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- 2025-12-24 05:42:10
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- Korea develops 2 new drugs and 2 biosimilars in 2022
- by Chon, Seung-Hyun Dec 29, 2022 06:04am
- In Korea, domestic pharmaceutical companies succeeded in developing 2 new drugs this year. The new drugs developed by SK Bioscience and Daewoong Pharmaceuticals reached the commercialization stage. This is the most amount of biosimilars developed in Korea in 7 years since 2015. ◆SK Bioscience receives approval for the first new homegrown COVID-19 vaccine...Daewoong receives marketing authorization for a new diabetes drug According to the Ministry of Food and Drug Safety on the 28th, domestic pharmaceutical and biohealth companies received approval for 2 new drugs this year. In June, SK Bioscience’s COVID-19 prevention vaccine SKYCovione Multi inj received marketing authorization in Korea as the 35th homegrown new drug. SKYCovione Multi Inj is a COVID-19 vaccine that induces an immunological response by administering the company’s proprietary gene recombination technology. SK Bioscience first discovered the COVID-19 vaccine candidate jointly with the Institute for Protein Design at the University of Washington. It was funded by Bill & Melinda Gates Foundation (BMGF) and Coalition for Epidemic Preparedness Innovation (CEPI), and the company succeeded in commercializing the drug after 2 years. On the 30th of last month, Daewoong Pharmaceutical received approval for its diabetes treatment Envlo as the 36th new homegrown drug. Envlo was approved as an adjunct to diet and exercise therapy in Type-2 diabetes patients. Envlo may be used as monotherapy, metformin combination therapy, and metformin and gemigliptin combination therapy. Envlo is the first SGLT-2 inhibitor class antidiabetic developed in Korea. The drug reduces blood sugar levels by inhibiting the reabsorption of glucose in the kidneys and allowing it to be excreted as urine. In October, Daewoong Pharmaceutical confirmed the blood sugar reduction effect and safety of the drug through a Phase III trial that was conducted on Type 2 diabetes patients. Envlo was first developed by GC Corp, and Da Daewoong acquired its exclusive license in 2016. With this, a total of 6 new drugs developed by Korean pharmaceutical companies were approved in the past 2 years, starting last year. In January last year, Yuhan Corp’s anticancer drug ‘Leclaza’ was approved, and in February and March, Celltrion’s COVID-19 treatment ‘Regkirona’ and Hanmi Pharmamceutcial’s neutropenia treatment ‘Rolontis’ received MFDS approval, respectively. In December last year, Daewoong Pharmaceutical’s ‘Fexclu’ was listed as the 34th new domestically developed drug. ◆3 homegrown biosimilars enter the market for the first time in 7 years since 2015 Korean pharmaceutical and bio companies have received approval for 3 biosimilars this year. Celltrion, Samsung Bioepis, Chong Kun Dang etc. succeeded in commercializing one biosimilar each this year. In May, Samsung Bioepis received approval for its Lucentis biosimilar Amelivu in Korea. Lucentis, which is being marketed by Roche and Novartis, is a drug used to treat macular degeneration and diabetic macular edema. It is a blockbuster drug that made KRW 4.4 trillion in global sales last year. Amelivu is the first biosimilar of Lucentis to be introduced to Korea. In October, Chong Kun Dang received marketing authorization in Korea for its Lucentis biosimilar, LucenBS. In September, Celltrion’s Avastin biosimilar, the anticancer drug Vegzelma was approved. And in March last year, Samsung Bioepis received approval for the first Avastin biosimilar Onbevzi, followed by Celltrion. No. of approved biosimilars developed by Korean companies by year (Unit: product amount, Data: MFDS) This is the first time in 7 years since 2015 that Korean pharma and bio companies received approval for 3 biosimilars. In 2012, Celltrion first released its Remicade biosimilar Remsima and then a Herceptin biosimilar Herzuma in 2014. In 2015, Celltrion developed 1 and Samsung Bioepis developed 2 biosimilars. Celltrion received approval for Mabthera biosimilar Truxima, and Samsung Bioepis commercialized its Enbrel and Remicade biosimilar Etoloce and Remaloce. In 2017, Samsung Bioepis received approval for Adaloce and Samfenet. Their respective original drugs are Humira and Herceptin. In 2018, LG Chem and Chong Kun Dang developed one biosimilar each, and last year, Samsung Bioepis and Celltrion received approval for one biosimilar each. By company, Samsung Bioepis received approval for most biosimilars, with 6 approvals. Celltrion follows with 5 approvals.
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- EUA for Zochova was not requested
- by Kim, Jin-Gu Dec 29, 2022 06:04am
- The government also keeps the door open to "monitoring overseas situations"...U.S. and Europe are under review. Ildong Pharmaceutical is expected to shift its strategy of introducing oral COVID-19 treatment Zochova (s-217622) in Korea from the EUA to conditional permission. On the 28th, the Central Disease Control Headquarters announced that it would not request Zochova's EUA from the Ministry of Food and Drug Safety. The Central Disease Control Headquarters explained that the decision was made after discussing the safety of Zochova and the necessity of emergency introduction in Korea three times with related ministries and infectious disease management committees. The pharmaceutical industry predicts that although the EUA has failed, Ildong Pharmaceutical will continue to push for the introduction of Zochova in Korea due to conditional approval. The EUA is not applied by a developer, but if the Korea Centers for Disease Control and Prevention deems it necessary, it asks the Ministry of Food and Drug Safety to approve it, and the Ministry of Food and Drug Safety quickly reviews and approves it. Conditional approval is applied by a developer and judged by the Ministry of Food and Drug Safety. It is expected that there will be an application for conditional approval from Ildong Pharmaceutical in the near future. A pharmaceutical industry official familiar with the company's internal situation said, "It means that there is no urgent need to introduce the drug in Korea, not the drug itself," adding, "It is expected to turn its domestic introduction strategy with conditional permission instead of EUA." "It has become a EUA in Japan and has begun reviewing emergency use approval in the U.S. and Europe," he said. "If the U.S. and Europe decide to introduce drugs, it will also help with domestic conditional approval." The government, too, has not completely blocked the possibility of introducing Zochova in the country. An official from the Korea Centers for Disease Control and Prevention said, "We will continue to monitor whether Zochova is approved for overseas emergency use, follow-up clinical results, and purchase and utilization situations." Zochova is an oral antiviral drug containing Ensitrelvir. It is a mechanism to selectively suppress 3CL-protease to prevent the proliferation of the SARS-CoV-2 virus that causes COVID-19. As a result of phase 2 and 3 clinical trials conducted in Japan and Korea, it took about 167.9 hours based on the median value to improve the symptoms of COVID-19 when Zochova was administered, which was significantly reduced compared to 192.2 hours in the placebo group, proving its effectiveness. The reduction of viral RNA in the body, a secondary evaluation variable, also met the criteria for validation. On the 4th day of the clinical trial after 3 doses of Zochova, viral RNA was found to have decreased in the Ensitrelvir administration group by 1.4 log10 copies/ml compared to the placebo group. Regarding the safety of the drug, no serious side effects or deaths occurred, and the drug resistance was also excellent. Unlike conventional treatments that require two or three tablets a day for five days, Zochova can be administered one tablet a day for five days.
- Company
- Daewoong and Neurorive will codevelop new antidepressant
- by Lee, Seok-Jun Dec 29, 2022 06:03am
- On the 28th, Daewoong Pharmaceutical announced it had signed an agreement with Neurorive to conduct joint research and development for a new drug candidate for depression. Under the agreement, the two companies will be jointly developing ‘NR-0601,’ a multi-target, non-narcotic oral depression treatment. Neurorive is a bio venture company that researches central nervous diseases including depression and Alzheimer’s. It is studying NR-0601 as the first new drug in its antidepressant pipeline. NR-0601 is an oral antidepressant that was derived using Neurorive’s drug screening platform that sends electric signals to living brain tissues to check the response of nerve cells. It has a multi-targeted mechanism of action and is expected to provide faster recovery from strong depression compared to conventional monoamine oxidase inhibitor oral antidepressants. It has a higher potential to work on patients with treatment-resistant depression (TRD) that do not respond to existing treatments. One in three patients with major depressive disorders is known to have TRD. Both companies will be collaborating in all stages of clinical development of NR-0601 which will enter clinical trials next year. Daewoong Pharmaceutical will be responsible for research to improve drug formulation, process development, chemistry, manufacturing and controls (CMC), good manufacturing standards (GMP), and advisory activities for clinical trials. Neurorive will be in charge of non-clinical development and testing, discussions with various regulatory authorities including MFDS, filing an investigational new drug (IND) application, and clinical development. Daewoong Pharmaceutical’s new drug product center that will take care of the research for improving drug formulation and the manufacture of investigational drug candidates owns various patents and differentiated technologies including its combination drug technology (Modified Release and Absorption by Tablet in Tablet MORATAT™, Double-Layered-Tablet DOLTAB®) technology), its sustained release technology ( the Multi-Target controlled release System, MuTAS™), and solubilizing technology (Nanotechnology of Optimal wet-Milling, NATOM®).
- Company
- LegoChem Bio may receive milestone payments next yr
- by Dec 28, 2022 05:49am
- 2nd generation ADC platform technology owned by LegoChem Bio LegoChem Bioscience’s drug candidates that have been licensed out are making their way into clinical trials. The company succeeded in making licensing deals for 10 antibody-drug conjugate (ADC) pipelines and is expected to start receiving milestone payments in earnest in line with their development progress. ◆Company may earn up to KRW 6.8 trillion if all 10 licensed-out ADC pipelines succeed in commercialization According to industry sources on the 29th, if the drug candidates licensed out by LegoChem Biosciences succeed in commercialization, the receptible milestone payments will amount to KRW 6.84 trillion at most. The company has signed 10 licensing-out deals with other companies. Recently, LegoChem Bio signed a technology transfer agreement with Amgen worth KRW 1.6 trillion. LegoChem Bio had previously signed similar deals with Fosun Pharma, Takeda Pharmaceutical, Iksuda Therapeutics(3 deals), CStone, Pyxis Oncology, Antengene, and SOTIO Biotech. In the deals made with Amgen, Iksuda Therapeutics. Pyxis Oncology, Antengene, and SOTIO Biotech, the company has also secured the right to earn a share of the profit when the drug candidate is commercialized. Its drug candidates that were licensed out are entering the clinical stage one after another. This is raising expectations on the additional milestones that the company may receive in the future The industry expects 5 of the milestone payments deals to pay out next year. 2 of the 3 technology export deals the company made with Iksuda Therapeutics are expected to start global Phase I trials next year. If global clinical trials are initiated, LegoChem Bio will receive a part of the milestone payments payable upon initiation of the trial. For the other 1 deal made with Iksuda Therapeutics, Iksuda plans to submit a clinical trial protocol for 2 drug candidates. If this trial is initiated, it will also allow LegoChem Bio to receive further milestone payments. In the case of Takeda Pharmaceutical, the company plans to derive a drug candidate by next year. SOTIO also plans to do the same within the next year. If the two companies succeed in deriving drug candidates, LegoChem will receive milestone payments for each. Also, expectations are rising on further milestone payments the company can receive after next year. Fosun Pharma is conducting a Phase 1b trial for the anticancer drug candidate LCB14 LegoChem Bio licensed out to Fosun Pharma. A Phase 1 trial is also underway for LCB71 as a treatment for solid cancer and blood cancer, which was licensed out to CStone. ◆Inks a technology transfer deal with the big pharma Amgen...proves technolgy LegoChem Bio signed a series of technology transfer deals with multinational pharmaceutical companies with its ADC platform technology based on its proprietary platform technology ‘ConjuAll’ and ‘LegoChemistry.’ ADCs are a class of cancer therapeutics that combines the advantage of antibody drugs that can distinguish tumor cells using an antigen-antibody response and the highly potent anticancer effect of chemical synthetic drugs. The drugs have the advantage of being able to show high efficacy with low side effects compared to existing technologies. ADCs are also evaluated to have good blood stability. LegoChem Bio is being recognized for owning competitiveness in the field of ADC, as it owns a binding method that can be implemented with a single substance, a linker that can specifically release drugs to cancer cells, and drugs that only activate in cancer cells, etc. In particular, the company’s recent licensing deal with the global big pharma Amgen has been raising expectations for more licensing-out deals to come in the future. LegoChem Bio recently signed a deal to transfer its original ADC platform technology to Amgen and conduct joint research. Under the deal, LegoChem Bio’s platform will be applied to 5 of Amgen’s antibodies to direct 5 targets. The deal totals up to be worth KRW1.61 trillion. If Amgen succeeds in commercializing the drug candidate, LegoChem Bio can separately receive profit. Unlike the upfront payment, the details of the deal, such as the specific amount of milestone payments per development stage were not disclosed. Until now, LegoChem Bio had mostly signed licensing-out deals with small and medium-sized global pharmaceutical companies. The pharmaceutical industry has evaluated LegoChem Bio’s successful technology transfer deal made with the big pharma Amgen as proof of the company’s technological competitiveness.
- Company
- More companies are overcoming patents for Otezla
- by Kim, Jin-Gu Dec 28, 2022 05:48am
- Pharmaceutical bio companies seeking to release generics for Otezla, a psoriasis treatment that has not been released in Korea, are expanding. In addition to the existing Daewoong Pharmaceutical and Dong-A ST, DongKoo Bio, Huons, and Chong Kun Dang succeeded in overcoming two out of three related patents. If they overcome the remaining usage patents, they will be eligible for early release of the Otezla generic. According to the pharmaceutical industry on the 27th, Chong Kun Dang recently received a decision to establish a claim in a passive judgment to confirm the scope of rights for Otezla's patent filed against Amgen. Otezla is protected by a total of three patents. These are two formulation patents (10-2232154, 10-2035362) expiring in 2032, and one application patent (10-0997001) expiring in 2028. Seven generic companies that are challenging this patent have avoided one out of two pharmaceutical patents in May this year. On top of that, a growing number of pharmaceutical companies have avoided even one remaining pharmaceutical patent. Following the avoidance of the patent, last month by Daewoong Pharmaceutical, Dong-A ST, DongKoo Bio, Huons, and Chong Kun Dang additionally succeeded in avoiding the patent this month. Mother's and Cosmax Pharma, which have not yet been decided, are also expected to win soon. Generics have filed a request for invalidation of the patent. If generic companies succeed in invalidating their use patents, all Otezla patent licenses will disappear in Korea. Generics have finished developing related products. Dong-A ST was approved for phase 1 clinical trial in Korea by Otezla General under the development name of "DA-5215" in March this year. The clinical trial was completed in June. It plans to apply for an item permit as early as this year. Chong Kun Dang also completed the vitality test of Oteszla General under the development name "CKD-235." ◆ Global blockbuster Otezla voluntarily withdraws after failing to register domestic benefits The original Otezla withdrew from the country after failing to register insurance benefits. Otezla was granted domestic permission by Celgene in 2017. At the time of approval, it drew attention as the only oral psoriasis treatment in Korea. Since then, Celgene has been challenged to register its benefits but failed due to differences in positions on drug prices between insurance authorities and companies, and its release was delayed. As Celgene was acquired by BMS in 2019, the domestic launch plan was further twisted. Initially, BMS tried to acquire Otezla's copyright, but FTC ordered the sale because it was concerned about monopoly. Eventually, BMS sold Otezla's global copyright to Amgen. As a result, domestic copyrights were transferred to Amgen. Amgen sat instead of Seeljin at the negotiating table with the insurance authorities but likewise failed to register. Amgen voluntarily withdrew its Otezla item license in June of this year. However, despite the withdrawal of the Korean market, Amgen still holds Otezla's domestic patent rights. Unlike Korea, Otezla is on a roll as one of Amgen's major products globally. According to Amgen, Otezla's sales in the first half of the year were $594 million, up 11% from $534 million in the first half of last year.
- Company
- Why no news is being heard on reimb extension for Bavencio
- by Dec 28, 2022 05:48am
- Merck and Pfizer’s cancer immunotherapy ‘Bavencio (avelumab)’ is having trouble expanding its reimbursement in Korea. Although the agenda has passed deliberations by the Cancer Disease Deliberation Committee (CDDC), the follow-up process was sluggish and no progress has been made for 8 months. According to the pharmaceutical industry on the 27th, the indication expansion agenda passed the Health Insurance Reimbursement and Assessment Service's CDDC deliberations in April, after which no news is being heard on its progress. The agenda was at a standstill because it was not presented for deliberation by the Drug Reimbursement Evaluation Committee (DREC). In April, CDDC established reimbursement standards for Bavencio in bladder cancere The CDDC passed the application submitted by Merck to expand the reimbursement for Bavencio to the bladder cancer (urothelial carcinoma) indication. This was when the reimbursement standards were set for Bavencio as first-line maintenance monotherapy for adult patients with locally advanced or metastatic urothelial carcinoma. However, its reimbursement for the bladder cancer indication is still far off. This is because DREC has not deliberated on expanding the coverage for Bavencio for the past 8 months with no hard plan set for its deliberation in the future. Bavencio is not the only drug that has seen little progress after passing CDDC. Ono Pharmaceutical’s ‘Bratovi’ passed CDDC meetings in January and received reimbursement standards in colorectal cancer, but has not been deliberated by DREC for a year since. AstraZeneca’s ‘Lynparza’ that was set reimbursement standards for the treatment of BRCA-mutated prostate cancer, To list or expand the indication of anticancer drugs for reimbursement, the agenda needs to pass CDDC deliberations and then undergo reimbursement adequacy review by DREC, drug pricing negotiations with the NHIS, and finally pass the Ministry of Health and Welfare’s Health Insurance Policy Deliberative Committee deliberations. In general, the statutory processing period for drug reimbursement evaluations conducted by HIRA's CDDC and DREC is set at 120 days (150 days for RSA drugs). However, with reasons such as requests for supplementary data, the statutory review period has not been properly observed until now. In particular, as the review period for reimbursement expansions is unclear and lower priority than new reimbursement listings, predicting when these agendas will be deliberated is virtually impossible. Also, with the rise of the COVID-19 pandemic and the introduction of high-priced new drugs, fiscal soundness has emerged as an important issue. This is why more and more reimbursement expansion deliberations for existing drugs are falling behind in priority. Bavencio’s indication as maintenance therapy that the company is attempting to expand reimbursement to is a sort of 1.5-line therapy used in patients with urothelial carcinoma who have not progressed after using standard chemotherapy. In the Phase III JAVELIN Bladder 100 trial, the median overall survival (OS) was extended by over 7 months for patients who received Bavencio+BSC compared to best supportive care (BSC) care alone and reduced the risk of death by 31%. The 1-year overall survival rate was 71.4% in the Bavencio group, higher than the 58.4% observed in the comparator group. The delay in DREC’s deliberation of Bavencio for reimbursement as maintenance therapy can also be partially attributed to the existence of other cancer immunotherapies. Currently, other immunotherapies including Keytruda, Tecentriq, and Opdivo also own bladder cancer indications. The specific indications approved may differ for each drug. Keytruda and Tecentriq are used in the first line. However, only patients that are PD-L1 positive and who are not eligible for cisplatin-containing chemotherapy are allowed to use the drugs. In the case of Opdivo, the drug is used as a second-line treatment in patients whose disease has progressed after chemotherapy treatment. Keytruda and Tecentiq can also be used in the second line. Pic of Bavencio Some cancer immunotherapies are also allowed reimbursement, but only in the second line. Tecentriq, which had been the only drug approved for reimbursement in the second line, was unable to meet the conditional approval requirements set by the MFDS and was removed from the reimbursement list in September, and Keytruda emerged in its place. Tecentriq withdrew all bladder cancer indications after failing to demonstrate an effect for cancer in a Phase III trial. The company’s actions are also expected to affect its approved indications in Korea. As a result, the only reimbursed cancer immunotherapy option is Keytruda in the second line. The industry sees the availability of a reimbursed immunotherapy option, although in the second-line, and the lack of a second-line option after using Bavencio as maintenance therapy as the barriers that interfere with the reimbursement expansion of Bavencio, as immunotherapies cannot be used in later-line therapies after failing treatment with such in previous lines of treatment. However, this means that patients have to wait until disease progression to use immunotherapies in the second line. And not all patients can use immunotherapies with disease progression. Therefore, the opinion has been raised on the need for earlier use of immunotherapies. Professor Se Hoon Park, Division of Hematology/Oncology at Samsung Medical Center, said, “Due to the limited amount of second-line treatment options for bladder cancer, it could be so far as said that no treatment exists for bladder cancer in the second-line, and we hope that the reimbursement adequacy evaluation for Bavencio will soon progress further based on scientific evidence.” Park said, “If a treatment can safely provide clinically significant effect over existing treatments, its reimbursement adequacy should be evaluated under the same standards regardless of whether the treatment is being used for other cancer types or not.” JinYoung Paik, President of the Korea Kidney Cancer Association, said, “Many bladder cancer patients have been asking about Bavencio’s reimbursement due to the lack of other effective treatment options after receiving first-line treatment with chemotherapy. Bavencio is recommended as standard treatment in overseas guidelines and many significant data have been presented on the drug, but many patients cannot use it for economic reasons. I hope reimbursement discussions on Bavencio be progressed soon.”
- Company
- Phase 1/2 of CJ Bio's Microbiome has been applied
- by Dec 28, 2022 05:48am
- CJ Bioscience announced on the 26th that it has submitted an IND of phase 1/2 of the Microbiome immuno-cancer drug "CJRB-101" to the U.S. Food and Drug Administration (FDA). CJRB-101 is a new immuno-cancer drug candidate secured by CJ Bioscience. It was developed through various immunological reviews based on the strain library that CJ has built. It is listed in the EFSA and has high safety for human administration, and unlike existing intestinal microorganisms, process development for mass production of medicines is underway, enabling long-term clinical trials for cancer patients. Phase 1/2 clinical trials evaluate the safety and preliminary efficacy of CJRB-101 in patients with metastatic cancer such as advanced or non-small cell lung cancer, head and neck squamous cell carcinoma, and melanoma. It will be conducted by a number of clinical trial institutions in the United States and Korea and will recruit 46 people in phase 1 and a total of 120 people in phase 2. The drug resistance, safety, and effectiveness of the immuno-cancer drugs Keytruda and CJRB-101 are evaluated in combination. In order to expand the utilization of new drug candidates, CJ Bioscience decided to conduct a clinical efficacy evaluation at the same time for lung cancer as well as other cancers (head and neck cancer and skin cancer) with high marketability and incidence It will submit a clinical trial plan to the Ministry of Food and Drug Safety in the first half of next year. CJ Bioscience was launched earlier this year as a subsidiary of CJ's Red Bio (pharmaceutical and healthcare). An official from CJ Bioscience said, "It is expected that CJRB-101 and immune checkpoint will be used together to increase the low response rate of existing immuno-cancer drugs and provide new treatment opportunities for intractable patients who do not see the effect of immuno-cancer drugs."
- Company
- Kisqali Extends PFS by 1 yr in poor prognosis breast cancer
- by Dec 28, 2022 05:48am
- Novartis Korea announced on the 26th that the progressive and metastatic breast cancer treatment Kisqali has extended the progressive survival period by about one year compared to the first treatment of hormone receptor-positive (HR+)/human epithelial cell growth factor 2 negative (HER2-) breast cancer patients. The results of this study were presented at the San Antonio Breast Cancer Conference (SABCS 2022) held from December 6 to 10. The company's Kisqali RIGHT Choice study is the first phase 2 clinical trial to compare CDK4/6 inhibitor Kisqali and endocrine therapy combinations in aggressive pre-menopausal and transmenopausal HR+/HER2-progressive breast cancer patients. It was conducted on 222 patients with HR+/HER2-progressive breast cancer in premenopausal and menopause transitions that show aggressive characteristics, such as patients with visceral metastasis with symptoms and patients with rapid progression of diseases or symptoms. In particular, more than 50% of patients with intestinal metastasis crises were included in this study. CDK4/6 inhibitors and endocrine therapy are used as standard treatments in the primary treatment of HR+/HER2-progressive breast cancer patients, but combination chemotherapy is still used in patients with rapid disease progression or intestinal metastasis crisis. Kisqali demonstrated an extension of the progression-free survival period (PFS) even in the group of patients who are difficult to treat through a RIGHT Choice study. As a result of phase 2, the median PFS value of the Kisqali combined group was 24.0 months, which was 11.7 months longer than the 12.3 months of the control group (HR=0.54). The median time until treatment failure in the Kisqali combined group was 18.6 months, which was longer than 10 months compared to 8.5 months in the control group (HR=0.45). In terms of safety, the combined Kisqali group had a lower incidence of serious adverse reactions related to treatment and the resulting discontinuation rate of treatment compared to the combined chemotherapy group. Kisqali showed a similar safety profile to existing data. Yoo Byung-jae, CEO of Novartis Korea, said, "Kisqali has confirmed the benefits of extending the progressive survival period in patients with fast cancer progression or poor prognosis, such as visceral metastatic patients with symptoms."
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- Samsung BioLogics did not receive 45.5 billion won
- by Dec 27, 2022 06:10am
- Cytodyn Main Pipeline (Data = Cytodyn)Samsung BioLogics has been in conflict with U.S. bio company Cytodyn over the past year to pay for commissioned production (CMO). Conflicts have continued for a year as Cytodyn is overdue the promised cost of the biopharmaceutical CMO. Late payments more than doubled from $13.5 million (17.2 billion won) in January this year. According to the U.S. Securities and Exchange Commission on the 26th, Cytodyn told Samsung BioLogics in a third-quarter report that the balance of overdue payments related to Leronlimab CMO was $35.7 million. Cytodyn is an American bio company that is developing AIDS, cancer, non-alcoholic fatty hepatitis (NASH), and COVID-19 candidates. In May 2019, Samsung BioLogics signed a contract with Leronlimab CMO for AIDS treatment. At that time, the minimum guarantee amount for the contract was $31 million (39.5 billion won). The minimum guarantee amount increased to $50.22 million (64 billion won) through a change in contract terms in July 2020. It is a contract that guarantees sales of $246 million (313.7 billion won) by 2027 through the production of commercial products if the license is successful. Cytodyn said Samsung BioLogics should pay $35.7 million in arrears. (Data = US Securities and Exchange Commission) Leronlimab is a fully humanized IgG4 monoclonal antibody treatment that targets CCR5 used in the process of the virus penetrating T cells as a mechanism to suppress cell infection of the HIV virus. Clinical trials for severe COVID-19 patients were also conducted through drug re-invention, but there was no significant difference from the placebo group in terms of efficacy. The payment conflict erupted when Cytodyn did not pay $13.5 million (17.2 billion won) to Samsung BioLogics at the end of last year. Samsung BioLogics sent a written notice to Cytodyn earlier this year demanding payment. According to the disclosure, the balance of arrears increased to $38.1 million as of May 31. As of August 31, it was slightly reduced to $35.7 million. The overdue balance seems to have decreased as some of the payments were made. Cytodyn said, "We will make reasonable efforts to fix serious violations. If we do not make reasonable efforts during the correction period, Samsung BioLogics can terminate the contract," and explained, "Cytodyn management is continuously discussing with Samsung BioLogics to solve the problem."
- Company
- LG Chem's Humira biosimilar applies for domestic permission
- by Dec 27, 2022 06:10am
- A researcher at LG Chem is looking at the data.(Source: LG Chem)LG Chem announced on the 23rd that it has applied for permission for Humira biosimilar LBAL items to the Ministry of Food and Drug Safety. Indications include rheumatoid arthritis, psoriatic arthritis, axillary spinal arthritis, adult Crohn's disease, psoriasis, ulcerative colitis, Betchett enteritis, and meningitis in adults. In addition, children (6 to 17 years old) have Crohn's disease, idiopathic childhood arthritis, and childhood plate psoriasis. LG Chem was approved on May 27, 2016, for a phase 3 clinical trial to evaluate the equivalence of LBAL and Humira in patients with active rheumatoid arthritis who responded inappropriately to Methotrexate. After registering the first target on June 23, 2016, the last target visit was completed on February 1, 2018. LG Chem confirmed equivalence in the LBAL and Humira groups as clinical results. In the safety sector, the incidence of adverse reactions (AE) was similar in the LBAL and Humira groups. The incidence of significant adverse reactions (SAE) was 8.3% in the LBAL group and 4.7% in the Humira group, showing no significant difference. There was no adverse reaction that resulted in death. LBAL is a biosimilar developed in a high-concentration formulation like Humira. It is a product that improves patient convenience by removing citrate that can cause pain to patients. An official from LG Chem said, "We expect to provide patients with more options for treating autoimmune diseases through the previously released Eucept and LBAL."
