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- 2025-12-23 15:16:51
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- The synergy between strengths & strengths
- by Kim, Jin-Gu Jul 21, 2023 05:41am
- The number of domestic pharmaceutical companies collaborating to jointly sell drugs has increased significantly. In the past, drug co-promotion contracts were mainly concluded between multinational pharmaceutical companies and domestic pharmaceutical companies. In the pharmaceutical industry, it is interpreted as a result in which the needs of both sides are well-matched. Companies with relatively weak sales power can enjoy the effect of increasing sales and securing customers by collaborating with companies that have expertise in a specific area. Companies entering the market through joint sales can expect the effect of expanding their product lineup. Here, it is analyzed that it can be relatively advantageous to enter the market through joint sales instead of selling products at low drug prices as generics. According to the pharmaceutical industry on the 4th, there are more than 10 cases of marketing and sales collaboration, such as co-promotion contracts for joint sales of drugs between domestic pharmaceutical companies this year. Last month ▲MOU for domestic sales and marketing of Insulin Glargine, a Lantus biosimilar between Dongkuk and GC Pharma ▲MOU between Dongkuk and Korea Pharmbio for intestinal sales co-promotion of Orafang ▲CCB series 3 between Samjin and Ilsung Four contracts were signed, including a co-promotional agreement for Azelblock, a first-generation hypertension treatment, and a co-promotional agreement between Anguk Pharm and CMG Pharmaceutical for rosuvastatin + omega 3 combination drug 'Mega M Dual Soft Cap'. Last month ▲ Dongkuk Pharm and GC Pharma's domestic sales and marketing business agreement for Lantus biosimilar Insulin Glargine, ▲ Dongkuk Pharm and Korea Pharmbio's booklet payment Orafang's hospital sales co-promotion business agreement, ▲ Samjin Pharm and Ilsung New Drug's CCB A co-promotion agreement was signed for Azelblock, a third-generation high blood pressure treatment affiliate, and ▲Mega M Dual Soft Cap, a rosuvastatin + omega-3 combination drug between Anguk Pharmaceutical and CMG Pharmaceutical. In January, ▲an exclusive sales contract between Kwangdong Pharm and Hanlim Pharm for the highly concentrated liquid nutritional tonic 'Horban', ▲an extension contract for joint sales of Edarbi and Edarbyclor between Donga ST and Celltrion Pharm, ▲HK Innoen and Samyang Holdings' domestic sales of Paclitaxel-based anticancer drug Genexol ·Marketing joint sales contract, and ▲Amortan-R' co-promotion contract between Anguk Pharm and CMG Pharmaceutical, a three-drug combination drug for hypertension and hyperlipidemia. Anguk and CMG Pharmaceuticals also signed a co-promotion for Lacbio, an intestinal medicine, in December last year. In the same month, SK Chemicals also signed an exclusive sales and distribution contract with Mothers Pharmaceuticals for Acerisone, a non-steroidal anti-inflammatory drug. (From left) K-CAB, Zemiglo, Shinbaro. It is regarded as an example of a successful co-promotion contract between domestic companies Since the end of last year, at least 13 domestic pharmaceutical companies have signed joint sales contracts in the past half year. It is evaluated that the cases of collaboration between domestic companies have increased significantly compared to the past. In the pharmaceutical industry, there is an analysis that collaboration between domestic companies is becoming a new trend. In the past, most of the co-promotional contracts in the domestic pharmaceutical bio-industry were in the form of multinational pharmaceutical companies borrowing the local area sales force of domestic pharmaceutical companies. It was mainly a method in which multinational companies were in charge of general hospitals and domestic companies were in charge of local clinics. The drug co-promotion between domestic pharmaceutical companies is interpreted as a result of the needs of the two contracting parties matching well. Pharmaceutical companies with relatively weak sales power can seek to increase sales by collaborating with companies that have expertise in a specific area. Even in the opposite case, it is an analysis that the pharmaceutical company can create synergy by expanding its lineup in the treatment area. Taking the Glarzia case of Dongkuk and GC Pharma as an example, Dongkuk is actively seeking to expand into the diabetes field. Dongkuk received approval for Daflzin, Tenelikan, Sitakan, and Sitakandapeul one after another from the end of last year. In April, a relay symposium was held for 500 medical staff in five regions across the country ahead of full-fledged sales promotion. Dongkuk Pharmaceutical's plan is to strengthen its diabetes treatment lineup by adding Glarzia, an insulin injection. GC Pharma plans to reverse the sluggish sales flow after the introduction of the product through collaboration with Dongkuk Pharmaceutical. GC Pharma introduced Glarzia from Indian pharmaceutical company Biocon and launched it in November 2018. At the time, Handok was in charge of domestic sales and marketing, but sales continued to be sluggish at around 1 billion won a year. It shows a big difference from the original Lantus, which generates sales of more than 20 billion won a year. Like K-CAB and Zemiglo, we also accumulated positive results from joint sales. It is analyzed that the steady accumulation of positive co-promotion results also contributed to the expansion of cooperation between domestic companies. A representative example is the joint sale of K-CAB by HK inno.N and Chong Kun Dang. HK inno.N signed a joint marketing contract with Chong Kun Dang and K-CAB in January 2019. As a result, K-CAB expanded its annual prescription amount to more than 130 billion won in four years of collaboration between the two companies. HK inno.N took on the challenge with P-CAB-type drugs at a time when PPI-type drugs were leading the market. It is an analysis that HK inno.N was able to quickly settle K-CAB in the market through collaboration with Chong Kun Dang. Chong Kun Dang has also established K-CAB as a product that greatly contributes to corporate performance. Daewoong and LG Chem jointly sold Zemiglo, GC Pharma and Daewon Pharm jointly sold Shinbaro, and Boryung and GC Pharma jointly sold Neulapeg. In the pharmaceutical industry, analysis is raised that there will be some impact from the stepped drug pricing system that took effect in July 2020. This system is a structure in which the drug price is reduced starting with the 21st registered drug. It means that the generic means that the drug price is lower. For generic companies, it may be more beneficial to jointly sell products that have already been released rather than belatedly developing generics and entering the market.
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- Exports of botulinum in the first half rose by 26%
- by Kim, Jin-Gu Jul 21, 2023 05:41am
- In the first half of last year, exports of domestic botulinum toxin increased by 26% compared to the previous year. In particular, exports to Brazil increased significantly. In the pharmaceutical industry, analysts say that Brazil is emerging as a major exporter of domestic botulinum toxin along with China and the United States. According to the Korea Customs Service on the 19th, the export of domestic botulinum toxin in the first half of last year was 166.1 million dollars (about 210 billion won). It increased by 26.4% compared to $131.4 million in the first half of last year. By country, exports to China and the United States still account for a large proportion. In the first half of the year, botulinum toxin exports to China amounted to US$23.55 million, accounting for 14.2% of the total. Exports to the US account for 13.9% at $23.01 million. Following China and the United States, Brazil has the third-highest export performance of botulinum toxin. In the first half of the year, exports of botulinum toxin to Brazil were $21.07 million. Compared to $13.32 million in the first half of last year, it increased by 58.1% in one year. The share of total exports increased by 2.6%p from 10.1% to 12.7% over the same period. If the period is extended, the increase in botulinum toxin exports to Brazil becomes even more remarkable. In the first half of 2020, three years ago, the export of botulinum toxin to Brazil was only $5.57 million. Its share of the total was 6.1%. In just three years, the amount of exports has increased nearly four times, and the share has more than doubled. In this process, it is similar to China and the United States, which are existing major exporters, and their share in total exports has increased. An official from the pharmaceutical industry explained, "It seems that interest in Korean botulinum toxin is growing in the South American market, especially in Brazil." “Recently, botulinum toxin exports are diversifying not only to South America but also to emerging markets such as Southeast Asia and the Middle East,” he said.
- Company
- Korean pharmas busy recruiting talent from global pharmas
- by Lee, Seok-Jun Jul 21, 2023 05:41am
- Korea's pharmaceutical and bio businesses are busy recruiting talents from multinational pharmaceutical companies to further accelerate their global entry. Handok appointed Miyeon Kim (56) as the new CEO as of July 1st. At Pfizer, the new CEO Kim worked as the Strategic Planning Manager, Product Manager, Marketing Manager, and as the BU Lead of the company’s Established Products Business Unit. Afterward, she was appointed VP of Pfizer’s Established Products Business Unit at Pfizer US and led the US Brands Team. Kim also has served as the Cardiovascular Metabolic Franchise Head and Country General Manager of Alcon. In June, Handok had appointed Yoon-Mi Kim as Executive Director to head its ETC business unit. Executive Director Kim started her career in 2001 as a sales and marketing manager at Handok. At Pfizer Korea, she served as the Marking Manager for Viagra and Champix, and as Director of Business Operations and Strategy, Oncology at Pfizer APAC Region. Until recently, she had served as a Hematology & Oncology BU Lead at BMS before returning to Hanok. Hana Pharm appointed Tae-Hong Choi (66) as its new President/CEO. President Choi had previously served as the CEO of Boryung Pharmaceutical from January 2013 to March 2019, then as CEO of Daewon Pharmaceutical from June 2019 to 2022. Choi has extensive experience in multinational pharmaceutical companies before leading various Korean pharmaceutical companies. He joined Janssen Korea in 1987 and served as the VP of the Korean and Hong Kong Janssen and as the Head of the North Asian region, etc. Anterogen will hold a special shareholders meeting on September 4th to discuss the appointment of Hong-Ki Ryu (66) as the full-time auditor. After working as a marketing and planning executive at various domestic and multinational pharmaceutical companies including AstraZeneca, Novartis, JW Pharmaceutical, etc., Rhu joined AbbVie (then Abbott) in 2004 and rose to the position of CEO in 2008. Rhu continued to lead the company until early 2019 even after Abbott separated into the current AbbVie and Abbott in 2013. Also, Shaperon has appointed former GSK executive Yeon-Sam Oh as Head of Business Development, and Lotte Biologics appointed former Roche and Genentech executive Hyungduk Yoo as Chief Operation Officer (COO) this year. Global business expansion The domestic pharma and bio companies’ recruitment of personnel from multinational companies is interpreted as the companies’ move to advance into the global market. Hana Pharm is one example. The company had posted annual sales of KRW 210.8 billion last year. Among them, exports amounted to KRW 1.3 billion, less than 1% of the total sales. The company’s sales depend on domestic demand. It had posted no overseas sales in the Q1 this year. President Tae-Hong Choi is well-versed in global affairs to the extent that he served as the General Manager of the North Asian region at Janssen Korea. While serving at Boryung Pharmaceutical, he demonstrated his overseas proficiency by winning several export contracts for Kanarb (high blood pressure drug). Most of Boryung Pharmaceutical's exports of Kanarb occurred after President Choi was appointed in 2013. Choi is expected to focus on the global business at Hana Pharm. He expects to create synergy with Director Yerim Cho (43, second daughter of the owner), who is in charge of the global business. The preliminary preparations for the global advancement are complete. Last year, Hana Pharm completed the construction of a production plant to produce the new anesthetic drug ‘Byfabo Inj.’ In 2020, the company acquired the right to sign exclusive contracts in 6 Southeast Asian countries to expand overseas sales of its new anesthetic drug. The company recently received approval in the Philippines, one of 6 countries, and is preparing to release Byfabo there in Q4. Also, the company is aiming to sign consignment manufacturing (CMO) export agreements in Europe and Japan.
- Company
- NHIS starts RSA reevaluations for AD drug Dupixent
- by Eo, Yun-Ho Jul 21, 2023 05:40am
- Sanofi has started reevaluation negotiations for its atopic dermatitis treatment ‘Dupixent,' which has been receiving reimbursement under the RSA (Risk Sharing Agreement). According to industry sources, Dupixent’s RSA term ends on December 31st, therefore, the drug is undergoing reevaluation negotiations with the National Health Insurance Service. In other words, the company needs to renew the RSA contract within the year to allow the drug to be applied for reimbursement without any issue. Of course, no company has failed to renew its RSA until now. However, the mechanism of the RSA makes it so that every time a reevaluation is conducted, the price is further reduced, raising tensions. In Korea, unlike general drugs that are listed after demonstrating cost-effectiveness through pharmacoeconomic evaluations, RSA drugs are required to receive additional evaluations for clinical utility and cost-effectiveness every time the contract term expires. The cost-effectiveness evaluations are inevitably affected by the price of its alternatives at the time of evaluation. And during the 5-year RSA term, the price of the alternative drug is also reduced through various follow-up measures (reduction in original drug price due to generic listing, price-volume price linkage system, ceiling price cut due to reimbursement extensions, etc). Furthermore, the revisions in the announcement made in 2020 allowed latecomers to receive reimbursement through RSA, allowing the price of the latecomers to directly affect the cost-effectiveness of the first entrants. This has added to the already long list of issues that have been constantly raised about RSA renewals in the industry. However, the entry of latecomer drugs to the RSA scheme has been a long-awaited wish come true from the industry’s perspective, and the government expanded its benefits after various considerations Also, it is not unreasonable for price adjustments to be made for drugs that have alternatives with the same mechanism of action, even if the indications are not identical. Meanwhile, reimbursement extensions for Dupixent to cover severe asthma and pediatric AD are also in progress. Whether Sanofi Korea can reach an agreement and receive reimbursement extensions remains to be seen.
- 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.
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- 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.”
- 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.
- Company
- FDA accepts NDA for HLB’s rivoceranib
- by Lee, Seok-Jun Jul 18, 2023 05:29am
- HLB’s hepatocellular carcinoma treatment ‘rivoceranib’ has now entered FDA’s review. Yang-Gon Jin, Chairman of the HLB Group, announced on the morning of the 17th that “HLB’s US subsidiary Elevar received an ‘NDA Filing Acceptance’ letter from the FDA.” Elevar submitted a new drug application (NDA) for rivoceranib on May 16 after completing a global Phase III study evaluating the efficacy and safety of rivoceranib+camrelizumab therapy. The FDA assigned a target action date of May 16, 2024, under the Prescription Drug User Fee Act (PDUFA). Therefore, the decision will be made for the new drug within 10 months. With the FDA’s acceptance of the NDA, the company plans to accelerate preparations for commercialization, such as expanding drug sales licenses and establishing joint marketing execution strategies. Also, the company is preparing for the on-site scheduled on-site FDA CMC (Chemical Manufacturing and Controls) inspection together with Jiangsu Hengrui Medicine. HLB holds the global patent for the targeted anticancer therapy rivoceranib. HLB Life Sciences holds the sales rights for rivoceranib in Korea and partial profit rights for the drug in Europe and Japan. Jiangsu Hengrui Medicine owns the sales rights in China. Elevar Therapeutics, Inc. holds global rights in all other regions.
