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- 2026-04-09 21:05:42
- Policy
- The more applications for pre-screening drugs, the higher
- by Lee, Tak-Sun Jul 20, 2023 05:34am
- .. Lee Jin-soo, chairman of the Medical Review and Evaluation Committee, "If the number of applications increases, the understanding of the benefit standards also increases." It was found that the higher the number of applications for pre-screening drugs, the higher the approval rate. It is an interpretation that the approval rate increases as the understanding of the salary standards accumulates. However, there is an interpretation that the salary standard is strict in the first place, so there is a high probability of disapproval of the salary in the pre-screening. Among pre-screening drugs, Soliris, which treats 'atypical hemolytic uremic syndrome (aHUS)', has a meager initial approval rate. The Health Insurance Review and Assessment Service presented an interpretation at the Korea Special Press Association meeting on the 18th that the understanding of the benefit standard was poor. In response to a question about the cause of Soliris' aHUS initial review approval rate and improvement plans, Chairman Lee Jin-soo explained, "I think the approval rate will increase if the clinical site fully understands the benefit standard and applies for it." He explained, “When we analyzed the status of approvals by the institution by 2022, we confirmed that the more cumulative applications there are, the more often they are approved.” According to the table released by the Clinical Review and Evaluation Committee, a total of 47 institutions applied for prior approval of Soliris in aHUS disease, and 51 cases (20.3%) out of 251 cases were approved. However, agency A, which applied the most, was approved for 10 out of 35 cases, with an approval rate of 28.6%, higher than the average. On the other hand, all 15 institutions that applied for prior approval were rejected. Regarding this, Chairman Lee explained, "As the number of applications for Solily increases, the understanding of the salary standard increases." Even so, it is pointed out that the approval rate of Soliris aHUS is too low compared to other drugs with an initial approval rate of more than 50%. In response, the Medical Review and Assessment Committee also said, "The expansion of the Soliris reimbursement standard was discussed at a recent advisory meeting, and the review results have been reported to the Ministry of Health and Welfare." In fact, it is pointed out that the Soliris aHUS salary standard is more difficult than overseas. In Korea, the benefit is approved only when all four criteria are satisfied: platelet count, mitotic red blood cell count, hemoglobin, and LDH, but the medical community says that the standard is higher than overseas. The Korean Society of Nephrology also submitted an opinion asking for relief standards to be relaxed. In March, Yoo Mi-young, head of the drug management office at HIRA, said, "A number of academic societies, including the Society for Nephrology, have submitted proposals for revising the reimbursement standards (for Soliris aHUS), including discontinuation of administration, administration standards, and evaluation methods." "We are currently reviewing the salary standards by identifying the reasons for pre-approval and disapproval and referring to expert opinions," she explained. It is noteworthy whether the pre-examination approval rate of Soliris will increase through the improvement of the benefit standard.
- Company
- MET-targeting Tepmetko lands in general hospitals in KOR
- by Eo, Yun-Ho Jul 20, 2023 05:34am
- The MET-targeted anticancer therapy ‘Tepmetko’ can now be prescribed at general hospitals in Korea. According to industry sources, ‘Tepmetko (tepotinib),’ a treatment for patients with locally advanced or metastatic non-small-cell lung cancer with MET exon 14 skipping mutations, passed the drug committees (DCs) of various medical institutions in Korea including Seoul National University Hospital, Konyang University Hospital, Chungnam National University Hospital, Chungbook National University Hospital, Kyungpook National University Chilgok Hospital, and Hanyang University Medical Center. The drug has been slowly expanding its scope of prescriptions since its official release in October last year. However, Tepmetko is still a non-reimbursed drug in Korea. The drug was unable to pass the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee review on February 2nd. The company voluntarily withdrew its reimbursement process. Tepmetko was approved at the same time as Tabrecta (capmatinib), which has the same mechanism of action as Tepmetko in 2021 and started the reimbursement process, but both drugs remain non-reimbursed until now. MET exon 14 skipping mutation is a rare type of cancer that is present in approximately 3-4% of patients with non-small-cell lung cancer (NSCLC). In particular, 1.9% of the 1,020 NSCLC patients in Korea were diagnosed with MET exon 14 skipping mutation. Tepmetko demonstrated its efficacy through the VISION study, which enrolled the largest number of patients among clinical trials for NSCLC patients with MET exon 14 skipping mutations. Results showed a significant life extension effect with a median progression-free survival (PFS) of 15.3 months and an objective response rate (ORR) of 56.8 percent. Also, the median duration of response (DoR) was 46.4 months, and the median overall survival (OS) was 25.9 months, showing continuous antitumor activity in the long term. Also, according to a presentation Ji-Youn Han, Professor of Oncology at the Center for Lung Cancer at the National Cancer Center, made at the Korean Association for Lung Cancer International Conference last year after analyzing 79 Asian patients that participated in the VISION study, the ORR was quite high at 66.7%, and 48.1% in the second-line treatment group.
- Company
- AZ and SK's Sidapvia is approved, first collab in 10 yrs
- by Jung, Sae-Im Jul 20, 2023 05:34am
- The first collaboration between a domestic company and big pharma has come to fruition. This is the first collaboration made in almost a decade since the development of Rovelito. Whether AstraZeneca, which is trying to increase the use of its diabetes treatment 'Forxiga' in clinics in Korea, and SK Chemicals, which is trying to increase production through global expansion with AstraZeneca, will create a synergistic effect is gaining attention. According to industry sources on the 19th, AstraZeneca and SK Chemicals succeeded in codeveloping a combination treatment for Type 2 diabetes. The drug, Sidapvia, is a combination of the SGLT-2 inhibitor dapagliflozin and DPP-4 inhibitor sitagliptin. Under the collaboration agreement, AstraZeneca will be in charge of the commercialization strategy and execution of Sidapvia. The company also holds the global commercialization rights to Sidapvia as its licensor. SK Chemicals will be in charge of its manufacture and supply. The executives of both compnaies are celebrating the first production of the diabetes combo drug in June at SK Eco Hub in Pangyo, Korea. (from the left)Yoon-Ho Kim (CEO, Pharma at SK Chemicals) Jae-Hyun Ahn (President and CEO, SK Chemicals) Choi Chang-won (Vice chairman, Discovery), Leon Wang (Executive Vice President, International and China President AstraZeneca), Sylvia Varela(Vice Presdient, Asia AstraZeneca), Ankush Nandra (Vice President, Finance and Chief Financial Officer International AstraZeneca), Sangpyo Kim ( Country President, AstraZeneca Korea) Both companies are looking forward to the synergistic effect that the collaboration will bring, accentuating their strengths and supplementing their weakness. AstraZeneca owns Forxiga, the original dapagliflozin drug. Also, as a global company with branches around the world, the company owns the infrastructure that can easily facilitate Sidapvia’s global entry. SK Chemicals will be supporting AstraZeneca, which does not own a domestic manufacturing facility, by manufacturing the dapagliflozin+sitagliptin combination in Korea. The collaboration between the two companies began in early 2020 when they signed an agreement for the development, manufacture, and global commercialization of a combination therapy for diabetes. To develop the combination, AstraZeneca supplied the API and invested R&D expenses to SK Chemicals. Based on such support, SK Chemicals conducted the R&D and domestic clinical trials for the combination drug. Building on Sidapvia’s approval in Korea, AstraZeneca plans to start the approval process for Sidapvia in 12 countries and plans to further expand the countries in the future. First combo drug collaboration made in 10 years It is rare for a global pharmaceutical company and a domestic pharmaceutical company to jointly develop and commercialize a drug. Combination drug for hypertension and hyperlipidemia produced through collaboration between Hanmi Pharm and Sanofi in 2013 One similar case was ‘Rovelito,’ a treatment for hypertension and hyperlipidemia. The drug was jointly developed by the global pharmaceutical company Sanofi-Aventis and domestic company Hanmi Pharm. The drug is a two-drug fixed-dose combination of the ARB class irbesartan and atorvastatin. Hanmi Pharm manufactured Rovelito and for the two companies to sell together. Unlike now, at the time of the companies' collaboration in 2013, combination drugs were an unfamiliar concept for hypertension and hyperlipidemia. Hanmi Pharm received attention for releasing an incrementally modified two-drug combination. One of Rovelito’s APIs, Avapro, was the original irbesartan drug owned by Sanofi. This was why the collaboration brought a synergistic effect. In fact, Rovelito posted annual sales of KRW 20 billion and was recorded as a commercialization success case. The drug also served a major role in establishing Hanmi Pharm as a strong player in the field of incrementally modified drugs. No other collaboration between a global company and a Korean company has risen since then. One reason was that Hanmi Pharm’s success prompted many Korean companies to jump into the combination drug market, making it difficult for such collaboration to lead the competition. Also, the change in the business strategy of global pharmaceutical companies played a role. The global pharmaceutical companies spun off their chronic disease businesses that lost profitability and started focusing on high value-added areas such as anticancer drugs and rare diseases, removing the areas for collaboration. Therefore, AstraZeneca and SK Chemicals agreement was the first collaboration made for a combination drug in 10 years in the field of chronic diseases. As Sidapvia’s licensor is AstraZeneca, the industry believes the collaboration reflects AstraZeneca’s strong will for the development of a combination drug. With the collaboration, AstraZeneca now owns a line-up of 4 products in Type 2 diabetes - ▲single dapagliflozin, ▲dapagliflozin+metformin combination, ▲ dapagliflozin+saxagliptin(DPP-4i) combination, and a ▲dapagliflozin+sitagliptin combination. AstraZeneca already owns the original DPP-4 inhibitor class saxagliptin drug ‘Onglyza,’ and also ‘Qtern,’ which is a combination of Onglyza and Forxiga. Also, Qtern posted the most monthly prescription sales in May, when sales of SGLT-2i+DPP-4i combos started. Despite such success, AstraZeneca is thought to have added Sidapvia to its lineup because sitagliptin holds the largest share of the DPP-4 inhibitor market. Sitagliptin accounts for over 25% of the DPP-4 inhibitor market and is the leading ingredient in the area. The Januvia family that contains sitagliptin had posted outpatient prescription sales of KRW 150 billion last year. Unlike DPP-4 inhibitors, which are widely used in private clinics around the nation, only half are using SGLT-2 inhibitors. This means that the combination drugs that contain DPP-4 inhibitors can benefit from the established DPP-4 inhibitor market and quickly broaden prescriptions for the combined SGLT-2 inhibitors as well. Owning a combination drug that contains sitagliptin, the most commonly used DPP-4 inhibitor, would facilitate the company in expanding the use of its SGLT-2 inhibitor as well. Il Shim, Director of the CVRM (Cardiovascular, Renal, and Metabolism) Business Unit at AstraZeneca Korea, said, “Sidapvia is a very special product we developed in collaboration with SK Chemicals. We hope our combination drug Sidapvia, which is based on Korea’s only SGLT-2 inhibitor that owns indications for Type 2 diabetes, chronic kidney disease, and chronic heart failure, will help patients to more easily and effectively manage their Type 2 diabetes.”
- Policy
- MFDS organizes a Clinical Trial Consultative Body
- by Lee, Tak-Sun Jul 19, 2023 05:20am
- The Ministry of Food and Drug Safety announced on the 17th that it has organized and is operating a ‘Clinical Trial Consultative Body’ with the industry to hold an ear out to the domestic clinical trial industry’s opinion and facilitate the smooth operation of the systems that are being newly introduced. The consultative body will consist of 14 members, experts in the bio-industry, including pharmaceuticals, vaccines, and cell therapies recommended by associations (Korea Pharmaceutical and Bio-Pharma Manufacturers Association, Korean Research-based Pharmaceutical Industry Association, Korea Biomedicine Industry Association), and the 1st meeting of the body was held on the 13th (Thurs) at the KRPIA head office. At the meeting, the MFDS discussed ▲the main improvements required for the factual survey on Good Clinical Practice and disclosure of the main results of the factual survey ▲ mandatory up-to-date Development Safety Update Reporting, and also ▲ shared and guided the system for the therapeutic use of investigational drugs overseas and discussed related standards, producers, and subjects in depth. In addition, the committee members proposed the ▲activation of a central IRB, ▲simplification of data reported to MFDS, etc. An MFDS official said, “The 'Clinical Trial Consultative Body' requested that we continue to propose reasonable system improvements in all areas related to clinical trials. Also, the members asked for the MFDS’s active support and utilization of the body so that it can play its role in developing regulations for clinical trials in Korea.’ The MFDS will continue to support the rapid development of safe and effective new products and the expansion of patient treatment opportunities through active communication between the public and private sectors based on the 'Clinical Trial Consultative Body'.
- Policy
- 22 items that exploded in use during COVID-19,
- by Lee, Tak-Sun Jul 19, 2023 05:20am
- While negotiations are underway for PVA Type Da items, 22 items are said to have undergone correction due to increased usage due to Corona 19 last year. The NHIS plans to finalize the negotiations by this month, including these items, and report the results of the negotiations to the Health Insurance Policy Deliberation Committee of the Ministry of Health and Welfare next month. According to the industry on the 17th, the government is negotiating by correcting the number of drugs that have increased usage due to Corona 19 last year and selecting a target for negotiation. Items subject to PVA Type Da are drugs that have not been negotiated at the time of initial registration, and if the billing amount increases by 60% or more compared to the previous year, by 10% or more, or by 5 billion won or more, the upper limit is reached through negotiation from the 4th year of registration. adjust the amount. The problem is that the demand for respiratory medicines such as cold medicine has increased significantly as the number of Corona 19 patients exploded last year. Drugs whose bills have increased significantly from the previous year are likely to have their upper limit reduced according to PVA, so the pharmaceutical industry suggested making an exception for drugs used for Corona 19. It is difficult for NHIS to exclude all drugs used for COVID-19 from the negotiation target, and instead decided to negotiate only those drugs that meet the standard by correcting the amount used. This is in accordance with Article 10 (2) of the PVA Negotiation Guidelines, which stipulates an exception to the application of PVA in the case of drugs used to support the treatment of infectious diseases. It is known that the NHIS, which has monitored about 2,600 items, including cold medicines and antibiotics that the Ministry of Food and Drug Safety has encouraged to produce since the beginning of this year, selected 22 items among them and proceeded with negotiations. The total number of Type Da negotiation items is known to be 60 items and 138 items in the same product group. The NHIS plans to complete the negotiations this month and submit the results of the negotiations to the Health Policy Deliberation Committee to be held next month to reflect the drug price adjustments in the reimbursement list in September. The NHIS explained that it lowered the upper limit on a total of 175 items according to the Type Da negotiations last year, resulting in a total of 44.7 billion won in financial savings.
- Policy
- No need to fear for the lack of Sabril after recall
- by Lee, Hye-Kyung Jul 19, 2023 05:20am
- The supply of Handok’s ‘Sabril Tab’ that was recalled by the company is expected to smoothen up soon. Its recall was issued by the health authorities due to the discovery of a small amount of an active pharmaceutical ingredient for a different drug, ‘tiapride,’ in its main active pharmaceutical ingredient, ‘vigabatrin.’ The Ministry of Food and Drug Safety (Minister Yu-Kyung Oh) said on the 18th, “We are aware of the concerns over the lack of epilepsy and infantile spasm treatment Sabril being raised by the industry. We have been discussing measures with Korea’s Children's Hospital Association, seeking expert advice, and meeting with the industry to closely understand the need and supply status in the field, and encouraged Handok, its domestic manufacturer, to promptly supply Sabril.” As a result, Handok decided to import 980,000 tablets (an amount that can be used for 5 months) of active ingredient (bulk tablets) that was scheduled to be imported in December in July, and its customs clearance is scheduled for July 21. Handok is known to be hastening its overseas import as there is no drug that can replace Sabril in Korea. The MFDS explained, “We have acquired information overseas on the discovery of another drug’s active pharmaceutical ingredient tiapride in some batches of Sabril’s active pharmaceutical ingredient, vigabatrin. Although the possibility of side effects is low, considering the fact that the safety of the detected ingredient for children has not been established, the MFDS recommended that the company recall a product with a specific lot number manufactured using the raw material on July 14 as a precautionary measure." Tiapride is an active pharmacuetical ingredient used to treat a variety of neurological and psychiatric disorders including movement disorders, neuromuscular pain, aggression, agitation, etc. The MFDS said, “ We have issued the recall recommendation as a preemptive measure for patient safety in comprehensive consideration of the potential distribution amount owned by the company (92,000 tablets that are not subject to recall) and the additional amount set to be supplied within July (980,000 tablets).”
- Opinion
- [Reporter's view]Time to think about price by indication
- by Eo, Yun-Ho Jul 19, 2023 05:20am
- Now is the time to think. The increasing number of non-insured indications and the steadily increasing number of indications for new drugs have now become quite a big snowball. In an age when a single drug has multiple indications and is used for multiple diseases, the emergence of drugs that target specific gene mutations and further activate the immune system itself has made it possible to focus on the mechanism, not the disease, and apply its efficacy to a wide range. The domestic drug price system, which has a mechanism of decreasing as the amount of use, that is, increases, makes negotiations between the government and pharmaceutical companies lengthy, and patients wait longer. How should we accept the existence of 'drugs that some people use and others can't' and the 'drug prices by indication' that are discussed along with them? 'Drug price by indication' is a method of setting drug prices separately according to the innovativeness of each indication, reflecting the current situation in which a drug is approved for various indications. KRPIA, a representative organization of multinational pharmaceutical companies, has already insisted on the necessity of introducing drug prices by indication several years ago. However, the government was closer to a stronger 'No' than 'I will review'. The problem is that there has been only the answer that it is difficult, but there is no alternative so far. Not long ago, the immune anti-cancer drug 'Keytruda' became a hot topic by submitting an application for insurance benefit registration for as many as 13 indications at once. In other words, 13 indications of cutting-edge new drugs called immuno-anticancer drugs were not actually being prescribed. In Korea's billing system, tracking by indication is difficult, and it may be difficult for patients to accept paying different amounts depending on the disease. However, it is also true that drugs that are clearly useful are not being used for the right patients. First of all, it is important to start a discussion in some way. Even after only 3 to 5 years, the problem of expanding indications for new drugs and accessibility to them will inevitably emerge much more than now. It does not have to be a differential application of refund rates or drug prices for each indication. It's time to put our heads together to find an alternative.
- Company
- Power of K-combos...Rosuzet leads outpatient Rx drug market
- by Chon, Seung-Hyun Jul 19, 2023 05:20am
- Hanmi Pharmaceutical’s new combination drug Rosuzet is ruling the outpatient prescription market in Korea. Rosuzet became the first domestically developed drug to lead quarterly outpatient prescriptions sales. Sales of HK Inno.N’s new drug ‘K-cab’ also continued to grow, taking part in the lead owned by domestically developed drugs in the outpatient prescription market. According to the market research institution UBIST, Hanmi Pharmaceutical’s Rosuzet recorded the most in outpatient prescriptions in Q2 with KRW 43.8 billion. Its sales rose 19.5% YoY and overtook the lead in quarterly prescriptions for the first time. Viatris’s Lipitor, which had held the lead until Q1 last year, was overtaken for the first time. By monthly prescriptions, Lipitor’s monthly prescriptions had exceeded Rosuzet’s by KRW 300 million until April. At the time, Lipitor’s posted sales of KRW 14.1 billion and Rosuzet KRW 13.8 billion. However, Rosuzet beat Lipitor (KRW 12.6 billion) by KRW 2.2 billion, posting KRW 14.8 billion in sales from May. Rosuzet maintained a KRW 2.1 billion sales gap with Lipitor with prescription sales of KRW 15.2 billion in June. Rosuzet is the first drug developed by a domestic pharmaceutical company to lead quarterly prescriptions in Korea. Rosuzet, which was released at the end of 2015, is a combination drug for hyperlipidemia that contains rosuvastatin and ezetimibe. Rosuzet has been continuing rapid growth in the market benefitting from its preoccupation of the market and the rising popularity of the statin and ezetimibe combination. Rosuzet’s prescription sales rose twofold in 3 years from KRW 24.9 billion in Q2 2020, continuing strong growth. Rosuzet’s sales exceeded KRW 100 billion for 3 consecutive years from 2020 and reserved the ‘KRW 100 billion sales club’ for the 4th consecutive year by making KRW 85.3 billion in 1H this year. Until this year, Lipitor had never lost its lead. Lipitor maintained its lead until Q1 this year, posting sales of KRW 49.2 billion, which is KRW 7.7 billion more than the second-runner Rosuzet. However, in Q2 this year, prescriptions had dropped 25.1% YoY and fell to 4th place. In 1H, Lipitor recorded KRW 87 billion in cumulative outpatient prescription sales, slightly ahead of Rosuzet (KRW 85.3 billion). Lipitor, which was introduced to the domestic market in 1999, is an atorvastatin-based dyslipidemia treatment. Although it continued to exert a strong influence in the prescription drug market despite the entry of its generics after patent expiry, its growth slowed down recently. HK Inno.N’s new drug K-cab has also continued to make strong sales. K-cab posted sales of KRW 38.5 billion in Q2, up 19.9% YoY and ranking 3rd in outpatient prescriptions. K-cab, which was released in March 2019, is a new -CAB (potassium-competitive acid blocker) class drug for gastroesophageal reflux disease (GERD). It has a new mechanism of action that inhibits gastric acid secretion by competitively binding to the proton pump and potassium ion located in the final stage of acid secretion. K-cab exceeded KRW 100 billion in prescriptions in its 3rd year of release in 2021 and recorded sales in the KRW 100 billion range for 2 consecutive years. K-cab made prescriptions of KRW 74.1 billion in the 1H this year, also heralding a record that exceeds KRW 100 billion won for three consecutive years. In addition to being approved for the treatment of erosive and non-erosive GERD, then gastric ulcer, K-cab acquired additional indications as an antibiotic combination therapy for the eradication of Helicobacter pylori in patients with peptic ulcer and/or chronic atrophic gastritis, and as maintenance therapy after treatment of GERD. Initially, the drug was granted reimbursement for the GERD and gastric ulcer indication among the 5, and was additionally granted reimbursement for the other indications. Therefore, K-cab's sales growth is expected to continue to increase further. Among domestically developed new drugs, Daewoong Bio’s brain function enhancer Gliatamin’s prescriptions rose 26.0% YoY in Q2 to record KRW 38.5 billion and rank 2nd in outpatient presciptions. Gliatamin’s increased its influence in the prescription market despite difficulties faced due to narrowed reimbursement standards, controversy over its efficacy, and the government's order to initiate negotiations to redeem the reimbursed claims amount. Chong Kun Dang Gliatirin, which also contains choline alfoscerate, also continued its high march in Q2, up 14.5% YoY and posting KRW 27.8 billion in prescription sales . Daiichi Sankyo’s anticoagulant Lixiana also sold KRW 25.9 billion in Q2 this year, an 8.6% increase YoY, and ranked among the top. Lixiana’s sales in 1H were KRW 52.4 billion and are expected to exceed KRW 100 billion for the first time in annual prescription sales this year.
- Company
- Will GC Pharma enter the US blood product market in 2013?
- by Chon, Seung-Hyun Jul 19, 2023 12:28am
- GC Pharma has challenged the US immunoglobulin blood product market worth 13 trillion won. For the past 13 years since it officially entered the US market in 2010, it has experienced growing pains such as failure to obtain permits and delays, but has attempted to enter the US market again. According to the industry on the 18th, GC Pharma submitted a BLA for its immunoglobulin blood product ALYGLO to the US Food and Drug Administration (FDA). ALYGLO applied for approval for primary immunodeficiency indication. GC Pharma satisfied all efficacy and safety evaluation parameters according to FDA guidelines in the North American phase 3 clinical trial completed in 2020. In the phase 3 clinical trial, ALYGLO was administered to 48 patients with primary immunodeficiency for 12 months, and the efficacy and safety were confirmed. ALYGLO is a liquid-type immunoglobulin preparation purified from plasma fractions. It is used to treat primary immunodeficiency diseases such as congenital immunodeficiency syndrome and immune thrombocytopenia. According to GC Pharma, the US immunoglobulin market is estimated at about 12.5 trillion won. With the recent increase in autoimmune diseases, the demand for immunoglobulins is continuously increasing. GC Pharma explained, “The blood product, which requires large-scale facility investment and advanced production experience, is known to frequently have a supply shortage because producers are very limited.” It is the confidence that ALYGLO will be able to secure sufficient market competitiveness if it enters the US market. This is the third attempt by GC Pharma to apply for FDA approval for a blood product. GC Pharma applied for approval of the IVIG-SN 5% product to the FDA at the end of 2015. FDA approval was expected at the end of 2016, but in November 2016, the FDA pointed out that the manufacturing process-related data should be supplemented. In September 2017, GC Pharma's approval was delayed again due to a request for additional supplementation of manufacturing process data. GC Pharma planned to enter the US market first with 5% products and later with 10% products undergoing clinical trials. However, as the approval of the 5% product was delayed, the company changed its strategy to release the 10% product, which has greater marketability, to the US market first. GC Pharma completed phase 3 clinical trials in North America for IVIG-SN10% ALYGLO in 2020 and submitted an application for product approval to the FDA in February 2021. However, in February of last year, it received a notice from the FDA to postpone the approval of the product. Due to the COVID-19 situation, a non-face-to-face evaluation was conducted in the fourth quarter of 2021, but the FDA decided to postpone the approval because of the need for an on-site inspection of the production facility. From April 17th to 28th, the FDA inspection team conducted an inspection of production facilities and quality systems such as fractionation, stagnation, and finished products of IVIG-SN at GC Pharma's Ochang plant. After completing the GMP inspection of the Ochang plant, GC Pharma resubmitted an application for permission after consulting with the FDA. The FDA's product approval process goes through a preliminary review after receiving the BLA, sets a target date for completion of the review, and starts the review process in earnest if the data is appropriate. A GC Pharma official said, “We are aiming to obtain product approval early next year and launch it in the US market in the second half of the year.” He said, “We will become a global leader in blood products based on our entry into the US market in the future.” If GC Pharma receives FDA approval for ALYGLO, it will enter the US market for the first time since its foundation. Yearly sales of Green Cross blood products (left) and percentage of sales (right) (unit: KRW 100 million, %, source: Financial Supervisory Service) Blood products, including immunoglobulins, are GC Pharma's core business areas. Last year, GC Pharma's blood product sales amounted to 420.4 billion won, accounting for 23.7% of the company's total sales. GC Pharma's blood product sales grew only 12.4% over the past 9 years from 341.5 billion won in 2013. Sales of blood products last year fell short of 429.6 billion won in 2019 and 425.4 billion won in 2018. The share of blood products in GC Pharma's sales reached 43.0% in 2013, but fell to the 30% level in 2014 and fell to the 20% level from 2020. Over the past nine years, the sales portion of blood products has declined by 19.4%. Blood product export growth is slow. Last year's GC Pharma blood product export performance was 90.9 billion won, up 48.3% from the previous year. However, considering that blood product exports recorded more than 100 billion won for four consecutive years from 2017 to 2020, a breakthrough in overseas markets is urgently needed. GC Pharma recorded 90.9 billion won in exports of blood products last year. If ALYGLO enters the US market, the proportion of overseas sales is expected to increase. In 2010, GC Pharma announced the entry of blood products into the US market. GC Pharma signed a contract with ASD Healthcare in 2010 to export blood product IV Globulin SN and hemophilia treatment GreenGene F worth a total of $480 million over three years. However, when the clinical trial period was delayed than originally planned, the memorandum of understanding with ASD Healthcare was also terminated in September 2015. GC Pharma also faced setbacks in its hemophilia treatment plan to enter the US market. In October 2016, GC Pharma decided to suspend the US clinical trial of GreenGene F, a recombinant hemophilia A treatment that is undergoing phase 3 clinical trials in the US. In 2012, it announced its withdrawal after 4 years of entering phase 3 clinical trials. The reason for the discontinuation of clinical trials in the United States was pointed out as “deterioration in business feasibility.” Due to the nature of rare diseases, the recruitment of new patients was slow, leading to delays in clinical trials and the emergence of competitive drugs with long duration of action. Due to GC Pharma's delay in entering the US market, the blood product supply strategy has also changed. Initially, GC Pharma sought to enter the blood product market through a local plant in North America. Green Cross Holdings spent 210 million Canadian dollars (about 187 billion won) in 2017 to complete the blood product plant in Montreal, Quebec, Canada. The plant, built on a land area of 63,000 square meters, has a process for producing blood products such as IV Globulin and albumin by fractionating up to 1 million liters of plasma per year. However, the North American subsidiary was liquidated as the US approval of IVIG-SN, a blood product, was delayed more than expected. In July 2020, Green Cross Holdings sold two of its North American blood products affiliates to Spain's Grifols, the world's largest blood products company, for a total of $460 million. GCBT (Green Cross BioTherapeutics), a subsidiary of Green Cross North America (GCNA), was sold for 189.1 billion won, while another US subsidiary, GCAM (Green Cross America), was also handed over. GCBT is a blood derivatives plant built by GC in Canada. GCAM is a corporation that supplies plasma in the US. It has 12 blood centers in the US. Initially, a structure in which GCBT would produce blood derivatives with raw plasma made from blood secured by GCAM was conceived, but the business strategy was drastically revised in consideration of the uncertainty caused by changes in business conditions. In the case of GCBT in Canada, although facility investment has been completed, it has been receiving manpower and technical support from GC Pharma's headquarters for commercial operation since 2018 due to a lack of local bio-production process experts. In this situation, as Grifols actively sought out the acquisition, the sale was carried out in a flash. GC Pharma is said to have recovered most of its investments in GCBT and GCAM. If ALYGLO obtains FDA approval, it will be produced at GC Pharma's Ochang plant and sold through GC Biopharma USA, a US GC Pharma subsidiary. A GC Pharma official said, "Immune globulin use in the United States is expected to increase further due to the increase in autoimmune diseases due to the aging population and improved awareness of the diagnosis and treatment of congenital immunodeficiency syndrome." “We expect to improve the situation of limited product supply,” he predicted.
- Company
- GC Pharma, reapplying to FDA for approval of immunoglobulin
- by Chon, Seung-Hyun Jul 19, 2023 12:20am
- Green Cross Ochang Factory GC Pharma planned to enter the US market first with 5% products and later with 10% products undergoing clinical trials. However, as the approval of the 5% product was delayed, the company changed its strategy to release the 10% product, which has greater marketability, to the US market first. GC Pharma completed phase 3 clinical trials in North America for IVIG-SN10% 'ALYGLO' in 2020 and submitted an application for product approval to the FDA in February 2021. However, in February of last year, it received a notice from the FDA to postpone the approval of the product. Due to the COVID-19 situation, a non-face-to-face evaluation was conducted in the fourth quarter of 2021, but the FDA decided to postpone the approval because of the need for an on-site inspection of the production facility. From April 17th to 28th, the FDA inspection team conducted an inspection of production facilities and quality systems such as fractionation, stagnation, and finished products of IVIG-SN at GC Pharma's Ochang plant. A GC Pharma official said, “We are aiming to obtain product approval early next year and launch it in the US market in the second half of next year.
