- LOGIN
- MemberShip
- 2026-03-17 19:30:54
- Company
- Hanmi Pharmaceutical's first technology export in a year
- by Chon, Seung-Hyun Nov 12, 2021 05:56am
- Hanmi Pharmaceutical is speeding up its efforts to secure profits from technology fees, which had slowed down for a while. It has secured a down payment of 10 billion won by exporting new drug technology in the past year, and expectations are high for subsequent new drug development. According to an industry on the 11th, Hanmi Pharmaceutical exported FLT3 inhibitor "HM43239," which is being developed as an innovative drug for AML treatment, to Aptose Biosciences on the 4th. Under the contract, Hanmi Pharmaceutical will receive a $12.5 million down payment (about 15 billion won) from Aptose Biosciences in cash and $7.5 million in Aptose Biosciences shares. After that, it will receive up to $47.5 million (about 485 billion won) in clinical, development, permission, and commercialization milestones for various indications. You will also receive a step-by-step royalty for sales. Hanmi Pharmaceutical completed the export of new drug technology in a year and three months. Hanmi Pharmaceutical exported a non-alcoholic steatohepatitis treatment to MSD in August last year. The GLP-1-based double agent whose rights were returned from Janssen was transferred back to MSD after a year. It is a double-acting treatment that simultaneously activates GLP-1, which helps secrete insulin and suppress appetite, and glucagon, which increases energy metabolism, and Hanmi Pharmaceutical's original technology for lapscovery, which increases drug efficacy duration, is applied. Hanmi Pharmaceutical's new technology export contract is also expected to expand technology fee profits. Hanmi Pharm is expected to temporarily recognize the down payment of $5 million (about 6 billion won) received in cash from Aptose Biosciences as technology fee revenue. Hanmi Pharmaceutical has established its technology fee revenue in earnest since 2015 when it began to produce technology export results in earnest. However, in recent years, when technology exports have become less successful, technology fee profits have decreased significantly. Until the third quarter of this year, Hanmi Pharmaceutical's technology fee revenue was only 200 million won. No technology fee revenue was generated in the first and second quarters, and 200 million won flowed in in the third quarter. Hanmi Pharmaceutical earned a total of 512.5 billion won in technology fees from down payments received from Lily, Beringer, Sanofi, and Janssen in 2015 and secured more than 10 billion won in technology fees every year. Hanmi Pharmaceutical posted 27.7 billion won in technology fees in 2016, which is the result of returning some of them due to the revision of the contract with Sanofi. Initially, Hanmi Pharmaceutical received a down payment of 400 million euros in 2015 when it signed three technology transfer contracts with Sanofi. At this time, Hanmi Pharmaceutical reflected only KRW 255.6 billion in its accounting books and chose a method of recognizing the rest in installments for 36 months. At the end of 2016, Hanmi Pharmaceutical returned 로를196 million through contract modification, including the return of the rights of some tasks (continuous insulin). Hanmi Pharmaceutical remitted about 160 million euros by revising the contract without recognizing about 160 billion won in down payment received from Sanofi as revenue (255.6 billion won in 2015 and 63.9 billion won in the first to third quarters of 2016). Hanmi Pharmaceutical earned 57.7 billion won in 2017, 44.6 billion won in 2018, and 20.4 billion won in 2019. During this period, the down payment received from Genentech was recognized in installments. Hanmi Pharmaceutical signed a technology transfer contract with Genentech in September 2016 for the RAF target anticancer drug "HM95573. If the down payment is $80 million and clinical development, permission, and commercialization are successful, the condition is to receive $830 million sequentially as a step-by-step milestone. Hanmi Pharm received a down payment of $80 million from Genentech on December 2, 2016. At that time, 93.8 billion won was deposited if 1,173 won was applied based on the won-dollar exchange rate. Hanmi Pharmaceutical recognized the down payment in installments for 30 months on its accounting books, and the period of recognition of the down payment in April 2019 ended. Last year, the company temporarily recognized $10 million in down payment secured through a technology export contract with MSD, generating 10 billion won in technology fee revenue. Hanmi Pharm has also secured additional milestones following the development of the anticancer drug "Auraxol" exported to Athensx. Hanmi Pharmaceutical can secure additional technology fees according to the development of technology export tasks. Belvarafenib, which transferred technology to Genentech, is currently conducting global clinical trials for commercialization by Genentech and Roche. "belvarafenib" is a pan-RAF inhibitor-based targeted anticancer drug. It acts as a mechanism to inhibit RAF, a type of mitogen-activated protein (MAP) kinase that mediates intracellular signaling. Genentech has proven excellent drug resistance and safety in combination with existing approved treatments and plans to expand global clinical trials for patients with NRAS melanoma. Roche added two cohorts of belvarafenib-related monologues and combination therapy to its ongoing large-scale clinical project, "TAPISTRY." "TAPISTRY" is a clinical trial aimed at providing customized treatments to metastatic solid cancer patients who cannot operate with certain mutations. According to a quarterly report submitted to the U.S. Securities and Exchange Commission by Hanmi Pharmaceutical's partner Spectrum Pharmaceuticals, Spectrum agreed to pay up to $358 million in milestones to Hanmi Pharmaceutical according to the commercialization performance of the anticancer drug Poziotinib. Spectrum plans to submit an application for FDA approval as early as this year. If "Rolontis," a treatment for neutropenia that has been applied for permission from the U.S. Food and Drug Administration (FDA), is approved, it will pay $10 million to Hanmi Pharmaceutical. Poziotinib is a pan-HER2 anticancer drug that Hanmi Pharmaceutical transferred to Spectrum in 2015. Rolontis, which was transferred to Spectrum in 2012, is a new biopharmaceutical applied with Hanmi Pharmaceutical's Labscovery platform technology that increases the duration of the drug's efficacy in the body.
- Company
- GX-17, aimed at treating COVID-19, resumes clinical trials
- by Kim, Jin-Gu Nov 12, 2021 05:54am
- Genexine's new anticancer drug candidate GX-I7, which had shown potential as a treatment for COVID-19, will launch a new clinical trial for anticancer drugs. On the 10th, the MFDS approved phase 2 clinical trials of Bevacizumab and Genexine GX-I7 in recurrent glioblastoma. Bevacizumab is the active ingredient of Roche's target anticancer drug Avastin. GX-I7 is a substance that Genexine is developing as a new anticancer drug. In 2017, the company launched phase 1b clinical trials for metastatic and recurrent solid cancer and began developing new anticancer drugs in earnest. Since then, he has initiated phase 1b combination therapy with cyclophosphamide in solid cancer in 2018, phase 1b/2 with Pembrolizumab (Keytruda) in recurrent and non-adaptive triple negative breast cancer, and phase 1/2 with Temozolomide (Temoram) in 2019. After the COVID-19 crisis began in earnest, the possibility as a treatment for COVID-19 was expected. In August 2020, it was approved for phase 1b clinical trials in Korea for mild COVID patients. In the United States, Genexine's U.S. affiliate NeoImuneTech launched phase 1 clinical trials for COVID-19 patients in November last year. However, in the case of COVID-19 clinical trials, it is prolonged than originally expected. The domestic clinical trial was to be conducted on 40 patients, but the recruitment of patients was still not completed after recruiting the first patient in March, seven months after clinical approval. US clinical trials of 30 people are also still recruiting patients. In this situation, Genexine is focusing again on clinical trials of GX-I7 anticancer drugs. In fact, it is confirmed that Genexine has recently been approved for clinical trials of anticancer drugs not only in Korea but also in the United States. Last month, NeoImuneTech launched phase 2 clinical trials for combination therapy with Atezolizumab (Tecentriq) of NT-I7 (US Development Name of GX-I7) in non-small cell lung cancer. Prior to this, in January this year, it was approved for phase 2 clinical trials with Opdivo for gastric and esophageal cancer patients. In August, phase 1b clinical trials were launched for patients with recurrent and refractory giant B-cell lymphoma. In addition to GX-I7, Genexine is developing GX-19N as a COVID-19 vaccine. Phase 1/2a clinical trials have been completed in Korea, and phase 3 global clinical trials are currently underway in Indonesia, Argentina, and Turkey. Genexine plans to release GX-19N in the first half of next year.
- Company
- Will BMS's 'Revlimid' be reimbursed as RVd therapy?
- by Eo, Yun-Ho Nov 11, 2021 06:01am
- Whether the multiple myeloma treatment ‘Revlimid’ will succeed in expanding reimbursement to its use in RVd therapy is gaining attention. According to industry sources, reimbursement of Revlimid (lenalidomide) for RVd therapy (Lenalidomide + bortezomib + dexamethasone) passed the Health Insurance Review and Assessment Services’ Cancer Disease Deliberation Committee review in September and is awaiting deliberation by the Pharmaceutical Benefits Appraisal Committee. The agenda is expected to be presented for PBAC deliberation in December. In Korea, the standard first-line therapy for multiple myeloma under reimbursement includes VMP (bortezomib+ melphalan+ prednisolone) and Rd (lenalidomie+dexamethasone) in patients who are not eligible for stem cell transplants, and VTd (bortezomib+thalidomide+dexamethasone) for patients eligible for stem cell transplants. However, the 5-year relative survival rate of multiple myeloma patients in Korea remains in the 40% range. RVD therapy is recommended as a priority in the first-line treatment of multiple myeloma in the US NCCN guidelines and EHA-ESMO guidelines. According to HIRA, among the 8,929 patients in Korea who were treated for multiple myeloma in 2020 (diagnosis code: C90, multiple myeloma, and malignant plasma cell neoplasms), 47% were over the age of 70 and were ineligible for transplant under the reimbursement standards. Elderly patients over the age of 70 have limited treatment options as they have difficulty receiving stem cell transplants, raising the demand for RVd reimbursement. Seok-Jin Kim, Professor of Hematology-Oncology at the Samsung Medical Center, said, “Treatment of multiple myeloma requires multiple considerations from the medical aspect as well as in the patient’s condition, treatment sequence, reimbursement conditions, etc. Both the patients and us HCPs will welcome a treatment option with a promising prognosis that can be used freely without reimbursement restrictions." He added, “I hope reimbursement for multiple myeloma treatments is extended to cover RVd therapy, maintenance therapy after autologous hematopoietic stem cell transplant, and R2 in follicular lymphoma to benefit more patients.” In a Phase III clinical trial, RVd therapy significantly extended PFS (progression-free survival) and OS (overall survival) compared to Rd therapy in patients with newly diagnosed multiple myeloma that are ineligible for stem cell transplant. In a network meta-analysis that assessed the relative efficacy of MM drugs used in newly diagnosed patients that are ineligible for stem cell transplant, RVd demonstrated significant extension in PFS and OS over Rd, and Rd over VMP.
- Company
- What do scholars refer to as effective tx for myeloma?
- by Nov 11, 2021 06:00am
- With the release of various new drugs over the past decade, treatment results for multiple myeloma have been gradually improving. This is because as options vary, opportunities for "customized treatment" to select drugs depending on patients expand. Professor Eom Hyun-seok (left) and Professor Kwee Yong (right) who are conducting video talks Medical staff's attention is focused on which patients should be used to maximize the effectiveness. In particular, third-drug therapy centered on second-generation proteasome inhibitors (PI) is a trend in patients with first recurrence. As KRd therapy (Carfilzomib+ Revlimid +Dexamethasone) centered on Kyprolis and IRd therapy (Ixazomib+Revlimid+Dexamethason) centered on Ninlaro compete, the process of identifying appropriate drug choices considering drug characteristics and patient conditions continues. Takeda held an academic conference between British and Korean medical staff on the treatment of recurrent and refractory multiple myeloma according to patient characteristics such as disease risk and cytogenetic high-risk groups. Eom Hyun-seok, director of the National Cancer Center Hospital (Professor of Hematology and Oncology), an authority in the field of blood cancer, and Kwee Yong, a professor at University College London, participated in the meeting. Professor Eom Hyun-seok: What are the guidelines for selecting IRd and KRd as secondary therapies for patients with recurrent and refractory multiple myeloma? Professor Kwee Yong: Proteasome inhibitor and Lenalidomide combination therapy are very good methods in secondary treatment. Most patients will reach a therapeutic response with this combination therapy. The issue is which one to choose between IRd and KRd. The risk of the disease is first identified, and then whether it recurred early or aggressive. If the disease is aggressive and recurs early, has extra-bone marrow lesions, has high M protein levels, and the disease progresses quickly, KRd should be selected. However, patients should be young and able to visit the hospital every week. It is a very intensive treatment. On the contrary, if the condition is not aggressive and recurrence is not carried out early, so the progressive survival period (PFS) is at least 18 to 24 months, IRd will be selected. It is a fairly comfortable treatment for patients in many aspects. The side effects of KRd's Kyprolis require more careful attention. In particular, they have a history of heart disease or kidney damage. Professor Eom Hyun-seok: If so, can high-risk groups be classified into KRd according to the patient's risk and IRd if it is a general risk? Professor Kwee Yong: There is no clear standard. This is because IRd responses are very good even in patients who are genetically at high risk. If we have to make a distinction, the aggression of the disease, the pace of disease progression, and the burden of the disease will be more consistent. Professor Eom Hyun-seok: How do you see the use of IRd in multiple myeloma with advanced extra-bone marrow lesions? Professor Kwee Yong: Treatment is very difficult when extra-bone marrow lesions have progressed. In terms of experience, even if the reaction appeared, it did not last very long. I will choose a combination treatment based on proteasome inhibitors and IMiD, an immunomodulatory anticancer drug. Even when extra-bone marrow lesions progressed, there were cases in which the response was very good with IRd treatment. Professor Eom Hyun-seok: In the case of early recurrence, there may be characteristics of high-risk groups, and if the response appears slowly while presenting the case, the duration of the reaction will be extended. Is there anything additional to say about the reaction time and timing of recurrence? Professor Kwee Yong: First of all, I would like to tell you that there is not only one type of high risk of disease. Some high-risk factors speed up disease progression and respond quickly. Some patients with chromosome defects 17 are thought to have a single opposing genetic effect. The important thing is that treatment should be maintained. If treatment is stopped, it does not work. In some high-risk patients, such as chromosome 1 acquisition or chromosome 17 defect, it takes a long time to respond, but if treatment continues, it will be maintained well. Professor Eom Hyun-seok: In the case of the high-risk patients, it is important to continue treatment. Professor Kwee Yong: So the advantage of IRd is that it can continue to treat proteasomes inhibitors. It is difficult in VRd or KRd. Professor Eom Hyun-seok: Another part is about clinical practice. There are a variety of important clinical trials related to secondary treatment, which are slightly different from real world data, so you should be careful in interpreting these data. Professor Kwee Yong: There are several clinical trials and the number of previous treatments varies from one to three. However, most of the large-scale clinical trials were conducted before Lenalidomide was widely used. These clinical trials are not very useful these days because the proportion of patients exposed to lenalidomide was small and they were not refractory to lenalidomide. This is especially true if the patient has already received lenalidomide treatment. Clinical trials have shown good results for Renalidomide three-drug therapy such as Daratumab-Lenalidomide-Dexamethason, KRd, and IRd. However, when looking at the meta-analysis data, the margin benefit is similar. In addition, these clinical trials exclude many patients with poor performance data, patients with renal dysfunction, and patients with low platelet levels that we meet at the clinic every day. Professor Eom Hyun-seok: In Real World, it is very important whether the drug resistance or treatment continues. For patients, discontinuation of treatment is not the best, but I think excellent drug resistance is one of the biggest advantages of IRd.
- Company
- Expectations rise for Rinvoq in treating severe AD
- by Nov 10, 2021 05:55am
- A second JAK inhibitor has been introduced to the field of moderate-to-severe atopic dermatitis treatment. Abbvie’s ‘Rinvoq (upadacitinib),’ with its double advantage in improved convenience and effect, is heralding new change in the field of AD treatment. Rinvoq was additionally approved for the atopic dermatitis indication on the 6th last month by the Ministry of Food and Drug Safety. With the approval, Rinvoq is now approved for patients with moderate-to-severe atopic dermatitis in adults and adolescents over the age of 12. Rinvoq became the second JAK inhibitor after ‘Olumiant’ to be approved for atopic dermatitis. Also, the addition of Rinvoq increased the number of options for AD to three – the biological drug ‘Dupixent,’ and JAK inhibitors Rinvoq and Olumiant – in an area where no new drug had been introduced for a long period of time. ◆Dupixent’ targets specific cytokines – ‘Rinvoq’ provides broader inhibition Numerous inflammatory mediators are entangled like a web in atopic dermatitis, and Dupixent and the JAK inhibitor Rinvoq treat atopic dermatitis with different mechanisms of action. Dupixent selectively and potently inhibits IL-4 and IL-13, the key and central drivers of the type 2 inflammation that causes atopic dermatitis. It provides a higher effect by targeting specific cytokines, but also may not be effective in some patients. On the other hand, JAK inhibitors including Rinvoq provide broader cytokine inhibition. Cytokines bind to the cell surface receptors to deliver signals through the JAK-STAT and other signaling pathways, and JAK inhibitors target the JAK enzymes that command the protein that plays a pivotal role in immune/inflammatory regulation. Among the JAK enzymes, Rinvoq specifically targets JAK1, which not only includes IL-4 and IL-13, but also is involved in various other cytokines including the itch-specific cytokine IL-31, keratin-involved TSLP, IL-22 that thickens the skin, and interferon-gamma. ▲ Yong-hyun Jang, Professor of Dermatology at Kyungpook National University College of Medicine This mechanism of action is how RInvoq was able to show immediate effect in such a short period of time. At the RInvoq press conference that was held on the 9th, Yong-Hyun Jang, Professor of Dermatology at Kyungpook National University College of Medicine, said, “Inhibiting only IL-4 and IL-13 cannot be a complete solution to atopic dermatitis, as the immunopathological mechanism of atopic dermatitis is very complex, and manifests differently by race or age. The introduction of Rinvoq has resolved this unmet need.” Also, another difference between the two drugs that arise from the differences in mechanisms is in their method of administration. The biologic Dupixent is an injection and JAK inhibitors like RInovq are small molecule inhibitors that can be taken orally. Rinvoq can be a more convenient option for patients who have difficulty making regular visits to hospitals for injections. Oral drugs also have the advantage of allowing easier dosage adjustments fit for each patients’ condition. ◆Rises among JAK inhibitors with its superior data… achieves convenience in administration and effect Another advantage of Rinvoq is its excellent clinical data. In Phase III studies that compared RInvoq with placebo (Measure Up1, Measure Up2, AD Up), 60~70% of patients who received Rinvoq achieved EASI75 (at least a 75% improvement in the Eczema Area Severity Index) at Week 16. The proportion was 70-80% in patients who receive a higher dose (30mg). Also, 42-53% (higher dose 58-66%) achieved EASI90 (at least 90% improvement). Also, RInvoq significantly reduced itching, the symptom patients find most difficult to bear, in about half of the patients. 42~53% (Worst Pruritus improvement≥4) The results were more positive than the data from Olumiant, where about half of phase 3 participants reached EASI75. In addition, Rinvoq also demonstrated superior efficacy and safety in a head-to-head trial compared to Dupixent, which has the sole lead in treating moderate-to-severe atopic dermatitis. In the 3b Heads Up study, 71.0% of patients treated with Rinvoq achieved EASI 75 at week 16, which was higher than the 61.0% in the Dupixent-treated group ▲ Dong-hoon Lee, Professor of Dermatology at Seoul National University HospitalAlso, recently updated analysis data shows that switching from dupilumab to RInvoq had shown significant improvement. Dong-hoon Lee, Lee of Dermatology at Seoul National University Hospital, said, “Both the patients who showed response or no response to dupilumab showed significant improvement when switching from dupilumab to Rinvoq at Week 24 or later. And the effect continued until Week 52. The significant improvement in skin clearance and itching reduction even after switching was notable.”
- Company
- Ono's BTK inhibitor Velexbru was approved for sale
- by Nov 10, 2021 05:55am
- Onopharm (CEO Choi Ho-jin) announced on the 9th that it has received approval from the MFDS to sell BTK inhibitor Velexbrew as a monotherapy for patients with B cell-induced PCNSL. The first BTK inhibitor has emerged as a PCNSL treatment that has not yet been established. The basis for approval is the results of phase 1/2 clinical trials (ONO-4059-02) evaluating the efficacy and stability of Velexbrew in patients with recurrent or refractory PCNSL in Japan. The first efficacy evaluation index was ORR according to BICR. In this study, the ORR of the Velexbrew administered group was 52.9% (9/17 patients). The main side effects of grades 3 and 4 included neutropenia, leukopenia, and hyperneutral lipidemia, respectively, and 11.8% (2/17 patients).
- Company
- Non-reimbursed prescriptions for migraine drug Ajovy begin
- by Eo, Yun-Ho Nov 09, 2021 05:55am
- The new migraine drug ‘Ajovy’ is now being administered without reimbursement in Korea. According to industry sources, Teva-Handok Pharma’s Calcitonin gene-related peptide (CGRP) targeting migraine drug, Ajovy (fremanezumab), which was released in Korea on the 18th of last month, is now available for prescriptions at several medical institutions, including the Shinchon Severance Hospital. However, the drug has only passed a few drug committee (DC) reviews at general hospitals yet. Instead, the company had set a pre-order system for the drug for supply due to a flood of inquiries from patients whose symptoms recurred after taking Lilly's Emgality (galcanezumab)', another migraine drug that was released before Ajovy, also without reimbursement. Patients with severe migraines have shown expectations that Ajovy will bring different results based on the fact that the two migraine drugs have different dosages and methods of administration, although the two are from the same class. Emgality can currently be prescribed in medical institutions nationwide, in the ‘Big 5’ that includes the Seoul National University Hospital and Sinchon Severance Hospital, as well as other institutions nationwide, such as the Kangbuk Samsung Hospital, Hallym University Dongtan Sacred Heart Hospital, and Nowon Eulji Medical Center. Ajovy is administered two ways: 225 mg monthly, or 675 mg every 3 months (where 3 subcutaneous injections of 225mg are injected consecutively). The drug demonstrated its efficacy in the HALO EM/CM clinical trial that was conducted for 12 weeks on 2,000 patients with episodic migraines (EM) and chronic migraines (CM). In the HALO EM study that was conducted to verify the efficacy and safety of Ajovy in comparison to a placebo, Ajovy met the primary endpoint by significantly reducing the monthly number of migraine days in both of the monthly and quarterly dosed groups. The proportion of patients with a 50% reduction in migraine days was also higher for the Ajovy administered group than the placebo group. 44.4% of subjects in the monthly dosing, 47.7% of subjects in the quarterly dosing group, and 27.9% in the placebo group showed a 50% or more reduction in migraine days. In the HALO CM study, the monthly average reduction in migraine days in the monthly dosing Ajovy group was 4.6±0.3 days, and 4.3±03 days in the quarterly dosing Ajovy group, both were significant compared to the placebo group’s 2.5±0.3 days. WonGu Lee, Professor of Neurology at Kosin University Hospital, said, “Unlike existing preventive therapies that had to be taken every day, patients may manage their migraines with once-a-month injection with CGRP targeted antibody drugs. The treatment cost remains an issue, however, we have high expectations for the drug because the more the patient receives the targeted therapy, the easier it is to treat."
- Company
- Will Ildong sell Nexium with annual sales of 50 billion won?
- by Kim, Jin-Gu Nov 09, 2021 05:54am
- Daewoong and AstraZeneca will terminate a joint sales contract for Nexium, a PPI-based gastroesophageal reflux disease treatment. The new joint sales partner of the large item, which generated about 50 billion won in sales last year, is said to be likely to be Ildong. According to the pharmaceutical industry on the 9th, Daewoong and AstraZeneca agreed to terminate the joint sales contract of Nexium last month. The contract is until December 31 this year. Nexium is a PPI-based gastroesophageal reflux disease treatment launched in Korea in 2000. Daewoong has been jointly selling with AstraZeneca since 2008. Sales have steadily increased over the next 14 years, making it the No. 1 item in the same ingredient market. According to the two companies, Nexium's sales reached 49.4 billion won last year. Instead of breaking up with Nexium, Daewoong plans to focus on sales and marketing of Fexuprazan, which is expected to be released next year. Daewoong is developing Fexuprazan, a P-CAB-based gastroesophageal reflux disease treatment. It is a drug of the same family as K-CAB of HK inno.N, which is rapidly growing in the market. Phase 3 clinical trials in 2019 have been completed. Currently, it has applied for item permission from the MFDS. It is also expected to be available as early as the end of this year. Daewoong Pharmaceutical has already been approved for generics with components such as Nexium in 2019. Starting next year, it is expected to sell Nexierd containing esomephrazole along with Fexuprazan. Ildong is said to be the most likely new co-selling partner of Nexium. Ildong is already jointly selling diabetes treatments such as Onglyza, Kombiglyze, and Qtern with AstraZeneca. On top of that, it is expected to further strengthen the combined front with AstraZeneca by jointly selling Nexus from next year. An official from Daewoong said, "The joint sales contract of Nexium will end at the end of this year," adding, "We decided not to extend the contract to focus on Fexuprazan, which is expected to be released next year." An official from the pharmaceutical industry said, "As far as I know, Ildong is likely to be the new partner of AstraZeneca, which will jointly sell Nexium," adding, "Unless there is a major change, the contract is expected to be signed soon."
- Company
- It is expected that the SGLT-2 combination will be activated
- by Eo, Yun-Ho Nov 08, 2021 05:52am
- Domestic approved SGLT-2 inhibitorsExpectations are also rising for revitalization of the combination drug market along with the expansion of combined benefits for the drug SGLT-inhibitors. According to related industries, pharmaceutical companies with SGLT-2 inhibitors and DPP-4 inhibitors, such as Beringer Ingelheim, AstraZeneca, and MSD, will go through the registration process of the complex when discussions on expanding the combined diabetes benefits are completed. However, it is expected that there will be differences in the actual registration speed due to the expiration of patents. ◆Esglito, co-developed by Beringer Ingelheim =Beringer Ingelheim and Lilly, is a combination of SGLT-2 inhibitor Jardiance and DPP-4 inhibitor Trajenta. Esglito was originally approved in Korea under the product name Glyxambi in 2017, but changed its product name at the beginning of this year. Currently, Jardiance has applied for an increase in benefit and is waiting for the HIRA's action. Beringer Ingelheim and Lilly's diabetes pipelines have been led by domestic promotion partners Yuhan Corporation. It remains to be seen whether Esglito will join Yuhan Corporation after the benefit issue has been resolved. ◆ AstraZeneca's Qtern= Unlike other complex, Qtern, combination of Forxiga (Dapagliflozin) and Onglyza (Saxagliptin) was launched in about four years. Ildong Pharmaceutical signed a domestic exclusive sales contract with AstraZeneca and began marketing and supply it in earnest from the 1st. Ildong Pharmaceutical is also expected to make decisions on Qtern if Forxiga's benefit is expanded. ◆MSD's Stegluzan=Stegluzan, combination of Steglatro and Januvia was released in October last year. MSD has also submitted an application for the expansion of Steglatro's combined benefits and is waiting for the HIRA's review. MSD plans to switch Stegluzan to release as soon as Stegluzan's benefit expansion is decided. A meeting of diabetes experts convened by the HIRA in September concluded in the direction of integrating and recognizing the combined use and three-drug benefits between DPP-4 inhibitors and SGLT-inhibitors. At the meeting, TZD-related drugs, which had cardiovascular side effects, were required to be judged by drug. Accordingly, prescription restrictions are expected to continue only for the combination of TZD. The HIRA is currently discussing the schedule for formal procedures, including the introduction of the Drug Reimbursement Evaluation Committee.
- Company
- K-Rare Disease Drug Hunterase that is more popular overseas
- by Chon, Seung-Hyun Nov 08, 2021 05:51am
- Hunterase, developed by GC Pharma, is speeding up its efforts to target global markets. It is successful as a treatment for rare diseases developed in Korea, generating more than three times more sales than domestic demand in overseas markets. According to GC Pharma on the 4th, Hunterase's sales rose 77.7% year-on-year to 23.1 billion won in the third quarter. It more than doubled from 11 billion won in the previous quarter. In the third quarter of this year, cumulative sales jumped 63.9% year-on-year to 47.2 billion won. Sales exceeded 46.2 billion won recorded over the past year. Hunterase, which was approved in Korea in 2012, is the world's second treatment for Hunter syndrome. Hunter syndrome, called Mucopolysaccharidosis type II, is a rare disease known to occur in the remaining 100,000 to 150,000 people. Hunter syndrome, a congenital metabolic abnormality disease, is a genetic disease that shows unpredictable symptoms such as skeletal abnormalities and decreased intelligence, but dies early around the age of 15 in severe cases. The number of patients in Korea is only about 70 to 80. Hunterase's recent steep growth is based on a high rise in overseas markets. Hunterase's export performance in the third quarter was 17.4 billion won, more than doubling from 7.8 billion won in the same period last year. It tripled in one quarter from 5.8 billion won in the previous quarter. Hunterase's domestic sales in the third quarter rose 9.6% year-on-year to 5.7 billion won, which means that it has realized a significant growth in overseas markets. Exports accounted for 75.3% of Hunterase's third-quarter sales. The company explained, "The use of Hunterase abroad has increased significantly and demand has soared in Russia." Hunterase is on sale in 14 foreign countries, including Russia, Egypt, Turkey, and Brazil. It is analyzed that Hunterase's competitive drugs are not many, and that it is recording stable sales growth due to the characteristics of rare disease treatments that are expensive and must be administered for a lifetime. Prior to the appearance of Hunterase, Eleapase was the only treatment. GC Pharma is also speeding up Hunterase's entry into the Asian market. In October last year, it obtained an item license for Hunterase from the NMPA. Earlier this year, it received permission for Hunterase ICV items from the MHLW. Hunterase ICV is a new formulation that inserts a device into the head and administers the drug directly to the ventricle. It has the advantage of overcoming the limitations of existing intravenous formulations that do not improve symptoms of intelligence degradation because drugs cannot penetrate the cerebrovascular barrier (BBB). China's licensed item is a Hunterase intravenous injection (IV) formulation, and the market preoccupation effect is expected in that there was no previously approved Mucopolysaccharidosis type II treatment in China. It is predicted that it will serve as a catalyst for overseas sales growth as it starts selling to China and Japan, which have large markets.
