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- 2026-03-18 17:36:35
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- Pharmaceutical industry rushes to recruit new GA managers
- by Eo, Yun-Ho Jan 22, 2021 06:26am
- The pharmaceutical industry is hectic seeking for government affairs specialists to recruit. An industry source reported, many of pharmaceutical companies and Korean Research-based Pharmaceutical Industry Association (KRPIA) are in search of new government affairs or market access managers, as their previous members are transitioning to other places. As the current healthcare policy director at KRPIA, Kang Tae-wook, was offered to teach at Sungshin Women’s University as a professor, the organization is looking for a successor. Before joining KRPIA in 2019, Director Kang was a healthcare policy researcher at the National Health Insurance Service (NHIS). Bayer Korea is in process of recruiting a Market Access-Government Affair Head, as the previous senior director of the department, Park Hanra moved to Bristol Myers Squibb (BMS). Organon, split from MSD, has decided to introduce Pyo Jihyun, a previous Policy and Stakeholder Relations Team Lead at Pfizer, as their new Head of Market Access, Government Affairs and Public Relations department. Pyo is expected to officially join Organon from coming February. Losing the key player in the company, Pfizer is also expected to search for a new lead in the team. Fine-tuning the new organization, Organon is looking for two more personnel to take over the government affairs and PR. Manager Paik Hee-jeong, previously worked at MSD, is decided to join the Organon market access department. Boehringer Ingelheim is newly recruiting a healthcare policy manager. Initially the company’s market access and government affairs were jointly managed by Senior Director Kim Mi-kyung, but the company has decided to hire another staff to solely manage the government affairs. Handok is also seeking a new market access manager as its previous Market Access Team Lead Park Sun has moved to UCB Korea. A government affairs manager at a multinational pharmaceutical company commented, “Because the job requires a specific skill set and experience, the companies inevitably looks for the new personnel within the industry. And that is why there is a chain of recruits and personnel assignment. Sometimes, however, companies look for someone from the National Assembly or news media for the government affairs.”
- Company
- Viatris·Organon's prescription performance declined
- by Kim, Jin-Gu Jan 22, 2021 06:26am
- Sales of major items owned by Viatris and Organon, which were spun off from Pfizer and MSD, are declining in the domestic outpatient prescription market. As of last year, Viatris' outpatient prescriptions fell 4% and Organon's 6% YoY. The decline in prescription results for most major items, such as Viatris' Lipitor·Lyrica and Organon's Singulair·Cozaar, has not been avoided. The prescription performance of the headquarters of Pfizer and MSD, which spun off its business divisions centering on patent-expired drugs, was relatively insignificant. ◆Viatris'L ipitor· Lyrica, 4% reduction in prescription performance According to UBIST, a drug market research organization on the 19th, Pfizer's outpatient prescription last year was ₩539.2 billion. Compared to ₩565.4 billion in 2019, it decreased by 11%. In 2018, Pfizer decided to spin off Pfizer Upjohn, focusing on drugs whose patents expired. Pfizer Upzone was officially launched in November last year under the name Viatris. However, the transfer and acquisition of Pfizer and its items has not been completed. Pfizer decided to hand over ▲Lipitor ▲Norvasc ▲ Lyrica ▲Celebrex ▲Viagra ▲Caduet ▲Neurontin ▲Xalatan ▲Cardura XL ▲Zoloft ▲Xanax ▲EfexorXR ▲Detrusitol ▲Zeldox ▲Xalacom ▲Zyvox to Viatris. The total amount of prescriptions for these items decreased by 4% from ₩453.1 billion in 2019 to ₩434.2 billion last year. Lipitor, the flagship product, was the most sold drug in the domestic outpatient prescription market for three consecutive years until last year, but it has been stagnant. The prescription amount last year was ₩185.5 billion, a 3% decrease from the previous year (₩191.4 billion). During the same period, Lyrica was 4% (₩67.3 billion → ₩64.5 billion), Celebrex 8% (₩44.3 billion → ₩40.4 billion), Caduet 15% (₩26.4 billion → ₩22.4 billion), Neurontin 14% (₩22.4 billion → ₩19.3 billion), Xalatan decreased by 1% (₩14.7 billion → ₩14.6 billion), respectively. Among the major items, only Norvasc increased by 1% (₩66.7 billion → ₩67.2 billion). The amount of outpatient prescriptions for the remaining items at Pfizer decreased by 7% from ₩112.3 billion to ₩10.5 billion. Compared to simple comparisons, Pfizer's remaining items declined more, but given the fact that the recent growth of anticancer drugs such as Ibrance and Xalkori, which have a large proportion of inpatient prescriptions, and vaccines such as Prevenar13, the actual decrease in prescription performance is not significant. ◆Excluding Organon's Atojet, Singulair and Proscar sharply decreased by around 10% MSD also decided to spin off some of the patent expired drugs, women's health products, and biosimilars. The name of the spin-off company is Organon. The items passed from MSD to Organon are ▲Atozet ▲Singulair ▲Vytorin ▲Proscar ▲Cozaar ▲Fosamax ▲Nasonex. Among them, prescription performance for other items excluding Atozet decreased significantly: Cozaar series 3% (₩52.4 billion → ₩50.6 billion), Singulair 29% (₩38.1 billion → ₩26.8 billion), and Vytorin 18% (₩24.8 billion → ₩20.3 billion). , Proscar 10% (₩19.1 billion → ₩17.2 billion), Fosamax series 9% (₩16.7 billion → ₩15.2 billion), and Nasonex 13% (₩8.2 billion → ₩7.2 billion), respectively. Atozet rose 14% from ₩65.8 billion to ₩74.7 billion. However, it is unclear how long Atozet's uptrend will continue. Generics for Atozet are expected to be listed as early as next month. Currently, it is known that about 20 companies, mainly Chong Kun Dang, are developing generics. MSD has decided to leave the Januvia series the only drug that has expired. The Januvia series' prescription performance last year was ₩176.2 billion, a 5% increase from the previous year (₩168.2 billion). The total outpatient prescriptions for items remaining in MSD, including Januvia, increased by 2% from ₩207 billion in 2019 to ₩29.9 billion last year. MSD plans to close the spin-off process with Organon in February. Currently, some of the 700 employees of MSD Korea have been relocated.
- Company
- Takeda to retry expanding all-comer coverage on Zejula
- by Eo, Yun-Ho Jan 21, 2021 06:15am
- An all-comer targeting anticancer treatment Zejula is shooting yet again for the healthcare reimbursement expansion this year. The pharmaceutical industry insider reported the drug could not overcome the hurdle of the Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee in last June, but the poly ADP-ribose polymerase (PPARP) inhibitor Zejula’s (niraparib), applied again in last August to expand the reimbursed indication. On Jan. 27, the Cancer Deliberation Committee would assess expanding the healthcare reimbursement on the drug’s indication as a monotherapy for the patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to first-line platinum-based chemotherapy, regardless of BRCA mutation. In last June, the Cancer Deliberation Committee reviewed using the drug as a single-agent maintenance therapy in patients with gBRCA-negative high-grade serous relapsed ovarian cancer who showed complete or partial response in platinum-based chemotherapy, and as a monotherapy in patients with relapsed ovarian cancer who previously received fourth-line or later chemotherapy. Ultimately, only the fourth-line monotherapy indication was approved, while the gBRCA-negative indication failed. But the government is still cautious of expanding the reimbursement on all-comer indication. The indication approval was based on the PRIMA study that evaluated Zejula’s efficacy as a first-line maintenance therapy on 733 adult patients diagnosed with ovarian cancer. The primary endpoint was a progression-free survival (PFS) in homologous repair deficiency (HRD) and overall population groups, which was evaluated by the Blinded Independent Central Review (BICR) in the order. The clinical study found the HRD patient group demonstrated a median PFS of 21.9 months, almost doubling that of the placebo group, and reduced the risk of disease progression and death by 57 percent. The control group’s median PFS marked 10.4 months. The overall population’s median PFS was 13.8 months with Zejula and 8.2 months with the placebo. The risk of disease progression and death was lessened by 38 percent. Professor Kim Jae-weon at Seoul National University Hospital Depart of Obstetrics and Gynecology noted, “The maintenance therapies each in first-line and second-line show a significant difference. Obviously, the survival rate goes up when the treatment is used at an earlier stage. Personally speaking, the healthcare coverage on the first-line maintenance therapy should be expanded for all possible patients.” Originally, Zejula’s reimbursed price was set at 76,400 won per capsule. Compared to the alternative option, Lynparza (olaparib) by AstraZeneca, Takeda’s option was evaluated as more cost-effective. But because Lynparza was listed with a pharmacoeconomic-analysis exemption through the risk sharing agreement (RSA), Zejula was also applied with the expenditure cap type RSA.
- Company
- Daewoong & Boryung challenged the patent for Sprycel
- by Kim, Jin-Gu Jan 21, 2021 06:13am
- Daewoong challenged the patent for BMS' chronic myelogenous leukemia treatment Sprycel (Dasatinib). As other domestic companies have failed to overcome the patents one after another, attention is focused on Daewoong's challenge. According to the pharmaceutical industry on the 19th, Daewoong recently requested an invalidation trial against use patent of Sprycel. At the end of last year, Boryung filed an invalidation trial on the patent. Sprycel is registered for product patent, crystalline patent, and use patent. Among them, the product patent expired in April of last year. Generics can release early if they overcome the use patent expiring in March 2024 and the crystalline patent expiring in February 2025. However, no pharmaceutical company has yet overcome the patent. In 2015, Hanmi, JW Pharma, Boryung, Ahn-gook, Huons, Yuhan, and Navipharm challenged Sprycel's patents, but were withdrawn. Sprycel's annual sales are ₩30 billion, which is growing every year. According to IQVIA, Sprycel's sales in 2019 were ₩29.7 billion, up 25% from ₩23.7 billion in 2019. Last year, it posted ₩26 billion in sales until the third quarter. With the expiration of the product patent last year, attention is focused on whether generic companies, including Boryung and Daewoong, will try to overcome the use patent and crystalline patent with a new strategy in the future.
- Company
- “Yuhan’s change is just warming up with Leclaza”
- by An, Kyung-Jin Jan 21, 2021 06:13am
- CEO Lee Jung-hee “We believed the path for Yuhan Corporation taking the step forward to another century ahead would be through new drug pipeline. We are exhilarated to see the world acknowledging the company’s first proud outcome of the open innovation strategy, Leclaza (lazertinib).” During an interview with Daily Pharm on Jan. 18, Yuhan Corporation CEO Lee Jung-hee seemed exceptionally composed, regardless of the news that the South Korean health authority approving Leclaza. He almost seemed unburdened by the news as if his whole maneuver in last six years was finally paid off. On the day, the Ministry of Food and Drug Safety (MFDS) authorized the marketing of a 31st Korean-made new drug and Yuhan Corporation’s next-generation novel drug for lung cancer, Leclaza. The drug is the South Korean company’s brand new novel drug to be developed since an ulcer treatment Revanex in 2005. CEO Lee reminisced and noted, “Year 2026 would mark a centennial anniversary of Yuhan Corporation. And I became the CEO at the pivotal point in time, just before the centennial anniversary. I kept thinking about how to change the public’s evaluation that the company’s new drug pipeline is weak compared to the revenue.” After a thorough contemplation, CEO Lee apparently made a first command; ‘Invest bold.’ This is how the company took a groundbreaking shift in the external investment strategy for last few years. “The answer was clear, once I put myself in the shoes of the late founder Dr. New Ilhan. Based on the abundant cash flow, I decided it was time to explore a future growth driver. And I came to a conclusion that the open innovation is the only way to push up the new drug R&D capacity the company was falling short of,” the CEO elaborated. It matched with the CEO’s philosophy that even a pharmaceutical company with a long history of 100 years should learn from a venture company’s speed and passion to not fall behind. Since his appointment in March 2015, CEO Lee immediately endeavored to reform the company to develop new drug. A vast number of R&D staffs were recruited, and the R&D investment ratio kept at 5 percent was doubled to 10 percent. Last year, the company spent 200 billion won in R&D. The South Korean company also boldly invested on promising venture companies financially hindered to develop new drug. Starting from Oscotec that originally found Leclaza, the company invested hundreds of billion wons in Genexin, Bioneer, Abclon, Pharmabcine, and NeoImmuneTech. The company was on to secure source technology that would leverage the future for the company. Yuhan Corporation is currently leading Phase III global clinical trials on Leclaza monotherapy in 17 different countries around the world. The company is speeding up the Leclaza commercialization to level with Janssen’s investigational drug amivantamab as a combination therapy. Although the clinical trials are still in progress, the anticipation on Leclaza is heightening. A global market research firm Global Data projected the value of lazertinib as both monotherapy and combination therapy would be valued at USD 569 million a year. The value of the pipeline soared as the company’s two-track strategy to develop both the monotherapy and combination therapy worked. The investigational drug Leclaza is already the company’s biggest cash cow. Besides the 50 million dollars paid upfront for the license-out deal, the drug generated over 100 million dollars of technology payment in last year only. Leclaza is the only Korean-made new drug that made over 100 billion won additional to the license-out upfront payment. CEO Lee said, “The company could have missed out on both the pipeline and profit, if it was only fixated on the short-term performance. But by ceaselessly seeking the external investment opportunity for the future growth driver, the public perception on the company was changed naturally.” “Yuhan’s change is just warming up. Watch how Yuhan Corporation takes the new leap as a global pharmaceutical company,” the CEO urged.
- Company
- Tumor-agnostic Rozlytrek applies for NHI coverage
- by Eo, Yun-Ho Jan 20, 2021 06:04am
- A tumor-agnostic anticancer medicine Rozlytrek is shooting for the National Health Insurance (NHI) reimbursement listing. A pharmaceutical industry source reported Roche Korea submitted a reimbursement listing application for a neurotrophic tyrosine receptor kinase (NTRK) targeted therapy Rozlytrek (entrectinib) to a South Korean health authority last year. Approved as an orphan drug in South Korea in last August, Rozlytrek is indicated to treat adult and pediatric patients 12 years of age and older with solid tumors that have a NTRK gene fusion without a known acquired resistance mutation, are locally advanced ROS1-positive or metastatic NSCLC. Technically, the treatment can be prescribed to any cancer patients confirmed to have NTRK gene. The treatment’s approval was based on results from the Phase I/II STARTRK-NG study targeting pediatric patients and the pivotal Phase II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA-372-001 trials. In STARTRK-2, Rozlytrek achieved an objective response rate (ORR) of 56.9 percent in patients with NTRK-positive solid tumors. The patients had ten types of different solid tumor and their median duration of response (DoR) was 10.4 months. And at the European Society for Medical Oncology (ESMO) Asia 2020 convened late last year, Rozlytrek unveiled its Asian subgroup analysis result. The subgroup analysis result found NTRK fusion-positive patients treated with Rozlytrek had ORR of 69.2 percent, the median DoR of 10.4 months, and median progression-free survival (PFS) of 14.9 months. The overall survival (OS) was unable to measure. Among ROS1-positive patient with NSCLC, the researchers confirmed ORR of 69.9 percent and median DOR of 14.9 months, when median OS and median PFS were 28.3 months and 13.6 months, respectively. And a second endpoint, the intracranial ORR (IC ORR) was 100 percent in patients with solid tumors that have a NTRK gene fusion, whereas ROS1-positive patient with NSCLC marked 36.4 percent. The central nervous system (CNS) metastasis progression confirmed with a scan was generally very low. Professor Ahn Myung Ju at the Samsung Medical Center Department of Hematology and Oncology said, “Based on the confirmed clinical evidence of Rozlytrek treatment efficiency in Asian patients and the introduction of the tumor-agnostic treatment to the South Korean market, we can expect to expand the rare cancer patients’ access to treatments customized to personal gene characteristic, and to create a positive cycle of precise medicine, which would feed the patients’ treatment information back to R&D.”
- Company
- Mavenclad can be prescribed at general hospitals
- by Eo, Yun-Ho Jan 19, 2021 06:02am
- New multiple sclerosis drug Mavenclad can be prescribed in general hospitals According to related industries, highly active recurrent multiple sclerosis treatment Mavenclad (Cladribine) by Merck has now passed the drug commitee (DC) of SMC, AMC, Shinchon Severance Hospital, and NCC. Mavenclad is the first short-term oral treatment that has shown a significant overall effect in terms of the degree of physical disability progression, annual recurrence rate, number of active lesions shown on MRI, and major disease activity indicators in patients with recurrent multiple sclerosis. Mavenclad's clinical trial program included long-term follow-up data from the 8-year prospective observational registry PREMIERE study, along with the CLARITY Phase 3 study and CLARITY EXTENSION, ORACLE MS, and ONWARD Phase 2 study corresponding to the CLARITY expanded clinical trial. As a result of post-hoc analysis of patients with high disease activity in the CLARITY 2,3 study conducted for two years, the annual recurrence rate of patients receiving Mavenclad decreased by 67%, and the Extended Disability Status Scale (EDSS), which indicates the degree of disability progression. Also, Mavenclad administration group showed a 82% decrease compared to the control group. However, Mavenclad’s significant adverse reactions are lymphopenia and shingles. The lymphocyte count of patients must be measured before and during Mavenclad administration to patients with multiple sclerosis. It is contraindicated in certain populations, including patients with impaired immune function and pregnant women. Seongmin Kim, Professor of Neurology, SNUH said, "Multiple sclerosis is a chronic inflammatory demyelinating disease that occurs in the central nervous system such as the brain and spinal cord. If not treated, symptoms may worsen and sequelae such as severe disorders may remain, so a new treatment option with high convenience is available. It was a necessary situation. Mavenclad can be taken orally and can help improve the quality of life for patients in that it provides lasting effects for 4 years with only short-term treatment of up to 20 days."
- Company
- Big Pharmas busy reaching out for KRAS targeted therapy
- by Kim, Jin-Gu Jan 18, 2021 06:14am
- Global pharmaceutical giants are eager to develop targeted therapy for ‘Kirsten rat sarcoma viral oncogene homolog (KRAS)’ mutation, initially considered as an impenetrable technology for last four decades. Apparently, KRAS mutation is found in about one out of four cancer types. Specifically, the mutation is frequently found in cancer types with bad prognosis like lung cancer, colon cancer and pancreatic cancer. Pioneered by Amgen, small and big companies like Novartis, Sanofi, Bayer, Boehringer Ingelheim, Merck and Mirati Therapeutics are fiercely competing against each other to dominate the blue ocean. ◆Why did MSD bet USD 2.5 billion on candidate medicine in preclinical trial phase? On Jan. 13 (local time), MSD exclusively licensed-in an anticancer candidate medicine targeting KRAS from Japanese-based Otsuka Pharmaceutical’s subsidiaries, Taiho and Astex. MSD has agreed to pay maximum 2.5 billion dollars (approximately 2.75 trillion won) including an upfront payment of 50 million dollars (approximately 55 billion won). To win the competition against Revolution Medicines, Boehringer Ingelheim decided to put forth a colossal bet. The reason behind MSD’s massive payment for a candidate medicine at a preclinical trial level coincides with the recent global pharmaceutical industry trend. Lately, the global pharmaceutical industry is hectic with KRAS targeted therapy R&D. Although the technology was thought to be impossible to crack for last 40 years, KRAS targeted therapy nabbed the Big Pharmas’ attention after Amgen showed the possibility in the commercialization in 2019. ◆40 years of going nowhere, KRAS targeted therapy results in a first clinical findings in 2019 KRAS is one of factors that cause cancer. KRAS activates transmission of signals from the cell surface receptor to the nucleus. It is at the same level as anaplastic lymphoma kinase (ALK), epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2), which already have developed targeted therapy for. It is actually the first cancer-causing gene the human race has discovered. But since the first discovery in 1982, the relevant treatment development was sluggish for four decades. Compared to other cancer-forming genes, KRAS has more frequent mutations and transforms the protein structure into a wide array of variations. And it has been hindering the targeted therapy development until lately. The frequency is apparently high for the KRAS mutation causing a number of lethal cancers like lung cancer, colon cancer and pancreatic cancer. And vast amount of researches were done to study the gene, but all of them failed at the end. In 2013, however, a group of researchers at University of California found a groundbreaking discovery of ‘binding pockets.’ Since then it was picked up as a candidate medicine and its first clinical findings were announced in 2019 after completing the preclinical phase. ◆Amgen takes the lead in R&D, sotorasib initiates Phase III clinical trial First, it was Amgen who presented the clinical results. AMG-510, also known as sotorasib, is evaluated as a frontier among the KRAS targeted therapy candidates. The Phase I clinical trial kicked off from August 2018. The result of the trial was unveiled at the 2019 International Association for the Study of Lung Cancer (IASLC). Cancer patients with non-small cancer lung cancer (NSCLC), colon cancer or pancreatic cancer showing KRAS mutation participated in the clinical trial. Five out of ten NSCLCL patients in the study had the KRAS mutation. A Phase II clinical trial, unveiled at the European Society for Medical Oncology conference last year, also demonstrated positive results. After using sotorasib in 53 patients with NSCLC, their progression-free survival (PFS) marked 6.3 months while the response rate reached 32.2 percent. Amgen is still currently conducting the Phase III trial that compares the drug against cell-killing chemotherapy docetaxel. In late last year, the U.S. Food and Drug Administration (FDA) designated the investigational drug as a Breakthrough Therapy. Besides the AMG-510 single therapy, the company is also running a clinical trial on a combination therapy with other various anticancer treatments. The drug is likely to get approval within this year at earliest. ◆Mirati, Sanofi, Novartis, Boehringer, Moderna and Bayer all on board Mirati Therapeutics is following Amgen closely. The company kicked off the clinical trial in January 2019, and now MRTX849 is in process of running a Phase 1/2 study. The Phase II interim analysis was disclosed late last year. The objective response rate (ORR) in 51 patients with NSCLC marked 45 percent. The company aims for the FDA approval in the latter half of the year. Moreover, Sanofi and Revolution Medicine are collaborating together on developing RMC-4630 since June 2019. In a partnership with Araxes Pharma, Johnson and Johnson started a clinical study on ARS-3248 from July 2019. Eli Lilly initiated the clinical trial on LY3499446 in November 2019. Last year, Mirati and Novartis started working on another candidate medicine TNO155, and its Phase 1/2 clinical trial began from last April. Navire Pharma and Erasca respectively started Phase I trial on BBP-398 in last August and Phase I trial on ERAS-601 in last December. Even more companies like Boehringer Ingelheim, Bayer, Moderna, Merck and Jacobio Pharmaceuticals are now into seeking KRAS targeted therapy with preclinical trial ongoing. In South Korea, Orum Therapeutics is reportedly exploring KRAS related R&D
- Company
- Celltrion's COVID-19 antibody tx reduces progression by 54%
- by An, Kyung-Jin Jan 18, 2021 06:13am
- Rekirona The result of Phase II clinical trial of Rekirona (Regdanvimab), COVID-19 antibody treatment developed by Celltrion, has been revealed for the first time. It is evaluated that it is useful to efficiently manage medical resources while reducing the incidence of severe patients requiring inpatient treatment by more than half and reducing the recovery period. Celltrion presented the results of global II clinical trials related to Rekirona at the 2021 High1 New Drug Development Symposium online event hosted by the pharmaceutical society of Korea on the 13th. This is a multicenter study that compared the efficacy and safety of 327 patients with mild or moderate COVID-19 infection with standard treatment and administration of Rekirona or placebo. 327 COVID-19 patients from Korea, Romania, Spain and the United States participated and completed the final medication on November 25 last year (Korean time). The data introduced on this day are the results of an analysis of 307 mild and moderate patients who were confirmed to be infected with COVID-19 immediately before administration. The presentation was made by Professor Joong Sik Eom (Infectious Internal Medicine, Gachon University Gil Medical Center), chief researcher (PI) and advisor. The researchers set the percentage of patients who died or required hospitalization or oxygen therapy due to COVID-19 infection by the 28th as the efficacy evaluation index. As a result of the analysis, when Rekirona 40mg/kg was administered to patients diagnosed as mild or moderate, the probability of progression to severe was decreased by 54% compared to placebo group. The severe progression rate of moderately ill patients over 50 is 68%. The benefits are expected to increase when Rekirona is administered to patients with higher disease severity in the elderly. The time it takes for the symptoms of COVID-19 to disappear was 5.4 days in Rekirona group, which was shortened by more than 3 days from 8.8 days in the placebo group. In the case of moderate or moderately ill patients over 50 years old, the time it took for symptom recovery after administration of Rekirona was more than 5-6 days with placebo. After administration of Rekirona, the time required for the concentration of virus in the body to decrease by 1500 times was 7 days, which was 3 days shorter than 10 days in the placebo group. No serious adverse events, including death, were reported among the patients participating in the clinical trial. There were no cases of discontinuing the study due to adverse events. Professor Eom said, "When Rekirona is administered to mild or moderate COVID-19 patients, it has been proven to significantly reduce the rate of progression to severe and shorten the recovery time. 56% of the participating patients over 50 years old and those with pneumonia were proven to be an encouraging result in that the participation rate of the high-risk group was high at 60%." Although it is phase II clinical trial, it is expected that it will greatly contribute to the management of medical resources by securing treatment beds to reduce confusion in the treatment field and to provide conditions to focus on moderately high-risk patients. Celltrion officials have completed production for 100,000 people in preparation for conditional marketing authorization of Rekirona. It is planning to conduct phase III clinical trial on a wider range of patients in 10 countries and further verify the safety and efficacy of Rekirona. It plans to conduct phase III clinical trials in more than 10 countries around the world to further verify the safety and efficacy of Rekirona confirmed in phase II clinical trials in a wider range of patients. A Celltrion official said, "We have already completed production for 100,000 people and are thoroughly preparing a supply plan so that we can supply them to the medical field as soon as we acquire CMA." He said, "We are systematically preparing a plan to produce treatments for up to 2 million people so that global supply will not be disrupted in accordance with the timing of approval in major overseas countries."
- Company
- LG Chem in full throttle seeking anti-obesity and NASH drug
- by An, Kyung-Jin Jan 15, 2021 06:10am
- LG Chem showcased its key new drug pipelines targeting obesity and non-alcoholic steatohepatitis (NASH) at a global event. The South Korean company plans to make the chimeric antigen receptor T (CAR-T) cell therapy and stem cell therapy development into their future growth engine. On Jan. 13, LG Chem announced it would participate in the virtually convened JP Morgan Healthcare Conference 2021 to present the key findings in 40 new drug pipelines. The South Korean company’s session presentation was led by the president of LG Chem Life Sciences Company, Son Jeewoong. At the event, the company addressed the key pipeline such as gout treatment currently undergoing clinical trial, hereditary obesity treatment and NASH treatment. The gout treatment LG Chem is developing as a ‘best in class’ is a new drug that inhibits excessive secretion of uric acid, a major cause of gout. In the Phase I trial in the U.S., the investigational drug was confirmed to effectively lower the uric acid level by only administering once-daily regardless of meal consumption. The drug was evaluated to have verified superior effect and safety compared to existing options as no adverse reaction of hepatotoxicity and cardiovascular system was reported. The company plans to complete the Phase II study in the U.S. in the second quarter and analyze the result. The company’s investigational anti-obesity drug activates an appetite regulating melanocortin-4 receptor gene (MC4R). In last November, an injection with the same mechanism was approved by the U.S. Food and Drug Administration (FDA), but LG Chem’s drug is expected to improve the administration convenience as a first orally taken drug in the class. In September last year, the FDA designated the drug as an orphan drug and granted a market exclusivity benefit to delay a follow-on drug approval for seven years. The investigational NASH drug that prevents expression of vascular adhesion protein 1 (VAP-1) related to liver inflammation and fibrosis currently has an ongoing Phase I clinical trial in the U.S. Its preclinical trial found the drug lessens the risk of drug-drug interaction by being highly selective on the target protein. Considering there is no NASH treatment commercialized worldwide at the moment, LG Chem is speeding up the Phase I clinical trial to complete it in the first quarter of 2022. And at the event, the Korean company also specified the plan to develop a breakthrough anticancer treatment utilizing CAR-T cell and induced pluripotent stem cell (iPSC) therapies. The presenter excitedly expressed the company’s commitment to seek a next-generation stem cell therapy using a treatment-purpose gene. President Son Jeewoong of LG Chem Life Sciences Company noted, “After the merge, the company invested approximately 600 billion won in R&D and drove the open innovation on at all corners to expand our pipeline with 40 candidate medicine. The company would leap as a global bio company with a foundation to continuously release innovative new drug to the market, and also enhance the global new drug competitiveness through constantly conducted clinical trials in the U.S.”
