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- 2026-06-21 13:47:31
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- K-Pharma focuses on developing CAR-NK cell therapies
- by Son, Hyung-Min Aug 20, 2024 06:34am
- Korean biopharmaceutical industry speeds up the development of chimeric antigen receptor (CAR)-NK cell therapy. GC Cell has recently entered the Phase 1 clinical trial in South Korea. Companies are collaborating on developing CAR-NK therapies through joint-research agreements: GI Cell and Y-Biologics and TS Bio and Maru Therapeutics. NKMAX has confirmed the potential of its candidate in a preclinical study. According to industry sources on August 19th, GC Cell received approval of Investigational New Drug (IND) application from the Ministry of Food and Drug Safety (MFDS) for a Phase 1 clinical trial of its CAR-NK therapy 'GCC2005' on August 14th. GCC2005, an allogeneic cell therapy utilizing NK cells derived from umbilical cord blood, targets CD5, which is highly expressed in T-cell lymphoma. CD5 is a biomarker highly expressed in many T-cell lymphoma subtypes. GCC2005 is a CAR-NK cell therapy designed to co-express CAR and interleukin (IL)-15, improving the short persistence of existing NK cells and enhancing efficacy. GC cell developed a technology to mass culture high-purity and highly active NK cells from a small quantity of umbilical cord. CAR-NK, an allogeneic therapy, has the advantage of improving side effects compared to existing CAR-T therapies. CAR-T induces cytokines, such as interleukins associated with neurotoxicity, whereas activated NK cells generally produce interferon-gamma (IFN-γ) and granulocyte-macrophage colony stimulating factor (GM-CSF). Accordingly, CAR-NK is less likely to cause cytokine release syndrome (CRS) or neurotoxicity. GC2005 demonstrated anticancer effects in various in vivo CD5+ T-ALL models (RPMI-8402, CCRF-CEM). GCC2005 showed a higher survival rate and tumor-suppressive efficacy than a vehicle. Additionally, GC Cell is developing the CAR-NK cell therapy 'AB-201' with the U.S. affiliate company Artiva. AB-201 targets solid cancers, including HER2-overexpressed breast cancer and gastric cancer. In 2022, Artiva received IND approval from the U.S. Food and Drug Administration (FDA) for Phase 1/2 trials of its AB-201. Then, in December last year, GC Cell received IND approval from the MFDS and Australia's Human Research Ethics Committees (HREC) for a Phase 1 trial of AB-201. GC Cell and its U.S. affiliate company Artiva is developing CAR-NK therapies (photo source=Artiva). NKMAX is developing a CAR-NK candidate product, HER2 CAR-SNK02. NKMAX's HER2 CAR-SNK02 comprises HER2 gene targeting CAR and a cytokine that prolongs survival and activation of NK cells in the body, which is then stored by cryo freezing. Based on a preclinical study recently disclosed by NKMAX, HER2 CAR-SNK02 was confirmed to survive in vivo and exert anticancer effects in a mouse model engrafted with human gastric cancer cells. Collaborative research to co-develop CAR-NK therapies Korean biopharmaceutical companies are conducting collaborative research to develop CAR-NK therapies. GI Cell, an affiliate of GI Innovation, and Y-Biologics have signed a collaborate research agreement last year, commencing the new CAR-NK anticancer drug development. These companies plan to develop new anticancer drugs utilizing GI Cell's CAR-NK cell development and mass cell culture technology and Y-Biologics' nanobody-based antibody discovery platform technology. GI Cell has previously completed the domestic Phase 1 trial of the NK cell therapy 'T.O.P. NK' in patients with solid cancer and blood cancer. Since GI Cell proved T.O.P. NK's tolerability and safety, it began conducting a Phase 2a trial last month. Additionally, GI Cell is conducting collaborative research with HK inno.N for CAR-NK. HK inno.N and GI Cell are jointly conducting a basic research on CAR-NK targeting seven targets. In addition to this joint research, HK inno.N is also conducting two basic research cases on its own. TiCRos has entered into a license-based collaborative research agreement with Catherics, an Australian company focusing on developing iPSC-derived CAR-NK cell therapy. Based on the agreement, the companies are developing CAR-NK therapy with improved tumor-killing effects by incorporating TiCRos' 'CLIP-CAR' on Catherics' CAR-NK therapy. TiCRos will manufacture a CLIP-CAR targeting an antigen designated by Catherics. Catherics will incorporate this into iPSC-derived NK cells and evaluate the function in vitro and in vivo. TS Bio has been conducting joint research with Maru Therapeutics for CAR-NK cell therapy since last year. Both companies plan to actively develop CAR-NK cell therapy targeting blood cancers and solid cancers through the agreement.
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- Will Handok’s Empaveli be reimbursed in 1H in KOR?
- by Eo, Yun-Ho Aug 19, 2024 05:47am
- Empaveli, a treatment for paroxysmal nocturnal hemoglobinuria imported by Handok Pharmaceuticals, has entered the final gateway to insurance reimbursement in Korea. According to industry sources, Handok will enter into drug price negotiations with the National Health Insurance Service for its new drug Empaveli (pegcetacoplan). Empaveli is a treatment for paroxysmal nocturnal hemoglobinuria (PNH) developed by the U.S. company Sobi. It is the first C3 protein-targeted therapy for the treatment of adult patients with PNH. Gaining attention as the first PNH drug that can prevent intravascular and extravascular hemolysis, Empaveli is approved for use in many countries, including the United States, Europe, Australia, and Japan. The drug was approved by the U.S. Food and Drug Administration (FDA) in May 2021 and the European Medicines Agency (EMA) in December 2021, and has completed two Phase III trials. According to the results of the Phase III PEGASUS trial that was published in the NEJM, Empaveli demonstrated superiority to eculizumab in changing hemoglobin concentration over 16 weeks. In an extension study, LDH levels, a marker of intravascular hemolysis, remained below 1.5 times the upper normal limit for 48 weeks in the Empaveli treatment arm. The percentage of patients who remained transfusion-free for 16 weeks was also higher in the Empaveli arm, at 85%, compared to 15% in the eculizumab arm. Empaveli also showed a 9.2-point improvement in the FACIT-fatigue score, a quality-of-life measure. A2-point or over change from the baseline of the FACIT-fatigue score is considered clinically significant. The efficacy of Empaveli was also confirmed in the PRINCE trial in complement inhibitor-naïve PNH patients. After 26 weeks of follow-up, 85.7% of patients in the Empaveli arm showed stabilized hemoglobin levels, and LDH levels were well controlled to below normal levels in the Empaveli arm. Meanwhile, Handok has entered into a strategic partnership with Sobi to introduce the rare disease drugs Empaveli and Doptelet (avatrombopag) to Korea. In April, the company officially launched its joint venture, Sobi-Handok, to strengthen its rare disease pipeline.
- Company
- Will Astellas’ gastric cancer drug Vyloy be approved in 2H?
- by Eo, Yun-Ho Aug 19, 2024 05:47am
- Zolbetuximab, a new targeted cancer therapy with a new mechanism of action for gastric cancer, may be commercialized in Korea in the second half of the year. According to industry sources, the Ministry of Food and Drug Safety (MFDS) is currently reviewing Vyloy (zolbetuximab), a treatment for patients with CLDN18.2 positive, unresectable, advanced, or recurrent gastric cancer. The drug was approved in Japan in March. Vyloy is an immunoglobulin (IgG)1 monoclonal antibody that targets Claudin 18.2, a cell surface protein expressed by gastric cancer cells. It binds to the claudin 18.2 protein expressed on the surface of cancer cells in gastric epithelial cells. However, unfavorable conditions to its approval also do exist. In January, Vyloy was denied approval by the U.S. FDA. The rejection was not based on any efficacy issues, including the drug's clinical data, but rather because of questions raised during the manufacturer's review. Astellas resubmitted its application to the FDA in June and the application is on track for Vyloy’s approval. Meanwhile, Vyloy has demonstrated efficacy in the Phase III SPOTLIGHT and GLOW studies. The POTLIGHT study evaluated the efficacy and safety of zolbetuximab+FOLFOX (fluorouracil, leucovorin, oxaliplatin) versus placebo+FOLFOX in 557 adult patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. In the trial, the zolbetuximab arm achieved a primary endpoint, progression-free survival (PFS), of 10.6 months, compared with the 8.7 months in the control arm. Additional study results showed that the zolbetuximab combination arm achieved an overall survival (OS) of 18.2 months, a 2.7-month improvement over the control arm. The zolbetuximab combination arm also showed an improvement in PFS and OS in the GLOW study. The study compared zolbetuximab+CAPOX therapy (capecitabine, oxaliplatin) with placebo+CAPOX therapy. Study results showed that the zolbetuximab arm had a PFS of 8.2 months, 1.4 months longer than that of the control arm. OS was 14.4 months in the zolbetuximab combination arm and 12.2 months in the control arm. In terms of safety, the most commonly reported adverse events were nausea and vomiting.
- Company
- Entresto faces competition in the heart failure market
- by Moon, sung-ho Aug 19, 2024 05:47am
- As the volume of treatment for patients with heart failure increases due to the aging population, the competition is accelerating in the market for the treatment. This is because there are more treatment options in clinical practices and higher chances of generics entry into the market. Growing competition in the market for heart failure, previously dominated by Entresto.According to the medical and pharmaceutical industry on August 13th, the medicine market saw significant growth following major academic associations' revision to the guidelines for treating heart failure and the release of major new drugs. In the current clinical practices, there are '4 pillars' strategy of standard therapy for treating heart failure consisting of 'ARNI/Angiotensin-Converting Enzyme Inhibitor (ACEI),' 'Beta-Blocker (BB),' 'Mineralocorticoid Receptor Antagonist (MRA),' and SGLT-2 inhibitors, which is now expanded its use in addition to diabetes. Novartis' chronic heart failure treatment 'Entresto (sacubitril/valsartan)' has shown significant growth among these treatments. Entresto is the first-in-class dual blocker ARNI combining valsartan, an angiotensin II receptor blocker (ARB) inhibitor, and sacubitril, a neprilysin inhibitor. The turning point for this drug was being approved as a first-line treatment for patients who had not been administered ACEI or ARB since March 2022. In the same year, it became available for prescription to hospitalized patients and outpatients. When the Korean Society of Heart Failure (KSHF) revised 'A Complete Revision of the Heart Failure Guidelines,' it advanced Entresto as the first-line standard therapy for treating heart failure with reduced ejection fraction (HFrEF). According to the pharmaceutical market research firm UBIST, Entresto generated KRW 57.5 billion in the clinical field last year and recorded KRW 32.9 billion in this year's first half. It has become true that the sales have surpassed those of the previous year. Another medicine that is receiving attention is 'Verquvo (Vericiguat, Bayer).' Verquvo, available with reimbursement coverage, can be administered to patients with chronic heart failure (NYHA class Ⅱ-Ⅳ) with an impaired left ventricular contractility and left ventricular ejection fraction (LVEF) of less than 45%. It is a second-line treatment that can be used for patients who have worsened disease despite undergoing standard therapy for over four weeks. However, it has not yet demonstrated sales growth in clinical practices. A year after obtaining reimbursement in the second half of the previous year, Verquvo only generated sales of approximately KRW 400 million in the first half this year, based on UBIST. One reason for this might be the wide variety of treatment options due to the expanded reimbursement range of the original SGLT-2 inhibitor diabetes drugs, including Jardiance (empagliflozin), for chronic heart failures. Furthermore, while Forxiga (dapagliflozin, AstraZeneca) withdrew from the domestic market, AstraZeneca Korea granted clinical documents to HK inno.N's generic Dapa N, thus Dapa N succeeding Forxiga's heart failure and kidney disease indications. Consequently, Dapa N is the only generic product with the original indication. The analysis shows that Verquvo is considered a last resort treatment option for treating heart failure in clinical practices. Currently, clinicians have more treatment options they can use. A cardiology professor from a university hospital in Seoul, who requested to remain anonymous, stated, "Verquvo is used as a second-line treatment following four types of first-line treatment options, so it is not in competition with the first-line treatments." He explained, "SGLT-2 inhibitors were already being prescribed in private practices for diabetes, which reduced the psychological burden and made it easier to prescribe for heart failure. Verquvo is initially prescribed in tertiary hospitals and used as patients move to secondary and primary care hospitals." "It would have been a different scenario for SGLT-2 inhibitors if it had been initially released as heart failure treatment," he added. "After being used primarily as a diabetes drug, it has gained attention for its effectiveness in treating heart failure. The situation might be different if it were the other way around."
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- Twice-yearly Uplizna enters last stage to reimb in KOR
- by Eo, Yun-Ho Aug 16, 2024 05:56am
- Uplizna, a new drug for neuromyelitis optica spectrum disorder (NMOSD) that is administered twice a year, has entered the final gateway for insurance reimbursement in Korea. According to industry sources, Mitsubishi Tanabe Pharma Korea entered pricing negotiations with the National Health Insurance Service (NHIS) for Uplizna (inebilizumab), a treatment used to treat adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are positive for anti-Aquaporin-4 (AQP4) antibodies. The company accepted the ‘below the evaluated amount’ condition set by the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee for the reimbursement of Uplizna (inebilizumab) last month. The drug is administered at an initial 300 mg dose, followed by an additional 300 mg dose 2 weeks later, and then every 6 months thereafter from the date of the initial dose. NMOSD occurs when AQP4 autoantibodies, a disease-specific biomarker produced by B cells, bind to AQP4, a target antigen present on glial cells in the central nervous system, and activate the immune responses, causing nerve damage. Uplizna is an anti-CD19 human monoclonal antibody that selectively binds to CD19, a B cell-specific surface antigen, depleting B cells that produce AQP4 antibodies, thereby preventing disease relapse. The safety and efficacy of Uplizna were demonstrated in the N-MOmentum study, which evaluated the use of Uplizna monotherapy in 230 patients without the use of concomitant immunosuppressive agents. Study results showed that 89% of patients treated with Uplizna did not experience a relapse during 197 days of follow-up, resulting in a 77.3% reduction in the risk of relapse compared to placebo. Safety evaluations Uplizna also showed comparable rates of adverse events to the placebo group. Also, in an extension study, Uplizna continued to reduce the risk of relapse for at least 4 years, with an 87.7% relapse-free rate. In terms of long-term safety profile, Uplizna was generally well tolerated, with no increase in infection rates due to B-cell depletion. NMOSD is a serious autoimmune disease in which most patients experience persistent relapses and incomplete recovery, resulting in accumulated nerve damage that can cause vision loss, gait disturbances, and even death from respiratory failure.
- Company
- OraTicx signs a distribution deal with U.S.-based Stratum
- by Son, Hyung-Min Aug 16, 2024 05:56am
- OraTicx, a company specializing in developing oral probiotics, announced that it has signed an exclusive distribution agreement for the North American region with Stratum Nutrion (hereafter referred to as Stratum), a U.S.-based dietary supplement ingredient supplier. Through this agreement, OraTicx will exclusively distribute its proprietary oral probiotics 'oraCMU,' 'oraCMS1,' and 'oraCMU' in the North American market. Stratum, a company under ESM Technologies in the United States, provides natural ingredients based on scientific research. Through this partnership, OraTicx is expected to utilize Stratum's broad distribution network to accelerate the entry of its products into the North American market. OraTicx has 10 patents in South Korea and the United States. It has expertise in researching oral probiotics, completing 10 cases of human studies, and publishing 36 research articles. Notably, its oral probiotics strain, oraCMU, was developed in an OraTicx-affiliated research center. Through joint research with a research team at Seoul National University School of Dentistry, oraCMU's human study results demonstrating an improvement in halitosis were published in the SCIE international journal, 'Frontiers in Microbiology.' oraCMU demonstrated the quality and safety of the ingredient through FDA GRAS (Generally Recognized As Safe) registration. oraCMS1 has been confirmed to prevent plaque formation and exhibit antibacterial efficacy against respiratory pathogens. Recently, OraTicx has obtained a patent for its composition aimed at preventing and treating respiratory diseases. OraTicx has launched oral probiotics products using proprietary research. It is expanding its product line-up focused on oral probiotics, including Green Breath, Dentee, kids' dental probiotics, Implantics with twice the units, and Pet Biome for pets. OraTicX President Yoon Eun-seop said, "The current exclusive distribution agreement with Stratum is an important opportunity to introduce our innovative oral probiotics to North American customers." He added, "We aim to establish a new value in the North American dietary supplement market and become a leading global company contributing to people living heathy lives until the age of 100." Stratum President Micah Osborne said, "OraTicx's advanced oral probiotics will strengthen our portfolio even more." He added, "Through this partnership, we are delighted to provide various and effective healthcare solutions to North American customers."
- Company
- K-Pharma speeds up marketing new drugs for bile duct cancer
- by Son, Hyung-Min Aug 16, 2024 05:55am
- Korean pharmaceutical companies are speeding up the development of new drugs for cholangiocarcinoma (also known as bile duct cancer). Handok's partnering company in the United States, Compass Therapeutics, has recently completed registering patients for the Phase 2/3 trials. Once the efficacy of the novel drug is confirmed, Handok plans to apply for approval in South Korea. According to pharmaceutical industry sources on August 16th, Compass Therapeutics has recently completed registering patients for the Phase 2/3 trials in the United States. The trials will evaluate the efficacy of HDB001A(CTX-009) for metastatic or recurrent cholangiocarcinoma and compare the efficacy of HDB001A in combination with paclitaxel to the paclitaxel monotherapy. HDB001A is a novel drug candidate developed by the Korean company ABL Bio. Handok has the domestic distribution rights, and Compass Therapeutics has the global distribution rights. This novel drug candidate is a bispecific antibody targeting Delta-like ligand 4 (Dll4) and vascular endothelial growth factor (VEGF), and it is known to form new blood vessels in the tumor microenvironment. Handok has confirmed the efficacy and safety of HDB001A in the Phase 2 trial conducted in South Korea. The clinical trials evaluated and compared HDB001A in combination with paclitaxel to paclitaxel monotherapy in 24 adult patients with advanced, metastatic, or recurrent cholangiocarcinoma who have received prior treatments. After a median follow-up of 12 months, patients treated with the combination therapy had an objective response rate (ORR) 37.5%, measuring the reduction in tumor sizes. The median overall survival (OS) was 12.5 months. The median duration of response (DOR) was 9.4 months, and the median progress-free period (PFS), duration without progression, was 9.4 months. However, the adverse events of HDB001A plus paclitaxel occurred at the highest rate. Treatment-related adverse events (TRAE) of all Grades, from 1 to 5, were reported in HDB001A plus paclitaxel combination therapy. 75% of patients had adverse reactions of over Grade 3. The most common adverse reactions over Grade 3 were neutropenia (50%), hypertension (16.7%), anemia (12.5%), and thrombocytopenia (8.3%). One case of Grade 5 pneumonia was reported. 25% of patients had confusion state, pulmonary embolism, and an increase in blood creatinine level. Once Handok confirms the efficacy and stable safety data from the U.S. clinical trial, it will apply for approval in South Korea. Confirming the potential of Keytruda combination therapy…enters the clinical trial Besides Handok, Genome & Company, GI Innovation, and SMT bio are developing novel drugs for cholangiocarcinoma. These companies are conducting clinical trials for Keytruda combination therapies. Korean pharmaceutical companies are conducting clinical trials for their candidate drugs in combination with various immune checkpoint inhibitors, including Keytruda.Keytruda was approved in April as a first-line treatment of cholangiocarcinoma in South Korea. Genome & Company, GI Innovation, and SMT bio plan to increase the possibility of commercializing their candidate products in combination with an efficacy-confirmed drug. Genome & Company is developing a new candidate product, microbiome-based immune checkpoint GEN-001, in combination with Keytruda for cholangiocarcinoma. Genome & Company aims to improve the efficacy of existing immune checkpoint inhibitors through combination therapy of 'GEN-001' and Keytruda. The company also plans to develop 'GENA-104,' an immune checkpoint inhibitor 'GENA-104' that suppresses novel target CNTN4, for patients who had not benefited from Keytruda targeting PD-L1/PD-1. The Phase 2 trial of GEN-001 for cholangiocarcinoma was approved for changes to the Investigational New Drug (IND) application in June. Genome & Company plans to evaluate the efficacy and safety of three-drug combination therapy, adding FOLFOX (fluorouracil, leucovorin, and oxaliplatin) to the existing GEN001 plus Keytruda combination therapy. Genome & Company confirmed the tolerability and safety of GEN-001 in the Phase 1 trial and determined the recommended dosage for the Phase 2 trial. The trial recently finalized patient treatments. SMT bio is conducting Phase 2b trials for allogenic Natural Killer cells (SMT-NK cells) in combination with Keytruda. The company is evaluating the efficacy of the combination therapy compared to the Keytruda monotherapy. Based on clinical results until now, the combination therapy had a PFS of 4.1 months, which is higher than 1.5 months of the Keytruda monotherapy. It showed improved ORR compared to monotherapy. Last year, the Ministry of Food and Drug Safety (MFDS) acknowledged the effectiveness of SMT-NK cells and approved the therapeutic use of under-trial pharmaceutical for treating patients with cholangiocarcinoma. GI Innovation is conducting a Phase 1 trial in the United States to evaluate the effectiveness of GI-101 in combination with Keytruda. The company aims to secure an indication for treating solid cancers, including cholangiocarcinoma. GI Innovation is also evaluating the marketing possibility of its candidate product in combination with a wide variety of immune checkpoint inhibitors, such as Imfinzi, in addition to Keytruda.
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- LG Chem begins Phase 2 trials for infant hexavalent vaccine
- by Hwang, Byung-woo Aug 14, 2024 05:51am
- LG Chem LG Chem prepares to commence the Phase 2 clinical trial for its hexavalent vaccine LR20062. The company aims to domestically produce infant combination vaccines in South Korea. Since South Korea has so far relied entirely on imported combination vaccines, the company plans to provide a stable supply network to meet mid- to-long term demand for immunization. On August 13th, LG Chem announced it will conduct the Phase 2 trials for the hexavalent 'acellular Pertussis (aP)' vaccine, 'LR20062' overseas and prepare to enroll study participants. The successful completion of the Phase 1 trial and entry into the Phase 2 stage indicate progress towards commercializing the first domestically produced combination vaccine. 'LR20062' is a 6-in-1 vaccine used to prevent Diphtheria, Tetanus, Pertussis, Polio, Haemophilus influenzae type b (Hib), and Hepatitis B. Compared to vaccine conjugates in commonly used 5-in-1 vaccines and Hepatitis B vaccines, it reduced the number of doses by two doses (6 doses to 4 doses). The Phase 2 trial involving healthy adults demonstrated vaccine reactions from all study participants. Regarding immunogenicity endpoints, the serum protection and conversion rates were above 90%, similar to the control group, which was the existing hexavalent combination vaccine. In terms of safety, the new vaccine also demonstrated similarly favorable endpoints compared to the control group. The Phase 2 trial will enroll 300 infants aged two months and older, the target immunization age group in the real-world, as study participants and evaluate the safety and immunogenicity of 'LR20062' compared to existing hexavalent combination vaccines. LG Chem aims to develop domestically produced combination vaccines and contribute to meeting mid- to long-term demand through developing hexavalent combination vaccines. To this end, the company plans to invest about KRW 200 billion in R&D and facilities. Jeewong Son, Head of LG Chem Life Sciences Company businesses, said, "Establishing the production technology for all six antigens is a significant milestone and crucial for establishing domestically produced vaccines." He added, "We will expedite the commercialization of domestic combination vaccine to ensure that parents can safely and reliably vaccinate their children." Additionally, LG Chem is conducting the Phase 2 trial for a while cell Pertussis (wP) hexavalent vaccine, ‘LR19114,’ intending to enter the procurement market of international organizations like UNICEF.
- Company
- 'Xtandi and Erleada' compete in the prostate cancer market
- by Hwang, Byung-woo Aug 14, 2024 05:51am
- The market for ARTA treatment used to treat prostate cancer has been dominated by Xtandi (enzalutamide). As prescription sales of Erleada (apalutamide) rise, the market is shifting. Astellas Pharma's Xtandi has increased its competitiveness with its indications, Janssen has started to face competition by expanding its portfolio, including Erleada, Zytiga, and Akeega. (From left) product photos of Erleada and Xtandi According to the pharmaceutical market research firm UBIST, Xtandi generated the highest outpatient prescription sales in this year's first half, KRW 14.1 billion. Analysis suggests that increased outpatient prescription sales are due to expanded reimbursement. In August 2022, Xtandi was selectively reimbursed for the treatment of patients with advanced prostate cancer accompanied by distant metastasis when used in combination with androgen deprivation therapy (ADT). Since November of last year, reimbursement has been made regardless of using other androgen synthesis inhibitors. However, the drug price was reduced from KRW 20,882 to KRW 14,170 due to the expanded reimbursement range, affecting prescription sales. Xtandi's prescription sales for this year's Q3 was KRW 8.1 billion, then reduced to KRW 6.6 billion in Q4. In November last year, the co-payment rate for Xtandi was adjusted from 30% to 5%, canceling out the prescription price reduction. Xtandi's sales recovered, with KRW 6.7 billion in this year's Q1 and KRW 7.4 billion in Q2. Also, in June, Xtandi expanded its indication to non-metastatic hormone-sensitive prostate cancer (nmHSPC), which is expected to increase prescription sales in the future. Sales trend of ARTA treatments used to treat prostate cancer (UBIST report reconstructed by Daily Pharm). With the expanded indications, Xtandi became the only ARTA treatment that can be prescribed to treat all prostate cancer stages following biochemical recurrence, including hormone-sensitive, castration-resistant, non-metastatic, and metastatic. An Astellas official said, "Xtandi is the only prostate cancer treatment that can be used to treat hormone-sensitive HSPC at early stages regardless of metastasis, non-metastasis, and the number of metastases." He said, "When the indication to treat nmHSPC was recently approved, the company focused on marketing to raise awareness of the importance of early ARTA combination therapy to treat HSPC." Erleada chasing Xtandi…Janssen, "To provide patient-individualized treatment option" Although Xtandi is the market leader, Janssen's Erleada, which has been reimbursed since last year, rapidly generates prescription sales. Erleada generated prescription sales of KRW 3.4 billion in last year's Q4. Its sales grew with a bigger margin, with KRW 4.8 billion in this year's Q1 and KRW 7 billion in Q2. Its prescription sales in Q2 were close to Xtandi. Analysis suggests that the close competition may be due to Xtandi's drug price reduction. Erleada appears to be established in clinical practice, as it has been a year since receiving reimbursement. On the other hand, the prescription sales of Janssen's Zytiga (abiraterone) have decreased after the introduction of generic versions. Last year, prescription sales for Xytiga decreased from KRW 4.9 billion in Q3 to KRW 3.5 billion in Q4. In this year's Q1 and Q2, it generated KRW 3.1 billion due to expanded prescriptions of competitor drugs and the introduction of generic products. After Hanmi Pharm's Abiterone was approved last year, generic version of Xytiga were introduced to the market for Xytiga. Furthermore, Hanmi Pharm launched the combination drug Abiterone Duo in February, and Ace Pharmaceuticals obtained approval for Amaron. With more competitors, Xytiga's prescription sales are expected to decrease even more. Changes to the reimbursed price of ARTA treatments used to treat prostate cancer (HIRA report reconstructed by Daily Pharm). Janssen plans to focus on expanding treatment options for prostate cancer sub-types to compete against Xtandi, which has broad indications. Janssen's prostate cancer treatment portfolio consists of Xytiga, Erleada, and Akeega. Akeega was approved in September of last year. Akeega is a treatment for BRCA1/2 mutation-positive metastatic castration-resistant prostate cancer. It is a combination drug combining abiraterone and the PARP inhibitor ingredient niraparib. Prescription sales of individual drugs may be lower than those of Xtandi, but the company's strategy is to face the competition by diversifying treatment options. A Janssen official said, "For the treatment of prostate cancer in South Korea, we have been putting efforts to provide various individualized treatment options and improve treatment accessibility." "We will strive to work as a market leader to provide Korean patients with prostate cancer with optimized treatment by expanding treatment options through Erleada and Xytiga and expanding our portfolio, including Akeega.
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- Nabota accounts for 24% of Daewoong’s ETC sales
- by Chon, Seung-Hyun Aug 13, 2024 05:47am
- Daewoong Pharmaceutical's botulinum toxin 'Nabota' continued its upward sales trend. The company's quarterly revenue exceeded KRW 50 billion for the first time, led by the company’s growth in overseas markets. Nabota’s share of Daewoong's specialty drug sales reached nearly 25 percent, driving the company's performance. According to Daewoong Pharmaceutical on the 12th, Nabota generated sales of KRW 53.1 billion in Q2, up 62.4% year-on-year. This is the first time since its launch that the drug’s quarterly sales exceeded KRW 50 billion, surpassing the previous record of KRW 42.6 billion set in Q1 last year in less than a year. Nabota’s sales increased 74.7% in 2 years, compared to sales of KRW 30.4 billion in Q1 2022. Daewoong Pharmaceutical Sales of Nabota in the U.S. market continued to rise steadily. Daewoong Pharmaceutical's sales partner for Nabota, Evolus, reported sales of USD 66.9 million (approximately KRW 92 billion) in Q2, up 35.6% from the USD 49.35 million made year-on-year. This marks the fifth consecutive quarter Evolus renewed its revenue record since the company reported USD 49 million in Q2 last year. Nabota's export performance has begun to surge since the closure of its strain theft lawsuit with Medytox, which began in 2019, and the established trust in Nabota based on the accumulated U.S. experience. In February 2021, Medytox entered into a settlement agreement with Daewoong Pharmaceutical's U.S. partners Evolus and AbbVie for the sale of Nabota (U.S. trade name Jeuveau) in the United States. Under the agreement, Medytox and AbbVie received the rights to continue marketing and distributing Jeuveau in the U.S. for certain payments from Evolus. Evolus is also looking to expand into the European market, having launched Nabota in Spain in June. In Europe, Nabota is currently available under the brand name Nuceiva and is now available in the U.K., Germany, Austria, Italy, and the U.S., in addition to Spain. In June, the company received marketing authorization for Nabota from Argentina's National Administration of Drugs, Food and Medical Devices (ANMAT), accelerating its international expansion as well. Nabota will be launched in Argentina under the brand name Clodew in Q4 this year through Daewoong’s local partner Oxapharma. Daewoong Pharmaceutical currently has botulinum toxin products licensed in more than 70 countries worldwide and partnerships in more than 80 countries. As a result, Nabota's presence in Daewoong's sales is also gradually expanding. In Q2 last year, Nabota’s sales accounted for 24.4% of Daewoong's KRW 218 billion in specialty drug sales, the largest share ever. Among the products developed and sold by Daewoong Pharmaceutical, Nabota has generated the largest sales volume. Daewoong's sales of specialty drugs increased 11.7% in 3 years from KRW 181 billion in Q2 2021, while Nabota’s sales more than tripled in the same period. Nabota's share of the company's specialty drug sales has nearly tripled in 3 years from 8.5% in Q2 2021. Nabota’s share in Daewoong Pharmaceutical's specialty drug sales exceeded 10% in Q3 2020 for the first time. After surpassing 20% in Q1 last year at 20.6%, it remained in the 10% range until Q1 this year. However, with the surge in Nabota’s sales, the drug accounted for more than a quarter of the company’s specialty drug sales in Q2. More recently, the company’s new drug Fexclue has also contributed significantly to company sales. In Q2, sales of Fexuclue more than doubled year-on-year to KRW 33.2 billion. Fexclue is a potassium-competitive acid blocker (P-CAB) drug that treats GERD. Fexuclue was approved by the MFDS in December 2021 and began full-scale sales in July 2022 after being listed for reimbursement on Korea’s health insurance benefit list. Nabota and Fexuclue jointly generated KRW 86.3 billion in sales in Q2, accounting for 39.6% of the company's specialty drug sales. Daewoong Pharmaceutical set a new performance record thanks to the steep growth of its self-developed drugs. On a standalone basis, Daewoong Pharmaceutical's Q2 revenue increased 6.0% year-on-year to KRW 325.5 billion, and operating profit increased 37.1% to KRW 49.6 billion. Both the revenue and operating profit in Q2 were the largest in the company's history. The operating profit margin as a percentage of sales was 15.2%, a significant improvement from the 11.8% it had made in the same period of the previous year, showing high performance. Daewoong Pharmaceutical's operating profit on a consolidated basis was KRW 42.3 billion in Q2, up 5.6% year-on-year, the largest ever. Revenue increased 3.0% year-on-year to KRW 360.5 billion, the second-highest amount ever recorded after Q4 of last year.
