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- 2026-05-07 16:19:18
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- Will Tagrisso finally be reimb in the 1st line after 4 yrs?
- by Eo, Yun-Ho Jan 04, 2023 05:32am
- Whether the third-generation targeted anticancer drug Tagrisso will be able to receive reimbursement expansions in 2023 is gaining attention According to industry sources, AstraZeneca Korea submitted additional supplementary data to extend reimbursement of its EGFR mutation-positive non-small cell lung cancer (NSCLC) treatment to the first line at the end of last year after submitting its application in October last year. Therefore, whether Tagrisso’s reimbursement application will pass the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee review and be finally extended to the first line after 4 years remains to be seen. Tagrisso, which added its first-line indication in December 2018 in Korea, attempted to extend its reimbursement to the indication in 2019. However, upon review by the Cancer Disease Deliberation Committee in October, the committee decided to defer the decision until the full data from the Phase 3 FLAURA trial that studied the overall survival (OS) of Tagrisso in NSCLC patients in the first-line was disclosed. Although AstraZeneca submitted the full FLAURA data and expressed their will to accept most of the cost-sharing plan proposed by the government afterward, the reimbursement fell through due to opposition from committee members (specialists) that raised the issue of the drug’s clinical efficacy. The new item the company brought in to support Tagrisso’s effect in 2023 is the results from the FLAURA China study that confirmed improved OS in Asians. In the FLAURA China trial that studied a cohort of Chinese patients, 71 patients were randomly assigned to the Tagrisso-treated group and 65 patients to the control group. In particular, patients in the control group were switched to use Tagrisso in the second line if their condition progressed to T790m-positive NSCLC, and 22 of the 65 patients in the control group thus continued treatment with Tagrisso. Results showed that The median OS in the Tagrisso group was 33.1 months, 7.4 months longer than the 25.7 months in the control group. Also, the risk of death was reduced by 15.2%. Also, the company added the Japanese real-world data that it had presented at ‘ESMO Asia Congress 2022.’ The real-world study evaluated the effect of Tagrisso in the first-line in clinical practice in 660 NSCLC patients with EGFR mutations from 2018 to 2020. 583 of the patients received Tagrisso in the first line, and the other 76 received another EGFR-targeted cancer therapy. Actual measurement was taken every 6 months in the 583 patients that received Tagrisso. The median follow-up period was 24.6 months. The real-world study results showed that the median progression-free survival (mPFS) in patients that were administered Tagrisso was 20.0 months. This is even longer than the mPFS of 18.9 months that had been identified in the global Phase III trial of Tagrisso. By mutation, Tagrisso’s mPFS in patients with exon19 deletions was 23.5 months. In those with L858R mutations, the PFS was 17.0 months. In terms of overall survival, the median OS was 33.1 months in the Tagrisso arm, 7.4 months longer than the 25.7 months in the control group, and the risk of death was found to be reduced by 15.2%. Meanwhile, the largest obstacle that blocked Tagrisso from receiving reimbursement in the first line was the Asian subgroup analysis results of the FLAURA trial. Tagrisso’s Os in the trial was 38.6 months, a significant extension of 6.8 months over its first-generation comparators ‘Iressa (gefitinib)’ and ‘Tarceva (erlotinib)’. The results were encouraging, considering that Tagrisso was the first EGFR TKI to demonstrate efficacy in the first line and that cross-over prescription was allowed for research ethics in patients with confirmed T790 mutations while receiving treatment with its first-generation comparators. However, the issue lay in the hazard ratio (HR) of the Asian subgroup analysis. HR was 0.995 when separately analyzing the Asian that received Tagrisso. An HR of 0.995 means that the difference between Tagrisso and the control group is 0.005, which could be interpreted as that there is virtually no difference between Tagrisso and its comparator. This was why the academic society raised the opinion that ‘Tagrisso’s OS in Asians, including Koreans, cannot be trusted in the first line,’ and the opinion had a dominant influence on the results of the CDDC review.
- Company
- ablbio will receive 32 billion won in technical fee
- by Jan 04, 2023 05:32am
- 1 trillion won technology export contract in January last year...Get 150 billion won in total. ablbio announced on the 2nd that it will receive $25 million (31.7 billion won) in short-term stages following the first administration of the dual antibody "ABL301" from Sanofi. The milestone is 594.2% of ablbio's sales of 5.3 billion won as of the end of last year. According to the contract, ablbio will receive the milestone within February 14. ABL301 is a candidate substance for the treatment of degenerative brain diseases such as Parkinson's disease, which ablbio exported technology to Sanofi in January last year. According to the contract, when ablbio completes the preclinical and phase 1 clinical trial, Sanofi proceeds from the subsequent stages. Sanofi has the right to develop and commercialize in markets around the world. The total amount of contracts, including $75 million in down payment, amount to $1.06 billion. Among them, the short-term milestone is $45 million, which is received according to the progress of ABL301's preclinical and phase 1 clinical development. In September last year, it received $20 million (25.4 billion won) as it completed a non-clinical toxicity test. As a result, ablbio will receive all the short-term milestones. Currently, the amount that ablbio receives from Sanofi amounts to 120 million dollars (152.5 billion won), including the down payment. ABL301 is a new drug substance that inhibits the accumulation of alpha-synuclein, the cause of Parkinson's disease, and IGF1R target BBB shuttle platform Grabody-B technology developed by ablbio is applied. This increased the transmittance by binding the receptor IGF1R that can pass through the vascular barrier to the end of the antibody, proving the BBB transmittance was 13 times higher than that of the sole antibody in animal experiments. On top of that, Parkinson's disease is fundamentally treated by adding a receptor that inhibits the accumulation of alpha-synuclein, known as the cause of Parkinson's disease.
- Company
- CTLA-4 inhibitor Imjudo is expected to commercialize
- by Eo, Yun-Ho Jan 04, 2023 05:32am
- The second CTLA-4 inhibition mechanism is expected to be commercialized in Korea this year. According to related industries, the Ministry of Food and Drug Safety is reviewing for approval of CTLA-4 inhibitor Imjudo, a combination therapy partner of AstraZeneca Korea's PD-L1 inhibitor Imfinzi. The combination therapy of Impinzi and Imjudo was approved by the U.S. FDA in October last year as a treatment for unstoppable hepatocellular carcinoma. The combination therapy is the only double immuno-cancer treatment approved so far for the primary treatment of liver cancer. The drug was recently approved by Japan's Ministry of Health, Labor, and Welfare, and EMA CHMP also expressed its support for approval. Combination therapy is a single Tremelimumab Regular Interval Durvalumab (STRIDE) strategy in which Impinzi is administered once and then Impinzi is administered at regular intervals every four weeks. The combination therapy demonstrated OS benefits by reducing the risk of death by 22% compared to the control Nexavar monotherapy in phase 3 clinical HIMALAYA study. The overall survival rate in the third year was 31% in the Impinzi and Imjudo combination therapy group and 20% in the sorafenib monotherapy group. Imjudo combination therapy was recently added to lung cancer indications in the United States. In phase 3 clinical POSEIDON study, which was the basis for permission, the patient group who received a combination of Impinzi, Imjudo, and platinum-based chemotherapy had a 23% lower risk of death than various chemotherapy controls. The overall survival rate in the second year was 33% in the combined group and 22% in the control group. Meanwhile, Imjudo is conducting phase 3 studies on combination therapy with an impingement in several types of cancers, including topical liver cancer (EMERALD-3 study), small cell lung cancer (ADRIATIC study), and bladder cancer (VOLGA and NILE study).
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- SK Chemical introduces Lou Gehrig's treatment Teglutik
- by Lee, Seok-Jun Jan 03, 2023 05:41am
- On the 2nd, SK Chemical announced it will be launching ‘Teglutik,’ a Lou Gehrig's disease treatment that was developed by the Italian pharmacuetical company, Italfarmaco, in Korea. The drug is indicated for the treatment of amyotrophic lateral sclerosis (ALS), a progressive neuromuscular disease that is also referred to as Lou Gehrig's disease, and is characterized by progressive degeneration of motor nerve cells and can lead to the paralysis of the limbs and respiratory muscles Teglutik, which contains riluzole, was approved by the Ministry of Food and Drug Safety in May last year as a treatment used to extend life or delay time to tracheostomy in patients with ALS. With no cure currently available for Lou Gehrig's disease in the market, treatment is performed to slow down the symptoms with drugs like Teglutik. Teglutik comes in a suspension formulation, which allows easier intake among patients suffering from difficulty swallowing. The company believes its improved convenience in intake will be of benefit in treating Lou Gehrig's disease. Hyun-Sun Park, Head of SK Chemical’s Pharma Planning Division, said, “We expect the introduction of Teglutik to bring synergy to the company’s well-established portfolio in neurodegenerative disease that includes products such as Wondron Patch and Ongentys Cap.
- Company
- U.S. first possible NASH therapy
- by Jan 02, 2023 06:04am
- ↑Expectations for the first NASH treatmentThe U.S. Madrigal Pharmaceuticals has succeeded in phase 3 clinical trials of Resmetirom, a new drug candidate for non-alcoholic fatty hepatitis (NASH). When new drugs are approved, Resmetirom appears as the first NASH treatment aimed at the 33 trillion won market. Yuhan Corporation, Hanmi Pharmaceutical, and LG Chem are also speeding up the development of NASH new drug candidates through technology transfer or its own clinical progress. On the 20th, Madrigal Pharmaceuticals announced that it has secured a positive top line in phase 3 clinical trials (MAESTRO-NASH), which studies Resmetirom as a NASH treatment. Resmetirom is a thyroid hormone receptor (THR)-beta agonist administered orally. NASH is a disease in which fat accumulated in the liver develops into inflammation, causing liver fibrosis and cirrhosis. It is highly likely to develop in obese and diabetic patients. According to Evaluate Pharma, a pharmaceutical market research company, the NASH treatment market is expected to grow more than 20 times from 277.1 billion won this year to 6.723 trillion won by 2026. It is expected to expand to 33 trillion won by 2030. Phase 3 clinical trials are a study that analyzes efficacy and safety for up to 54 months after administering Resmetirom 80 mg/100 mg and placebo for 52 weeks in 955 patients with confirmed NASH. The first evaluation index is "the standard for resolving more than two points of fibrosis without worsening liver fibrosis" and "the standard for improving the first stage without worsening fibrosis." It was effective in both the 80 mg and 100 mg groups. The clinical trial was successfully completed by obtaining statistical significance compared to the placebo group. The secondary evaluation indicators are 'whether LDL cholesterol decreases at week 24' and 'based on liver enzymes'. The 80 mg group and the 100 mg group reduced LDL cholesterol by 12% and 16%, respectively, to obtain statistical significance. The placebo group increased by 1%. A significant decrease was also confirmed in the liver enzyme standard. Compared to placebo, it was confirmed that fibrosis decreased through biomarkers and imaging tests in the Resmetirom treatment group. Resmetirom was safe and drug resistant in both 80 mg and 100 mg doses. The frequency of severe side effects (SAEs) was similar across the target group, with each group showing around 12%. Paul Freedman, CEO of Madrigal Pharmaceuticals, said, "This clinical trial is reasonably likely to predict Resmetirom benefits and has achieved both major indicators proposed by the U.S. Food and Drug Administration," adding, "We will submit an application for a new drug to approve resmetirom acceleration in the first half of 23." Domestic pharmaceutical companies are also speeding up the development of NASH treatments. Yuhan Corporation signed a technology transfer contract with global pharmaceutical companies Beringer Ingelheim and Gilead, respectively, in 2019. NASH's new drug candidate "YH25724," which was transferred to Beringer Ingelheim, is undergoing phase 1 clinical trials in Europe. YH25724 is a candidate material developed by Yuhan Corporation. In this process, it is a fusion protein that combines "Hybrid FC" (HyFc), an antibody fusion protein platform technology of bio company Genexine. There are two types of synthetic materials transferred to Gilead, Yuhan Corporation and Gilead will jointly conduct non-clinical research, and Gilead will conduct global clinical trials. Hanmi Pharmaceutical transferred NASH's new drug candidate "Dual Agonist" to MSD in 2020. MSD has been undergoing phase 2 global clinical trials since last year. Another candidate substance, LAPSTriple Agonist, was also designated by the FDA as a fast track development drug for NASH treatment. If it is designated as a fast-track drug, it can have close consultations with the FDA at each stage of development and receive full support. LG Chem is developing its own NASH new drug candidate "LG203003" through the LG Chem Life Science Innovation Center in Boston, USA. In March, the FDA approved a phase 1 clinical plan (IND). In July, phase 1 was launched for 88 healthy adults and NASH patients to observe safety and drug resistance, pharmacokinetics, pharmacology, and changes in fat volume in the liver. LG203003 is a mechanism that suppresses fat accumulation in liver cells by selectively interfering with the activation of DGAT-2, a neutral fat synthase. LG Chem also has another NASH candidate, 'LG303174. It inhibits the expression of VAP-1 protein, which is known to affect inflammation in the liver. In August 2020, LG Chem signed a technology transfer contract from TransThera Biosciences in China to introduce LG303174's right to global development and commercialization.
- Company
- The dismissal of 18 employees of Zuellig Pharma is unfair
- by Jan 01, 2023 10:43pm
- According to the pharmaceutical industry on the 29th, the 11th Civil Affairs Department (chief judge Park Tae-il) of the Seoul Western District Court ruled in favor of some of the plaintiffs in a lawsuit filed by 18 fired Zuellig Pharma SSK against the company on the 22nd. According to the Democratic Pharmaceutical Union, the first trial court judged that "the company's layoffs themselves are invalid due to illegal and unfair dismissal in violation of the current Labor Standards Act." In order for layoffs to meet the prescribed requirements of the Labor Standards Act, they must meet ▲ urgent management needs ▲ company's efforts to avoid dismissal ▲ fair dismissal standards, and target selection ▲ consultation procedures 50 days in advance. The court said, "The layoffs did not meet the urgent management needs and did not make efforts to avoid dismissal." Considering the fact that workers endure unpaid leave at a time when operating losses in 2020 are insignificant, only a small number of customers can operate their business units, and labor costs are mostly operating costs, it is difficult to say that they are in an urgent management crisis. In addition, it was difficult to say that the government took measures to minimize the scope of dismissal, given that it decided to abolish its business unit immediately just a month after the strike ended, which led to the departure of the customer base, which led to the layoffs. Zuellig Pharma SSK, Zuellig Pharma's digital marketing division specializing in healthcare, is divided into a marketing division and a PC (Patient Card) division. The layoffs were made for the PC division. Zuellig PharmaSSK announced a voluntary retirement and dismissal plan in December 2020 along with the abolition of the PC division due to management difficulties. The layoffs took place on March 31, 2021, about three months later. The Democratic Pharmaceutical Union claimed that the company's layoffs were intended to suppress the union. When members of the Zuellig Pharma SSK branch went on strike due to the breakdown of wage negotiations, they fired all members by abolishing the business unit. Four months after the layoffs, SSK CEO Irwan Wolf left Korea after his term in office, making it difficult to hold him accountable. In response to the court's ruling on unfair dismissal, the Democratic Pharmaceutical Union said, "The company seems to be willing to proceed with the appeal, but it will continue its legal struggle until the end for the legitimate reinstatement of laid-off employees."
- Company
- Pharmaceutical shares capitalization of ₩56 trillion
- by Chon, Seung-Hyun Jan 01, 2023 10:42pm
- This year, pharmaceutical bio companies' stock prices were sluggish. It has never recovered from its peak on the first day of the stock market opening. The market capitalization of major companies fell by more than 56 trillion won. More than two out of ten have seen their market capitalization shrink by less than half in a year. According to the Korea Exchange on the 29th, the KRX Healthcare Index closed this year at 2,634.49. It fell 29.2% in a year from 3721.17 at the end of last year. The KRX sector index is an index that divides listed stocks in the securities market and KOSDAQ market into 17 industrial groups and selects and calculates representative stocks for each industry group. KRX Healthcare consists of 83 major pharmaceutical bio shares selected by the exchange. This means that stock prices of major pharmaceutical bio companies listed in Korea fell 29.2% on average. This year, pharmaceutical bio companies' stock prices have remained sluggish throughout the year. The KRX Healthcare Index recorded 3751.82 on January 3, the first day of its opening this year, the highest this year. The KRX Healthcare Index fell 27.4% in six months to 2,723.45 on June 23 but recovered 20.6% to 3,284.61 on August 9. However, it fell again, falling to 2,463.10 on October 13. It fell 34.3% in nine months compared to January 3. The KRX Healthcare Index has been on a slight rise since November but failed to make up for the previous decline. As a result, the KRX Healthcare Index fell sharply for the second consecutive year. The KRX Healthcare Index soared 89.3% from 2915.31 to 5517.31 in 2020 but fell 32.2% to 3742.91 last year. At the end of this year, the KRX Healthcare Index shrank 52.3% compared to two years ago. This year, most of the market capitalization of major pharmaceutical bio companies fell sharply from the end of last year. As of the end of last year, the market capitalization of 92 pharmaceutical bio companies that made up the KRX Healthcare index totaled 222.3191 trillion won, down 55.834 trillion won to 166.4851 trillion won in a year. The market capitalization of major pharmaceutical bio companies has decreased by 25.1% in a year. 86 out of 92 major pharmaceutical bio companies saw their market capitalization decrease compared to the end of last year. SK Bioscience evaporated 11.5689 trillion won from 17.2125 trillion won in market capitalization at the end of last year to 5.6436 trillion won in a year. In June, SK Bioscience was the first Korean company to receive a license for SKY Covione multi, a vaccine for preventing COVID-19, as the 35th new drug developed in Korea. However, as SKY Covione was not used much and the size of the COVID-19 vaccine consignment business of multinational pharmaceutical companies decreased, the stock price fell significantly. The stock price of SK Bioscience was 73,500 won, down 67.3 percent from 225,000 won at the end of last year. Celltrion's market capitalization was 22.5992 trillion won, down 4.7143 trillion won from 27.3135 trillion won at the end of last year. Celltrion Healthcare decreased by 3.2552 trillion won from 12.43 trillion won to 9.1781 trillion won during the same period. Celltrion Pharmaceutical's market capitalization has decreased by KRW 2.246 trillion over the past year. SD Biosensor, SK Biopharm, Seehene, Mezzion, Hanmi Science, Samsung Biologics, Alteogen, BNC Korea, and GC Pharma saw their market capitalization fall by more than 1 trillion won this year. The market capitalization of 20 out of 92 major pharmaceutical bio companies has decreased by more than 50% in a year. Mezzion's market capitalization fell 82.0% from KRW 1.932 trillion to 347.6 billion won. BNC Korea, Anterogen, Cellid, Ubiotics, Eyegene, and Aptabio saw their market capitalization fall by more than 70% in a year. Enzychem, Genexine, SK Bioscience, Medpacto, Prestigebiologics, Korea Pharma, Geneone Life Science, Seegene, GC Cell, PCL, United Pharmaceutical, and Olivia Pharma have seen their market capitalization fall by less than half compared to 1 year ago.
- Company
- Korea develops 2 new drugs and 2 biosimilars in 2022
- by Chon, Seung-Hyun Dec 29, 2022 06:04am
- In Korea, domestic pharmaceutical companies succeeded in developing 2 new drugs this year. The new drugs developed by SK Bioscience and Daewoong Pharmaceuticals reached the commercialization stage. This is the most amount of biosimilars developed in Korea in 7 years since 2015. ◆SK Bioscience receives approval for the first new homegrown COVID-19 vaccine...Daewoong receives marketing authorization for a new diabetes drug According to the Ministry of Food and Drug Safety on the 28th, domestic pharmaceutical and biohealth companies received approval for 2 new drugs this year. In June, SK Bioscience’s COVID-19 prevention vaccine SKYCovione Multi inj received marketing authorization in Korea as the 35th homegrown new drug. SKYCovione Multi Inj is a COVID-19 vaccine that induces an immunological response by administering the company’s proprietary gene recombination technology. SK Bioscience first discovered the COVID-19 vaccine candidate jointly with the Institute for Protein Design at the University of Washington. It was funded by Bill & Melinda Gates Foundation (BMGF) and Coalition for Epidemic Preparedness Innovation (CEPI), and the company succeeded in commercializing the drug after 2 years. On the 30th of last month, Daewoong Pharmaceutical received approval for its diabetes treatment Envlo as the 36th new homegrown drug. Envlo was approved as an adjunct to diet and exercise therapy in Type-2 diabetes patients. Envlo may be used as monotherapy, metformin combination therapy, and metformin and gemigliptin combination therapy. Envlo is the first SGLT-2 inhibitor class antidiabetic developed in Korea. The drug reduces blood sugar levels by inhibiting the reabsorption of glucose in the kidneys and allowing it to be excreted as urine. In October, Daewoong Pharmaceutical confirmed the blood sugar reduction effect and safety of the drug through a Phase III trial that was conducted on Type 2 diabetes patients. Envlo was first developed by GC Corp, and Da Daewoong acquired its exclusive license in 2016. With this, a total of 6 new drugs developed by Korean pharmaceutical companies were approved in the past 2 years, starting last year. In January last year, Yuhan Corp’s anticancer drug ‘Leclaza’ was approved, and in February and March, Celltrion’s COVID-19 treatment ‘Regkirona’ and Hanmi Pharmamceutcial’s neutropenia treatment ‘Rolontis’ received MFDS approval, respectively. In December last year, Daewoong Pharmaceutical’s ‘Fexclu’ was listed as the 34th new domestically developed drug. ◆3 homegrown biosimilars enter the market for the first time in 7 years since 2015 Korean pharmaceutical and bio companies have received approval for 3 biosimilars this year. Celltrion, Samsung Bioepis, Chong Kun Dang etc. succeeded in commercializing one biosimilar each this year. In May, Samsung Bioepis received approval for its Lucentis biosimilar Amelivu in Korea. Lucentis, which is being marketed by Roche and Novartis, is a drug used to treat macular degeneration and diabetic macular edema. It is a blockbuster drug that made KRW 4.4 trillion in global sales last year. Amelivu is the first biosimilar of Lucentis to be introduced to Korea. In October, Chong Kun Dang received marketing authorization in Korea for its Lucentis biosimilar, LucenBS. In September, Celltrion’s Avastin biosimilar, the anticancer drug Vegzelma was approved. And in March last year, Samsung Bioepis received approval for the first Avastin biosimilar Onbevzi, followed by Celltrion. No. of approved biosimilars developed by Korean companies by year (Unit: product amount, Data: MFDS) This is the first time in 7 years since 2015 that Korean pharma and bio companies received approval for 3 biosimilars. In 2012, Celltrion first released its Remicade biosimilar Remsima and then a Herceptin biosimilar Herzuma in 2014. In 2015, Celltrion developed 1 and Samsung Bioepis developed 2 biosimilars. Celltrion received approval for Mabthera biosimilar Truxima, and Samsung Bioepis commercialized its Enbrel and Remicade biosimilar Etoloce and Remaloce. In 2017, Samsung Bioepis received approval for Adaloce and Samfenet. Their respective original drugs are Humira and Herceptin. In 2018, LG Chem and Chong Kun Dang developed one biosimilar each, and last year, Samsung Bioepis and Celltrion received approval for one biosimilar each. By company, Samsung Bioepis received approval for most biosimilars, with 6 approvals. Celltrion follows with 5 approvals.
- Company
- EUA for Zochova was not requested
- by Kim, Jin-Gu Dec 29, 2022 06:04am
- The government also keeps the door open to "monitoring overseas situations"...U.S. and Europe are under review. Ildong Pharmaceutical is expected to shift its strategy of introducing oral COVID-19 treatment Zochova (s-217622) in Korea from the EUA to conditional permission. On the 28th, the Central Disease Control Headquarters announced that it would not request Zochova's EUA from the Ministry of Food and Drug Safety. The Central Disease Control Headquarters explained that the decision was made after discussing the safety of Zochova and the necessity of emergency introduction in Korea three times with related ministries and infectious disease management committees. The pharmaceutical industry predicts that although the EUA has failed, Ildong Pharmaceutical will continue to push for the introduction of Zochova in Korea due to conditional approval. The EUA is not applied by a developer, but if the Korea Centers for Disease Control and Prevention deems it necessary, it asks the Ministry of Food and Drug Safety to approve it, and the Ministry of Food and Drug Safety quickly reviews and approves it. Conditional approval is applied by a developer and judged by the Ministry of Food and Drug Safety. It is expected that there will be an application for conditional approval from Ildong Pharmaceutical in the near future. A pharmaceutical industry official familiar with the company's internal situation said, "It means that there is no urgent need to introduce the drug in Korea, not the drug itself," adding, "It is expected to turn its domestic introduction strategy with conditional permission instead of EUA." "It has become a EUA in Japan and has begun reviewing emergency use approval in the U.S. and Europe," he said. "If the U.S. and Europe decide to introduce drugs, it will also help with domestic conditional approval." The government, too, has not completely blocked the possibility of introducing Zochova in the country. An official from the Korea Centers for Disease Control and Prevention said, "We will continue to monitor whether Zochova is approved for overseas emergency use, follow-up clinical results, and purchase and utilization situations." Zochova is an oral antiviral drug containing Ensitrelvir. It is a mechanism to selectively suppress 3CL-protease to prevent the proliferation of the SARS-CoV-2 virus that causes COVID-19. As a result of phase 2 and 3 clinical trials conducted in Japan and Korea, it took about 167.9 hours based on the median value to improve the symptoms of COVID-19 when Zochova was administered, which was significantly reduced compared to 192.2 hours in the placebo group, proving its effectiveness. The reduction of viral RNA in the body, a secondary evaluation variable, also met the criteria for validation. On the 4th day of the clinical trial after 3 doses of Zochova, viral RNA was found to have decreased in the Ensitrelvir administration group by 1.4 log10 copies/ml compared to the placebo group. Regarding the safety of the drug, no serious side effects or deaths occurred, and the drug resistance was also excellent. Unlike conventional treatments that require two or three tablets a day for five days, Zochova can be administered one tablet a day for five days.
- Company
- Daewoong and Neurorive will codevelop new antidepressant
- by Lee, Seok-Jun Dec 29, 2022 06:03am
- On the 28th, Daewoong Pharmaceutical announced it had signed an agreement with Neurorive to conduct joint research and development for a new drug candidate for depression. Under the agreement, the two companies will be jointly developing ‘NR-0601,’ a multi-target, non-narcotic oral depression treatment. Neurorive is a bio venture company that researches central nervous diseases including depression and Alzheimer’s. It is studying NR-0601 as the first new drug in its antidepressant pipeline. NR-0601 is an oral antidepressant that was derived using Neurorive’s drug screening platform that sends electric signals to living brain tissues to check the response of nerve cells. It has a multi-targeted mechanism of action and is expected to provide faster recovery from strong depression compared to conventional monoamine oxidase inhibitor oral antidepressants. It has a higher potential to work on patients with treatment-resistant depression (TRD) that do not respond to existing treatments. One in three patients with major depressive disorders is known to have TRD. Both companies will be collaborating in all stages of clinical development of NR-0601 which will enter clinical trials next year. Daewoong Pharmaceutical will be responsible for research to improve drug formulation, process development, chemistry, manufacturing and controls (CMC), good manufacturing standards (GMP), and advisory activities for clinical trials. Neurorive will be in charge of non-clinical development and testing, discussions with various regulatory authorities including MFDS, filing an investigational new drug (IND) application, and clinical development. Daewoong Pharmaceutical’s new drug product center that will take care of the research for improving drug formulation and the manufacture of investigational drug candidates owns various patents and differentiated technologies including its combination drug technology (Modified Release and Absorption by Tablet in Tablet MORATAT™, Double-Layered-Tablet DOLTAB®) technology), its sustained release technology ( the Multi-Target controlled release System, MuTAS™), and solubilizing technology (Nanotechnology of Optimal wet-Milling, NATOM®).
