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- 2026-05-13 23:39:14
- 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."
- InterView
- Avodart, Real World Data
- by Dec 28, 2022 05:48am
- GSK's large-scale real-world clinical results of Avodart, a treatment for prostatic hypertrophy, which marks the 13th anniversary of its launch in Korea, have been released for the first time. Based on actual field data, the company expressed its ambition to further strengthen Avodart's position in early hair loss treatment.LEAD clinical trials are the first RealWorld study conducted to evaluate the long-term clinical usefulness of Avodart in Korean male hair loss patients. It was compared with Finasteride, the two major mountain ranges for oral hair loss treatment. 600 patients participated in five general hospitals in Korea, including Inha University Hospital and Gangdong Kyung Hee University Hospital, and the average analysis period reached 3.4 years. In particular, the Korean Hair Loss Type Classification Act (BASP) developed by the Hair Institute for data analysis with the domestic medical staff was applied. The accuracy of the evaluation was improved by using the Korean classification method, not the Western classification method, which is difficult to apply to Koreans. Dr. Gary Ong, general manager of GSK Global Dermatology Medical, who led the LEAD clinical trial, said, "This study confirmed that Avodart is more effective in treating male hair loss based on Korean classification," adding, "M-shaped hair loss is the part that patients care the most, and Avodart showed good results compared to Finasteride." LEAD clinical results showed that Avodart had a significantly higher cumulative number of patients with improved symptoms compared to Finasteride in most types of hair loss. In M-shaped hair loss, which is most common in Korean men, the proportion of patients with improved symptoms was 86.0% for Avodart and 45.5% for Finasteride, showing a difference of more than 40%p. The improvement rate of hair growth was also about twice as high in the Avodart group as in the Finasteride group. A common misconception about Avodart is that it has higher side effects than Finasteride, which inhibits only type 2 by inhibiting both type 1 and type 2 of 5-alpha reductase. As a result of the Real World study, Avodart showed only a similar level of adverse reactions to Finasteride. Dr. Gary Ong said, "As a result, Avodart was more effective, and safety was similar. "I think the results of this study not only help reduce misunderstandings and prejudices about Avodart but also help doctors make more appropriate decisions when prescribing it in real life," he explained. Based on the results of the first Real World, GSK set a goal of further enhancing Avodart's position as a primary treatment in the Korean hair loss market. This is because there is still a high perception that finasteride is used first in the early stages of hair loss and Avodart is used after further progress. Dr. Gary Ong said, "This study broadens the path to prescribing Avodart as a primary treatment. Male-type hair loss is a progressive disease, so you need to start treatment as soon as possible to get better results in the long term, he stressed. In order to achieve this goal, GSK Korea has recently increased its marketing staff. BM Kim Hwan-geun, who joined Avodart marketing two months ago, said, "Avodart has maintained the top prescription for oral male hair loss treatment from the fourth quarter of 2020 to the second quarter of 2022, and real-world data for 600 Koreans will have a positive impact on Avodart's prescription expansion." "Avodart started as a latecomer amid fierce competition and showed double-digit growth every year," said BM, in charge of Avodart. As it is expected to grow further in the future, two managers will join us in marketing, he said. "We will try to make Avodart the epitome of hair loss treatments next year."
- Policy
- Abbott’s Lipidil NT 145mg listed with reimbursement
- by Lee, Tak-Sun Dec 27, 2022 06:10am
- The original developer of the hyperlipidemia treatment fenofibrate will be releasing a 145mg product that can be taken on an empty stomach. This is the second drug to be released, following Yuhan Corp. As such, the two products are expected to compete fiercely in the market next year. According to industry sources on the 26th, Abbott Korea’s Lipidil NT (fenofibrate 145mg) will be listed at a ceiling price of KRW 339 from the first of next month. The price has been set the same as Yuhan Corp’s Fenowell Tab 145mg. The Health Insurance Review and Assessment Service decided for Lipidil NT’s price to be set at the same level as Yuhan Corp.'s Fenowell Tab 145mg was the only identical drug available and its price had already been adjusted to 53.55% of the original’s price. Although Lipidil NT had been listed later than Yuhan’s drug, its entry is expected to receive attention for being produced by Abbott, the original fenofibrate drug developer. Fenofibrate 160mg tablets are currently mainstream in the market, and the drugs recorded KRW 165 billion in outpatient prescriptions (UBIST) last year. The current market leader, GC Corp’s ‘Lipidil Supra,’ is also a 160mg strength tablet. Lipidil Supra has been developed by Abbott. However, the 160mg tablets have the inconvenience of needing to be taken with the main meal due to absorption issues in the stomach. On the other hand, gastrointestinal absorption of the 145mg tablets are absorbed quicker, and therefore can be taken with or without meals. As the new strength supplemented the shortcomings of existing products, there have been prospects that prescriptions will shift to the 145mg formulation with their release. Due to this element, a fierce competition is expected in the market with Yuhan Corp when Abbott releases Lipidil NT Tab The industry believes the result between the two companies will depend on how well Yuhan Corp preoccupied the market for the 5 months since its reimbursement listing in July this year. However still, it is analyzed that Abbott may quickly absorb the market as the original maker, even though it is the latecomer in the market. If GC Corp, which has already been targeting the domestic market in partnership with Abbott, adds on its support, Lipidol NT’s penetration rate in the market may accelerate further. GC Corp has also been approved for a 145mg product. Its product is Neofeno Tab. The product is being manufactured by Yuhan Corp upon consignment, but unlike Yuhan Corp, the company has not applied for reimbursement. Accordingly, there has also been analysis that GC Corp will collaborate with Abbott in marketing Lipidil NT, just like for Lipidil Supra.
- Company
- 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."
- Product
- “Immediately stop enforcing the Healthcare Data Act”
- by Dec 27, 2022 06:10am
- Five major healthcare associations in Korea have called for the discontinuation of the enforcement of the Healthcare Data Act. The Korean Pharmaceutical Association (President: Kwang-Hoon Choi), Korean Medical Association (President: Pil-Soo Lee), Korean Hospital Association (President: Dong-Seop Yoon), Korean Dental Association (President: Tae-Geun Park), Association of Korean Medicine (President: Joo-Eui Hong) issued a joint statement on the 23rd criticizing the government's enforcement of the 'Act on the Promotion of Digital Healthcare and Utilization of Healthcare Data.’ The associations criticized, “From the 23rd of last month, the 5 associations had asked the government to consult on the details related to healthcare data services with medical and pharmaceutical associations under the premise that ‘healthcare services should be designed around public safety and health rather than from an economical or commercial point of view.’ However, the Ministry of Health and Welfare has been pursuing legislation of the Act from an economic and commercial perspective without any prior consultation.” In other words, the associations agree on the purpose of the legislation in promoting public health and contributing to improving the quality of life. However, the issue is in how the actual act overlooks the importance of healthcare data, which is highly sensitive information, and the need to manage it more strictly than any other information. The associations pointed out, “What’s most important is to ensure that the primary essential element of healthcare - protecting the life and health of the people – is not infringed by secondary by-products such as promotion of the industry in the course of applying digital technology. However, the MOHW is allowing sensitive data, not only the public’s diagnosis results, treatment history but also genetic information and life-related information to be leaked outside of healthcare institutions based on individual intent without supervision from healthcare institutions.” They added, “This goes to show that the measures for the safe use of healthcare data that had been discussed in-depth in the health, medical, and pharmaceutical industry are not being reflected at all in the legislation. Although medical information is sensitive information that requires the highest level of security, the government plans to transmit it to a private company without obtaining consent from healthcare institutions, which are in charge of producing and managing such clinical medical information, in an electronic format that is vulnerable to hacking, etc.” Also, the associations explained that the act contradicts other laws including the Medical Service Act, Bioethics and Safety Act, Personal Information Protection Act, Copyright Act, Data Industry Act, etc., and therefore may likely cause national confusion. The associations said, “In conclusion, we agree with the legislative purpose of contributing to the improvement of national health and quality of life and fostering the digital and biohealth industry, but as the legislation and institutionalization of a system that emphasizes industry promotion over public value and disregards the issues of safety and efficacy, poses a serious threat to public health and protection of personal information. Therefore we strongly oppose to the enactment of the law and request the following 4 conditions be met to guarantee the rights of healthcare data generators, ensure fair value evaluation and protection of personal information, and minimize infringement on the public’s right to health.” The four conditions suggested by the association are: ▲as healthcare institutions are obligated to directly produce, process, manage and protect healthcare data, the government should guarantee the status and rights of healthcare institutions as the principal subject of healthcare data; ▲ the government should guarantee a reasonable right of refusal to healthcare institutions against the third party’s and one-sided personal right to request transfer as the current Act only imposes obligations on healthcare institutions and overlooks the fact that a leakage of the large amount of concentrated healthcare data in the process can lead to a national disaster; ▲ the information that can be subject to the right to request transfer should be limited to information provided by individuals to healthcare institutions; ▲the government should ensure mandatory participation of healthcare institutions and representatives of industry types to represent the voices in the field and industry when forming of various national data policy medical expert committees including the Healthcare Data Policy Deliberative Committee, and the Digital Healthcare Policy Deliberative Committee, etc.
