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Company
Celltrion develops anticancer drugs using ADC platform
by
Oct 21, 2022 05:47am
Celltrion announced on the 17th that it has signed a contract with domestic bio company Pinotbio to introduce options for implementing ADC Linker-Payload platform technology. With this contract, Celltrion paid advance payments and secured the right to utilize Pinotbio's ADC Linker-PINOT-ADC for up to 15 targets. Celltrion plans to develop ADC anticancer drugs targeting solid cancer by applying PINOT-ADC technology to pipeline candidate materials under development. For a total of 15 target options secured this time, Celltrion can use the technology for one target for each option event, and advance payments, milestones, and royalties for each option event are set separately. ADC Linker-PBD technology is a technology that combines payloads with excellent therapeutic effects with antibodies that react only to specific antigens so that drugs can selectively act on cells expressing antigens. The maximum therapeutic effect can be expected with the minimum drug administration, and the drug can be selectively delivered to the target cell. Celltrion has secured anticancer drugs such as blood cancer treatment Truxima, breast and gastric cancer treatment Herzuma, metastatic direct bowel cancer, non-small cell lung cancer, and ovarian cancer treatment Begzelma. The contract is expected to enable the development of more diverse anticancer drugs by securing options for implementing ADC platform technology. Celltrion signed a contract with Pinotbio to introduce platform technology implementation options, as well as a stake investment and joint research contract. The two companies decided to focus their development capabilities as much as possible to achieve the joint goal of developing ADC treatments while establishing a long-term partnership through equity investment and joint research contracts. An official from Celltrion said, "The introduction of Linker-Payload platform technology has added momentum to the development of ADC anticancer drugs as a future growth engine project. We will actively expand new growth engines through continuous cooperation with promising biotech such as Pinotbio."
Company
LG Chem acquires US pharma company for KRW 800 billion
by
Chon, Seung-Hyun
Oct 19, 2022 05:49am
LG Chem will invest KRW 800 billion to acquire a US bio-company. With the acquisition, the company will also be securing an anticancer drug that is being sold in the US. On the 18th, LG Chem announced that it would acquire AVEO Pharmaceuticals for $566 million (approx. KRW 800 billion). LG Chem will be acquiring a 100% stake in AVEO Pharmaceuticals, a company known for its FDA-approved renal cell carcinoma treatment ‘Fotivda.’ This will be the first time a Korean company acquires a company that owns an FDA-approved new drug. AVEO Pharmaceuticals was established in Boston, MA in 2002. It owns full capabilities ranging from clinical development, approval, sales, and marketing in the oncology market. Listed on the Nasdaq in 2010, the company received FDA approval for its targeted therapy Fotivda for the treatment of renal cell carcinoma in 2021. AVEO Pharmaceuticals is expected to record sales of KRW 150 billion this year, which will abe a threefold year-on-year growth. If the ongoing clinical trial that is evaluating Fotivda in combination with an immuno-oncology drug becomes successful, Fotivda’s indication will expand, raising expectations for its further growth. LG Chem will use its assets to finance the funds for the acquisition to LG Chem Life Science Innovation Center (LG CBL), which is based in Boston, US. LG CBL will then establish a special purpose corporation (SPC) to proceed with the M&A of AVEO Pharmaceuticals. The overall deal is expected to be completed in around 3-6 months, after receiving majority approval from AVEO’s general shareholders' meeting and undergoing deliberation by the Committee on Foreign Investment in the United States. LG Chem said, “With the acquisition, we will be able to secure anticancer commercialization capabilities in the US in a short period of time while establishing a bridgehead to launch various in-house new drugs to the US, the world’s largest pharmaceutical market.” LG Chem made the decision to acquire AVEO Pharmaceuticals, a company that has successfully entered the commercialization stage, as it is possible to operate a business in oncology with a sales organization that focuses around on a small number of medical institutions specializing in cancer. Fotivda received a Category 1 Recommendation in the NCCN Guidelines in August and was evaluated to have settled in the renal cell carcinoma treatment market. In addition to Fotivda, AVEO Pharmaceuticals also owns 3 oncology pipelines including the head-and-neck cancer treatment that is undergoing a Phase III clinical trial, etc. LG Chem has a total of 20 new drug pipelines in the development stage, which includes 9 oncology pipelines including cell therapies in solid cancer, as well as treatments for gout, NASH, and obesity. LG Chem plans to accelerate market entry from the beginning of the launch of its new drugs by securing U.S. commercialization capabilities early on. LG Chem aims to record KRW 2 trillion in sales in Life Sciences by 2027 by internalizing AVEO’s commercialization and clinical capabilities. Ahk Cheol Shin, Vice Chairman & Chief Executive Officer at LG Chem, said, “This acquisition decision is the most important milestone in the 40-year history of LG Chem’s biology business. It will lay the foundation for the business to take the global leap forward. We will continue to strengthen commercialization capabilities in the US and actively expand local sales while further enhancing our clinical and licensing capabilities in the US to accelerate our advance into a global innovative pharmaceutical company.”
Company
Novo Nordisk appoints Sasha Semienchuk as new GM
by
Eo, Yun-Ho
Oct 19, 2022 05:48am
Sasha Semienchuk, VP & General Manager, Novo Nordisk Korea On the 18th, Novo Nordisk announced that it has appointed Sasha Semienchuk as the VP and General Manager of its Korean subsidiary effective in October. Sasha Semienchuk owns over 20 years of experience in healthcare across sales, marketing, research, and management at multinational pharmaceutical companies and startups in 7 countries on three continents. After joining Novo Nordisk in 2012, Semienchuk was engaged in various diseases and therapeutic areas. From 2015, Semienchuk served as a Senior Director of Global Marketing in the obesity disease area at Novo Nordisk in Denmark and led communication and commercial activity between global exepert organizations. From 2018, Semienchuk worked as the Senior Marketing Director at Novo Nordisk Japan and led the launch of various new insulin products in its Insulin team. Meanwhile, his predecessor, Rana Azfar Zafar, has been appointed as Vice President of Novo Nordisk's CEM (Commonwealth Independent States Emerging Market) cluster and will be overseeing business in Kazakhstan, Azerbaijan, Georgia, Armenia, Uzbekistan, Turkmenistan, Tajikistan, Kyrgyzstan, and Mongolia.
Company
Forxiga & Jardiance are expected to surpass 100 billion won
by
Nho, Byung Chul
Oct 19, 2022 05:48am
The SGLT-2-inhibited original diabetes treatment market recorded 53 billion won in the first half of this year, which is expected to surpass 100 billion won by the end of this year. The SGLT-2 original drug market was divided into Forxiga and Beringer Ingelheim Jardiance, and sales of 22.1 billion won and 30.9 billion won in the first half, respectively. The total sales of both Forxiga and Jardiance products last year were 91.6 billion won, up 94% from 47.1 billion won in 2018. From 2018 to 2021, Jardiance's sales were 19.8 billion won, 26.1 billion won, 29.4 billion won, and 32.3 billion won. During the same period, Jardiance Duo recorded 2.5 billion, 6.5 billion, 13.8 billion, and 21.1 billion won. Compared to the pace of growth between 2018 and 2021, Jardiance Duo increased by 63% (19.8 billion → 32.3 billion) and 744% (2.5 billion → 21.1 billion). Jardiance Duo's overall sales last year were 53.4 billion won, 15.3 billion more than Posh's 38.1 billion won. Jardiance Duo's sales in the first half of this year were 17.5 billion won and 13.3 billion won, respectively, and if such an elastic curve is maintained, it is expected to grow by 8.26% compared to the previous year. Forxiga's growth rate over the past four years is 54%, and its appearance between 2018 and 2021 recorded 24.7 billion won, 27.9 billion won, 32 billion won, and 38.1 billion won. Forxiga 10mg, which was approved in Korea in 2013, maintained 784 won at the beginning of its launch but was cut by 24 won to 760 won in May this year. This drug is used in type 2 diabetes monotherapy and is effective in reducing the risk of chronic heart failure and chronic kidney disease hospitalization and death. In particular, Forxiga is expected to compete fiercely in the market between original and generic due to the expiration of material patents in the first half of next year. When the patent expires, the original drug Forxiga will be recognized for 70% (532 won) of the existing drug price, 68% (516 won) of the generic released by innovative pharmaceutical companies, and 59.5% (452 won) of the generic. Jardiance, which was approved in 2014, is also used as a single and combination therapy for blood sugar control in type 2 diabetic patients, just like Forxiga. Jardiance 10 and Jardiance 25mg prices are 660 won and 852 won, respectively. Jardiance Duo 5/500, 5/850, 5/1000, 12.5/500, 12.5/850, and 12.5/1000 mg receive insurance drug prices of around 330 won to 469 won. New diabetes drugs with SGLT-2 inhibition mechanism have advantages of more advanced efficacy and low side effects, such as less strain on the kidneys while showing excellent blood sugar drop effects compared to existing treatments.
Company
Shingrix costs 600,000 won
by
Kim, Jin-Gu
Oct 17, 2022 10:51pm
The inoculation price of Shingrix, a shingles vaccine scheduled to be supplied in December, is expected to be around 600,000 won. It is four to five times the existing inoculation price. According to the pharmaceutical industry on the 15th, GSK and GC Pharma recently officially signed a domestic joint sales contract for Shingrix. The two companies agreed to supply the next-generation shingles vaccine at around 160,000 won. The inoculation price reflecting the supply price is expected to be around 300,000 won. In the case of Shingrix, considering that immunity is completed with two vaccinations, the total vaccination price to be paid by the patient is around 600,000 won. The existing vaccines MSD Zostavax and SK Bioscience SKY Zoster were sold for 150,000 won to 200,000 won at the front-line opening price. In the case of Shingrix, vaccination prices have been set at four to five times the level of existing vaccines. GSK and GC Pharma plan to start distributing Shingrix nationwide in December. The first volume is 360,000 degrees, which can fit 180,000 people. GSK obtained Shingrix permission from the Ministry of Food and Drug Safety in September last year. It was originally planned to be released in February this year, but the schedule was delayed day by day. Shingrix is a vaccine used to prevent herpes zoster in adults over the age of 50 and immunocompromised people over the age of 18. When Shingrix is released, it is expected to be the third shingles vaccine in Korea after MSD Zostavax and SK Bioscience SKY Zoster. It is evaluated that the effect of preventing shingles confirmed in clinical trials is superior to that of the two existing vaccines. In Shingrix clinical trials (ZOE-50) for adults over the age of 50, the effect of preventing shingles was 97% at 3.2 years after vaccination. In clinical trials (ZOE-70) for those aged 70 or older, it was 90% at 3.7 years after vaccination. In the case of Zostavax, a competitive product, it has a preventive effect of 51% for those over 50 and 41% for those over 70. SKY Zoster demonstrated Zostavax and specific heat in clinical practice. It is analyzed that there is no significant difference from Zostavax in terms of prevention rate. GC Pharma has experience in co-selling MSD's herpes zostavax vaccine in the past. GC Pharma co-sold Zostavax for eight years until 2020 through a contract extension once after signing a co-promotion contract with MSD since 2013. In the process, Zostavax has grown into a large item with annual sales of 80 billion won. However, SK Bioscience launched its competitive product SKY Zoster at the end of 2017, and sales have decreased significantly since 2020 as the overall market size has shrunk due to the prolonged Corona crisis. According to IQVIA, a pharmaceutical market research firm, Zostavax sales last year amounted to 27 billion won, down 68% in four years from 83.7 billion won in 2017. This year, sales were only 11.6 billion won until the first half of the year. The pharmaceutical industry expects Shingrix to lead the domestic shingles vaccine market to rebound. In the global market, Shingrix's sales, which had already been dampened by the Corona crisis, began to recover in the second half of last year. In the first half of this year, Shingrix's global sales were £1.429 billion, more than doubling compared to the same period last year.
Company
Pfizer Korea leaves its beloved 15-year Myeongdong office
by
Eo, Yun-Ho
Oct 14, 2022 05:53am
Pfizer Korea will be soon leaving its Pfizer Tower in Myeongdong where it had resided for 15 years. The company will relocate to the nearby Namsan State Tower later this month. In other words, the company’s lease contract for the Myeongdong Pfizer Tower will expire on the 30th. The new office building may be smaller in size, and executive rooms including the one for the CEO will be removed. Also, the smart office format will be expanded in line with the recent trend of multinational pharmaceutical companies' increased telecommuting, etc. The Pfizer Tower, which had been under sale, is now back on the market. GRE Partners, the owner of Pfizer Tower recently suspended the sales process that it had started in May. Although the company had selected JLL Korea as its sales agent and started a bid, the bid price reportedly fell short of the seller's desired amount. A Pfizer official said, “Our new office was designed to be more efficient, modern, and an inspiring workplace for our executives and employees, based on which we expect to provide an environment that can realize our purpose of ‘delivering breakthroughs that change patients’ lives.’” Pfizer had relocated from Gwangjang-dong in Gwangjin-gu, Seoul to the Myeongdong office in June 2007. Before then, in June 2006, the company bought the Myeongdong office at KRW 58 billion. According to real estate agents, the price of Pfizer Korea’s Myeongdong office is estimated to be around KRW 100 billion to 120 billion. This is a profit of over KRW 60 billion generated in 13 years. The sales and relocation of the previous Pfizer office are being made due to the spin-off of Viatris, which was formed through the merger of Patent’s off-patent drug division and Mylan.
Company
Xofluza, is aiming for a rebound in sales
by
Oct 14, 2022 05:53am
As soon as it was released, Xofluza, an unfortunate flu treatment that had little sales due to COVID-19, is seeking to rebound. As the flu pandemic warning has been issued for the first time in three years and the number of flu patients is increasing, Roche will also start selling Xofluza in earnest. ◆ New drug Xofluza for the first time in 20 years Xofluza is the next generation of flu treatment that Roche will succeed inTamiflu. Tamiflu is the only drug for new influenza and is a representative flu treatment for 20 years. Developed as a new mechanism of action in 20 years, Xofluza inhibits polymerase acid endonuclease, which is essential for cloning influenza viruses, preventing the progression from the early stages of virus replication. Xofluza dramatically reduced the number of doses. Unlike Tamiflu, which requires taking twice a day for five days, Xofluza only needs to be taken once within 48 hours of symptoms. In other words, 1 tablet of Xofluza can replace 10 tablets of Tamiflu. Xofluza, which received a lot of attention even before its approval and was approved by the Ministry of Food and Drug Safety in November 2019, had low sales due to the massive outbreak of unexpected COVID-19. As expected, sales of Xofluza had to rise from the 2020-2021 season, there were few opportunities for Xofluza to be used due to the unusually low flu epidemic for two consecutive years. This is because the entire nation is obligated to wear masks and social distancing has been strengthened. According to IQVIA, a pharmaceutical market research firm, Xofluza's quarterly sales were less than 100 million won. In the fourth quarter of 2020, which had the most sales, was only 75 million won. Despite sluggish sales, Xofluza has steadily expanded its indication. In January 2021, an indication of influenza prevention therapy was added. Xofluza can be taken as a preventive measure if in contact with an influenza-infected patient. In addition, in the United States this year, the indication has been expanded so that children aged 5 to 11 can use Xofluza. In Korea, only adolescents or adults aged 12 or older are subject to administration. Based on related research data, the age at which administration can be administered is expected to expand in Korea in the future. ◆Re-examination of Xofluza in the flu pandemic warning Xofluza, which has not been seen for two years due to COVID-19, is expecting a full-fledged increase in sales this year. This is because the flu is expected to be prevalent in the 2022-2023 season. The Korea Centers for Disease Control and Prevention issued a national flu pandemic warning for the first time since the COVID-19 pandemic. From the 4th to the 10th of last month, the proportion of influenza doctors (patients with suspicious symptoms) met the epidemic standard at 5.1 per 1,000 people and issued a pandemic warning earlier than usual. Trends in the proportion of suspected flu patients in the 2022-2023 season (Data: Korea Centers for Disease Control and Prevention) In fact, the number of patients with suspected symptoms per 1,000 outpatients is rapidly increasing. In the last week of September (September 25 to October 1), the number of patients showing suspicious symptoms per 1,000 outpatients was 7.1 per 1,000 patients, up 44.9% from the previous week. In preparation for the increase in the number of flu patients, Roche has also secured enough supplies of Xofluza. The Xofluza effect was demonstrated in phase 3 clinical trials (CAPSTONE-1, CAPSTONE-2, BLOCKSTONE). In a CAPSTONE-1 clinical trial of 1,436 patients aged 12 and over, Xofluza shortened the duration of influenza-related symptoms by more than one day compared to a placebo. It had a slight edge over Tamiflu. Xofluza significantly reduced the time to improve symptoms compared to placebo in high-risk groups aged 65 or older with a high risk of accompanying influenza complications (CAPSTONE-2). Subsequently, as a result of prophylactic administration of Xofluza to family members in contact with influenza-infected patients, the risk of developing influenza was reduced by 90% compared to the placebo (BLOCKSTONE). In order for Xofluza to be widely used like Tamiflu, it must be made. Roche attempted to register Xofluza salary in 2020 but received conditional non-payment at HIRA, the first gateway. The Pharmaceutical Evaluation Committee attached the condition that benefits are possible if the evaluation amount is less than or equal to the evaluation amount. Xofluza is still non-reimbursed as it ran parallel in the drug price negotiation process. It is not expected to be easy to apply for benefits during the 2022-2023 flu season. If Xofluza is prescribed as a non-payment, the price of the drug that the patient has to pay is known to be around 80,000 won to 90,000 won.
Company
PARP anticancer drugs raise expectations of ovarian cancer
by
Oct 14, 2022 05:53am
Lee Taek-sang, professor of obstetrics and gynecology at Boramae Hospital, Seoul Metropolitan Government As benefits are applied to the primary maintenance therapy of PARP inhibitors in ovarian cancer treatment in Korea, the treatment site is rapidly changing. Above all, a specialist evaluates that the use of PARP inhibitors for early treatment has significantly improved the patient's prognosis. However, the expansion of benefits and commercialization of HRd diagnosis in BRCA negative patients are considered tasks to be improved. ◆ Improved prognosis with recurrent ovarian cancer and PARP inhibitors Unlike other solid cancers, ovarian cancer has less remote metastasis and excellent sensitivity to anticancer drugs. Therefore, regardless of the stage of ovarian cancer, surgery and chemotherapy are considered the first-line treatment. However, the initial symptoms were insignificant, so cancer was often diagnosed after progression, and eight out of 10 patients suffered recurrence after the first treatment, making treatment difficult. PARP inhibitors have made new changes in the treatment of ovarian cancer. In the past, in addition to cytotoxic anticancer drugs, vascular endothelial growth factor (VEGF) inhibitors have appeared, but they were far from customized treatments due to specific biomarkers. PARP inhibitors were able to perform customized treatment according to biomarkers such as BRCA and homologous recombination deficiency (HRd). In an interview with Dailypharm, Lee Taek-sang, a professor of obstetrics and gynecology at Boramae Hospital, said, "PARP inhibitors have improved ovarian cancer prognosis and changed the treatment paradigm with survival rate. The PARP inhibitors used in Korea are Takeda's Zejula and AstraZeneca's Lynparza. Recently, PARP inhibitors in the U.S. have withdrawn their indications for the fourth or higher treatment of ovarian cancer, but the impact is expected to be minimal as both drugs are used in early treatment such as primary maintenance therapy. ◆ Same but different Zejula Lynparza Zejula and Lynparza show some differences in primary maintenance therapy. Basically, both drugs are used as maintenance therapy in platinum-sensitive patients, while Zejula can be used regardless of BRCA or HRd, while Lynparza can be used alone in BRCA-positive and in combination with Avastin in HRd-positive patients. Professor Lee said, "Lynparza is also likely to be effective in patients without BRCA or HRd mutations, but there is no indication because it was only for patients with BRCA mutations in the clinical trial on the basis of permission." Zejula added that through large-scale phase 3 clinical trials, consistent data are also available in BRCA-negative and HRp (homologous recombinant negative) patients. Health insurance benefits apply only to BRCA-positive patients on both drugs. In addition, when Lynparza is used as primary maintenance therapy, the benefit is applied only up to two years after initial administration, while Zejula can be used continuously until recurrence. This is because the follow-up period was only up to two years in clinical trials on which Lynparza permits were based. In addition, the two drugs also show differences in the number, dose, and safety profile of the drug. This difference is the standard for selecting drugs in the clinical field. Professor Lee said, "Lynparza is taken twice a day, but Zejula is taken only once a day. In addition, Zejula has data that shows consistent treatment effects even with adaptive doses, he said. "The more worrisome part is the benefit recognition period, and patients taking Lynparza are converted to non-reimursement two years after the benefit is applied," he said. ◆What is the direction of ovarian cancer treatment? The disappointing part of the benefit standard is the BRCA-negative patient. Zejula also demonstrated consistent benefits in BRCA-negative patients but was not recognized for benefit adequacy in the group. Professor Lee said, "It is certain that Zejula is helpful in this patient group, but the patient has to make a difficult decision because the drug has to be used as a non-payment." For HRd biomarkers, improving the diagnostic environment is a priority. Unlike the BRCA test, the HRd test method has not yet been commercialized, so it is limited to some institutions on a trial basis. The cost of the test also amounts to 5 million won. It is judged that more patients will be able to benefit from PARP inhibitors only when an environment where HRd tests can be freely used at the medical site is created. Professor Lee said, "If the results show that PARP inhibitor + Avastin combination therapy is more meaningful, the treatment pattern and paradigm can be changed again. In this case, the drug will be selected in consideration of the side effects and cost problems caused by Avastin, he said. "If the non-inferiority results show that there is no significant difference between the two treatments, it is expected to be a landslide victory for PARP inhibitor alone."
Company
The release of a flu vaccine exclusively for the elderly
by
Oct 13, 2022 06:09am
The development of domestic companies is still far away. In order to prevent influenza (flu) infection in the elderly, a high-performance vaccine with improved preventive effects will appear in Korea. One of the two representative products has been approved in Korea, and the other is likely to be introduced. According to the pharmaceutical industry on the 13th, CSL Seqirus's tetravalent flu vaccine Fluad, which contains immunostimulants for the elderly aged 65 or older, has completed domestic approval and is preparing for its introduction. Due to the schedule, it is difficult to sell in the 2022-2023 season, but it is expected to be released next year during the flu season. Sanofi is also considering introducing a high-dose flu vaccine in Korea for those aged 65 or older. In the United States, it has been sold under the name Fluzone since it was approved in 2019. ◆ Influenza vaccines that have increased effectiveness for the elderly with reduced immunity appear Older people aged 65 or older are considered high-risk groups for flu, so active prevention is recommended with vaccination. Korea provides free flu vaccinations to senior citizens aged 65 or older through NIP. However, with conventional vaccines, the preventive effect tends to be somewhat reduced in the elderly with a reduced immune system. Accordingly, flu vaccine developers have started to develop new vaccines to increase preventive effects. Fluad, developed by CSL Seqirus, can improve the immune response by adding an immune enhancer called MF59. MF59 is an immune enhancer made using squalene ingredients produced in the liver. MF59 induces a cellular immune response to promote antigen absorption by antigen-presenting cells, thereby increasing the immune response through the activation of T cells and B cells. Even with a small amount, it can exert a strong antibody effect. MF59 was also used during the swine flu epidemic in 2009. According to a study by CSL Seqirus comparing the difference in disease burden according to the type of vaccine for senior citizens aged 65 or older in Korea, it is predicted that the burden of flu-related diseases will be significantly reduced when switching from the existing flu vaccine to a vaccine containing immune enhancers. Vaccines containing immunostimulants are expected to prevent 35,390 cases of flu, 1,602 cases of flu-related complications, 709 cases of hospitalization, and 145 cases of deaths per year compared to existing vaccines. Fluzone, developed by Sanofi, is a product that increases the number of antigens, unlike Fluad, which has added immune enhancers. It is known to have four times more antigens than existing doses. It was first approved in the U.S. in 2019 and is considering introducing in Korea. It is predicted that vaccinations with high doses will reduce the burden of diseases similar to vaccines containing immunostimulants. ◆ Vaccination for the elderly being reorganized with high-performance In the United States, flu vaccines for the elderly are changing mainly to high-performance products. This is because the analysis of studies in recent years has proved that high-performance vaccines are more advantageous in reducing the risk of hospitalization and death in the elderly over 65. In terms of safety, side effects such as pain at the injection site were reported more frequently after high-performance vaccination, but they were resolved naturally over time. Based on this, the U.S. ACIP revised its flu vaccination guidelines and recommended that senior citizens aged 65 or older receive a high-dose flu vaccine (Fluzone) or a flu vaccine containing immunostimulants. On top of that, only recombinant vaccines containing three times more antigens than existing vaccines were additionally included in the recommendation list for vaccination for the elderly. When the domestic high-performance flu vaccine market opens, multinational pharmaceutical companies are expected to dominate the market for a while. This is because only one domestic company is developing a high-performance flu vaccine, and even this has been slow to develop. GC Pharma has started developing GC3114, the first high-capacity flu vaccine in Korea. In 2018, the phase 2 clinical trial plan of GC3114 was approved and the clinical trial was completed the following year, but it was found to be in a holding state for three years. It is estimated that it will take more than five years to commercialize it as it has not yet entered phase III and has not set a specific schedule.
Company
How about collaboration?
by
Kim, Jin-Gu
Oct 13, 2022 06:09am
4th largest population in the world, the advantage of clinical performance. Indonesia is emerging as a new market for the Korean pharmaceutical bio industry. In addition to the potential of being the world's fourth-largest population, the pharmaceutical market seems to be expanding rapidly as national income has recently increased overall. In line with this trend, the Indonesian government is strengthening benefits for locally produced drugs. Analysts say that for Korean pharmaceutical bio companies seeking to enter Indonesia, establishing local subsidiaries or collaborating with Indonesian companies will be an effective strategy rather than directly exporting. ◆ Indonesian government emphasizes local production On the 12th, "Global Bio & Pharma Plaza 2022" was held at Lotte Hotel World in Songpa-gu, Seoul, hosted by the Ministry of Trade, Industry and Energy. Dr. Banun attended the "Pharmaceutical Overseas Advancement Strategy Briefing" held together on the same day at the Indonesian Ministry of Health to explain the recent changes in Indonesia's policy to foster the pharmaceutical industry. According to him, the Indonesian Ministry of Health has been planning to foster the pharmaceutical and medical device industries with a 10-year long-term plan since 2016. The key is to encourage the production of medicines, raw materials for medicines, and medical devices in Indonesia. Tinkat Komponen Dalam Negeri (TKDN) was specified, and for raw material drugs, the proportion of domestic production was increased to 65%. Through this, the Indonesian government's goal is to reduce the high dependence on imports of raw materials and drugs. Dr. Banun said, "By 2024, we will make efforts to develop the pharmaceutical industry at the national level." He said, "In particular, we are focusing on the domestic manufacturing and production of medicines. "We will spare no financial support for the domestic production of major drugs," he explained. "Whether it's raw material or finished product, it's giving a lot of benefits to companies that produce medicines in Indonesia," he said. He said, "We are attracting overseas pharmaceutical companies by establishing free economic zones along with special tax cuts. "If Korean pharmaceutical companies collaborate with Indonesia, we expect good results," he stressed. ◆"Daewoong and Chong Kun Dang's cooperation with local companies, best practices for entering Indonesia" Dr. Banun cited Daewoong Pharmaceutical and Chong Kun Dang's entry into Indonesia as an exemplary example. Among Korean pharmaceutical companies, Daewoong Pharmaceutical entered Indonesia in 2012 and Chong Kun Dang in 2015 through joint ventures with local companies. Daewoong Pharmaceutical completed the construction of a pharmaceutical plant in Surabaya in cooperation with local pharmaceutical company Infion. This factory is certified halal for medicine. Currently, it ranks first in the anemia treatment (EPO) market in Indonesia. Chong Kun Dang entered the local market through a joint venture with another local pharmaceutical company, OTTO. In 2018, it completed the first halal-certified anticancer drug plant in Indonesia. Dr. Banun emphasized the "halal certification" received by the two pharmaceutical companies. Halal certification is essential in addition to its own GMP certification to enter Indonesia, he explained. "Daewoong Pharmaceutical and Chong Kun Dang have successfully established themselves as halal-certified pharmaceutical companies," Dr. Banun said. "It is a successful case of cooperation between Korean and Indonesian companies." Dr. Banun said, "In Indonesia, Halal certification is required. If there is a Korean company entering Indonesia, (the Ministry of Health of Indonesia) will help with quick certification, he said. "If we get halal certification here, it will be easy to enter the Middle East or other Southeast Asian countries that need the same certification." ◆ Interested in cooperation with Korean pharmaceutical companies in drug and health product development" In the case of Genexine, a joint venture named Kalbe and KGBIO is being established and developing immuno-cancer drugs GX-17 and new anemia drug GX-E4. "In the case of Indonesia, it has the advantage of conducting clinical trials as the world's fourth-largest population," said the CEO. "In recent years, interest in health products has also been heating up." "We are interested in developing cooperative relationships with Korean pharmaceutical companies that have excellent health products," he said.
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