standard of care in HFrEF. SGLT-2 inhibitors were recommended for administration regardless of the patient’s diabetic status to reduce hospitalization from HF or cardiovascular deaths. In addition, the new guidelines recommended patients continue receiving the standard of care treatment even if the patient’s symptoms improve and EF increases to 40% or higher after standard of care. (Class I, Level of Evidence B). If EF continues to decrease despite standard drug therapy, the guidelines recommend treatments such as ivabradine, vericiguat, or digoxin as second-line treatments Also, diuretics, SGLT2 inhibitors, and ARNIs were recommended as primary treatments for HFmrEF and HFpEF, In the HFmrEF and HFpEF group, diuretics and SGLT2 inhibitors (empagliflozin or dapagliflozin) were recommended as a priority (Class I), and ARNI was then recommended (Class IIa, Level of Evidence B) Hyun-Jae Cho, Director of Clinical Practice Guidelines in KSHF (Professor of Cardiology at SNUH), said, “The revised guidelines contain updated definition and classification of HF that is more detailed than before. The changed treatment methods and drug recommendations are also included in detail.”
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- How will the prescription market react?
- by Chon, Seung-Hyun Jul 25, 2022 05:57am
- Pharmaceutical companies are also paying keen attention to the rapid increase in the number of COVID-19 confirmed cases this month. Since the spread of COVID-19 in the past two years, the prescription market seems to be closely watching recent changes in the situation. According to the Central Disease Control Headquarters of the Korea Centers for Disease Control and Prevention on the 20th, a total of 76,402 new COVID-19 confirmed patients were counted as of 0 o'clock that day. The figure was 73,582 on the 19th, the largest in 83 days since April 27 (76,765), and the figure was 70,000 for two consecutive days. The "double" phenomenon, in which the number of confirmed cases doubled compared to the previous week, has continued for three weeks. The pharmaceutical industry seems to be closely watching the impact of the surge in COVID-19 confirmed patients on the prescription market. The domestic prescription drug market seems to have regained its previous year's upward trend this year after slowing down until last year after the spread of COVID-19. According to UBIST, a pharmaceutical research institute, the total amount of outpatient prescriptions in the first half of this year was 8.2874 trillion won, up 6.1% from 7.8129 trillion won in the same period last year. It increased 6.5% year-on-year to 4.1248 trillion won in the first quarter, and increased 5.7% year-on-year in the second quarter. It has achieved higher growth than in 2020 and 2021. The prescription amount in the first half of 2020 and 2021 grew only 2.9% and 2.6%, respectively, compared to the previous year. This year means that the growth rate of the prescription drug market is more than twice as high as that of the past two years. Analysts say that this year's recovery in the prescription drug market is related to a surge in the number of COVID-19 confirmed patients. Earlier this year, as many as hundreds of thousands of COVID-19 confirmed patients poured out a day, prescriptions for antipyretic painkillers, cold medicines, and antibiotics used to alleviate COVID-19 symptoms increased significantly. As the supply of cold medicines has not kept up with demand, the government has encouraged pharmaceutical companies to increase production and even received weekly reports of production and inventory. This is quite different from the two-year slowdown in the prescription drug market in the aftermath of COVID-19 until last year after the spread of COVID-19. In 2020, when COVID-19 began to spread, the amount of outpatient prescriptions was15.6365 trillion won, up 2.7% from the previous year. Outpatient prescription performance last year was 16.1126 trillion won, an increase of only 3.0% from the previous year. The amount of prescriptions in 2018 and 2019 increased by 8.1% and 8.2% compared to the previous year, respectively, and the growth rate fell by one-third for the second consecutive year since the spread of COVID-19. It is analyzed that COVID-19 has directly contributed to the sluggish prescription drug market over the past two years. After the spread of COVID-19, strengthening personal hygiene management such as hand washing and wearing masks has greatly reduced the incidence of infectious diseases, leading to a decrease in visits to medical institutions. Looking at the quarterly prescription market trend until last year after the spread of COVID-19, the growth rate exceeded 5% in the third quarter of 2020 and the fourth quarter of last year alone. For the rest, the growth rate of quarterly prescriptions remained between 0 and 3.2 % compared to the previous year. In the second quarter of 2020, the prescription scale growth rate was only 0.7%, and as COVID-19 spread in earnest, chronic patients such as HTN and DM avoided visiting medical institutions and received long-term prescriptions, there was a gap in the prescription market. In the fourth quarter of 2020, the growth rate of the prescription market was 0.0%. At that time, the market for prescription drugs seems to have been reduced due to a decrease in hospital visits due to a decrease in people's external activities as the operation of entertainment bars and singing practice centers was suspended and the number of restaurants was limited. Despite the same COVID-19 spread issue, the prescription market was also affected by the opposite depending on the social atmosphere.
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- Strong dollar slows sales of Epis’s 3 biosimilars in Europe
- by Jul 22, 2022 05:53am
- (From the left) Product pictures of Benepali, Imraldi, Flixabi The 3 autoimmune disorder biosimilars developed by Samsung Bioepis (Benepali, Imraldi, Flixabi) made slower sales in Europe in the first half of this year. Total sales fell by 4.7% compared to the previous year. Sales of the products had suffered a hard blow from the recent strong dollar and the continued pressure to cut prices. According to the Biogen’s earnings call that was on the 21st (local time), the 3 biosimilars Benepali, Imraldi, and Flixabi made $388.2 million (₩510.1 billion) in sales in the period. This is a 4.7% drop YoY from the $407.5 million (₩535.5 billion) the products had made in the same period last year. Benepali’s sales dropped 5.2% to $230.5 million (₩302.9 billion) and Flixabi’s sales dropped 15.4 % to $43 million (₩56.6 billion). Only Imraldi’s sales rose 1.1% to $114.7 million (₩150.7 billion). Unit: $1 million, Data: Biogen Samsung Bioepis has been selling three of its biosimilars through Biogen in Europe. Benepali is a biosimilar of Pfizer’s TNF- α inhibitor ‘Enbrel,’ and Imraldi is a biosimilar of Abbive’s TNF- α inhibitor ‘Humira.’ Flixabi is a biosimilar of Johnson&Johnson’s TNF- α inhibitor ‘Remicade.’ All three are used to treat autoimmune disorders. The three biosimilars, which had raised slightly less than $200 million in sales in 2019, had first recorded $219 million (₩287.7 billion) in Q1 2020. In the second quarter that immediately followed, sales were stagnant at first due to the explosive increase in the number of confirmed cases of COVID-19 across Europe but rebounded since. In Q4 last year, it made a new sales record of $220.9 million (₩290.2 billion). This year, sales of the three types of biosimilars have again shown a decreasing trend. In Q1, sales of the three biosimilars were $194.3 million (₩255.3 billion), which fell 12% from the previous quarter. Sales continue to decrease in Q2, making $193.9 million (₩254.7 billion). It is believed that the exchange rate and price pressure caused by the strong dollar had an impact on sales. In fixed currency rates, Biogen mentioned that sales increased by 3%. "Although production of biosimilars had increased, this increase was offset by exchange rate effect and price pressure. As in last year, revenue from biosimilars will continue to decrease this year.” With sales of the current three autoimmune disease biosimilars expected to remain at that level, attention is rising on ‘Byooviz,’ which was developed by Samsung Bioepis. Byooviz is a biosimilar of the blockbuster age-related macular degeneration (AMD) drug ‘Lucentis’ and the first product Samsung Bioepis showcased in ophthalmology. The drug was approved as the first Lucentis biosimilar in the US and was released in June. Biogen will be in charge of selling Byooviz in the US. According to Biogen, Byooviz made $500,000(₩700 million) in the first month of its release in the US
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- Takeda's anti-cancer drug Exkivity has been approved
- by Jul 22, 2022 05:53am
- A second targeted anticancer drug targeting EGFR Exxon 20 insertion mutation has emerged. Takeda Pharmaceutical Korea announced on the 20th that it has received approval from the Ministry of Food and Drug Safety for the EGFR Exxon 20 insertion mutant non-small cell lung cancer treatment Exkivity (Mobocertinib). Exkivity is a TKI that inhibits the growth of cancer cells by targeting the EGFR Exxon20 insertion mutation gene. With this permit, Exkivity can be used to treat locally advanced or NSCLC adult patients with EGFR Exxon 20 insertion mutations that have previously been treated with platinum-based chemotherapy. EGFR exon20 insertion mutations are rare, accounting for about 10% of EGFR mutations in non-small cell lung cancer and about 2% in all non-small cell lung cancer. EGFR Exxon20 insertion mutation Non-small cell lung cancer has a survival period twice as short as that of Exxon19 deficiency and Exon21 (L858R) replacement mutation, which accounts for most of the EGFR mutation. In addition, the prognosis for existing first and second-generation EGFR TKI target treatments and immunotherapy was poor and the response rate was low, so most patients used platinum-based chemotherapy for treatment, so the demand for unmet Exxon20 insertion mutation target treatments was high. Exkivity is an irreversible binding to EGFR Exxon20 insertion mutations that inhibit cancer cell growth and proliferation with a mechanism that blocks binding to ATP, the energy source of cancer cells. Earlier in February, Janssen's Rybrevant, which targets EGFR Exxon 20 insertion mutations, was approved. Unlike the injection Rybrevant, Exkivity is an oral drug Exkivity is the first oral treatment for EGFR Exxon 20 insertion mutant non-small cell lung cancer, which can be taken once a day regardless of meals. The company explained that this not only improves the convenience of taking medicine compared to injections, but also makes it easy to control the dose for adverse reactions, which can help patients improve their quality of life while maintaining their daily lives. The approval was based on a phase 1/2 clinical study conducted on 114 patients with EGFR Exxon20 insertion mutant non-small cell lung cancer who previously received platinum-based chemotherapy. As a result of the clinical trial, the ORR evaluated by IRC was 28% and the mDOR was 17.5 months in the patient group who took 160 mg of Exkivity. In particular, the median reaction time after administration of Exkivity was 1.9 months, and it was confirmed that the drug effect quickly appeared from the beginning of treatment. The mPFS was 7.3 months and the MOS was 24.0 months. The safety profile was also shown to be good. The most common adverse reactions were diarrhea, rash, and fatigue, and can be managed by controlling the dosage. Ahn Myung-joo, a professor of hematologic oncology at Samsung Medical Center, said, "We are very pleased to hear the news of the domestic approval of Exkivity, as the target treatment options have been limited in EGFR Exxon 20 insertion mutant non-small cell lung cancer. The EGFR Exxon 20 insertion mutation had a poor prognosis even with existing treatment options, but Exkivity improved major indicators such as ORR and mPFS median through clinical studies."
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- Imbruvica makes 4th attempt to extend reimbursement
- by Eo, Yun-Ho Jul 21, 2022 06:04am
- Already for the fourth time, Janssen is attempting to expand reimbursement for ‘Imbruvica’ as a first-line treatment. According to industry sources, reimbursement of Imbruvica (ibrutinib) as a first-line treatment for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Leukemia (SLL) will once again be deliberated by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee. Imbruvica’s reimbursement for its first-line indication, which had been deliberated by the CDDC three times from October last year to June this year, had been turned down all three times. The drug was able to receive reimbursement extensions to the second line after being listed through the PE exemption pathway but is having trouble extending its indication further into the first line. However, with voices rising on the need to extend Imbruvica’s reimbursement and HIRA's judgment that there is no problem in Imbrvica's clinical efficacy, there is a possibility that the company will finally see positive results if it proposes an appropriate fiscal sharing plan this time. In fact, the industry’s expectations are rising the agenda is expected to be deliberated at the next CDDC meeting after being turned down at the meeting that immediately preceded it. Imbruvica is a first-in-class oral Bruton's Tyrosine Kinase (BTK) inhibitor that is taken once daily. With its oral formulation, the drug has the strength of being able to be administered in the outpatient setting. Since it was approved in April 2018, the drug is being used as ▲ a second-line treatment for adult patients with recurrent or refractory CLL, ▲monotherapy for the treatment of adult patients aged 65 years or older with previously untreated CLL, ▲ combination therapy with obinutuzumab for the treatment of adult CLL patients over the age of 65 or those who have comorbidities or at high-risk under the age of 65 with previously untreated CLL.
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- Tabrecta is scheduled to be introduced in August
- by Eo, Yun-Ho Jul 20, 2022 05:50am
- MET anticancer drugs will enter the first stage of registration of insurance benefits. According to related industries, Tabrecta will be introduced to the HIRA Cancer Disease Review Committee on August 10. Tabrecta was approved in Korea in November last year as a non-small cell Lung Cancer (NSCLC) treatment that confirmed MET Exxon 14 deficiency as the first MET inhibitor. MET mutations are a rare type that accounts for about 3% to 4% of metastatic non-small cell lung cancer, and as there have been no treatments, interest in these new drugs is increasing. Effectiveness was confirmed through GEOMETRY mono-1 study in 97 patients with METex14. As a result of the study, the overall response rate was 68% in patients who had never been treated and 41% in patients who had previously been treated. Among the patients who took Tabrecta, DoR of the previously untreated patient was 12.6 months, and DoR of the treated patient was 9.7 months. Tabrecta is also stepping up research for future combination therapy. In particular, it is expected to solve the problem of EGFR TKI resistance in lung cancer. In fact, Tabrecta is conducting clinical trials in combination with AstraZeneca's third-generation EGFR TKI Tagrisso. Patients with EGFR mutated non-small cell lung cancer with T790M negative and MET gene amplification during treatment with 1st and 2nd generations EGFR TKI or Tagrisso were targeted The combination therapy of Tabrecta and Tagrisso is compared with platinum-based chemotherapy. Han Ji-yeon, a professor of hematologic oncology at the National Cancer Center, said, "It is very important that MET gene number has been identified as prognostic factors. It is very meaningful that drugs such as Tabrecta, which proved a clear effect only on the MET Exxon 14 defect mutation, were approved." Janssen Korea is also in the process of registering the MET inhibitor Rybrevant, but failed to pass the committee last month.
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- Moderna to soon release bivalent COVID-19 vaccine
- by Jul 20, 2022 05:49am
- Moderna is determined to promptly commercialize its new bivalent COVID-19 vaccine “mRNA-1273.214 (214)” in Korea. On the morning of the 19th, Moderna held a “Moderna’s mRNA technology and strategy in the endemic era” press conference at JW Mariott Hotel. At the conference, the company stated that it can “supply the 214 globally by the end of August, and plans to submit data for its approval in a few days.” (From the left) Hee Soo Kim, Medical Director at Moderna Korea; Paul Burton, Chief Medical Officer at Moderna Global ; Ji-Young Sohn, General Manager of Moderna Korea; Francesca Ceddia, Senior Vice President of Respiratory Vaccines at Moderna Global The 214 that was developed by Moderna combines a vaccine that targets the original strain and the Omicron variant BA.1. The vaccine achieved superior neutralizing geometric mean titer ratio (GMR) over the current vaccine against the original virus as well as Omicron subvariants BA.4/5. Specifically, GMR of the 214 was 1.24 against the original virus, and 1.78 against BA.1. The GMR against BA 4/5 was relatively lower at 1.68. Even so, Moderna explained that this demonstrates a superior protective effect compared to the current vaccine. Francesca Ceddia, Senior Vice President of Respiratory Vaccines at Moderna Global, said, “ A GMR of 1 or higher means it has a superior effect over its comparator. In this sense, the 214 has demonstrated a superior effect against BA.4/5. We plan to submit data for its approval to the Ministry of Food and Drug Safety, and will work closely with the regulatory authorities to supply our vaccine by end of August.” However, one obstacle that remains to its use is the FDA’s position. The US FDA had recently requested vaccine manufacturers Moderna and Pfizer to add omicron BA.4/5 spike protein component to the current vaccine composition in the development of their vaccine combos. In consideration of the additional time required for clinical trials, the FDA also emphasized that it will accept animal testing data for approval. Moderna’s position is that its bivalent vaccine, the 214, also shows superior effect against Omicron compared to the current vaccine and should be first administered. The company referred to how other countries and the World Health Organization requested the company to add a BA.1 component to the company’s bivalent vaccine. SVP Ceddia explained, “Moderna is working to take into account the different requests made by each country. The important matter is that our bivalent vaccine is an effective solution. If supplied, the 214 will also provide protection against the BA.4/5 subvariants." Ji-Young Sohn, General Manager of Moderna Korea, said, “The MFDS is also known to be positively reviewing 214. I believe it is important to receive vaccination with a certain vaccine at a certain period according to virus variants. Therefore, rather than waiting several more months for the release of a vaccine against BA.4/5, it would be more beneficial to use a readily available vaccine and protect public health.”
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- Big Pharma are making all efforts to preoccupy orphan drugs
- by Jul 20, 2022 05:49am
- New drugs are emerging one after another for rare diseases such as multiple Castleman's disease, beta thalassemia, Fabri's disease, and spinal muscular dystrophy, which were not well known and had no medicine. Global pharmaceutical companies such as Johnson & Johnson, AstraZeneca, and Roche are leading new drugs for rare diseases. It was suggested that Korea should also provide institutional support and active development in the rare disease market dominated by global companies. ◆ Global company focused on rare drugs. 26% of total sales in 2026 According to the "Global Rare Disease Market Research Report" published by KIMCo, the global orphan drugs market is expected to grow by 12% annually, and sales of orphan drugs are expected to account for 20% of the total prescription drug market by 2026. Global Big Pharma is aggressively dominating the market through active technology transfer and mergers and acquisitions. In fact, the M&A case of a global pharmaceutical bio company in the first half of this year also reveals the high interest of Big Pharma in rare diseases. Pfizer acquired Biohaven, a developer specializing in treatments for rare nervous system diseases, for $11.6 billion. It is the largest deal in the first half of this year. GSK and UCB also spent $1.9 billion each to buy biotechs that developed treatments for rare cancers and rare epilepsy. Last year, AstraZeneca spent $39 billion to acquire Biotech Alexion, which specializes in treating rare diseases. It is predicted that 79% of the global new drug pipeline currently being developed is rare drugs, and the trend of global new drug development in the future will focus on more rare drugs. It is predicted that sales of rare drugs will reach an average of 26% of Big Pharma's total sales in 2026. ◆"Korea Has Less Development and Poor Support. Development strategies for orphan drugs" Behind the global big Pharma's rush to turn to rare diseases is the policies of major countries that give strong benefits to the development of orphan drugs. The U.S. Food and Drug Administration (FDA) provides up to 50% of tax benefits for R&D costs for new drugs designated as orphan drugs. It also advises on the design of subsidies and protocols for clinical development and exempts for orphan drugs for application for examination. If a new drug is commercialized, the exclusive right period will also be given seven years, two years longer than five years of general new drugs. This year, it also established a priority review for orphan drugs. Europe also has tax benefits for orphan drugs, exemption from examination application fees, and priority review systems. Monopoly rights can be granted up to 10 years from the date of marketing authorization, and the monopoly period is set through re-evaluation five years after marketing. Tax benefits are given from the development stage and various incentives such as priority review, post-marketing monopoly rights, and extension of item permits can help pharmaceutical companies secure growth engines in the long run. Global Big Pharma is taking a strategy to maximize drug sales by continuously expanding the indication of non-rare diseases after entering the market after phase 2 with an orphan drug designation and rapid screening program. Korea has implemented the Rare Disease Control Act since 2017, relatively late, and has prepared a legal basis for incentives for orphan drugs. Under this law, orphan drugs are given a 10-year validity period. In addition, the priority review system can be applied to orphan drugs, and fees will be reduced. The exclusive right shall be granted for four years from the date of marketing authorization. Some point out that the domestic benefit policy for orphan drugs, which are relatively expensive, is still insufficient. At the "policy debate to improve the environment of pediatric rare diseases" held at the National Assembly on the 13th, Professor Lee Bum-hee of AMC argued that orphan drugs designated by the Ministry of Food and Drug Safety and rare disease treatments are separated. Professor Lee Bum-hee pointed out that even if a new drug is developed successfully, the market will not be able to be activated unless an environment that can be used properly is supported.
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- Maximizing JW Pharma's platform technology
- by Chon, Seung-Hyun Jul 20, 2022 05:48am
- JW Group is implementing an active open innovation strategy to maximize R&D capabilities. In order to boost the potential of two core platform technologies developed by themselves, they are mobilizing all resources that can be utilized from domestic bio ventures to overseas investment institutions. According to industries on the 13th, JW Group signed a business agreement with ARCH Venture Partners, a U.S. venture capital (VC). ARCH Venture Partners is the largest venture capital in the United States that invests in companies with early innovative technologies in the healthcare field. It is recognized for commercializing technologies developed by academic institutions, corporate research institutes, and national research institutes, and is investing in companies jointly established by major scientists and entrepreneurs to showcase innovations in life and physical science to the market. JW Group will be provided with the ARCH technical service program under this business agreement. ATS provides promising biotech and technical information selected by ARCH Venture Partners to strategic investors interested in business cooperation with venture companies around the world. This is the first time for a domestic pharmaceutical company to work together with a VC specializing in bio and healthcare in the U.S. for open innovation in the field of discovery stage. The reason why JW Group joined hands with ARCH Venture Partners is to maximize its own platform technology. JW Group is currently operating a new drug development program using two platform technologies, JWELRY and CLOVER. Its goal is to discover new targets that can increase the utilization of these platform technologies by utilizing ARCH Venture Partners' ATS program. Both JWELRY and CLOVER are big data platforms based on chemical and bioinformatics built by JW Pharmaceutical. JWELRY is a platform that distinguishes between activity and inhibition of Wnt signals. Wnt signaling pathways are preserved across all species, from nematodes and fruit flies to mammals, and play an essential role in cell proliferation or differentiation, animal organ development, and morphogenesis. Although the Wnt signaling pathway is involved in many diseases, there are no new drugs involved in this pathway so far. It is developing a treatment for hair loss (JW0061). The blood cancer and stomach cancer treatment (CWP291), developed based on the Wnt platform, is undergoing phase 1 clinical trials worldwide. New drugs are also being developed in the field of immune disease and tissue regeneration. CLOVER is a big data platform that accumulates cancer cell lines, tissues, genetic information and compounds, as well as pharmacological efficacy prediction data. CLOVER, which is capable of deriving low-molecular substances that inhibit or activate STAT signals, is evaluated as a platform capable of overall performance of mechanical and biomarker studies. STAT is an essential signaling system that regulates cell growth, mutation, proliferation, differentiation, and apoptosis. Abnormal STAT signals can cause various diseases affecting the skin, cancer, and immune system. JW Pharma has discovered more than 10 species through CLOVER so far. Among them, atopic dermatitis treatment (JW1601), gout treatment (URC102), and solid cancer treatment (JW2286) have entered the clinical stage. In addition, atopic dermatitis treatment and gout treatment were exported to global companies, respectively. JW Pharma signed a technology export contract with Leo Pharma in August 2018 for JW1601, an atopic dermatitis treatment. The total amount of contracts, including 17 million dollars in down payment, is 402 million dollars. In August 2019, Nanjing Simcere Dongyuan Pharmaceutical signed a technology export contract for the gout treatment URC102. The down payment is $5 million and the total down payment is $70 million. JW Pharma is expanding joint research with domestic bio companies to maximize the potential of its own new drug development technology. JW Pharma signed a joint research contract with bio-venture ILIAS Biologics last month. It is about developing a target type exosome treatment equipped with a low-molecular anticancer drug. The contract aims to develop a global innovative new drug that applies ILIAS's own exosome platform technology to low-molecular anticancer new drug candidates secured by JW Pharmaceutical. Earlier, JW Pharmaceutical also signed a joint research cooperation contract with Voronoi, SyntekaBio, Oncocross, and Organoidscience. The study with Voronoi is a method of applying Voronoi's (PROTAC; Proteolysis-targeting chimera) technology to JW Pharm's STAT3 target low-molecular anticancer drug candidates. PROTAC is a new drug development platform that removes target proteins using the in vivo proteolysis system. During the development process, Voronoi is in charge of designing compounds, synthesizing them, and deriving clinical candidate materials, while JW Pharm is in charge of intermediate clinical research including candidate material evaluation. SyntekaBio and Oncocross are pushing to develop new drugs using AI. JW Pharma has been discovering candidate materials for innovative new drugs for SyntekaBio and specific protein targets since last year. It is jointly planning innovative new drug tasks that work on specific proteins and speeding up the discovery of innovative new drug candidates with DeepMatcher, an AI platform owned by SyntekaBio, and drug 3D simulation technology. Since March, JW Pharma has been exploring new indications of new drug candidates and existing drugs with Oncocross and verifying the possibility of development. Oncocross has a RAPTOR AI platform. RAPTOR AI is an R&D platform that screens for optimal indications for new drug candidates or previously developed drugs, increasing the probability of clinical success and shortening the development period. In May, it signed a joint research contract with Organoids. It builds an R&D platform that makes Organoid's genomic information into DB. Organoid develops an organoid model using tissue samples from patients, and JW Pharma is responsible for decoding the genes of the organoid model and building a platform that accumulates the information. JW Pharma's R&D investment is also increasing. JW Pharma estimated this year's R&D investment cost at 85 billion won, up 65.7% from last year.
- Company
- Novartis nears reimb for its 2 ultra-high-priced new drugs
- by Eo, Yun-Ho Jul 19, 2022 05:16am
- With Novartis Korea nearing reimbursement listing for its 2 ultra high-priced drugs, how the two drugs will progress is receiving attention. The two Novartis drugs that have continuously raised issues since its domestic approval are ‘Kymriah (tisagenlecleucel) and Zolgensma (onasemnogene abeparvovec-xioi). Among the two drugs, Kymirah was first listed for reimbursement in April, and the drug pricing negotiations with the National Health Insurance Service for Zolgensma were also completed recently. When Zolgensma passes deliberation by the Health Insurance Policy Deliberation Committee (HIPDC), the drug will also be applied the prior approval system like Kymriah. If approved, it will be the first time in the history of Korea’s insurance reimbursement system that two drugs were consecutively applied the prior approval system for reimbursement benefit. The reimbursement process for the drugs was far from smooth. And when considering the long wait endured by the patients, it wasn’t even that ‘quick.’ However still, given the unprecedented cost of administration and the immense fiscal investment required, as well as its ‘one-shot’ concept, the results achieved by the two drugs are quite encouraging. The gov't and pharmaceutical companies’ rapid response shone through for Kymriah The reimbursement of the ultra-high-priced one-shot CAR-T new drug Kymirah was made possible through the combined efforts of the government, pharmaceutical companies, and patients. Kymriah is indicated for the treatment of ▲ adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) after two or more lines of systemic therapy, and ▲pediatric and young adult patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (B-ALL) that is refractory or in second or later relapse. The company had submitted a reimbursement application for both indications. The drug started its reimbursement listing process after it was approved by the Ministry of Food and Drug Safety in March last year through the ‘approval-reimbursement review linkage system.’ Six months later, Kymriah was first put up as an agenda for NHIS’s Cancer Disease Deliberation Committee (CDDC) review, but the committee deferred its decision. Immediately upon news of the deferral, the Korea Leukemia Patients Organization among others strongly criticized the government and the pharmaceutical company. The KLPO had before criticized the authorities over the delay in Kymriah’s agenda being put up for deliberation by the CDDC. In the end, Kymriah’s reimbursement agenda passed the CDDC review in October of the same year. This was also the first day HIRA disclosed the results of CDDC deliberations to the public. Also, Kymriah's reimbursement agenda passed the first Drug Reimbursement Evaluation Committee (DREC) meeting held in 2022. After then, the company successfully completed drug pricing negotiations and officially listed Kymriah for insurance benefit in April. Slower but fast enough results derived for 'Zolgensma' reimbursement The progress made for Zolgensma was slower than that of Kymriah. Although both drugs are high-priced one-shot treatments developed by the same company, Zolgensma is a rare disease treatment. Novartis submitted its reimbursement application for the spinal muscular atrophy (SMA) treatment Zolgensma in May last year, but the agenda was put up for deliberations a year later, in May of this year. As Zolgensma is a rare disease drug, the pharmaceutical reimbursement standard subcommittee must first set a reimbursement guideline for the drug before undergoing DREC review. However, discussions were delayed due to repeated requests for data supplements made by the government and their submission by the pharmaceutical company. As a result, the reimbursement progress for Zolgensma progressed at a much slower speed than Kymirah, which had applied for reimbursement approximately a month before Zolgensma. However, the process sped up after DREC deliberations. After passing DREC deliberations on May 12th, Zolgensma entered drug pricing negotiations in the same month and reached a drug pricing agreement without period extensions before the 60-day negotiation period expired. As a result, Zolgensma will likely be reimbursed as early as next month (August), or in September at the latest given HIPDC’s schedule. Zolgensma is a gene therapy that contains genetic material that functionally replaces defective genes. The Ministry of Health and Welfare had approved the drug as the second advanced biopharmaceutical after Zolgensma. Advanced biopharmaceuticals are cell therapies or gene therapies that use live cells, tissues, or genetic material as ingredients.
