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- 2026-04-10 08:38:09
- InterView
- Samsung Bio, investing in Swiss ADC bio company
- by Hwang, Jin-joon Apr 13, 2023 05:43am
- Panoramic view of Samsung Biologics. (Photo Samsung Biologics) Samsung Biologics announced on the 12th that it invested in Araris Biotech AG through the 'Samsung Life Science Fund' along with Samsung C&T. This investment was conducted exclusively by Samsung as a strategic investor (SI) prior to Araris Biotech AG's Series A phase. The investment is expected to be used for the further development of antibody-drug conjugate (ADC) candidates by Araris Biotech AG. ADC is a drug that combines a drug with an antibody and is one of the next-generation treatments. Araris Biotech AG is a company established in 2019 through the Federal Institute of Technology in Zurich, Switzerland. It has next-generation ADC linker technology. Araris Biotech AG's next-generation ADC linker technology has the advantage of attaching drugs to off-the-shelf antibodies without the need to redesign the antibody. This can reduce the time and cost required for drug development. Samsung plans to cooperate with Araris Biotech AG in the field of ADC treatment production and development. Previously, in July 2021, Samsung created a life science fund worth 150 billion won to discover new businesses in the biofield.
- Company
- LSK's contracts for early-phase clinical trials increase
- by Lee, Tak-Sun Apr 12, 2023 05:54am
- After analyzing Korea’s clinical trial trend through the number of its contracted research, LSK Global Pharma Services Co., Ltd. (LSK Global PS) announced that the number of early-phase clinical trials increased significantly recently. As of March 2023, the company’s number of contracted clinical research was 1,503, including 164 global clinical trials and 1,339 domestic clinical trials. Since its establishment in 2000, the company’s number of contracted research cases reached 1,000 in 2018 and then increased by 50% in 5 years thereafter. By research type, the number of Phase III clinical trials was the highest at 372 cases, and the rate of increase or decrease in the trials compared to 2018 showed that early phase trials such as Phase II clinical trials (▲ 62%) and Phase I clinical trials (▲ 49%) increased the most. A similar trend can be observed when dividing the domestic clinical trial approval status by phases. In the past, late-stage clinical trials were more actively conducted than early-stage clinical trials in Korea. However, with various domestic clinical trials being conducted by CROs and accumulated experience, early clinical trials are now being actively conducted, and related infrastructure has also been established. To accommodate the increase in demand, in 2021, LSK Global PS explained that it has been providing differentiated services by operating a team dedicated to early-phase trials to respond to the increasing demand for early-phase clinical trials. This also aligns with the global drug development trend. Anticancer drugs are still the most actively researched area in new drug development due to high unmet demand, and 10 to 20 new drugs are approved by the US FDA every year in the area. In Korea, R&D investment and recruitment of research personnel in the field of anticancer drugs is being actively carried out recently. Young-Jack Lee, CEO of LSK Global PS, said, “Unlike treatments for other diseases that are highly prevalent, there are many factors to consider when developing an anti-cancer drug, such as disease complexity, tumor heterogeneity, toxicity, and resistance, and require huge time and monetary investments. LSK Global PS offers medical consulting throughout clinical trials for anticancer drugs from setting target patient groups, study design, and efficacy endpoint suggestions to help establish and conduct strategic clinical trials.” A total of 129 clinical trials (54 global, 75 domestic) related to Investigational New Drug Applications (IND) that are conducted to receive approval from regulatory authorities were found to be in progress. By clinical stage, Phase I and Phase II clinical trials, and by disease group, anticancer drugs increased the most, showing a similar trend with the change in the total number of contracted clinical research. In addition to the continuous rise in the number of contracted clinical research related to new drug development, marked growth has also been observed in the fields of digital therapeutics and medical devices. Compared to 2018, the number of contract clinical research cases for medical devices had increased around threefold, 10 of which trials are related to digital therapeutics. LSK Global PS newly established a medical device clinical team in January of last year to provide more specialized services.
- Policy
- The results of the PVA improvement plan study were disclosed
- by Lee, Tak-Sun Apr 12, 2023 05:54am
- The NHIS, which is promoting PVA improvement, disclosed the results of service research conducted last year and announced plans to seek improvement measures with the private sector in May. In this improvement plan, it is expected that items with a 10% billing amount and more than 5 billion won will be added to the Ka-type negotiation target, which is a new drug, and a plan to raise the standard for exclusion from negotiation to 3 billion won to 5 billion won a year will be pursued. According to industry sources on the 11th, the NHIS released last year's 'PVA Performance Evaluation and Improvement Study,' in which Bae Seung-jin, professor of pharmacy at Ewha Womans University, participated as the research director. This seems to be a measure to secure transparency of the improvement plan by disclosing the research results internally and externally prior to the working group in May. The results of the study mainly suggest ways to relax the existing standards in terms of financial savings. In the case of Type Ka, it is currently included in the negotiation only if the billing amount increases by more than 30%, but like Types Na and Da, a plan to include items with a billing amount of 10% & 5 billion won or more were included. If items with an increase of 10% & 5 billion won or more in the ka type are included in the negotiation target, the amount of savings will increase by about 4.4 billion won (22.4 billion → 26.8 billion won) as of 2022. In addition, as a short-term improvement plan, it was proposed to increase the efficiency of negotiations and system acceptance by raising the exclusion standard from the current claim amount of 2 billion won to 3 to 5 billion won. Some of the research results were also disclosed at the meeting of Sang-Il Lee, executive director on salary, with the Korea Special Press Association on the 7th. The NHIS plans to make a booklet of the research results and distribute them to pharmaceutical organizations such as KRPIA, and to hold a meeting at the end of April prior to the operation of the working group in May. The working group runs from May to August and aims to implement improvement measures next year by revising related regulations in the second half of the year.
- Policy
- 16% of PVA-applied products cut more than 2 times
- by Lee, Tak-Sun Apr 12, 2023 05:54am
- The items with the highest cumulative reduction rate fell 25.2% in total with three cuts. It was found that about 16% of the total products had the upper limit price lowered twice or more with PVA. The remaining 84% of products were cut once. Compared to the pharmaceutical industry's complaints about repeated cuts, the number of products with repeated cuts did not appear high. According to the 'PVA Performance Evaluation and Improvement Study report recently published by the NHIS, 62 product groups (16%) out of 380 identical product groups in which the usage-drug price interlocking system was applied from 2012 to 2021 had an upper limit twice or more. the amount has been reduced. 318 products (84%) of the same product group were cut only once. There were 36 product lines cut twice (19 domestic, 17 multinationals), 15 product lines cut three times (4 domestic, 11 multinationals), and 9 products cut four times (3 domestic, 6 multinational). The maximum number of iteration cuts reaches 6 times. For one product group, the upper limit was lowered six times due to the usage-drug price linkage system. The price of this product in 2012 was reduced by a total of 13.9% due to the application of the system six times. There was also one 5-time cut product line. The research team explained, “Among the products that were repeated less than three times, there were 9 products from domestic pharmaceutical companies and 17 products from multinational pharmaceutical companies. In addition, the product with the highest cumulative reduction rate was cut three times, a total of 25.2%. This investigation stemmed from the complaints of pharmaceutical companies over repeated cuts. Statistically, however, the repeated cut was not so large. The research team said, “About 16% of the total product groups were subject to repeated application twice or more, and when applied three or more times, they were generally blockbusters. At 14%, it was relatively low compared to the increase in finances.”
- Company
- PharmaEssentia attempts to reimb its first new drug BESREMi
- by Eo, Yun-Ho Apr 12, 2023 05:53am
- The Taiwanese pharmaceutical company PharmaEssentia is attempting to list its first new drug ‘Besremi’ for reimbursement. According to industry sources, PharmaEssentia submitted an application for the reimbursement of its polycythemia vera treatment, Besremi (Ropeginterferon alfa-2b) on March 28th. Polycythemia vera is a rare blood disorder where a somatic cell mutation in the bone marrow abnormally activates bone marrow function and produces excessive red blood cells. It has a short survival period and is so fatal that 10~15% of patients with polycythemia vera develop myelofibrosis or leukemia within 10 years. Although hydroxyurea had been used as the standard of care, it was difficult to fundamentally cure the disease with hydroxyurea, and patients who could not be treated with hydroxyurea had limitations as there were practically no drugs available for them in Korea’s domestic reimbursement environment. Besremi is an interferon treatment that selectively removes JAK2 mutations that cause polycythemia vera. In Korea, the drug received approval in October 2020 to treat low-risk and high-risk patients with polycythemia vera without symptomatic splenomegaly. The drug demonstrated its potential as a radical treatment for polycythemia vera in patients who had not received cytoreduction therapy or received less than 3 years of treatment with hydroxyurea. Therefore, whether the only interferon treatment option approved for polycythemia vera will be reimbursed is gaining attention. Besremi demonstrated its efficacy and safety in the Phase III PROUD/CONTINUATION-PV trial that was conducted on polycythemia vera patients. Trial results showed that 53% of the patients in the Besremi arm achieved a complete hematological response, an improvement compared with the hydroxyurea patient arm (38%). The response rates at 72 months were high at 80.4% and 65.3% in low-risk and high-risk patients, respectively, and showed high hematologic and molecular responses. Regardless of their risk, patients treated with Besremi did not require phlebotomy even 6 years after administration. Sung-Soo Yoon, Professor of Hemato-Oncology at Seoul National University Hospital, said, “Polycythemia vera is currently left unattended in terms of reimbursement in Korea. Patients that show no response to hydroxyurea, the current standard of care, had no appropriate treatment options available for use and had no option but to wait for their condition to progress further. He added, “Korea’s clinical practice guidelines recommend interferon and ruxolitinib as second-line treatment for patients who show intolerance or are refractory to hydroxyurea, but both drugs are currently unreimbursed, and other interferon treatments have withdrawn from the Korean market. Therefore, as the only treatment option available, Besremi is in urgent need of reimbursement.” Besremi is recommended as a first-line or second-line treatment for polycythemia vera by the National Comprehensive Cancer Network (NCCN) and European Leukemia Network (ELN) guidelines, regardless of previous treatment experience.
- Policy
- The alternative drug pricing system will be improved
- by Nho, Byung Chul Apr 12, 2023 05:53am
- It is expected that the specific direction of the public-private consultative body for rational drug price calculation of domestically developed innovative new drugs will be set, and system improvements will be promoted from May at the earliest. According to the industry, the public-private consultative body for improving the drug pricing system, composed of officials from the Ministry of Health and Welfare, KPBMA, and KRPIA, has held five rounds of discussions since last December and is expected to give positive incentives to new drugs. The drug price system improvement classification plan that the health authorities and the industry have formed a consensus on ▲innovative value for new drugs, ▲recognition of appropriate value for natural medicines (formerly new natural medicines), ▲derived system improvement for raw material self-sufficiency, and ▲stabilization of pharmaceutical supply maintenance of the period of accrual of the amount, etc. This proposal is a point of convergence in the larger framework, and the specific calculation method needs to be narrowed down through a general meeting of the public-private consultative body around the middle of this month. The most noteworthy part is the method of assigning value to new drugs and IMDs, and it is expected to be able to receive up to 10% higher drug prices than existing ones. If the alternative drug was reduced to 53.55% due to patent expiration, an additional 86.8% (100% 53.55%) is requested. IMD is expected to be recognized for up to 110% of development target products, including drugs for which the Ministry of Food and Drug Safety has approved data submission, as well as new usage and dosage. It is also eye-catching to prepare measures to strengthen its status as the originator of oriental medicine and to promote herbal medicine and herbal preparations. In the case of herbal medicines with improved clinical usefulness, it is likely to apply an additional 110% of the highest price of alternative medicines. For drugs using domestically produced drug substances, the additional period will be extended from 1 year to 5 years, and an exception to the follow-up management system will be applied. It is expected that the system will be improved so that if the number of companies for administration routes and products of the same dosage form is two or less, the addition of already-listed products will be maintained until there are three or more.
- Policy
- Leukemia Scemblix·Onureg passed the Evaluation Committee
- by Lee, Tak-Sun Apr 11, 2023 06:11am
- Leukemia treatments Scemblix and Onureg are recognized for their suitability for reimbursement and will move on to drug price negotiations with the NHIS. The HIRA held the 4th Pharmaceutical Reimbursement Evaluation Committee and reviewed the appropriateness of reimbursement for the six drugs for which the decision was applied. As a result of the deliberation, two out of six items passed, one item conditionally passed, two items failed, and one item decided to be re-discussed. The items that passed the committee first were Scemblix and Onureg. Scemblix 20, 40 mg is indicated for the treatment of adult patients with chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) previously treated with 2 or more TKIs. At the beginning of the year, the Cancer Disease Review Committee succeeded in setting the reimbursement standard. Onureg 200, 300 mg is used for maintenance therapy after induction therapy in adult patients with AML. The item that passed conditionally was Nephoxil 500mg (ferric citrate monohydrate) from Kyowa Kirin Korea. This drug is used for hyperphosphatemia in patients with chronic kidney disease undergoing hemodialysis. Tabrecta 150 and 200mg and Vyndamax 61mg are items that have not passed the committee due to non-reimbursement decisions. Tabrecta is a drug used for locally advanced or metastatic non-small cell lung cancer in which MET exon 14 skippings have been confirmed, and Vyndamax is a rare disease treatment used for ATTR-CM. Meanwhile, Lilly's RET-targeted anti-cancer drug Retevmo 40, 80mg will be discussed again. This drug has efficacy and effectiveness in RET fusion-positive non-small cell lung cancer, RET-mutated medullary thyroid cancer, and RET fusion-positive thyroid cancer.
- Company
- Luxturna, a one-shot retinal disease treatment
- by Eo, Yun-Ho Apr 11, 2023 06:11am
- Luxturna, a one-shot retinal disease treatment, is once again aiming to enter insurance coverage. As a result of the coverage, Novartis Korea recently resubmitted a reimbursement application for Luxturna, a treatment for Inherited Retinal Dystrophy. This is a quick resumption of the process after the HIRA's non-reimbursed decision last month. As the company's will to be listed on the salary is firm, it remains to be seen whether this re-challenge will be successful. This drug submitted an application for reimbursement in September 2021, but there was no progress in the listing process so far, and it was first introduced this year. Although it is expensive one-shot gene therapy, it seemed difficult to register because the disease is not directly related to life. Luxturna restores the function of the defective or defective RPE65 gene, one of the causes of IRD, by replacing it with a normal gene with just one administration. This means that the fundamental treatment of the disease is possible. Therefore, the key is how much Luxturna can achieve the value of preventing blindness. This drug was designated by the US FDA as Breakthrough Therapy in 2014, Orphan Drug in 2016, and Priority Review in 2017, and obtained expedited approval in 2017. IRD is a rare and intractable disease in which vision loss occurs due to mutations in the gene responsible for the structure and function of retinal photoreceptors. It includes more than 20 different eye diseases, and there are about 300 causative genes. IRD caused by RPE65 gene mutation causes an abnormality in the visual cycle in the retina, which converts visual information entering the eye into nerve signals and transmits them to the brain. RPE65 gene mutation reduces the RPE65 protein, which is essential for visual circuitry, and destroys retinal cells, gradually narrowing the field of vision and eventually leading to blindness. Luxturna proved its effectiveness through a phase 3 clinical trial targeting patients with hereditary retinal diseases in which a biallelic mutation in the RPE65 gene was confirmed. As a clinical result, the functional vision of patients treated with Luxturna improved statistically significantly compared to the control group who did not receive treatment at 1 year of treatment. As a result of evaluating the average score of the Multi-Luminance Mobility Test (MLMT), which evaluates the ability to pass through an obstacle course of various heights in various levels of illumination by recreating a daily walking environment, as the primary evaluation variable at 1 year of treatment, Luxturna treatment group The score change of was 1.8 points, which was 1.6 points higher than the control group's score change of 0.2 points.
- InterView
- CDK4/6 latecomer Kisqali exudes confidence in its effect
- by Jung, Sae-Im Apr 11, 2023 06:11am
- Novartis’s Kisqali (rivociclib), a latecomer CDK4/6 inhibitor used in metastatic breast cancer, is taking on an unexplored path, away from other CDK4/6 inhibitors. The drug has demonstrated efficacy in aggressive forms of breast cancer, which had not been attempted by other CDK 4/6 inhibitors. Aggressive breast cancers appear relatively often in Korea where the proportion of younger aged patients is large, but the patients’ only available option was to use highly toxic chemotherapy. In a recent interview with Dailypharm, Seock-Ah Im, Professor of Hemato-Oncology at Seoul National University Hospital said, “Younger breast cancer patients have a higher probability of accompanying visceral metastasis because of their rapid cancer growth and aggressive clinical pattern. However, due to the clinical practice guidelines that recommended using chemotherapy for the past 20 to 30 years, there were doubts about whether to use CDK4/6 inhibitors. However, Kisqali's recent study convinced me of the viability of using CDK4/6 therapies." The recent study mentioned by Professor Im is the RIGHT Choice trial that was released in December last year. The trial studied aggressive hormone receptor–positive, HER2-negative advanced breast cancer patients that had symptomatic visceral metastasis, rapid disease progression or impending visceral compromise, or marked symptomatic nonvisceral disease. Although the CDK4/6 inhibitor+ endocrine therapy is currently used as the standard treatment for breast cancer in the first line, chemotherapy was still used in patients with rapid disease progression or visceral metastasis. Metastatic breast cancer often spreads to the lungs, liver, or brain, and when metastasis occurs, symptoms such as shortness of breath and pain may arise. In such cases, it is difficult to quickly reduce tumor size with hormone therapy alone. CDK4/6 inhibitors have been introduced as a new option in this field, but no data existed demonstrating their effectiveness in these patients. Kisqali is the only CDK4/6 inhibitor class drug to demonstrate an improved effect over combined chemotherapy in aggressive breast cancer. Results showed that the median progression-free survival (PFS) of the Kisqali + endocrine therapy combination was 24.0 months, a 1-year extension over the 12.4 months recorded by the control group (HR=0.54). The median time to treatment failure in the Kisqali combination group was 18.6 months, which was at least 10 months longer than that of the control group (HR=0.45). In terms of safety as well, the Kisqali combination group had a lower rate of treatment-related serious adverse reactions and treatment discontinuation rate compared to the combination chemotherapy group. Professor Lim said, "The scope of use of CDK4/6 inhibitors including Kisqali in HR+ breast cancer has increased significantly over the past two years. In line with the broadened scope of use of CDK4/6 inhibitors that changed the treatment paradigm of HR+ breast cancer, the ground is being laid to allow their more active use.” Professor Seock-Ah Im-I heard that Asian doctors first suggested the initiation of the RIGHT Choice trial = I am a member of a group of researchers that seek to improve the treatment of young breast cancer patients. As members, specialists from Asian countries, including Korea, Taiwan, Hong Kong, and Singapore, gather together to discuss and study how to improve the treatment environment for young breast cancer patients. During a meeting, the researchers suggested that a combination therapy that uses a CDK4/6 inhibitor could improve the quality of life and have a better antitumor effect than combination chemotherapy, and a research proposal was sent to pharmaceutical companies based on the suggestion. We proposed a study because young patients in their 40s and 50s occupy the majority population in Asia, compared to the West, which is dominated by elderly patients in their 60s and 70s. Breast cancer often takes on an aggressive form among young patients due to the fast cancer growth rate and relatively faster cell division. This means patients are highly likely to have accompanied liver or lung metastases. These doctors had been using chemotherapy as the first-line treatment for HR+ patients because it takes a long time to improve the patient’s symptoms by reducing cancer size with hormone treatment. Chemotherapy allows the tumor size to reduce within 1 to 2 months and the symptoms improve. However, it is also highly toxic. Therefore, a consensus was reached on how combining hormone therapy and targeted therapy instead of chemotherapy, which is difficult to be approved, would yield better results. Novarits’s Kisqalit team accepted the request, and so the RIGHT Choice study was conducted to demonstrate the actual improvement effect.. -How would you interpret the RIGHT Choice trial results? s= There had been clinical trials comparing hormone therapy and CDK4/6 inhibitors with oral anticancer drugs. However, this study is the first to show improvement compared to a combination therapy that is administered in two injections of cytotoxic anticancer drugs. In general, if a patient starts anticancer therapy, the tumor size is first reduced and then starts to grow again. The time until disease progression, that is, the time to symptom relief after chemotherapy and relapse is about 5 to 6 months. In clinical practice, the median time to treatment failure in the Kisqali combination group was 18.6 months, about twice as large as 8.5 months in the control group. Median progression-free survival was also extended by about 1 year compared to the control group. In particular, this study brings more significance because it includes premenopausal women and proves that a more comfortable initial treatment can be performed in premenopausal patients with more aggressive liver cancers or those with lung metastases. The limitation is that the study enrolled patients whose control group could be either one of two cytotoxic anticancer drugs and have a normal range of liver function and daily performance ability to some extent. The study did not include patients whose daily performance is so poor that they are almost bedridden. There are some cases we feel it’s inappropriate to conduct chemotherapy in some patients with visceral metastasis. However, on the other hand, there were many questions about whether it was really okay to use CDK4/6 inhibitor combination therapies. The study convinced me of the potential held by 'CDK4/6 therapy.’ -Kisqality was the last of the three CDK4/6 inhibitors to be introduced to the market. However, if you look at the recent sales records reported by the market research institution IQVIA, Kisqali made notable sales. How reliable are new drugs like Kisqali? =The data was interesting. Having participated in the trial of all three CDK4/6 inhibitors, Ibrance, Verzenio, and Kisqali, I am well aware of the benefits and disadvantages of each drug. Therefore, doctors tend to select drugs after comprehensively considering each patient’s safety, the patient's environment, and condition. In the case of postmenopausal women, side effects such as age, presence or absence of pulmonary embolism or venous thrombosis, and probability of pneumonia are considered. In addition, bone marrow function, liver function, electrocardiogram abnormality, and diarrhea are also considered. However, re-menopausal breast cancer patients didn't have as many options to choose from. Before Ibrance, the patient had to first remove both ovaries to use Ibrance. Fortunately, the combination therapy with Ibrance after ovariectomy did not require chemotherapy, and had only a few side effects other than a slight decrease in white blood cell count, so this method was mainly used. Later, the MONALEESA-7 study played a significant role.in allowing premenopausal women to use Kisqali combination therapy without ovarian resection.
- Company
- One-shot CAR-T tx, approved for domestic items
- by Eo, Yun-Ho Apr 11, 2023 06:11am
- According to related industries, Janssen Korea's Kavicty was approved last month, and Novartis Korea's Kymriah obtained additional approval for indications on the 5th. The second domestically approved CAR-T new drug, Kavicty, is an anticancer drug that inserts genetic information to recognize BCMA into the patient's immune cells (T cells) and then injects these T cells into the patient's body. B-cell maturation antigen, which is selectively expressed during plasma cell differentiation and not expressed in other major organs, represents an ideal target for plasma cell cancer (multiple myeloma). This drug is indicated for patients with relapsed or refractory multiple myeloma who have received at least four prior therapies, including ▲proteasome inhibitors ▲immunomodulators, and ▲anti-CD38 antibodies. In the case of Kymriah, the indication was expanded to treat adult patients with recurrent or follicular lymphoma after two or more treatments. With this expansion of the indication, Kymriah ▲relapses or secondary relapses after transplantation and subsequent relapses or refractory B-cell ALL (Acute lymphoblastic leukemia) and ▲ in pediatric and young adult patients under the age of 25 A third indication was obtained following recurrent or diffuse large B-cell lymphoma after two or more systemic treatments. Kymriah's new indication was based on ELARA, a phase 2 clinical trial targeting adult patients with relapsed or refractory follicular lymphoma (n=97). As a result of the study, the Overall Response Rate was 86.2%, including 69.1% of Complete Remission. Meanwhile, in March 2021, it was approved as a domestic advanced regenerative medicine bio law No. 1 treatment, and in April 2022, insurance benefits are applied to the two previously approved indications.
