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- 2026-05-17 12:17:55
- Company
- Ildong Idience’s Venadaparib IND approved in China
- by Kim, Jin-Gu Dec 13, 2021 05:56am
- On the 10th, Ildong Holding’s new drug development subsidiary Idience announced that its IND(Investigational New Drug) application for ‘Venadaparib (IDX-1197)’ for gastric cancer patients was approved by China’s National Medical Products Administration. Venadaparib, a PARP (ADP-ribose polymerase) inhibitor, is a new targeted therapy candidate that is being developed to target breast cancer, ovarian cancer, gastric cancer, and PARP inhibitor-resistant cancers. Idience plans to evaluate the safety and efficacy of Venadaparib in combination with irinotecan, an established anticancer drug, on gastric cancer patients in China as soon as all the requirements are met. Idience is in clinical trials with Venadaparib in Korea and the US after receiving approval for its IND application from Korea’s Ministry of Food and Drug Safety and the US Food and Drug Administration. The company had presented results that demonstrate the efficacy of Venadaparib in PARP inhibitor-resistant cancer and BRCA mutation-negative cancer at academic conferences held this year by the American Association for Cancer Research (AACR), American Society of Clinical Oncology (ASCO), and the European Society for Medical Oncology (ESMO). An official from Idience said, “The high incidence of gastric cancer and relatively high number of patients in China make the country advantageous for clinical trials. The IND approval in China will allow us to speed up the development and commercialization of Venadaparib.” He added, “We will also continue research to confirm the effectiveness of Venadaparib and present our development progress, research results, and differentiated strengths of the drug at academic meetings and conferences overseas”
- Policy
- MFDS is considering changing the permission of Remdesivir
- by Lee, Tak-Sun Dec 13, 2021 05:56am
- Attention is focusing on whether COVID-19 treatment Veklury (Remdesivir) will be officially approved. In July last year, Veklury of Gilead Science Korea was conditionally licensed based on non-clinical test literature and interim clinical trial analysis results. At that time, the MFDS quickly approved the final results of clinical trials, some GMP data, and additional risk mitigation measures on the market. According to the industry on the 9th, Veklury submitted data that satisfies the conditions granted at the time of approval to the MFDS and applied for permission to change. On the 7th, an advisory meeting of the Central Pharmaceutical Affairs Council was also held. For now, there is a high possibility of Veklury's permission to change. The U.S. FDA officially approved Remdesivir in October last year. In a clinical trial conducted on 1,062 COVID-19 patients in the United States, the Remdesivir-treated group showed 10 days to recover, and the placebo-treated group showed 15 days, indicating that it was effective in shortening treatment time. However, the WHO announced that Remdesivir was not effective, sparking controversy. In October last year, the WHO reported that in a large-scale clinical trial, Remdesivir was found to have little or no effect in overall mortality, hospitalization period, and need for ventilation. In a small clinical trial released in July this year, Remdesivir drew attention by saying that it had no antiviral effect. In Korea, researchers at 20 university hospitals led by Professor Baek Kyung-ran of Infectious Diseases at Samsung Medical Center earlier this year announced the results of clinical effects. As a result of the analysis of 110 patients, 22.9% of the Remdesivir dosing group deteriorated enough to apply mechanical respiration as of the 28th day of hospitalization, lower than that of other treatment groups (44.7%). Based on this, some argued that Remdesivir should be administered early to severely ill COVID-19 patients. In Korea, Remdesivir and Dexamethasone, which controls immune response inflammation, are used in combination for severely ill patients who are hospitalized and treated. According to Central Disease Control Headquaters, Veklury was administered to 172 hospitals and 22,571 patients by the 3rd. Currently, only Remdesivir and Celltrion's Regkirona are approved treatments for COVID-19. Regkirona is being used to treat mildly high-risk COVID-19 and all secondary adult patients with permission to change. Currently, the MFDS is reviewing the EUA, Merck's oral treatment, and Pfizer's products are also being reviewed in advance before the approval review. Remdesivir is needed until a treatment that shows a definite effect is released. Attention is focusing on whether the controversy over the efficacy will disappear through this review of the change permit.
- Company
- GC Pharma, stopped discussing consignment of Janssen vaccine
- by Kim, Jin-Gu Dec 13, 2021 05:56am
- GC Pharma announced on the 9th that it will suspend discussions on Janssen's consignment production of the COVID-19 vaccine. GC Pharma said it has suspended discussions with Johnson & Johnson on consignment production of vaccines as of today (9th). It has been about four months since GC Pharma announced in August that it will produce Janssen's COVID-19 vaccine on consignment. At the time, a local media reported that GC Pharma was discussing consignment production of COVID-19 vaccines with Janssen. At that time, GC Pharma made an official position that "it has not been confirmed." The pharmaceutical bio industry expected that if GC Pharma signs a consignment production contract with Janssen, it will be the third case of domestic production of the global corona vaccine after SK Bioscience-AstraZeneca and Samsung Biologics-Moderna. Janssen's COVID-19 vaccine was approved in Korea in April. One vaccination has a preventive effect. The preventive effect is 66.9%. However, it is known that the preventive effect decreases sharply over time after inoculation.
- Company
- PH3s of Daewoong’s SGLT-2i antidiabetic near completion
- by Kim, Jin-Gu Dec 10, 2021 05:53am
- #1i Clinical trials for the new antidiabetic SGLT-2 inhibitor ‘Enavogliflozin’ in development by Daewoong Pharmaceutical are gaining speed. One of the three Phase III clinical trials is already complete, and the remaining two are also nearing their final stages after completing patient recruitment. With such progress, the industry expects the authorities to grant marketing authorization for Enavogliflozin within the first half of next year, then be released in 2023. ◆Phase III trial on two-drug combo complete… trials on monotherapy and three-drug combo also in final stages According to the industry on the 10th, Daewoong Pharmaceutical had recently completed the Phase III trial for its Enavogliflozin(DWP16001)+metformin combination therapy. Enavogliflozin, a new SGLT-2 inhibitor antidiabetic, is the first SGLTi developed by a domestic pharmaceutical company. Other antidiabetic SGLTi options available include AstraZeneca’s ‘Forxiga,’ Boehringer Ingelheim’s ‘Jardiance,’ Astellas’ ‘Suglat,’ MSD’s ‘Steglatro,’ among others. Last year, Daewoong Pharmaceutical had received approval to initiate a Phase III clinical trial on 190 patients with type 2 diabetes in 24 hospitals in Korea, including Seoul Saint Mary’s hospital, to assess the efficacy of its Enavogliflozin+metformin combination therapy. After registering the last patient in May this year, the company completed observations on the last patient in November and is currently analyzing clinical data. The company had initially expected to complete the trial by December 2023, but due to smooth progress, the end date was pulled forward by a year. Other clinical trials on Enavogliflozin are also in smooth progress. Daewoong Pharmaceutical is currently running 3 trials related to Enavogliflozin. In addition to its two-drug combination trial on Enavogliflozin+metformin, the company is also assessing Enavogliflozin as a monotherapy and a three-drug combination that uses metformin and DDP-4 inhibitor in addition to Enavogliflozin. Among these, the Phase III trial on the Enavogliflozin monotherapy has started in September last year on 140 patients in Korea. Patient recruitment is now complete and observation of the last patient is expected to be completed within this year at the earliest. The patient recruitment for the three-drug combo has also been completed. Daewoong Pharmaceuticals had received approval to initiate a Phase III trial to assess the efficacy of the Enavogliflozin+metformin+DPP-4 inhibitor combination on 256 patients last October. LG Chem’s gemigliptin was selected as the DPP-4 inhibitor for the three-drug combo, and patient recruitment was completed in August this year. With all three Phase III trials coming to an end, prospects on when the drug will be authorized have also been rising. The pharmaceutical industry believes that it is strongly likely that the company will apply for marketing authorization next year and release the drug in 2023. Daewoong Pharmaceutical had originally planned to release its drug in 2023. The pharmaceutical industry believes that there is a strong possibility that the company will apply for product approval in the first half of next year and release it in 2023. Daewoong Pharmaceutical had originally planned to release it in 2023. ◆ Extension studies for data acquisition also in smooth progress… started trials to enter global market For the Enavogliflozin monotherapy and the two-drug combination using metformin, an extension (long-term administration) trial is also underway in addition to the Phase III trial. Trials on long-term administration of drugs are usually conducted after the product is released, but Daewoong Pharmaceutical plans to release the drug after securing relevant data. The company’s move to first secure the long-term clinical data is interpreted as a strategic attempt to compete with existing SGLT-2 inhibitors. The extension trial for the Enavogliflozin monotherapy was approved in August this year. The clinical trial size is 70. The company started the trial in full by starting recruitment in September last year. The extension trial for the two-drug combination therapy using metformin was approved in March this year, and the company had succeeded in recruiting all 100 patients in November. The trial is expected to be completed by the first half of next year. With existing Enavogliflozin trials entering completion, the company has also been initiating new trials. The company had started a Phase I trial targeting Koreans, Westerners, and Latin American patients on December 1st. It is explained that the trial was prepared with global expansion in mind. The company is also actively seeking indication extensions. In August this year, the company had received approval to initiate a Phase I trial for DWP30600. DWP30600 is a combination of Enavogliflozin and an anorectic agent (DWC202010).
- Opinion
- [Reporter's view] Despite ↑reimbursed drugs for rare dz
- by Eo, Yun-Ho Dec 10, 2021 05:52am
- The need for improvement emerges every year, but patients with rare diseases are still struggling. In particular, even if there are drugs, the number of patients is so small that it is difficult to prove the cost effectiveness and predict financial consumption, making it difficult to register insurance benefits. There were many opinions this year. Kang Sun-woo, a member of the National Assembly Health and Welfare Committee, began holding a parliamentary debate in May to strengthen access to new drugs for rare genetic diseases, and in August, Kang Byeongwon, Kim Won-i, Seo Young-seok, and Shin Hyun-young held a public hearing to discuss ways to improve the treatment environment for rare diseases. But the HIRA reported that the average benefit rate for treatments for rare diseases was 85.3% (2016-2020) and 100% in 2020. At this rate, it is thought that the patient's access to the treatment for rare diseases was perfect. Then, why were there still many opinions on expanding benefits for treatments for rare diseases? The results announced by the HIRA differed from the benefit rate of drugs with rare diseases actually licensed as the benefit rate for drugs that went through the screening and evaluation process. Various factors such as dropout and voluntary withdrawal were excluded. According to data surveyed by the KRPIA and the KPBMA, only about 50% of the items designated as rare drugs over the past decade have been listed on the insurance benefit list for rare diseases. In order for the benefit rate of treatments for rare diseases to rise, the use of RSA and PE systems must eventually increase. Rare diseases are diseases in which the number of patients is less than 20,000 or difficult to diagnose, making it difficult to know the number of patients. In many cases, clinical trials themselves are difficult due to the small number of patients. Due to the small number of patients, it is difficult to actively develop new drugs because it is difficult to expect profitability in the market, and even if new drugs are developed with difficulty, it is difficult to prove cost effectiveness through PE. As a solution to this, the industry has insisted on expanding the PE exemption system. If there is no alternative drug, the PE exemption system should be applied even if it is approved for placebo control data, or the number of patients should be applied in accordance with the special calculation criteria. However, drug price adjustment for drugs subject to PE exemption has recently been predicted. The figure of 80% of the lowest A7 adjustment price has made the industry difficult for a while. In this regard, it is said that the HIRA and KRPIA meetings have recently clarified that they are at the "reference" level. The point is that PE exemption drugs increased and the government thought additional management measures were needed. The point is that PE exemption drugs increased and the government thought additional management measures were needed. If the government has reduced the risk factors, it should look at blind spots.This is because it is an area with few patients and no medicine.
- Policy
- Janssen Korea voluntarily withdrew Tylenol 500mg
- by Lee, Tak-Sun Dec 10, 2021 05:51am
- It is known that the item license for Janssen Korea's antipyretic analgesic "Tylenol 500mg" will be withdrawn soon. This was expected to some extent because the Hyangnam plant will be shut down at the end of this year. Janssen has already been approved for imported items with the same ingredients and the same dosage. According to the MFDS on the 9th, Janssen Korea expressed its intention to withdraw "Tylenol 500mg," which was approved in Korea in 2001. This product has been manufactured at Janssen Korea's domestic factory (Hyangnam). However, as Janssen announced that the Hyangnam plant will be shut down this year, related manufacturing items are also undergoing withdrawal procedures. Janssen's Hyangnam plant was acquired by Whanin Pharmaceutical for about 46 billion won in November last year, and it was decided to withdraw from Korea for the first time in 38 years. In preparation for the withdrawal of the item, Janssen has already been approved for imported items with the same ingredient (Acetaminophen) in August. The product name is Janssen Acetaminophen. This product is expected to replace 500 mg of Tylenol, which is suspended from manufacturing in Korea. Janssen is known to have put in a large number of inventory items this year as demand for "Tylenol 500mg" surged to ease the break from COVID-19 vaccination. Tylenol recorded cumulative sales of 50.1 billion won in the third quarter of this year based on IQVIA, showing a whopping 177% year-on-year growth. In particular, the demand for Tylenol is likely to increase as the number of COVID-19 confirmed cases has soared recently and new and additional vaccinations are expected to increase as vaccine passes are implemented. Janssen is expected to make the most of the inventory items manufactured at the Hyangnam plant, but to hurry to introduce imported items. Until now, it has been found that there is no shortage of Tylenol inventory on the market.
- Company
- ₩150 bil export of Celltrion’s Regkirona on track to
- by Kim, Jin-Gu Dec 10, 2021 05:51am
- Export of Celltrion’s COVID-19 antibody treatment ‘Regkirona (regdanvimab)’ is now fully on track. On the 9th, Celltrion Healthcare announced that it had completed shipping 150,000 vials of the initial load of Regkirona for 9 countries in Europe. Celltrion Healthcare has been discussing exporting Regkirona with 70 countries. In addition to the 9 countries that the company is supplying its initial load to, the company has signed supply agreements with a total of 18 countries. The total amount that has been and will be supplied in December alone is expected to reach ₩150 billion. Demand for the supply of Regkirona has been increasing due to the increased product reliability following the European Commission's (EC) marketing approval and the rapid increase in the number of confirmed COVID-19 cases. Celltrion Healthcare plans to supply the maximum amount this year through close cooperation with Celltrion, which is in charge of production. Regkirona received official marketing authorization in Korea and Europe. Also, the drug received conditional approval or emergency use authorization in other countries including Australia, Indonesia, Brazil, and Peru. Celltrion Healthcare said that the company is expanding discussions to sign new agreements with these countries. As a result, the industry experts expect the company to supply more Regkirona next year compared to this year. An official from Celltrion Healthcare said, “With additional approvals continuing around the world following the EC approval, we plan to continue to increase making supply agreements. In addition to Regkirona, the Celltrion group will continue to contribute to overcoming the global COVID-19 pandemic by developing innovative solutions such as CT-P63 to tackle new variants and inhalable forms of treatment.
- Policy
- The method of writing for HBP combination is improved
- by Lee, Tak-Sun Dec 10, 2021 05:51am
- The method of writing permission for HBP and dyslipidemia combinations is improved more efficiently. Previously, information on individual ingredients was simply listed, but in the future, it will be prepared based on a comprehensive evaluation of combinations. According to the pharmaceutical industry on the 6th, the MFDS prepared a plan to improve the method of writing permission for high blood pressure and dyslipidemia combination drugs and guided them through pharmaceutical organizations. According to the improvement plan, the efficacy of the high blood pressure and dyslipidemia combination will be described in consideration of the purpose of administration, clinical trial results, and primary and secondary therapy. In particular, precautions related to the treatment of individual ingredients for dyslipidemia should not be described. However, in the case of a composite containing Ezetimibe, the matters related to diet, administered drugs, and lipid tests described in the "effect" can be stated in the "Precautions for Use." The precautions for use include prohibition of administration of each main ingredient, careful administration, and general caution related to administration as a complex agent. As for the adverse reaction, the contents of the clinical trial conducted as a composite agent may be first described, and then the adverse reaction may be additionally described as a single agent. However, adverse reactions of unlicensed ingredients can be omitted. For example, in the case of the fourth composite, the adverse reactions of the second to third composite agents should not be described. As the existing permission for high blood pressure and dyslipidemia complex drugs lists information on individual components, it is difficult for the general public to recognize the product characteristics of the combination drugs, and only the attached documents are prolonged. In this improvement plan, the MFDS said, "The permission for complex drugs should provide information so that experts and patients can use the drug safely and effectively." The MFDS explained, "It should be mainly prepared based on information obtained from combination or combined administration, and information obtained when individual ingredients are administered alone can be additionally presented if appropriate." An official from the MFDS said, "There was an opinion that it was difficult to read the existing description method because it lists individual ingredients." The MFDS distributed a revision to the "Guidelines for Clinical Trial of Combination Drugs" along with this improvement plan to guide efficacy, effectiveness, and approval of primary therapy. According to the guidelines, if an unlicensed single agent is developed as a combination agent, in principle, it is possible to obtain permission only for the efficacy of the combination drug through clinical trials (therapeutic confirmation clinical trials, etc.). In order to be approved as a primary therapy, the feasibility of development as a primary therapy must first be proven in consideration of the mechanism of action of individual main components of the complex and clinically recommended treatments. In particular, it is possible when a therapeutic confirmation clinical trial is conducted on patients who need to administer complex drugs from the beginning to reach the target treatment effect, and safety and effectiveness are proven.
- Company
- Signifor Lar discontinued in the lacking acromegaly Tx mkt
- by Eo, Yun-Ho Dec 09, 2021 05:59am
- A considerable blow is expected in the already lacking acromegaly treatment market with the discontinuation of one of its very few available options. According to industry sources, the domestic supply of the acromegaly treatment ‘Signifor LAR (pasireotide)’ has been discontinued. The decision was made as Novartis sold the rights to Signifor La to Recordati SpA.,an Italian pharmaceutical company. As a result, the drug that had been developed by Novartis and distributed by Samoh Pharm will now be discontinued in Korea. However, the problem lies in the patients. Signifor LAR is a second-line treatment for acromegaly that was listed for reimbursement in November 2017. At the time, Signifor LAR was the only second-line treatment option available in the market. However, Pfizer’s ‘Somavert (pegvisomant)’ was listed in September, adding one more option as a second-line treatment. The discontinuation in its supply would most greatly affect those who are currently receiving Signifor LAR. As a rare disease treatment, around 10 patients in Korea have been using Signifor LAR, but they may experience insurance cuts if they switch to Somavert due to unclear reimbursement standards. And the patients cannot return to the drugs that they had used for first-line treatment after already failing treatment with the same drugs. Also, there are only two options available in the first-line – Ipsen’s ‘Somatuline Autogel (lanreotide acetate)’ and Novartis’ ‘Sandostatin LAR (octreotide).’ Acromegaly is a rare disease in which the pituitary tumor causes hypersecretion of growth hormones to result in facial deformation and hypertrophy of the hands and feet. The key treatment objective for acromegaly is to reduce the level of growth hormones and insulin-like growth factor-1 (IGF-1) secretion. However, 45% of the patients who were treated with first-generation somatostatin analog (SSA) were unable to achieve biochemical control. Meanwhile, in a Phase III trial that compared Signifor LAR with a maximum dose first-generation SSA, Signifor LAR demonstrated superiority in ▲ Biochemical control (mean GH level under 2.5㎍/L and normal range IGF-1 level) ▲GH and IGF-1 control ▲decrease n tumor size Patients whose acromegaly was not adequately controlled after being treated for over 6 months existing SSA (octreotide 30mg or lanreotide 120mg) participated in the trial and were randomly assigned to Signifor LAR 40mg, 60mg, or first-generation SSA for treatment. Study results showed that the proportion of patients that met the primary endpoint of biochemical control at 24 weeks was 15% for the Signifor LAR 40mg group and 20% for the Signifor LAR 60mg group, which was higher than that of the control group (0%).
- Policy
- The ruling party shouted to review the Judiciary Committee
- by Lee, Jeong-Hwan Dec 09, 2021 05:58am
- Democratic Party of KoreaThe ruling party members of the Health and Welfare Committee issued a statement and strongly protested when the revision to the National Health Insurance Act, which included strict regulations on doctor licenses, and the bill to return and refund drug prices, were put on hold at the stage of the Legislation and Judiciary Committee. Members of the Democratic Party of Korea and of the Welfare Committee, urged the bill to be immediately proposed, saying that the leak of national health insurance finances is intensifying due to the brakes of the agenda of the Legislation and Judiciary Committee. On the 7th, the ruling party's welfare committee members adopted and published a statement. The ruling party's welfare committee members asked the People Power Party to withdraw its opposition to the revision of the Health Insurance Act and immediately cooperate with the Legislation and Judiciary Committee on the agenda.This is the second time that ruling party members have issued a statement after the bill on health medicine has been canceled. Earlier on February 26 this year, the ruling party's welfare committee held a press conference and issued a statement after the revision to the medical law, including the cancellation of a serious crime doctor's license, failed to be reviewed during the extraordinary National Assembly in February. In addition, the Democratic Party of Korea's welfare committee criticized the People Power Party for blocking the review of the revision to the Health Insurance Act. Democratic welfare committee members say that despite the administrative litigation of pharmaceutical companies' suspension of execution over the past five years, the People Power Party has prevented the bill from being proposed only with opposition from some pharmaceutical companies. In addition, members of the Democratic Party of Korea pointed out that the Health Insurance Act also included a bill to recover all unfair profits from illegal health insurance recipients such as illegal secretariat hospitals, and that the process was delayed due to opposition from the People Power Party. In addition, the Democratic Party of Korea's welfare committee members said, "An alternative to the Health Insurance Act passed by the ruling and opposition parties at the plenary session of the Welfare Committee was not presented on the agenda of the Legislation and Judiciary Committee on December 8th." They pointed out, "People Power Party argues that the Moon Jae In government's strengthening of health insurance coverage is at stake, but opposes legislation that leaks health insurance finances due to indiscriminate overuse of lawsuits by pharmaceutical companies." He then said, "Alternatives to the Health Insurance Act also included provisions to block illegal supply and demand by collecting all unfair profits from illegal hospitals run by the office manager." They emphasized, "It is a betrayal of interest to leave the office manager's hospital, which gnaws away insurance finances, and insist on protecting health insurance premiums while leaving the health insurance leak intact due to indiscriminate administrative litigation by pharmaceutical companies."
