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- 2026-04-13 04:34:39
- Policy
- Roche applies for approval of its new drug faricimab
- by Lee, Tak-Sun Dec 27, 2021 05:56am
- The global pharmaceutical company Roche has applied for the approval of its newly developed treatment for macular degeneration, ‘faricimab.’ The company had submitted an application for faricimab in the US, Europe, and Japan. If approved, the drug will be competing with Bayer’s ‘Eylea (aflibercept)’ and Novartis’ ‘Beovu (brolucizumab-dbl)’ in the next-generation treatment market for macular degeneration. According to the industry on the 24th, Roche applied for the marketing authorization of ‘faricimab’ to the Ministry of Food and Drug Safety. Faricimab was registered under the brand name ‘Bavismo inj.’ in Korea. Faricimab is the first bispecific antibody treatment developed for ophthalmologic diseases. It simultaneously blocks both pathways involving the Ang-2 that causes various retina conditions and VEGF-A and promotes vascular stability and improves the vision outcome of patients in the long term. A Phase III study that was disclosed earlier this year showed that faricimab was well tolerated with a consistent safety profile in four studies that assessed faricimab on age-related macular degeneration (nAMD) and diabetic macular edema (DME) under a dosing schedule that administers the drug at a maximum of 48 weeks apart. Macular degeneration is a major cause of vision loss in adults over the age of 60. With the aging society, the size of the treatment market has also been growing exponentially. Last year, the market size recorded 37 billion won, with the global market recording 13 trillion won. According to global data announced by a market research institution, the market size of the macular degeneration market is expected to spike to record 21 trillion won by 2028. The market is currently led by ‘Eylea (aflibercept)’ and ‘Lucentis (ranibizumab ).’ Also, the development of biosimilars for the two drugs is speeding up upon the imminent expiry of Eylea and Lucentis’s patents. Novartis has released Beovu in preparation for the Lucentis biosimilars. The prefilled syringe formulation of Beovu was approved in Korea last year, and reimbursed and sold since April this year. Beovu’s strengths lay in the improved patient convenience and compliance provided with its 12-weekly dosing schedule. On the other hand, Lucentis is administered every 4 weeks. Faricimab is administered every 16 weeks at most and therefore is expected to further improve patients’ convenience in administration. Roche had completed applying for the marketing euroization of farcical in Japan in June, and in Europe and the US in July, and is awaiting authorization from the respective authorities.
- Policy
- The suspension of execution for Legalon has been extended
- by Kim, Jung-Ju Dec 27, 2021 05:56am
- It is an extension of the grace period for deleting insurance drug benefits due to prolonged lawsuits. Abbott's Cholib, which item license has been revoked by the licensing authority, is automatically removed from the list according to the company's decision to withdraw from the market. The MOHW announced the court's decision to extend the suspension of execution of the drugs currently being sued and follow-up measures on insurance drugs following the cancellation of the MFDS' item license.12th division of the Seoul Administrative Court decided to extend the deadline for suspension of the execution of Bukwang Pharmaceutical, which was scheduled for the 17th, as the lawsuit was prolonged. The government previously conducted a re-evaluation of this year's benefit for a total of five ingredients, Vitis Vinifera, Avocado-Soya, Ginko X, Bilberry Gunjo X, and Silymarin. Milk-thistle Fruit Dry Extract, to which Bukwang Pharmaceutical products belong, was confirmed to be withdrawn, and the government deleted the list after three months of action (deferred). Accordingly, the company decided to file a lawsuit and applied for a suspension of execution to the court at the same time, and the suspension was extended this time. The period of suspension of execution is 30 days from the date of the sentence of the judgment, and during this period, the deletion of benefits is suspended. However, since the government suspended it for three months at the time of the announcement, medical institutions are not expected to undergo significant changes in prices for the time being. The insurance price of Legalon cap 70 is 137 won per capsule and 242 won per capsule for Legalon cap 140. Abbott's Cholib 145/20 mg and 145/40 mg products are removed from thel list according to the withdrawal of the company's market. Earlier on June 10, the MFDS suspended sales for six months (June 24th to December 23rd) due to a lack of the number of survey subjects required for the reexamination PMS. The disposition period has been extended due to the second violation, and if the reexamination data is not submitted again, the item permission will be automatically revoked. As a result, the insurance drug benefit list will also be deleted. The deletion period is on the 24th.
- Company
- To introduce a phase 3 clinical drug preferential policy
- by Nho, Byung Chul Dec 27, 2021 05:56am
- Attention is focusing on whether the industry, the National Assembly, and the MOHW will be able to derive a reasonable and efficient institutional direction in relation to the "policy for preferential treatment of new drugs in phase 3 clinical trials for Koreans." According to related industries on the 23rd, after the drug preferential regulations for innovative pharmaceutical companies were deleted during the 2018 Korea-US FTA negotiations, Article 17-2 of the Pharmaceutical Industry Promotion Act was introduced, but the legislation process seems urgent. Generic, which is released by innovative pharmaceutical companies, can get additional drug prices if it meets certain items of drug decision and adjustment standards, while there is no incentive for new drugs developed by all domestic and foreign pharmaceutical companies, that is, new drugs that have conducted clinical trials in Korea. As the global innovative drug preferential system was virtually stranded due to trade friction such as WTO and FTA three years ago, drug preferences such as 10% of the highest price of alternative drugs to encourage innovative pharmaceutical companies to develop new drugs and application of similar drugs (adjusted lowest price) in A7 countries have disappeared. With the outbreak of the COVID-19 Pandemic, public opinion on the formation of public opinion on the independence of vaccines and treatments and the government's justification for establishing pharmaceutical sovereignty is also gaining momentum. As Big Pharma such as Pfizer, Moderna, AstraZeneca, and MSD exclusively develop vaccines and treatments, other countries may suffer supply and demand difficulties at any time, as well as the fact that they are not the main clinical subjects. The "Phase 3 Clinical New Drug Treatment for Koreans" is a system that benefits 5-10% of alternative drugs when domestic and foreign pharmaceutical companies conduct clinical trials (300-1000 people) or higher in Korea when developing innovative drugs. In order to prevent international trade problems such as negotiations on the revision of the Korea-US FTA in 2018, there is an international obligation to introduce a drug price system within the scope of compliance with the agreement. The regulations in question in the FTA agreement at the time allow drug and medical device registration or procedures, rules, standards, and guidelines applied to establishing benefits for medicines and medical devices to apply for benefit based on evidence of safety. The phase 3 clinical drug preferential treatment for Koreans is a system that provides common benefits not only to domestic companies but also to foreign companies, so there is no concern about trade friction. In the case of new drugs that have proven that there is no difference in safety and effectiveness of drugs due to ethnic factors, they have the advantage of creating customized drug therapy, providing appropriate treatment, and securing clinical data while maintaining the maximum drug effect. The revision of the HIRA's drug adjustment standards can achieve the desired results, preventing waste of time and unnecessary costs due to the preparation of new bills such as legislation of the National Assembly and government. According to Article 7 (7) of the Drug Adjustment Standard, the cost of medical care benefits for drugs that omit drug price negotiations is 90% of the weighted average price of alternative drugs, but exceptionally 100% for new drugs, biopharmaceuticals, and rare diseases. An industry official said, "As a result of reviewing 122 drugs registered over the past six years, 4·13 domestic and foreign drugs will be applied to the preferential treatment of phase 3 clinical drugs in Korea." This can benefit in common from domestic and foreign pharmaceutical companies through various legal review, so there is no concern about trade friction due to the application of special cases, he said. In addition, he predicted, "Multinational pharmaceutical companies' drugs are unlikely to be subject to the revision as they are exempted from submitting Bridge study data due to anticancer drugs and rare drugs, and biological drugs will need to be given 100% of the average drug price."
- Policy
- What are the variables for the release of Forxiga+ Januvia?
- by Lee, Tak-Sun Dec 24, 2021 05:49am
- MSD Januvia and AZ Forxiga Daewon Pharmaceutical and Dongkoo Bio's combination of Dapagliflozin (Forxiga) and Sitaglipin (Januvia) is approved. Since both ingredients are widely used in the diabetes treatment market, attention is being paid to whether there will be a change in the market due to the emergence of complex drugs. However, there are still steps to overcome, such as patents and benefits. On the 21st, Daewon Pharmaceutical was approved for "Dapacombi 10/100mg," a combination that combines Dapagliplozin and Sitaglipin. On the 23rd, Dongkoo was then approved for Sitagliptin 10/100mg, which combines Papaglipozin and Sitagliptin. The salt and solubilizing materials are slightly different, but the active ingredients are the same. Both drugs are administered as supplements to diet and exercise therapy to improve blood sugar control in patients with type 2 diabetes whose combined administration of Sitagliptin and Dapagliplozin is suitable. The original brands of Sitagliptin and Dabagliplozin are leading the domestic diabetes treatment market. According to UBIST's outpatient prescriptions, MSD's Januvia recorded 21.2 billion won in the first half of this year and AZ Forxiga recorded 18.3 billion won. It was also known that the proportion of combined prescriptions for the two drugs was also high. Therefore, it is analyzed that the emergence of a Forxiga+Januvia complex with convenience of use will have significant market value. However, the Forxiga+Januvia complex developed by a domestic pharmaceutical company has to wait until next year to be released in Korea. This is because Januvia's material patent will not end until September 1, 2023. Forxiga's material patent expires on April 7, 2023, ahead of that. Along with this, it is a variable for applying benefits. This is because the SGLT-2+DPP-4 complex, which was approved in Korea before the Forxiga+Januvia complex, has not yet obtained insurance benefits. Domestic approved SGLT-2+DPP-4 complexes are AZ "Qtern" (Dapagliflozin+Saxagliptin), Beringer Ingelheim Esglito (Empagliflozin+Linaglipin), and MSD "Stegluzan(Ertugliflozin L-pyroglutamic acid). Qtern was first released in November as a non-reimbursment. Recently, insurance authorities are discussing the improvement of benefit standards for the combined prescription of SGLT-2 and DPP-4 drugs. A growing number of domestic pharmaceutical companies are also developing SGLT-2+DPP-4 combination due to the possibility of entering the reimbursed market. Recently, SK Chemicas, Donghwa, and GL Pharm Tech have begun clinical trials for Dapagliflozin+Sitaglipin combinations.
- Company
- Reimb of SGLT-2i combos unclear... nears PMS expiry
- by Eo, Yun-Ho Dec 24, 2021 05:49am
- SGLT-2 inhibitors approved in Korea Anticipation has turned to tension. The companies that own SGLT-2 and DPP-2 combination therapies are facing hardships ahead of their post-marketing surveillance period expiry. At the diabetes expert meeting that was held by the Health Insurance Review and Assessment Service in September, the members concluded that the authorities should integrate and accept reimbursement of 2-drug and 3-drug combinations that use DPP-4 inhibitors with SGLT-2 inhibitors. The conclusion harbored industry hopes of being granted reimbursement listing for their non-reimbursed combinations. However, no progress has been made since in extending the insurance benefits to the combinations so far, putting pressure on the Post Marketing Surveillance (PMS) results. The PMS results of combination therapies such as Boehringer Ingelheim Korea’s ‘Esglito (empagliflozin/ linagliptin), AstraZeneca’s Qtern (dapagliflozin/saxagliptin)’ that is sold by Ildong Pharmaceutical, and MSD Korea’s ‘Steglujan (ertugliflozin/ sitagliptin) is due to the MFDS by 2023-2024. Only 1-2 years are left until the deadline. However, hundreds to thousands of patients need to enroll and register to conduct PMS, and due to the nature of the diabetes treatment market, it is difficult to recruit and attract prescriptions for non-reimbursed drugs. In other words, unless the drugs receive reimbursement, the companies will not be able to meet the number of patients required for PMS that was set by the Ministry of Food and Drug Safety. An official from a pharmaceutical company with an SGLT-2 inhibitor said, “In this pace, the license will inevitably be revoked. With the government policy supporting the active use of combinations, treatment accessibility is hindered if patients cannot be prescribed the drug due to non-reimbursement. I hope reimbursement is extended to SGLT-2 inhibitor combinations as soon as possible.” Meanwhile, at the expert meeting, the authorities decided that TZD class drugs that have cardiovascular risks should be reviewed ‘case by case.’ Therefore, the use of TZD combinations will continue to be restricted depending on individual ingredients.
- Policy
- Govn’t to prepurchase 10 mil of SK Bio’s COVID-19 vaccine
- by Kim, Jung-Ju Dec 24, 2021 05:49am
- The government plans to purchase 10 million courses of domestic COVID-19 vaccine in advance this year. Also, the government will support a total of ₩545.7 billion on overcoming COVID-19 next year - ₩321 billion in the development of vaccines and treatments, ₩119.3 billion in the establishment of research and manufacturing infrastructure, ₩36.4 billion in the advancement of disease control and prevention material and devices, ₩69 billion in the advancement of basic research. On the 23rd, the government held the 12th meeting of the Pan-Government Committee for COVID-19 Treatment and Vaccine Development to review the progress and discuss ▲COVID-19 treatment and vaccine development status and support, ▲reinforcing R&D support for the development of COVID-19 treatment and vaccine, ▲budget allocation for COVID-19 treatment and vaccine development support. At the meeting, Minister of Science and ICT (co-chair) Hyesook Lim, Second Vice Minister of Health and Welfare Ryu Geun-hyuk, and other relevant ministries and domestic experts in the field of treatments and vaccines participated in the meeting. ◆ COVID-19 treatment and vaccine development status and support = Other than the COVID-19 antiviral treatment that was officially approved on September 17th, 16 companies are currently conducting clinical trials on 17 local COVID-19 treatment candidates. The government has been increasing the number of residential treatment centers, short-term·outpatient treatment centers, and long-term care facilities while conducting efficacy assessments of the antivirals developed on COVID-19 variants. The government has also prepared measures to improve clinical trials on COVID-19 treatments so that latecomer COVID-19 treatments can continue to be developed. Also, with the increased at-home COVID-19 treatment cases for trials, the government prepared measures to more easily accommodate these patients into clinical trials. Eligible patients who are treated from home may participate in clinical trials through outpatient care or researcher visits from research nurses or other researchers. The government will also pursue the advance purchase of 10 million courses of the local COVID-19 vaccine developed by SK Bioscience to support local COVID-19 vaccine development. SK Bioscience’s vaccine has met the pre-purchase requirements set by the government at the 10th Pan-Government Support Committee (announcement of Phase II trial at interim results and approval of Phase III trial protocol). After a comprehensive review of the safety, immunogenicity, and utilization of the vaccine based on the interim results of the Phase II clinical trial, the government decided to purchase the vaccine in advance. The advance purchase agreement will be made as soon as possible after the details on the practical terms of the agreement are discussed. ◆ Reinforcing R&D support for the development of COVID-19 treatment and vaccine = To government also plans to support clinical trials of COVID-19 treatments and vaccines to the end and reinforce R&D support of clinical trials to accelerate development and improve the probability of success. Also, in consideration of the public interest and potential of succeeding in the R&D of COVID-19 treatment/vaccine, the government also plans to strategically review measures to reduce corporate out-of-pocket expenses for clinical trial R&D projects. Companies that participate in the COVID-19 treatment·vaccine clinical trial support project need to cover a fixed proportion of the R&D expense (50-25% of the total R&D expense) themselves. The government plans to review measures to reduce the clinical expenses borne by small-and-mid sized companies by easing regulations made to support the rate borne by private companies in cash, but only for ▲(vaccine) Phase I-III trials and ▲(treatment) Phase II-III trial and new drugs (excluding repurposed drugs) ◆ budget allocation for COVID-19 treatment and vaccine development support= The government will be supporting a total of ₩545.7 billion for the development of COVId-19 treatments and vaccines. This is a 107.7% (₩283 billion) increase from the main budget that was set for COVID-19 in 2021. The government plans to reinforce research support at clinical and non-clinical stages and seek advance purchase of locally developed COVId-19 vaccines by investing ₩321 billion in the development of COVID-19 treatment and vaccines and the success of their clinical trials. More specifically, the Ministry of Health and Welfare is investing ₩89.3 billion in the clinical support of COVID-19 treatments and vaccines and ₩10.5 billion in the clinical support of mRNA vaccines; the Ministry of Science and ICT investing ₩10 billion in bio and medical technology development; and the Korea Disease Control and Prevention Agency investing ₩192 billion on the advance purchase of local vaccines. Also, the authorities plan to support ₩119.3 billion on the development of test methods for COVID-19 treatments and vaccines while establishing testing facilities and devices to lay the foundation for manufacturing. Specifically, the MOHW will invest ₩4.8 billion to establish a system for clinical trial support, KDCA ₩8.2 billion to establish a national healthcare research infrastructure, the MFDS ₩22.7 billion to strengthen the international competitiveness of biopharmaceuticals, the MSTI ₩12.2 billion to the Center for National Preclinical Trial Support, and the MOTIE ₩16.7 billion to support companies that promote the industrialization of vaccines using the vaccine demonstration support center. Ryu Geun-hyuk, Second Vice Minister of Health and Welfare, said, “We will reinforce support on clinical trials to provide support for vaccine and treatments to the end. Through this, we will establish a development system for biopharmaceuticals that can rapidly respond not only to COVID-19 but also to other infectious diseases that may arise in the future.”
- InterView
- Ibrance can be used regardless of underlying condition in BC
- by Dec 24, 2021 05:48am
- It has been 5 years since Pfizer’s breast cancer treatment ‘Ibrance (Palbociclib)’ was introduced to the Korean market. As the first cyclin-dependent kinase 4/6 (CDF 4/6) inhibitor, the drug had innovated the treatment paradigm for patients with metastatic and recurrent hormone receptor-positive (HR-positive) and human epidermal growth factor receptor 2-negative (HER2-negative) breast cancer. With 5 years' worth of accumulated data, Ibrance has settled in as a trusted and reliable drug for doctors. In particular, Ibrance is considered the ‘go-to drug’ for those who have underlying conditions or have side effect concerns. At a meeting with Dailypharm, Kyong-Hwa Park, Professor of Oncology and Hematology at Korea University Medical Center, said that “Ibrance is suitable for use in patients who have poor liver conditions, the elderly, and those with poor kidney functions as it demonstrated long-lasting effect with little side effects in the field. Detailed QA of Dailypharm’s interview with Professor Park is listed below. Professor Kyong-Hwa Park -What has the diagnostic status been like for breast cancer in Korea recently? =The number of breast cancer patients has increased greatly recently. Korea’s prevalence rate of breast cancer had surpassed Japan and is now ranked highest in Asia. One silver lining is that the long-term survival rate of Korean patients is very good. Although there are some drugs that are not reimbursed, Korea’s breast cancer treatment environment in terms of treatment, medical service, and accessibility is quite good. - After Ibrance, other CDK4/6 inhibitors have also been started to enter the market. Nevertheless, Ibrance seems to be considered as the drug that can be stably used due to the immense amount of accumulated data and prescription experience. = That is true. Ibrance is the first CDK4/6 inhibitor that was approved in Korea and owns the most amount of long-term data as well as clinical experience. This is why it is a good choice for patients with various concerns. For example, patients who are at risk of side effects due to underlying diseases, old age, etc, may require a period of adaptation when using a drug or take various medications. It would be difficult for the doctor to opt for other CDK4/6 inhibitors in these cases. - Ibrance demonstrated consistent efficacy in patients with underlying diseases in clinical trials. Were you also able to observe this in the field? = A more diverse range of patients always exist in the real world. Some patients are very old, there are those who have poor kidney function, those with bad heart function, and even liver cirrhosis. The number of patients with such underlying conditions increase immensely if we add those who have diabetes or high blood pressure. All of these patients may use Ibrance. For example, I have a patient who has rheumatoid arthritis. She had a fatty liver due to long-term use of rheumatoid arthritis drugs. By using Ibrance with liver condition management, the patient is currently on Ibrance for 4 years with stable liver function. The drug can also be stably used in patients with bad kidney function as well. Also, in Korea, there are patients who have bad liver due to hepatitis B or C. In these patients, we first use the drug and then adjust the dose if they develop leukopenia/neutropenia or thrombocytopenia. - A total of 3 CDK4/6 inhibitors including Verzenio, Kisqali, and Ibrance are available in the market. What other considerations do you make other than the patient’s underlying condition when selecting the kind of CDK 4/6 inhibitor for use? = ECG monitoring is required for the use of Kisqali, at least up to its second cycle, due to its influence on heart activity. Also, the drug may not be used in patients with observed QT prolongation. However, Kisqali is the only drug reimbursed for premenopausal patients who have never received endocrine therapy in Korea, and we induce menopause in such patients to allow the use of various drugs with the same indication. In the case of Verzenio, patients adapt quickly to the drug if educated well on the treatment process, but it is difficult to use in patients who may not be able to tolerate diarrhea. On the other hand, the advantage of Verzenio is that it is good for patients who have metastases to the liver or those who we would have considered using chemotherapy first in the past. -A large-scale real-world data on Ibrance was presented this year in the U.S. The study demonstrated PFS and OS improvement in combination with letrozole in the first-line. This may be similar or different in Korea’s case. How did you interpret the data? =The average age of breast cancer patients in the US is around 15 years older than those in Korea. Also, medical accessibly is not as good in the US as in Korea. However still, the real-world results were comparable to that of clinical trials. The median OS had not been reached yet, but I believe the results would show an improvement. With the younger patient population, better accessibility to treatment, and higher self-management ability, results in the Korean patient population in clinical trials has always exceeded the performance observed in the overall patient population. Therefore, I believe the real-world data in Korea would also come out similarly. -The role of CDK4/6 inhibitors is expected to continue to grow in the field of breast cancer treatment. What direction should Ibrance pursue in the aspect? =Ibrance is being frequently selected as a combination therapy option in novel endocrine therapy combination studies. Although it is currently used in combination with an aromatase inhibitor or faslodex in the first-line, many other 3rd generation oral endocrine therapies are also currently in development. And all of these oral therapies are being developed in combination with Ibrance, so I believe Ibrance will be able to solidify its position as a first-line treatment while switching its partner drugs. Also, PIK3CA mutation is a very important mechanism in endocrine resistance, and studies to tackle this with a three-drug combination are also being conducted using Ibrance. The toxicity of the three drugs does not overlap, so I believe it can be well used in this aspect as well.
- Policy
- Domestic approval of EU-approved Novavax is imminent
- by Lee, Tak-Sun Dec 24, 2021 05:48am
- As the European Union (EU) approved the conditional sale of the NovaVax COVID-19 vaccine, attention is being paid to when it will be approved in Korea. As the MFDS is known to be preparing for Novavax's approval for national lot release, analysts say that approval is imminent in Korea. On the 20th, the European Commission (EMA) approved the conditional sale of the COVID-19 vaccine developed by Novavax. A few hours ago, the European Medicines Agency (EMA) recommended conditional sales approval. The EMA recommended approval for the use of the vaccine to prevent COVID-19 over the age of 18. Novavax was found to have a preventive effect of 90% in clinical trials of about 45,000 people in the United States, Mexico, and the United Kingdom. Side effects are also mostly mild symptoms such as pain in the inoculation site, muscle pain, and fatigue.On the 17th, Novavax, which is produced in India, was approved for emergency use by the WHO. Approval screening is currently underway in Korea. On the 15th of last month, SK Bioscience, a consignment producer in Korea, applied for permission to manufacture and sell items to the MFDS. However, while EU-approved products are multi-use vials, domestic products have different methods which is PFS type. As it has been approved by the WHO and the EMA, the MFDS is also expected to speed up approval. The MFDS has established a policy to process the COVID-19 vaccine as soon as possible. Existing licensed AstraZeneca and Pfizer vaccines were approved within 40 days of application. Therefore, it is predicted that permission can be obtained at the end of this month, around 40 days after application. Some analysts say that the MFDS has recently set up a major test item for Nuvaxovid PFS, and that approval may be imminent. This is because the national lot release is the last quality inspection for the market after approval of biological products such as vaccines. The MFDS is planning to proceed with the national lot release of the COVID-19 vaccine within 20 days of approval as soon as possible. Even if it is approved at the end of the year, it will be difficult to use it immediately in Korea. It is interpreted that it will only be available at the end of the third inoculation because the third vaccination is being conducted with Pfizer or Moderna. Hong Jung-ik, head of the COVID-19 vaccination response vaccination management team, also said in a media briefing on the 21st, "The entire amount of Novavax vaccines signed this year will be carried over," adding, "If approved by the MFDS, we will apply for supply next year."
- Company
- GI Innovation·A/Z, a study on immuno-cancer drugs combined
- by Nho, Byung Chul Dec 24, 2021 05:48am
- The appearance of GI Innovation clinical team members challenging large-scale global clinical trials. (Photo provided = GI Innovation)GI Innovation (CEO Hong Joon-ho) announced on the 17th that it has signed a clinical supply contract with AstraZeneca in the UK to develop a combination therapy with GI-101, an immuno-cancer drug, and Impinzi (Durvalumab). With this contract, GI Innovation will conduct clinical trials with AstraZeneca to evaluate the combination of immuno-cancer drugs GI-101, Impinzi, and chemotherapy. This clinical trial targets patients with small cell lung cancer, gastric/gastroesophageal junction cancer, biliary tract cancer and triple-negative breast cancer in the United States, Australia, and Korea. GI Innovation will be provided with Infinzi necessary for this clinical trial from AstraZeneca, and it will gain the driving force to conduct successful clinical trials by jointly designing clinical trial designs based on AstraZeneca's expertise in developing immuno-cancer drugs. The clinical trials of both companies aim to treat patients with combination therapy with GI-101, an immuno-cancer drug, in addition to the current standard treatment, chemotherapy, in metastatic and advanced cancers. Despite the use of immuno-cancer drugs in clinical settings, small cell lung cancer, gastric/gastroesophageal junction cancer, biliary tract cancer, and triple negative breast cancer did not show sufficient efficacy alone. To compensate for this problem, a combination of chemotherapy and immuno-cancer drugs has recently been attempted, and some carcinomas have shown encouraging therapeutic effects. A typical example is that a combination of chemotherapy and Imfinzi in small cell lung cancer has been approved as a primary treatment. GI Innovation is a strategy to maximize the treatment effect through the combination of GI-101, chemotherapy, and Imfinzi. The IL-2 site of GI-101 not only directly proliferates and activates apoptotic T cells and natural killer cells in the tumor microenvironment, but also effectively inhibits CTLA-4, an immune gateway expressed in immune cells through CD80. Through CD80-CD28 interaction, it is also possible to activate the immune response of cell killing T cells. Finally, it also has a mechanism to relieve immunosuppression by regulatory T cells that express CTLA-4, an immune gateway, in large quantities. Another immune gateway, PD-L1, can be expected to have excellent anticancer immunity when used in combination with Imfinzi, which activates immune cells. GI Innovation's clinical trial was designed as an adaptive and basket trial to confirm the anticancer activity of four solid cancers in one clinical trial and to register more patients in solid cancers that are effective depending on the results of interim analysis. The clinical trial will be conducted at about 20 medical institutions in Korea, the United States, and Australia. Yoon Nari, head of GI Innovation's clinical division, said, "GI-101 is a bispecific fusion protein that has a complex immune regulation function that proliferates and activates cell-killing T cells and natural killer cells only with monotherapy. The combination of GI-101, Imfinzi, and chemical anticancer drugs is designed to fully utilize the inherent mechanisms of the drug to recover the degraded immune response in cancer patients, respectively. Through this clinical trial, we will do our best to secure meaningful clinical differentiation data.
- Policy
- The PV guideline amendments may not be applied on Jan. 1st
- by Lee, Hye-Kyung Dec 23, 2021 05:42am
- It is believed that the improvement of the detailed guidelines for the Price-Volume agreement negotiations (PV) prepared by the National Health Insurance Service may not be implemented on January 1st of next year. This is in part due to the authorities’ internal affairs including its reorganization schedules, but also due to the strong opposition shown by the industry regarding the amendment. However, the NHIS plans to finish the guideline amendments through discussion with the Ministry of Health and Welfare by February next year when the selection of pharmaceuticals subject to monitoring for PV negotiations begins. The NHIS had presented a plan on improving the PV negotiation reservation (exclusion) system at the 10th public-private consultative meeting that was held on the 2nd. The improvements proposed included the revision of Article 6.1.1 of the guideline that calls for expanding the "same product group with an annual claims amount of less than ₩1.5 billion" to "less than ₩2 billion" and Article 6.1.2 that reduces "items with an upper limit of less than the arithmetic average of the main component code” to “less than 90% of the arithmetic average”. The increase of the claims amount from ₩1.5 billion to ₩2 billion was made based on the reference standards used when legislating the guidelines in 2014. At the time, the average claims amount in 2012 was ₩1.52 billion. Products that are less than 90% of the arithmetic average follow the negotiation conditions set for new drug negotiations Among new drugs, drugs that are listed without pricing negotiations usually accept a price at 90% of the weighted average of alternative drugs, therefore, the standards for PV negotiations were also set in line with this standard to less than 90% of the arithmetic average to be exempt from negotiations when the company voluntarily cuts its drug price by 10%. Upon the announcement, the pharmaceutical industry submitted a statement opposing the PV guideline improvements. The industry conveyed its position that the amount subject to exclusion from PVA that is set for the same product group with an annual claims amount of less than ₩1.5 billion should be set to ₩10 billion or less, and items whose price is less than the arithmetic average should be maintained at the present state. The Korea Pharmaceutical and Bio-Pharma Manufacturers Association said, “In line with the purpose of implementing the price-volume linkage system, the negotiation endeavors need to focused on mid-to-large sized items whose use increased to exceed ₩10 billion and the amount subject to exclusion from PVA be set to all drugs below ₩10 billion. The arithmetic average is a social convention and an absolute standard for judging whether the insurance finances can be saved, and therefore, it is in line with the system to exclude drugs that cost under the arithmetic average from negotiations.” Meanwhile, the NHIS plans to first review the opinion statement submitted by the pharmaceutical industry, then discuss it with the MOHW to prepare a plan for the final PV guidelines. However, it seems that it will take some time for the PV guideline improvements to be prepared and announced as personnel transfers of Deputy Ministers and Director-Generals in HIRA's Drug Price Management Office may occur this week or early next week at the latest.
