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- 2026-05-08 05:23:36
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- Wet AMD tx new option to shorten Eyelea's minimum cycle
- by May 16, 2022 06:13am
- Bayer's macular degeneration treatment Eyelea took the lead in establishing an optimized treatment strategy for patients by shortening the minimum treatment cycle. It is evaluated that a new option was presented in macular degeneration treatment that determines the treatment cycle according to the patient's condition. According to the pharmaceutical industry on the 6th, Eylea's minimum administration interval has recently been shortened from 8 weeks to 4 weeks. Accordingly, medical staff can increase the treatment interval from at least 4 weeks to up to 16 weeks through monitoring after injection once a month for the first three months of treatment with Eyelea. As T&E therapy is widely used in macular degeneration treatment, the medical staff believes that there is room for reducing the minimum dose interval to address the unmet demand. T&E therapy is a method of monitoring patients after initial three-month treatment and adjusting the treatment interval. It is a widely used treatment method around the world by overcoming the shortcomings of the post-treatment method, such as PRN therapy, which is more efficient than fixed treatment cycles and continues treatment when symptoms worsen. Dailypharm listened to the meaning of changing minimum administration cycle of Eyelea through Director Jang Woo-hyuk. Director Jang served as a clinical doctor at the Wills Eye Institute at Thomas Jefferson University in Philadelphia and a professor at the ophthalmology department at Yeungnam University University. Director Jang Woo-hyuk Macular degeneration begins with dryness and progresses into habit. Dry macular degeneration is a stage in which only wastes accumulate in the retina. When waste accumulates and oxygen permeation becomes difficult, new blood vessels are created to forcibly supply oxygen. In the process, abnormal neoplasms bleed and exudates leak out. This stage is wet macular degeneration. Failure to receive proper treatment can lead to blindness. The number of patients with habitual macular degeneration is also rapidly increasing due to rapid aging. Director Jang said, "There are overwhelmingly many elderly patients in the clinical field. This is because aging is the biggest cause of wet macular degeneration. Environmentally Westernized eating habits and the increase in adult diseases are also affecting it, he explained. The most important goal of treating wet macular degeneration is to preserve vision that can maintain the quality of life. Therefore, it can be seen that the core of the treatment is to restore vision as much as possible with initial active treatment and then maintain vision at least with damage. The drug mainly used for treatment is an anti-VEGF injection. Representative treatments include Eylea and Lucentis, and recently Beovu has also emerged as new treatment options. The medical staff determines the drug according to the patient's condition because the medication cycle varies slightly from drug to drug. According to IQVIA, a pharmaceutical market research firm, Eyelea is the treatment that generates the most sales in Korea, recording sales of 70.5 billion won last year. In response to the recent reduction in the minimum administration interval for Eyelea to four weeks, Director Jang said, "There was clearly a need for injections at clinical sites at shorter intervals than eight weeks. Even after injection treatment every eight weeks, there are no signs of deterioration, no improvement, or persistent exudation causes vision to gradually decrease," he said. "In the past, in this case, we had no choice but to use off-label drugs or increase the dose, but even this was not very effective. The reduction of the minimum administration interval of Eylea to four weeks is a very welcome change," he said. Reducing the administration interval to 4 weeks mainly occurs in long-term treatment. This is because the drug's effectiveness decreases even if it is injected every eight weeks because of long treatment. "There are few patients who need to be treated every four weeks from the beginning. If resistance develops or the effectiveness of the drug decreases after a year or two of treatment, we will consider shortening the interval," he added. In order to perform only four-week intervals, anatomical examinations must show clear deterioration. There are still ambiguous situations where it is difficult to boldly apply the four-week interval. Director Jang explained, "This is the case when it continues to not deteriorate when it is done every eight weeks, or when there are findings of exudation in monitoring, it is better than eight weeks ago." He said, "At this time, medical staff tend to worry about reducing the interval to four weeks and then reducing the benefit. Since the four-week interval has not been long since it was applied, it is difficult to reduce it to four weeks unless there are clear deterioration findings," he said. Patients with good treatment effects are treated by widening the interval to a maximum of 16 weeks. According to Director Jang, about 20 to 30% of all patients show good treatment results, extending it to 16 weeks. "The longer the injection period is, the more patients are satisfied. There may be anxiety about watching without treatment for four months, but experience has shown that the symptoms rarely worsen severely among patients who have extended it to 16 weeks. If there is any recurrence, the interval will be reduced by two weeks again, he said.
- Company
- Bio Clusters gather to compete at BIO Korea 2022
- by Kim, Jin-Gu May 13, 2022 05:46am
- Major Bio Clusters of local governments have gathered in one place. Major Bio Clusters of local governments including Osong, Incheon, Hongneung, Gimhae, Wonju, and Daejeon municipalities as well as the event’s co-host Chungcheongbuk-do are in heated competition to promote their cluster in the ‘BIO KOREA 2022’ event that is being held from May 11th to the 13th at Coex Seoul to promote their region. At the event, the clusters are working hard to attract companies and investments by distributing handouts to participants and introducing the features of each bio cluster to corporate officials. ◆ Chungcheongbuk-do Bio Valley = Chungcheongbuk is promoting 5 Bio Valleys in its province. The five Valleys are ‘Osong Bio Valley,’ which has the Osong High-Tech Medical Complex, the ‘Chungju Bio Valley,’ which is scheduled to be completed by 2027, ‘Jecheon Oriental Medicine Bio Valley,’ ‘Okcheon Medical Device Valley’, and ‘Goesan Organic Bio Valley.’ The Chungcheongbuk-do province had released a blueprint to attract 1,600 bio-companies in its 5 Bio Valleys by 2030. The region has attracted 422 companies up to now. Through the recruited companies, the region aims to increase production from the current ₩ 1.8 trillion to ₩7 trillion and human resource training from 3,050 to 50,000. In particular, the province has been introducing corporate support incentives in detail at the exhibition hall. Up to 24% of facility investment made by the companies will be supported by the province. Also, a ₩500,000 subsidy for employment and education & training will be provided per month for all individuals for one year, and ₩2 million per month for one year if the company hires researchers. The province also emphasized its tax reduction benefits. In the case of the national tax, the corporate tax on capital gains is deferred for 5 years, then can be paid out in installments in the following 3 years. Corporate tax is reduced by 100% for 7 years and 50% for 3 years thereafter. Chungbuk will be also reducing the local acquisition tax and property tax by 75% each for 5 years. ◆ Osong High-Tech Medical Complex = The Osong Medical Innovation Foundation prepared a separate exhibition hall from Chungbuk to promote its Bio Cluster. Osong emphasized that it can provide full-cycle support for new drug R&D. By full cycle, the complex provides support from basic research to the derivation of candidate materials, clinical trials, permission, and production through its New Drug Development Support Center, Non-Clinical Support Center, Advanced Medical Device Development Support Center, Laboratory Animal Center, Biopharmaceutical Manufacturing Center (GMP), and Korea Bio Human Resources Development Center. Also, officials added that further support will be provided through the Advanced Clinical Trial Center which is scheduled to open this year, and the Innovation Startup Technology Commercialization Center, which is scheduled to open in 2024. In addition, the complex is close to the Osong Health Technology Administration Town where the ▲Ministry of Food and Drug Safety, ▲ National Institute of Food and Drug Safety Evaluation, ▲Korea Disease Control and Prevention Agency ▲National Institute of Health reside and have great accessibility to national and public research institutes such as the ▲National Biobank of Korea, ▲ National Center for Stem Cell and Regenerative Medicine Research, ▲ National Center for Medical Information and Knowledge, and the ▲Korean Vaccine Research and Development Center for Public Vaccines. In addition, the complex also actively promoted its Osong Bio Industrial Complex and Osong Cosmetics Industrial Complex which are scheduled to be sold in 2023, and the Osong 3rd Life Science Complex which is scheduled to be sold in 2025. ◆Incheon Technopark = Incheon Technopark, where Celltrion·Samsung Biologics reside, also introduced its various business support services. The supports provided by the Incheon Technopark include support for bio equipment use support, bio-health care product development, bioproduct effectiveness evaluation, biopharmaceutical raw material commercialization, etc. The support for bio equipment includes the use of 80 or more equipment including HPLC, GC-FID, MALDI-TOF, etc. at an inexpensive price at the joint laboratory. Companies that move into the Bio Cluster will receive a 20% discount on equipment usage. As efficacy assessment support, the Bio Cluster will support ₩18 million for non-clinical and clinical drug trials to 3 companies selected among those that have moved into the Incheon Bio Cluster. As startup support, the Incheon Technopark introduced the establishment of a K-Bio Health regional center, the Incheon Startup Park support project, the creation and operation of the Incheon start-up fund, and support for the Bio Cluster establishment. ◆Seoul Biohub= The city of Seoul also promoted its Seoul Biohub, located in Hongneung-dong, Seoul. Seoul Biohub first made a kick-off in 2017 with the opening of the Industrial Support Building. In 2019, the city added a research laboratory building, and an open region building, and in 2020, the Seoul Bio-Innovation Community Center and Industry-University Cooperation Center were opened. Last year, the BT-IT Convergence Center was opened to expand the bio-startup ecosystem. The Seoul Biohub is concentrating on attracting bio startups. The companies will be able to move into the biohub in 2 years and are provided opportunities to pursue joint challenges with global bio companies such as Johnson&Johnson, Novartis, and MSD. In particular, the companies may receive policy support for new technology demonstration and tax reduction as the region was designated as a special Innotown in 2020. ◆ Gimhae Biomedical Industry Promotion Agency = The Gyeongnam Gimhae city plans to establish a biomedical industry complex that specializes in the manufacture of medical devices by 2025 around the Biomedical Center it established in 2008. In addition, the city aims to bring in technologies such as AI-based image reading, bio-functional materials, and 3D bioprinting. Companies that move into the complex will receive various development support including those for patents, certification, and design development as well as marketing support such as for participation in domestic and foreign exhibitions. The city plans to discover R&D projects jointly with local medical institutions such as the Inje Paik Hospital and Pusan National University Yangsan Hospital, and provide clinical trial support.
- Company
- Lumakras is a new opportunity for lung cancer patients
- by May 13, 2022 05:45am
- "Lumakras is the first-in-class and best-in-class for patients with KRAS G12C mutated non-small cell lung cancer who failed existing treatment. The reliability of drugs has also increased over the past two years with long-term data, and it is expected that they may be used in combination with other drugs such as immuno-cancer drugs in the future." Kim Hye-ryeon, a professor of oncology at Yonsei Cancer Hospital, expressed the meaning of the launch of the new cancer drug Lumakras. Lumakras is the first and only KRAS targeted anticancer drug that was approved by the MFDS in February. It targets non-small cell lung cancer KRAS G12C mutations. KRAS gene mutation is common in non-small cell lung cancer. In Asia, EGFR mutations are the second most common. Although the KRAS tumor gene was already discovered 40 years ago, it remained a homework that could not be solved for a long time due to molecular biological characteristics and drug toxicity. Amgen succeeded in commercializing it with FDA approval three and a half years after first discovering the Lumaras candidate material in November 2017. Lumakras binds to a P2 pocket near KRAS G12C Switch II to immobilize the mutant protein in an inactive state. By selectively blocking tumor-causing signals, only cancer cell growth can be prevented without affecting the KRAS normal gene. Professor Kim said in a meeting with Dailypharm, "The prognosis of patients for KRAS mutated non-small cell lung cancer has not been good because there is no targeted treatment. KRAS mutated non-small cell lung cancer is closely related to smoking, and nine out of 10 people have previously smoked or are currently smoking, so the high tumor heterogeneity is also considered a cause of poor prognosis, he said. "The launch of Lumakras is significant in that it has met the medical demand for lung cancer treatment." Since KRAS mutations generally do not overlap with other gene mutations with targeted treatments such as EGFR and ALK, chemotherapy was the only drug that patients could use. Fortunately, immuno-cancer drugs that can be used by patients without EGFR and ALK mutations have recently emerged, but the regret remains that there are no targeted treatments. This is because drugs that have a definite response and guarantee effectiveness are rare as targeted treatments that target specific gene mutations. Professor Kim said, "It is a retrospective study, but there are reports that the survival rate of patients has increased after targeted treatment in lung cancer treatment. Given the experience of prescribing other gene mutations, I think it is basic to use the treatment first." Amgen recently released long-term Lumakras data for two years, increasing reliability. This is the result of follow-up observation of 174 patients who participated in the Phase 1/2 CodeBreaK100 study, which was the basis for permission, for two years. It is the longest-running follow-up observation among targeted treatments for non-small cell lung cancer of KRAS G12C mutation. In this study, Lumakras confirmed long-term efficacy and safety. The ORR including CR and PR in the Lumakras administration group was 40.7%, and the reaction duration mDOR was 12.3 months. In addition, DCR 83.7%, mPFS 6.3 months, and OS 12.5 months were found. At the time of two years of treatment, 32.5% of all patients were alive. For two years of treatment, there were no reports of new adverse reactions that had not existed before. Regarding the two-year long-term data, Professor Kim said, "From the perspective of medical staff, 'long-term data' means really reliable," adding, "There are treatments that usually show good results in the first half of the phase, but Lumakras showed better response rates in the two-year long-term follow-up." In particular, considering that they are patients who have failed existing treatments, I think they are clinically valuable." The release of Lumakras has also changed the diagnosis of lung cancer. Professor Kim said, "When diagnosed with non-small cell lung cancer adenocarcinoma, this hospital based on five tests, including PD-L1, an indicator of immuno-cancer drugs, along with representative lung cancer genetic mutations such as EGFR, ALK, BRAF, and ROS1. With the emergence of treatments targeting minority mutations, including KRAS targeted treatments, we will now conduct additional NGS (next-generation gene sequencing) tests that can check other gene mutations together if all four previous gene mutations are confirmed negative, she explained. Professor Kim highly predicted the possibility of expanding Lumakras in the future. This is because immuno-cancer drugs and good synergy are expected. She said, "There have been no cases in which targeted treatments and immuno-cancer drugs have been approved for other gene mutations such as EGFR and ALK. This is because the treatment effect was not significant and the drug toxicity was strong. However, the KRAS mutation showed good results in the target + immunotherapy in the in vivo test. It is speculated that the high association with smoking may be affected, he said. "The response rate is also high when treating immuno-cancer drugs, so clinical trials related to targeted + immuno-combination therapy are actively being conducted."
- Company
- LG Chem’s partner enters Phase I trial on its immunotherapy
- by Kim, Jin-Gu May 13, 2022 05:45am
- On the 12th, Cue Biopharma, LG Chem’s partner in developing a cancer immunotherapy, announced it had won FDA approval to initiate Phase 1 clinical trials for ‘CUE-102 .’ LG Chem has exclusive rights to develop and market the candidate in 11 Asian countries including Korea, China, and Japan. With the trial approval, Cue Biopharma will assess CUE-102’s safety, tolerability pharmacokinetics, pharmacodynamics, and preliminary efficacy in treating Wilms' Tumor 1 (WT1)-positive recurrent/metastatic cancers, with an initial focus on gastric, pancreatic, ovarian and colon cancers. CUE-102 is a cancer immunotherapy that selectively engages and modulates targeted T cells that recognize and remove WT-1-positive tumors. Unlike existing T cell treatments that require the patients' T cells to be extracted, modified outside the body (ex vivo), and reinfused, CUE-102 is delivered directly into the patient's body (in vivo), In the preclinical trial, the candidate was found to proliferate and activates T cells that selectively respond to WT-1 positive tumors. CUE-102’s development is expected to accelerate further as the Phase I trial was approved as a dose-escalation trial to begin dosing at 1 mg/kg was supported by the interim safety and tolerability data from a Phase I trial for CUE-101, the first biologic from the CUE-100 series. In the trial for CUE-101, the starting dose was 0.06 mg/kg and required approximately 9 months to dose escalate from 0.06 mg/kg to 1 mg/kg. Based on the Phase I trial data of its partner, LG Chem will be designing the Phase II trial and directly participating in its development in the Asian region. With the trial entry of CUE-102, LG Chem’s anticancer candidate pipeline has increased to 4. In addition to Que Biopharma’s CUE-101·CUE-102, LG Chem also owns Korean Genome&Company’s solid cancer treatment ‘GEN-001' by the and Belgium and Frech PDC*line Pharma’s NSCLC treatment ‘PDC Lung.’ GEN-001 is now in Phase I trials in the US, and PDC lung is in Phase I trials in Europe.
- Company
- K-Cab & Fexuclu are quickly targeting the global market
- by Chon, Seung-Hyun May 12, 2022 06:07am
- New drug products developed by domestic pharmaceutical companies with their own technologies are accelerating their targeting in the global market. However, some point out that it is difficult to predict commercial success because there are many variables such as the situation of the local market even if they have reserved to enter the overseas market. ◆K-Cab Expands to 34 Export Contracting Countries...Maximum contract size of ↑1 trillion won According to the industry on the 11th, HK inno.N signed a contract with Indian pharmaceutical company Dr. Reddy's Laboratories to export new K-Cab for gastroesophageal reflux disease. Seven countries have signed export contracts, including India, South Africa, Russia, Kazakhstan, Uzbekistan, Ukraine and Belarus. With this contract, the number of countries where K-Cab has entered the market in the form of technology exports or finished product exports has increased to 34. HK inno.N signed a technology export contract with Chinese pharmaceutical company Luoxin for K-Cab in 2015. It is a condition to receive $18.5 million in technical fees for each stage according to down payment, clinical development, permission, and commercialization. The company estimated that if royalties from sales occur after local commercialization, the contract will rise to $95.29 million. In February 2019, HK inno.N signed an export contract for K-Cab with Mexican pharmaceutical company Laboratorios Carnot to 17 Latin American countries. It is worth $84 million over 10 years, including the amount of supply of products. Export contracts have become more active since K-Cab was released in Korea. In September 2019, contracts were signed to supply finished drugs to Indonesia, Thailand, and the Philippines, and in 2020, export contracts were signed to Mongolia and Singapore. Last year, it signed export contracts for Vietnam, Malaysia, the U.S., and Canada. The largest export contract of K-Cab is technology exports signed with U.S. company Braintree Laboratories Inc. in February, with a contract size of up to $540 million. The company explained that K-Cab's export contract will exceed KRW 1 trillion. ◆Fexuclu, export contract to 15 countries, maximum Contract Size 1.2 Trillion Among the new drugs developed in Korea, Daewoong Pharmaceutical's Fexuclu is showing the most active entry into the overseas market. Fexuclue is a potassium competitive gastric acid secretion inhibitor (P-CAB)-based gastroesophageal reflux disease treatment drug, which is the same as K-cap. It received domestic permission at the end of last year and is expected to be released in the second half of this year. Through six export contracts, Daewoong Pharmaceutical has booked Fexuclu exports to 15 countries including North America, Latin America, China and the Middle East. Daewoong Pharmaceutical began to enter Latin America in 2020 by handing over the local permission and sales rights of Fexuclu to Mexican pharmaceutical company and Brazilian pharmaceutical company EMS, respectively. In March last year, it signed an export supply contract worth about 384.5 billion won with Shanghai Haini of China. In June last year, it handed over Fexuclu's right to develop, license, and sell in the U.S. and Canada. Under the contract, Daewoong Pharmaceutical secured a 5% stake in Neurogastrx as an upfront fee and was guaranteed up to $430 million in the name of a step-by-step technology fee (milestone) for development, licensing and commercialization stages. Daewoong Pharmaceutical was promised to enter 10 countries in Latin America and the Middle East through two export contracts last year. Daewoong has secured up to 1.2 trillion won through Fexuclu's export contract. ◆ There are many cancellations and returns after the export contract Variables such as changes in the local market environment The industry expects K-Cab and Fexuclu to achieve commercial results in overseas markets. Domestic new drug products have tapped overseas markets in various ways, but have yet to produce successful cases. This is because even if an export contract is signed, the export contract does not guarantee commercial performance due to the nature of taking a considerable amount of time to sell through local licensing procedures. Overseas drug expansion is largely divided into technology transfer and exports of finished drugs. Technology transfer is a structure in which partner companies are in charge of commercializing products that have not yet been developed. Technology transfer is often terminated or rights returned depending on the partner company's intention to develop or the marketability of drugs. The contract for the supply of finished drugs is a structure in which exporters sell products that have succeeded in commercialization abroad. Although it is evaluated that the success rate of contract implementation is relatively high compared to technology transfer, there may be a number of cases that are terminated depending on local circumstances. The export contract between K-Cab and Fexuclu has a large proportion of completed drug supply contracts. It is a structure in which profits are generated only when sales are made through overseas local licensing procedures. In the case of K-Cab, it received Chinese permission last month and is expected to make full-fledged overseas sales are expected. Fexuclu is in the process of licensing items in the Philippines, Indonesia, and Thailand. Another variable is that the down payment already secured is not large. Although HK inno.N did not disclose the amount of down payment secured by K-Cab's export contract, it is known to be insignificant compared to the total size of the contract. There are two down payments secured through the Fexuclu export contract disclosed by Daewoong Pharmaceutical. In March last year, 6.8 billion won in advance received from Shanghai Haini was the largest. Daewoong Pharmaceutical's 5% stake from Neurogastrx was valued at 4 billion won as of the end of last year. An industry official said, "Even if finished drugs are already well-selling in Korea, various unexpected variables such as changes in the market environment will inevitably occur in overseas markets," adding, "Even if there is no problem with the product, it is highly likely that they will not achieve the export target set in the first place."
- Company
- 17 are immuno-cancer drugs out of 111 KDDF support projects
- by Kim, Jin-Gu May 12, 2022 06:06am
- Kim Soon-nam, head of the R&D division of the National New Drug Development Project, is presenting at 2022 BIO KoreaOf the 111 KDDF support tasks selected by the government last year, 17 are confirmed to be immuno-cancer drugs. Kim Soon-nam, head of KDDF R&D, who is leading the project, predicted, "In the future, R&D tasks related to immuno-cancer drugs will increase further." Kim Soon-nam, head of the headquarters, attended a session under the theme of "Trends in the Development of Immuno-cancer Drugs" at "2022 BIO Korea" held at COEX in Seoul on the 11th and introduced it as such. According to him, the government will invest a total of 2 trillion won for 10 years from 2021 to 2030 to develop KDDF. The goal of the project is to support a total of 1,234 projects over a decade and produce four new drugs approved by the FDA or EMA and one new global blockbuster drug before the project is over. In 2021, the first year, a total of 111 tasks were selected for support. Among the supporting tasks, anticancer drugs are the most important. Nearly half of the 52 (47%) projects were selected for support. It is followed by metabolic diseases (15), immune diseases (11), and central nervous system diseases (9). Government contributions were also focused on developing anticancer drugs. Of the total 127 billion won supported last year, 60.3 billion won was invested in research and development projects for anticancer drugs. Director Kim explained that there have been many recent research projects related to immuno-cancer drugs among anticancer drugs. She said, "32% (17) of the 52 anticancer drug tasks were immuno-cancer drugs," and predicted, "We expect more research on immuno-cancer drugs in the future." "Even within immuno-cancer drugs, the field of research is being subdivided in various directions," he said. "There will be more research on combination therapy, targeting, and biomarker studies." "KDDF is providing support from the stage of finding candidate materials to phase 2 clinical trials. In the end, the goal is to approve the sale of new drugs by global licensing agencies," she stressed.
- Company
- GLPharmtech has obtained approval IMD for Janumet XR
- by Nho, Byung Chul May 12, 2022 06:06am
- (CEO Wang Hoon-sik) announced on the 11th that it has obtained an item approval from the Ministry of Food and Drug Safety for a new salt-improving drug of Janumet XR (Sitagliptin Phosphate+ Metformin Hydrochloride. GLPharmtech items licensed this time adopted Sitagliptin, a modified salt drug for Chong Kun Dang Sitaformin XR/Hanmi Pharmaceutical Sitamefor XR, which was designated as generic for exclusivity in 2016. GLPharmtech will be able to compete simultaneously, away from the influence of generic for exclusivity secured by Chong Kun Dang/Hanmi Pharmaceutical until June 1, 2024. It plans to produce this product through technology transfer to Shinil, and will also be sold in Ildong, Dong-Wha, and Futecs. "Our subsidiary GL Pharma launched another DPP-4 inhibitor, GL Vildagliptin, in March," said Park Jae-kyung, director of GL Pharmtech's development division, the director said that we will continue to release additional products of DPP-4 inhibitors and SGLT-2 inhibitors, which are leading diabetes treatments, to expand our presence in the diabetes treatment market.
- Company
- Will Luxturna be reimbursed by the end of this year?
- by Eo, Yun-Ho May 11, 2022 05:56am
- Attention is focusing on the procedure for registering insurance benefits for another one-shot gene therapy. According to related industries, discussions are underway to register the benefit of Novartis' Inherited Retinal Dystrophy (IRD) treatment Luxturna. As the application for benefits was submitted in September last year, it remains to be seen whether it will be possible to announce the HIRA's drug benefit evaluation committee within the first half of the year. Depending on the speed of the procedure, Luxturna can enter the benefit right within this year. Luxturna restores function by replacing the deficient and defective RPE65 gene, one of the causes of IRD, with a normal gene only once administered. In other words, fundamental treatment of diseases is possible. The drug was designated by the U.S. FDA for Breakthrough Therapy in 2014, Orphan Drug in 2016, and Priority Review in 2017, and was quickly approved in 2017. IRD is a rare and intractable disease that causes visual loss due to mutations in the genes responsible for the structure and function of cells in the retina. It includes more than 20 different ophthalmic diseases and has about 300 causative genes. IRD, which is caused by RPE65 gene mutation, causes abnormalities in the visual cycle in the retina, which converts visual information into neural signals and transmits it to the brain. The RPE65 gene mutation reduces the RPE65 protein, which is essential for visual circuits, and destroys retinal cells, gradually narrowing the field of view, and eventually reaching blindness. Kang Se-woong, chairman of the Korean Retina Society (Samsung Medical Center's ophthalmology professor), said, "Luxturna's single injection is expected to restore not only vision but also independent walking without the help of a guardian"
- Company
- Domestic COVID-19 vaccine developers at a crossroads
- by Kim, Jin-Gu May 11, 2022 05:55am
- HK Inno. N announced it will voluntarily discontinue the development of its COVID-19 vaccine due to the sudden change in the spread of COVID-19 in Korea. With the marketing approval of SK Bioscience’s COVID-19 vaccine imminent, the indecisiveness among the other vaccine developers in Korea is increasing According to industry sources on the 10th, HK Inno. N has decided to discontinue the development of its COVID-19 vaccine, ‘IN-B009’ in Korea. The company had been developing a recombinant vaccine, the same as SK Bioscience’s GBP510 or Novavax’s Nuvaxovid in terms of platforms. The company pointed to the rapid change in the Korean COVID-19 situation as a reason for discontinuing its trial. Unlike in July last year when HK Inno. N received approval for the Phase 1 trial of IN-B009, the company said the need for COVID-19 vaccines had reduced significantly. HK Inno. N said, “Most of the people in Korea have secured immunity to COVID-19, being infected or through multiple vaccinations. The COVID-19 situation has now changed rapidly. With the situation moving to the endemic phase, there is no clear purpose for us to enter a late-stage clinical trial." ◆Second company after Genexine to discontinue development… 7 companies remain The company became the second after Genexine to drop the development of its vaccine. Before HK Inno. N, Genexine had announced that it will voluntarily discontinue its Phase II and Phase III trials in March. At the time, Genexine also explained that it “determined that the business feasibility of GX-19N was low in the rapidly changing COVID-19 market in consideration of the global vaccine supply and demand.” With Genexine and HK Inno. N’s voluntary withdrawal, 7 domestic COVID-19 vaccine developers now remain in the market. The companies that remain are SK Bioscience, Eubiologics, Cellid, Geneone Life Science, Quratis, Eyegene, and ST Pharm. Among the companies, SK Bioscience’s GBP510 is soon to be commercialized. On the 29th of last month, the company applied for the marketing authorization of GBP510 under the name ‘SKY Covione.’ The drug is currently under review by the Ministry of Food and Drug Safety and is likely to receive an approval within the month. Eubiologics is continuing the development of its‘EuCorVac-19’ through a global Phase III trial. After receiving approval for its trial in three countries in Africa, Eubiologics also initiated a Phase III trial in the Philippines on the 7th of this month. As such, the company has entered Phase III trials by securing a comparator vaccine overseas. In Korea, the company also received approval for its Phase 3 trial protocol and is in search of comparator vaccines. ◆ Companies change trial plan due to low marketability…concerns deepen among developers Excluding the two, no other company has entered Phase III trials yet. The industry is paying attention to the possibility that more companies will stop developing COVID-19 vaccines. Cellid has started its Phase IIb trial for 'AdCLD-CoV19-1' in Korea. Cellid has prepared a two-track strategy to continue clinical trials for its vaccine for primary inoculation that was in development while developing another vaccine as a booster shot (additional inoculation). Geneone Life Science changed its strategy from developing a vaccine for primary inoculation to developing a booster vaccine. Last month, the company announced that it had completed the registration of subjects for the Phase IIa clinical trial of 'GLS-5310', which is being developed as a DNA vaccine. After confirming the safety and efficacy of clinical trials in a Phase IIa trial, the company plans to continue on studying its vaccine through Phase IIb and III trials as a booster vaccine. The changed COVID-19 situation is analyzed to have played a decisive role in the changes in the development strategy of the two companies. With the COVID-19 pandemic entering the endemic stage, the market competitiveness of vaccines has been greatly reduced. The other companies are having difficulty in the patient recruitment stage. Quratis and Eyegene received approval for their Phase I and Phase I/2a trial in July and August last year but are still recruiting patients. ST Pharm has received approval for the Phase I trial plan of its mRNA platform-based 'STP2104' in March this year and is starting to recruit patients.
- Company
- Kakao is throwing the hat into the healthcare business
- by Kim, Jin-Gu May 10, 2022 06:14pm
- Large domestic companies are throwing their hat into the healthcare business. In the past year, leading conglomerates such as Lotte, Kakao, Doosan, Hyundai Heavy Industries & Construction, GS, CJ, and OCI have formalized their entry into the healthcare market. Analysts say that Samsung and SK have succeeded in the pharmaceutical bio business one after another, stimulating these companies. ◆Lotte Biologics' pre-debut notice at "BioUSA" According to the pharmaceutical industry on the 9th, Lotte Group announced that it will attend the "BioUSA" in the U.S. in June. Lotte Biologics, which recently completed its trademark application, is expected to make its debut through BioUSA. In March last year, it became the second-largest shareholder by acquiring part of the stake in Enzychem. In August last year, Lotte Group's ESG Management Innovation Office established a new growth team (biological team) and a new growth team (health care team). Lotte Biologics, which is about to be officially launched, is known to be in charge of the CMO business of biopharmaceuticals. Lee Won-jik, a former executive director of Samsung Biologics, is said to be leading the new growth team, which will be the mainstay of Lotte Biologics. ◆ GS, CJ, Doosan, Hyundai Heavy Industries, Kakao, OCI In addition to Lotte, GS, CJ, Doosan, Hyundai Heavy Industries, Kakao, and OCI have visualized their entry into the healthcare business in the past year. GS acquired Hugel in August last year. A multinational consortium led by GS Group, APHRODITE ACQUISITION HOLDINGS LLC, signed a stock transfer contract to purchase a 46.9% stake in Hugel. The acquisition amount amounts to 1.724 trillion won. ▲ GS acquired Hugel, OCI acquired Bukwang, and CJ acquired ChunLab, signaling full-fledged entry into the pharmaceutical bio business OCI acquired Bukwang Pharmaceutical in February this year. OCI became the largest shareholder as it secured an 11% stake in Chairman Kim Dong-yeon, founder of Bukwang Pharmaceutical. It is interpreted as a signal that it will enter the pharmaceutical bio business in earnest. At this year's general meeting of Bukwang Pharmaceutical's shareholders, Lee Woo-hyun, vice chairman of OCI, became co-CEO of Bukwang with the existing CEO Yoo Hee-won. CJ officially launched CJ Bioscience under CJ group in January this year. CJ Bioscience selected Microbiome as its core business. To this end, it acquired ChunLab, a microbiome company, in October last year. CEO Chun Jong-sik, who led ChunLab, will continue to represent CJ Bioscience. Kakao newly established 'Kakao Healthcare' in March. Healthcare CIC, which was previously operated as an in-house independent corporation, was separated into separate corporations. Prior to this, Hwang Hee, a professor at Seoul National University Bundang Hospital, who was recruited in December 2021, was appointed. Kakao Healthcare is expected to focus on digital healthcare businesses such as AI-based medical solution development and service industry, health care by life cycle, and smart medical care. Doosan added a medical device business to its business area through the revision of its articles of association at a shareholders' meeting held in March this year. Doosan is planning to target the biopharmaceutical container market. In December last year, it invested $100 million in SiO2, a U.S. drug storage container company. At the same time, it secured exclusive business rights in Asia and Oceania for all SiO2 products. It is planning to start manufacturing in South Korea in the future. Hyundai Heavy Industries Holdings, the holding company of Hyundai Heavy Industries Group, changed its name to HD Hyundai at a shareholders' meeting in March this year and announced plans to support four future industries, including healthcare. Hyundai Heavy Industries Holdings established 'AMC' last year and is also developing new drugs. In the pharmaceutical industry, it is interpreted that the success of Samsung and SK, which entered the field first, served as a stimulus to large companies' entry into the bio business. Samsung Biologics, SK Bioscience, and SK Biopharm, affiliates of the two groups, have become leading companies in the industry before and after the Corona crisis. Large domestic companies began the pharmaceutical bio business with enthusiasm in the past, but withdrew one after another in the mid-2010s. Lotte Pharmaceutical was launched in 2002 when it acquired a subsidiary of Ilyang Pharmaceutical's health functional food. However, in 2011, Lotte Pharmaceutical was merged into Lotte Confectionery and withdrew from the market. In 2014, CJ spun off CJ Healthcare as a separate subsidiary of the pharmaceutical division, driving the pharmaceutical bio business. However, it sold its 100% stake in CJ Healthcare to Kolmar Korea for 1.31 trillion won in 2018. Hanwha established the pharmaceutical business department in 2996 and launched Dream Pharma by absorbing and merging H-PHARM in 2004. Although it made a large-scale investment to develop a biosimilar of Enbrel, a TNF alpha inhibitor through Dream Pharma, it eventually sold Dream Pharma to Alvogen in 2014 as product development was delayed and related contracts were terminated. AmorePacific sold its subsidiary Pacific Pharmaceutical Co. to Handok in 2013 to focus on its beauty business.
