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- 2026-05-08 01:10:32
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- Keytruda leads the market for 3 consecutive years
- by Chon, Seung-Hyun Feb 22, 2023 05:54am
- The immuno-oncology drug Keytruda has topped the rank in pharmaceutical sales for 3 consecutive years. Also, new drugs from multinational pharmaceutical companies, such as Gardasil 9, Prolia, Opdivo, and Dupixent showed strong growth and joined the KRW 100 billion club after exceeding KRW 100 billion in sales last year. On the 22nd, according to the pharmaceutical research institution IQVIA, MDSD's Keytruda's sales topped the market by recordeingKRW 239.6 billion last year. This is a 19.7% YoY increase from the previous year. This is the third consecutive year the drug has held the lead after taking the top spot for the first time in 2020 with sales of KRW 155.7 billion. Also, Keytruda’s sales exceeded 200 billion won for 2 consecutive years since 2021. Keytruda is an immune checkpoint inhibitor that inhibits PD-1 proteins expressed at the surface of activated T cells, thereby inhibiting its binding to PD-L1 and activating the immune system to treat cancer. The drug is currently approved for 16 cancers: ▲Lung cancer, ▲head, and neck cancer, ▲ Hodgkin lymphoma, ▲urothelial carcinoma (bladder cancer), ▲esophageal cancer, ▲ melanoma, ▲renal cell cancer (kidney cancer), ▲endometrial cancer, ▲stomach cancer, ▲small intestine cancer, ▲ovarian cancer, ▲pancreatic cancer, ▲biliary tract cancer, ▲colorectal cancer ▲triple negative breast cancer, and ▲cervical cancer. It is indicated for the largest number of cancer types among cancer immunotherapies approved in Korea. In the early years of its release, in 2016 and 2017, its sales had only been KRW 100 billion and KRW 12.2 billion. However, its sales started to surge with reimbursement approval. After reimbursement was applied for non-small-cell lung cancer (NSCLC) in August 2017, its sales soared over fivefold to KRW 70.3 billion in 2018, and then exceeded KRW 100 billion by 2019. In 2020, the drug outsold the then-lead Lipitor and rose to the lead. Last year, Keytruda continued strong growth amid favorable and unfavorable events. Keytruda’s insurance ceiling price had fallen 25.6% with its reimbursement extension to first-line treatment of NSCLC in March this year. Its sales in Q1 last year had fallen 8.4% compared to the same quarter the previous year due to the price cut – to KRW 40.4 billion – but it recovered its momentum after the benefits from its first line reimbursement were applied in earnest. When considering the price cut that was applied to Keytruda, its sales volume has increased by over 60%. New drugs from multinational pharmaceutical companies showed strong sales and made the ranks last year. MSD’s HPV vaccine Gardasil 9 ranked third last year with sales of KRW 117 billion, rising 61.2% from the previous year. Gardasil 9 is an improved version of the company’s Gardasil, which offers protection for four serotypes (6, 11, 16, and 18). Gardasil 9 offers protection for five more serotypes (31, 33, 45, 52, 58) than Gardasil. Also, It contains the most HPV types among cervical cancer vaccines. Vaccinations among males for Gardasil 9, which was released at the end of 2016, have also been rising every year with the news spreading that Gardasil 9 offers protection for HPV-related diseases other than cervical cancer, such as anal cancer, genital warts, and precancerous lesions. Also, the revaccination rate has also risen greatly among adults who already received vaccination after the recommended age was expanded from 9-26 to 27-45 in July 2020. Sales of Gardasil 9 had increased over twofold in 2 years from KRW 42.5 billion in 2020 to exceed KRW 100 billion for the first time last year. Amgen’s Prolia ranked fourth raising KRW 115.7 billion YoY last year. Prolia, a biological osteoporosis treatment that targets the RANKL protein essential for the formation, activation, and survival of osteoclasts that destroy the bone, was released in November 2016 in Korea. Its sales started to rise after it was applied reimbursement as a second-line treatment in 2017. After additionally being approved for reimbursement in the first line from April 2019, Prolia’s sales rose explosively and its annual sales exceeded KRW 100 billion for the first time. Prolia is copromoted by Chong Kun Dang in Korea. Sales of Ono Pharmaceutical’s cancer immunotherapy Opdivo increased 29.3% YoY to record ₩109.9 billion this year. Opdivo, which was approved in 2015, recorded a high growth rate of 64.7% in two years from the 66.7 billion it had earned in 2020, and its annual sales exceeded 100 billion for the first time last year. Sales of Sanofi’s atopic dermatitis treatment Dupixent rose 36.3% YoY to record ₩105.2 billion last year. Dupixent is the first targeted biologic for the treatment of moderate-to-severe atopic dermatitis that is not well controlled with prescription topical therapies or who cannot use topical therapies. Sales of Dupixent, which was approved in March 2018, increased rapidly after it was approved for reimbursement for severe atopic dermatitis in January 2020, and exceeded KRW 100 billion last year. Roche’s Perjeta’s annual sales rose 9.4% YoY to record KRW 102.7 billion last year. Perjeta is approved for use in combination with docetaxel and trastuzumab in patients with metastatic or unresectable locally advanced HER2-positive breast cancer who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer. The drug was approved for reimbursement to treat patients with metastatic or unresectable locally advanced HER2-positive breast cancer who have not received anti-HER2 therapy in 2017. After the drug was granted selective reimbursement in May 2019, trastuzumab and combination therapy settled as the standard adjuvant therapy and its sales exceeded KRW 100 billion. Among new drugs developed by domestic pharmaceutical companies, HK.Inno.N’s K-CAB’s sales rose 16.0% YoY to record KRW 104.8 billion and ranked eighth last year. K-CAB, which was released in March 2019. 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.
- Company
- GC Biopharma receives WHO Pre-Qualification for Barycela
- by Kim, Jin-Gu Feb 21, 2023 05:52am
- Pic. of Barycela GC Biopharma announced that the World Health Organization (WHO) has granted prequalification (PQ) for its varicella vaccine, Barycela. Vaccines that receive the WHO prequalification decision after a review of their safety and efficacy become eligible for procurement by the United Nations agencies to be used in national immunization programs. With the approval of its varicella vaccine, the company now owns 3 PQ vaccines along with its H1N1 pandemic and seasonal influenza vaccines. Barycela is a live attenuated varicella virus vaccine that contains the MAV/06 strain, a virus exclusively attenuated by GC Biopharma. The product has improved stability while containing a higher amount of virus compared to its previous product. In a global trial, the company demonstrated Barycela’s noninferiority in terms of immunogenicity and an equivalent level of safety compared with Varivax, an existing prequalified vaccine in the market. The vaccine is produced in a state-of-the-art aseptic system through cell culture, virus infection, and purification. It has the characteristic of being the only varicella vaccine produced without antibiotics. With the WHO's PQ decision, the company believes that there is a rising possibility that its ‘MAV/06 strain’ will be registered in the WHO Technical Report Series (TRS) in addition to the previously listed OKA strain. Also, GC Biopharma plans to actively target the global market with Barycela by utilizing the global supply network it had previously established supplying its existing varicella vaccine. Eun Chul Huh, President of GC Biopharma, said, “We hope to continue contributing to reducing the world's social and economic cost incurred by varicella outbreaks with Barycela.” In 1993, GC Biopharma received approval for ‘Suduvax,’ the first varicella vaccine in Korea and the world's second varicella vaccine. Over 28 million doses of Suduvax have been sold worldwide over the past 3 decades through PAHO and others.
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- 3rd PARPi Talzenna may be prescribed at hospitals in Korea
- by Eo, Yun-Ho Feb 21, 2023 05:52am
- Korea’s third PARP inhibitor, ‘Talzenna’ can now be prescribed at general hospitals in Korea. According to industry sources, Pfizer Korea’s breast cancer susceptibility gene (BRCA)-mutated (gBRCAm) treatment ‘Talzenna (talazoparib)' passed the drug committee reviews of various medical institutions in Korea, including the National Cancer Center St. Mary’s Hospital and Yeouido St. Mary's Hospital. Talzenna was approved in Korea in July 2020 as monotherapy for the treatment of adult patients with germline BRCA mutations who have HER2-negative locally advanced or metastatic breast cancer with previous treatment experience. Afterward, the company applied for reimbursement, and the agenda was selected for review by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee in November of the same year but was unable to pass CDDC deliberations, and no progress had been made since. The health authorities are known to have been expressing concerns about reimbursing PARP inhibitors like Talzenna in breast cancer due to their broad indication in the disease. AstraZeneca’s Lynparza was the first PARP inhibitor to receive reimbursement in Korea. Lynparza was listed for reimbursement in October 2017 and was applied the Expenditure Cap type of the Risk Sharing Agreement (RSA) through the pharmacoeconomic evaluation exemption system. Listing of Takeda’s ‘Zejula’ followed in December 2019. The drug may be prescribed as maintenance monotherapy for adult patients with platinum-sensitive recurrent ovarian cancer who are in complete or partial response to platinum-based chemotherapy. However, its first reimbursement was only approved for approved the BRCA-positive indication. However, both drugs are experiencing difficulty extending reimbursement to breast cancer. Meanwhile, Talzenna’s efficacy was demonstrated through the large-scale, open-label, randomized, international Phase III trial, EMBRACA. The trial compared the efficacy of Talzenna monotherapy versus chemotherapy of the investigator’s choice in patients with gBRCA-mutated HER2-negative locally advanced or metastatic breast cancer who received no more than 3 prior cytotoxic chemotherapy regimens for their metastatic or locally advanced disease. Results showed that the median progression-free survival (mPFS), the primary efficacy endpoint, was 8.6 months for the Talzenna monotherapy arm, which was a significant improvement compared with the 5.6 months in the chemotherapy arm. Also, the risk of disease progression or death was 46% lower in the Talzenna monotherapy arm compared to the chemotherapy arm. Such significant improvement in PFS in patients treated with Talzenna was consistently observed across major patient subgroups, which were defined by the number of prior cytotoxic regimens, hormone receptor status (HR+ or TNBC), and history of CNS metastases. Also, the secondary endpoint, objective response rate (ORR), was 62.6% for the Talzenna monotherapy arm, which was more than double the 27.2% achieved in the chemotherapy arm.
- Company
- Organon ‘Samsung’s Humira biosimilar to make KRW 100 billi
- by Jung, Sae-Im Feb 20, 2023 05:53am
- Samsung Bioepeis’ U.S partner Organon projected that the sales of the company’s Humira biosimilar will reach a maximum of KRW 123.5 billion in the first year of its release. On the 16th (local time), Organon projected so while presenting its full-year 2022 financial results, announcing that the company “will be launching the Humira biosimilar ‘Hadlima’ in the U.S. July this year.” Hadlima is a Humira biosimilar that was developed by Samsung Bioepis. Humira is a blockbuster drug that held the ranks as the most-sold drug worldwide for a decade. Its global sales recorded USD 21.24 billion (approximately KRW 27 trillion) last year, of which sales in the U.S. accounted for USD 18.62 billion (approximately KRW 24 trillion). Starting with Amgen, various companies including Samsung Bioepis, Boehringer Ingelheim, Pfizer, and Coherus are set to release Humira biosimilars this year. Amgen’s ‘Amjevita’ has already been released to the market. In particular, up to 8 companies including Samsung Bioepis are expected to competitively release their biosimilar products in July this year. Building on their successful launch of Hadlima in Canada and Australia, the company expects the experience to positively impact the launch in the U.S. market. Also, it pointed to Hadlima’s equal product composition and pen device technology as what differentiates its biosimilar from other products. Organon said, “We have launched Hadlima in Canada and Australia in 2021 and achieved good results. The data we collected from the launches will support our launch of the same in the U.S. Both the citrate-free, high-concentration formulation and the low-concentration formulation will be released then. The design of the pen that contains the drug can also be a differentiating factor. As a device design and manufacturing expert, the company designed the pen to ensure a smooth transition for the patients switching from Humira to Hadlima.” Organon expects Hadlima to make sales of up to USD 96.75 million (KRW 123.5 billion) this year, the first year of its launch in the US. This amount was derived based on the expectation that Hadlima sales will not exceed 1.5% of the estimated total sales of USD 92.25-96.75 million (KRW 117.8-123.5 billion), which roughly amounts to USD 92.25-96.75 million (KRW 117.8-123.5 billion). This will be around fivefold of what Hadlima made last year (USD 19 million, KRW 24.2 billion). Organon said, “We expect sales of Hadlima to rise gradually with competition among biosimilars to be officially listed by major Pharmacy Benefit Managers (PBMs) in the U.S. From the next year after the biosimilar market is formed in earnest, Hadlima will grow into Organon's second largest grossing product.” The ‘interchangeable biosimilar’ designation sought by Samsung Bioepis was expected to be achieved in Q2 to Q3 of 2024. The interchangeable biosimilar designation is made by the U.S. Food and Drug Administration for biosimilars that are very similar to and have no clinically meaningful differences from the original drug. Drugs that are approved as interchangeable biosimilars may be substituted at the pharmacy without a separate order for switching by the prescribing health care provider. Organon said, “We expect to be able to receive the interchangeable biosimilar designation around one year after Hadlima’s release in July. Our other Humira biosimilar competitors will also be able to receive designation by then. For the first 1-2 years after a drug is launched, whether the drug received the interchangeable biosimilar designation does not become a key point of differentiation for biosimilars during discussions with PBMs. As long as give convince them that we can receive the designation within a reasonable period of time, it will not be a major point for discussion at the negotiation table."
- Company
- Novartis’s Jakavi makes a step towards reimb for GvHD
- by Eo, Yun-Ho Feb 20, 2023 05:52am
- ‘Jakavi’ is now one step closer to extending reimbursement to Graft versus Host Disease (GvHD) in Korea. According to industry sources, Novartis Kroea’s Jakavi (ruxolitinib) recently passed deliberation by the Drug Reimbursement Evaluation Standard Subcommittee. The next step is for the drug to be reviewed by the Drug Reimbursement Evaluation Committee. Novartis Korea submitted an application to extend reimbursement for Jakavi (ruxolitinib) to Graft-versus-Host Disease (GvHD), immediately after receiving approval for the indication in May 2022. The application passed review after being pending at this stage for 8 months. GvHD is a potentially serious complication that may occur after allogeneic stem cell transplantation. When the donor’s T cells (the graft) view the patient’s healthy cells (the host) as foreign and attack and damages them, affecting various organs including the skin, the gastrointestinal tract, the liver, and the lungs. As symptoms can appear throughout the body, GvHD poses another challenge to patients who have survived allogeneic hematopoietic stem cell transplantations by affecting the patient’s quality of life. Steroids are used as standard first-line therapy, but unmet needs exist as no standard-line therapy exists in the second-line for the 50% of patients that fail treatment in the first-line. In this area, Jakavi arose as an option that can be used to treat patients aged 12 years and older with acute or chronic GvHD who have an inadequate response to corticosteroids or other systemic therapies. Hee-Jae Kim, the Chief Chair of the Korean Society of Blood and Marrow Transplantation (Professor of Hematology at the Catholic University of Korea), said, “Jakavi demonstrated superior effect in treating acute and chronic GvHD patients in clinical studies and has shown similar results in the field, and opened up new possibilities for patients suffering from the lack of an appropriate treatment option” Meanwhile, Jakavi has demonstrated its efficacy in the Phase III REACH2 trial. Results showed that the overall response rate with Jakavi at Day 28 was 62% (96/154), compared to the 39% that was achieved with the best available therapy (61/155) Also, the durable overall response was found to be twice higher in the Jakavi group at Day 56 at 22% (34/155) compared with 40% (61/154) in the control group.
- Company
- Leclza’s partner ‘Rybrevant’ lands in Big 5 hospitals
- by Eo, Yun-Ho Feb 17, 2023 05:50am
- The anticancer drug Rybrevant which targets a small number of lung cancer patients has landed at general hospitals in Korea. According to industry sources, Janssen Korea’s Rybrevant (amivantamab), which is used to treat EGFR exon 20 insertion non-small-cell lung cancer (NSCLC) that is insensitive to currently available EGFR tyrosine kinase inhibitors (TKIs), has passed the drug committees of 18 medical institutions in Korea including tertiary hospitals such as the Samsung Medical Center, Seoul National University Hospital, Seoul St.Mary’s Hospital, Seoul Asan Medical Center, and Sinchon Severance Hospital, as well as other institutions nationwide, such as Gangnam Severance Hospital, National Cancer Center, Konyang University Hospital, Kyungpook National University Hospital, Ajou University Hospital, Incehon St.Mary’s Hospital, Jeonbuk National University Hospital, Chungnam National University Hospital, Kyungpook National University Chilgok Hospital, and Chonnam National University Hwasun Hospital. The drug has landed relatively quickly for prescriptions after being approved in Korea in February last year. However, Rybrevant is currently a non-reimbursed drug. Janssen applied for reimbursement but was unable to pass deliberations by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee. The company is known to be preparing to reapply for reimbursement. EGFR exon 20 insertion mutations in NSCLC are so rare that it is found in only 2% of all NSCLC patients harboring EGFR mutations in Korea. With no suitable treatment available for the specific condition, even the NCCN guidelines have only been recommending platinum-based chemotherapy for the patients. And even this is subject to expenditure cuts. Although lung cancer in itself is not a rare disease, NSCLC with EGFR exon 20 insertions can be classified as a rare condition. Unlike other common EGFR mutations, NSCLC patients with EGFR exon 20 insertion mutations have a 75% higher risk of death, a 5-year survival rate of 8%, and a life expectancy of less than 2 years. Rybrevant, which is well known for its combined use with ‘lasertinib (Leclaza),’ was the first targeted therapy approved in Korea for the treatment of NSCLC with EGFR exon 20 insertion mutations in February this year. The approval for the drug was based on the results from the CHRYSALIS study, where the drug demonstrated an overall response rate (ORR) of 40%, a 4% complete response (CR), and 36% partial response (PR) rate. The U.S. Food and Drug Administration (FDA) granted accelerated approval for the drug based on Phase I trial results in recognition of its value as a treatment for a rare type of cancer. Following the approval in the U.S., the drug also was designated for expedited review and approved in Korea. However, the issue lies in whether its value will be accepted during the reimbursement review. As the drug was approved based on data from a single-arm clinical trial that was conducted without a control group, Rybrevant needs to take the pharmacoeconomic evaluation exemption track for reimbursement. Therefore, the key issue lies in whether Rybrevant’s value as a treatment for a rare cancer, not just lung cancer, will be acknowledged during the reimbursement review. Byoung-Chul Cho, Chief of the Lung Cancer Center at Yonsei Cancer Center, said “EGFR exon 20 insertion presents in various subtypes, and the sub-analysis of the CHRYSALIS study showed that Rybrevant showed an even response rate across several subtypes. In addition to its target inhibition effect, Rybrevant shows more promise due to its immune cell-directing activity.”
- Company
- Samsung Bioepis Soliris patent partially invalidated
- by Kim, Jin-Gu Feb 16, 2023 05:52am
- SolirisSamsung Bioepis succeeded in partially invalidating the 'Solaris patent. A blue light has been turned on for the release of the Soliris biosimilar this year. According to the pharmaceutical industry on the 13th, the Korean Intellectual Property Tribunal ruled in favor of Samsung Bioepis and ruled in favor of Samsung Bioepis in the invalidation trial filed in the Soliris usage patent. Soliris is a rare disease treatment developed by Alexion in the U.S. It is known to be an ultra-high-priced drug with an annual drug cost of 500 million won. Handok is in charge of sales in Korea. In January 2010, PNH was approved in Korea as an indication. Since then, the indications have expanded to the atypical uremic syndrome, systemic severe work history, and optic nerve scoliosis. In Korea, Samsung Bioepis is challenging the development of Soliris biosimilars. Phase 3 clinical trials were completed in October 2021. In July last year, the Ministry of Food and Drug Safety applied for an item license. It then applied for and registered trademarks named "EPYSQLI" and "EPIZQA." At the same time, the Soliris patent was requested to be invalidated. Soliris has two patents registered. However, among the two patents, the patent for "a method for treating glomerulonephritis and other inflammatory diseases and a composition for treatment" expired in July 2015. The remaining "how to treat hemolytic diseases" patents expire in February 2025. However, as Samsung Bioepis succeeded in partially invalidating the patent, the possibility of releasing related biosimilars within this year has increased. The pharmaceutical industry is paying attention to the timing of the release of the Soliris biosimilar. This is because Soliris is rapidly being replaced by Ultomiris, a follow-up drug. According to IQVIA, an actual drug market research firm, Soliris' cumulative sales in the third quarter of last year were KRW 7.7 billion, down a quarter from 28.4 billion won a year earlier. Ultomiris, on the other hand, increased 3.7 times from 8.9 billion won to 32.7 billion won during the period. Samsung Bioepis should release the product as soon as possible. Soliris should be administered daily for the first four weeks and then administered with a retention dose every two weeks thereafter. On the other hand, Ultomiris can be administered once every 8 weeks from 2 weeks after the initial dose administration.
- Company
- Open Innovation Trend
- by Jung, Sae-Im Feb 16, 2023 05:52am
- China is pushing for a policy to restrict its biopharmaceutical technology from escaping abroad. In the pharmaceutical industry, where open innovation has become a trend, the U.S. and China are taking the opposite step by fighting for technological supremacy. According to a report published by the Bioeconomic Research Center of the Korea Bio Association on the 14th, China's Ministry of Commerce recently collected public opinions on revising its export-restricted technology catalog. The notice posted on China's commerce ministry's website calls for revising the list of technologies that will restrict exports based on the Foreign Trade Act and the Technology Import and Export Management Regulations with the Ministry of Science and Technology. The technology export referred to here refers to the transfer of technology from China to overseas through the transfer of patent rights or patent application rights, patent enforcement permits, technology secret transfer, and technology services. In the revision of the list of technology export restrictions, technologies such as the Internet, solar and new energy, autonomous driving, and biopharmaceuticals that have made rapid progress in China in recent years have been raised. Biopharmaceutical technology includes human-related cell cloning and gene editing technology, CRISPR gene editing technology, and synthetic biology technology. In particular, gene editing and synthetic biology are areas that are actively being studied around the world. Genetic editing technology refers to deleting or rewriting genetic information by cutting a specific part of DNA for the purpose of treating or preventing diseases. Reproductive cell editing is strictly limited to ethical issues and potential risks, so most companies use patient somatic cells. Synthetic biology technology is a technology that redesigns biological systems such as enzymes, biosynthetic pathways, and cells to create biological systems with new functions. China is promoting innovation in synthetic biology technology and applying it to a wide range of areas such as new drug development and resource supply through the 14th Five-Year Bio-Economic Development Plan. While open innovation, which is jointly conducted by multinational pharmaceutical companies, is actively carried out, the battle for supremacy between China and the United States over innovative technologies continues. Earlier, the U.S. strengthened its trading monitoring for fear of China taking biotechnology away. In 2018, the Foreign Investment Risk Review Modernization Act (FIRMA) was enacted, which could restrict foreign investors such as China from accessing the U.S. market. This is to strengthen transaction monitoring on Chinese capital, from simple license transactions to M&A transactions. Recently, the government is also pushing for the enactment of the National Core Capacity Defense Act (NCCDA), which regulates investment and transaction activities in overseas concerned countries such as China. In addition to semiconductors, batteries, artificial intelligence, and quantum technologies, pharmaceuticals and bioeconomics were included in the technologies subject to national core competencies. China's push to restrict exports of biopharmaceutical technology is seen as a countermeasure to the U.S. move. It also shows confidence that China is not behind the U.S. in gene editing technology and synthetic biology. The report said, "China's recent attempt to designate bio-medicine-related technologies such as gene editing technology and synthetic biology as export-restricted technologies are believed to be on par with the U.S. in this technology field."
- Company
- Sorrento Theraputics Inc. filed for bankruptcy protection
- by Hwang, Jin-joon Feb 16, 2023 05:51am
- Sorrento Theraputics Inc. researchers are studying candidate materialsSorrento Theraputics Inc., a U.S. bio company invested by Yuhan Corporation, filed for bankruptcy protection in the Southern Texas Bankruptcy Court. Bankruptcy protection is a system similar to Korean court receivership. Sorrento Theraputics Inc. recently lost a damage suit worth 222 billion won, resulting in a short-term cash liquidity crisis. Its subsidiary Sciplex plans to continue its business regardless of Sorrento Theraputics Inc.'s bankruptcy protection procedures. According to industries on the 14th, Sorrento Theraputics Inc. filed for bankruptcy protection with the bankruptcy court in accordance with Chapter 11 of the U.S. Bankruptcy Act the previous day. Sorrento Theraputics Inc. is a new antibody drug development bio company listed on the Nasdaq. In 2016, 12.1 billion won was invested by Yuhan Corporation in the name of simple investment. Yuhan Corporation's stake in Sorrento is 0.6%. Through a joint venture, the two companies also established ImmuneOncia, a bio company specializing in developing new drugs specializing in immuno-cancer drugs. Chapter 11 of the Bankruptcy Act, which Sorrento filed with the Bankruptcy Court, is a system that seeks corporate rehabilitation by conducting restructuring procedures under the supervision of the Bankruptcy Court. It can be seen as similar to domestic court management. Unlike liquidation, which closes its business after clearing assets and liabilities, bankruptcy protection is a way to revive companies through government support and debt restructuring while carrying out projects such as R&D and investment attraction. Earlier, United Airlines, General Motors, and Chrysler revived through Chapter 11. The bankruptcy court accepts the Chapter 11 application if it deems it more economically profitable to normalize a company by means of cancellation or suspension of repayment of some or all of its liabilities. However, if the bankruptcy court determines that the rehabilitation plan is inappropriate, it may proceed with liquidation in accordance with Chapter 7 of the Bankruptcy Act. Sorrento filed for bankruptcy protection due to a short-term cash liquidity crisis. Sorrento explained that as of the date of filing for bankruptcy protection, it has more than 1.2685 trillion won in assets, including 158.6 billion won in damages against NantPharma and others, regarding the dispute over the right to sell the anticancer drug Cynviloq. During the same period, the debt was 298.1 billion won. The cash liquidity crisis occurred when Sorrento filed a lawsuit with Nant Pharma and others. NantPharma introduced the North American copyrights and pipelines of the anti-cancer drug Sinbilock, which was introduced by Samyang Holdings in 2015, with an advance of 114.2 billion won. The maximum contract amount, including technical fees according to the development stage, is 1.6491 trillion won. NantPharma has not released Sinviloc in the North American market. Sorrento filed a lawsuit, claiming that Patrick Sunxion, chairman of Abraxis Bioscience, who had a relationship with NantPharma for not releasing Sinviloc, introduced competitive drugs to protect the market status of Abraxane, an anticancer drug, in the early stages of its launch. The court recently ruled that Sorrento should compensate NantPharma subsidiary Nantcell for 222 billion won worth of damage. Of the total, 158.6 billion won was suspended for 70 days, but 63.4 billion won was decided to be immediately enforceable. If not implemented, the interest rate is 9%. After the results of the lawsuit were announced, Sorrento's stock price fell 72% from $0.94 the previous day to $0.26. Sorrento explained that it submitted an application for bankruptcy protection to protect the company, judging that the business operation and development of new drugs could be suspended due to the cash liquidity crisis following the result of the damage suit. As of the third quarter of last year, Sorrento's cashable assets are worth 88.8 billion won. Sorrento Theraputics Inc. also stressed that it will continue to develop new drugs in connection with the bankruptcy protection filing.
- Company
- Exports of Dong-A ST’s anemia biosimilar exceed KRW 10 bil
- by Chon, Seung-Hyun Feb 16, 2023 05:51am
- The first biosimilar developed by Dong-A ST has made over KRW 10 billion in exports for 2 consecutive years. The cumulative export sales amount of the drug reached KRW 35.6 billion only 3 years after the drug entered the Japanese market. According to Dong-A ST on the 1st, the overseas sales of ‘Darbepoetin-α’ last year recorded KRW 13.3 billion, a 6.4% increase from KRW 12.5 billion in 2021. Darbepoetin-α is a biosimilar of the second-generation anemia treatment ‘Nesp (darbepoetin-α)’ that was co-developed by Amgen and Kyowa Kirin. The erythropoietin (EPO) in the drug accelerates red blood cell production by stimulating the erythroblasts and is used to treat chronic kidney disease or anemia in patients who receive chemotherapy. Annual exports of Darbepoetin-α (Unit: KRW 100 million, Data: Dong-A ST The overseas sales of ‘Darbepoetin-α’ solely depend on the drug’s exports to Japan. After conducting the Phase 1 clinical trial on’ Darbepoetin-α,’ Dong-A ST signed a licensing-out agreement on the development and sale of its drug to Sanwa Kagaku Kenkyusho (SKK). Based on a Phase III trial conducted in Japan to compare the efficacy and safety of ‘Darbepoetin-α’ to the original ‘Nesp,’ SKK received marketing approval from Japan's Ministry of Health, Labor and Welfare the drug in September 2019, and launched the drug for sale in November of the same year. Since then, Dong-A ST has been exporting the finished product to SKK, which was produced by STGen Bio, a biosimilar company under Dong-A Socio Group, with SKK responsible for its local sales. After generating KRW 1 billion in exports in Q4 2019, the drug sold KRW 8.8 billion and KRW 12.5 billions' worth each in exports in 2020 and last year, respectively. In Q4 last year, exports amounted to KRW 35.6 billion. By last year, the cumulative exports of Darbepoetin-α were found to be 35.6 billion won. The rise in sales is analyzed to be connected to the increase in reliability based on accumulated use experience in the field. Following Japan, Darbepoetin-α is now set to be introduced to the Turkish market. Dong-A ST singed signed a licensing and supply deal with the Turkish pharmaceutical company Polifarma in November last year, Under the agreement, Dong-A ST will transfer the exclusive development and marketing rights to Darbepoetin-α in Turkey, Brazil, and Mexico to Polifarma. Under the deal, Dong-A ST will receive an upfront payment and milestone payments for each stage of development and commercialization while being in charge of the exclusive supply of finished products. Polifarma is a Turkish pharmaceutical company that owns a global sales network in over 50 countries. The company has experience exporting more than 500 drugs to the United States, Europe, Brazil, and Mexico, among other countries, and accumulated relevant approval experience.
