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- 2026-05-04 14:01:12
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- Industry concern rises over the spread of the medical strike
- by Kim, Jin-Gu Jun 14, 2024 05:46am
- Some large hospitals are restricting access to pharmaceutical company employees’ access in the wake of a medical gap created by their resident doctors’ leave of absence. The pharmaceutical industry's situation worsens as the medical community is threatening to take a collective leave of absence due to conflict with the government over increasing medical school admissions. There are voices that say if the leave of absence, which is being made by doctors and some medical professors, spreads throughout the medical community, it will inevitably affect the industry’s Q2 performance results. There are already reports of companies predicting operating losses for their second quarter and some entering a state of emergency management. Medical representatives (MRs) in charge of general hospitals are on the verge of nervous breakdown, being unable to meet with medical professors. Pharma industry closely monitors the development of the medical strike ..." de facto emergency management system in place" According to industry sources on the 13th, the Korean Medical Association will take a collective leave of absence on the 18th. The association also announced a general strike at Yeouido Park in Seoul. In addition to the Big 5 hospitals, an increasing number of university hospitals have announced their participation in the strike. The faculty council of Seoul National University Hospital and Seoul National University Bundang Hospital decided to take a complete leave of absence on the 17th. Doctors at Severance Hospital will also take an indefinite leave of absence from the 27th. The Samsung Medical Center has also joined the collective leave of action, with other large hospitals also discussing plans. The medical strike, which had been ongoing amongst doctors and some medical school professors, seems to be spreading to large hospitals and clinics. The pharmaceutical industry is also watching the situation closely. Industry insiders say that if the medical community continues to take a leave of absence, the move will inevitably hurt the industry’s second-quarter earnings. Some companies are already forecasting losses for the second quarter and have effectively gone into emergency management. "Since last week, meetings involving executives from all departments have been held frequently," said an official from a large pharmaceutical company, "and it has been concluded that the company’s Q2 results will fall far short of the original target. We are currently discussing ways to minimize the damage." An official from another pharmaceutical company said, "If you look at our results through May, we're looking at a loss for the second quarter. The problem is that we don't have a good way to make up for it. We are keeping a close eye on the situation in the healthcare industry." An MR in charge of general hospitals confesses, "I haven't done anything for 2 months," The departments in charge of sales and marketing are also concerned about the spread of the medical strike. Departments that have launched or are planning to launch new products are said to be particularly affected by the prolonged medical-government conflict. An official from the marketing department of a domestic pharmaceutical company that recently launched a new product said, "Companies with existing products that have a high market share may not have a big problem, but companies that are planning to launch new drugs or new products are facing difficulties. We originally planned a large-scale launch symposium, but it has now been postponed indefinitely." The official added, "Recently, many medications are being prescribed in the long-term, for 6 months, making it very difficult for new drugs to be prescribed. This is a big risk for new drug sales and marketing teams." For departments related to general hospitals, the situation is worse as the MRs in charge could not meet with their medical professors since the start of the strike at the beginning of the year. Some surgeons and residents have returned to work, but in the internal medicine department, most full-time doctors and residents have not returned, with faculty members on call 2-3 times a week in rotation. An MR from a domestic pharmaceutical company in charge of a general hospital in Daejeon said, "I haven't worked since last month. Before that, I was at least receiving training, but now I am doing nothing. The company is just telling me to wait and see what happens. I don't want to force meetings with professors because it could backfire." An official in charge of clinical affairs at a multinational pharmaceutical company said, "It is also difficult to enroll patients in global late-stage clinical trials. Doctors are reluctant to attend even when we offer meetings to encourage participation in multicenter investigator-initiated trials (IITs). There are many restrictions to them attending not only investigator meetings but also pharmaceutical company events held in the evening or on weekends."
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- The first APDS drug 'Joenja' gets orphan drug status in KOR
- by Eo, Yun-Ho Jun 13, 2024 05:48am
- Pharming Group A rare disease treatment 'Joenja' has received orphan drug designation in South Korea. The Ministry of Food and Drug Safety (MFDS) states this through the report on the designation of Orphan Drugs. Joenja (leniolisib), developed by the Dutch company Pharming group, is the first treatment for activated phosphoinositide 3-kinase delta syndrome (APDS). The drug was approved by the U.S. Food and Drug Administration (FDA) in March of last year. APDS is caused by a mutation in either the PIK3CD or PIK3R1 gene, essential to immune cell development and function. It occurs in 1 per 1-2 million. APDS patients commonly develop autoimmunity and inflammatory symptoms. They may suffer from ear, paranasal, and upper and lower respiratory infections. Moreover, APDS patients are susceptible to swollen lymph nodes and enlarged spleen, as well as an increased risk of cancer, such as lymphoma. Joenja’s approval was based on results from a multinational, triple-blind, placebo-controlled, randomized phase 2/3 clinical trial evaluating the efficacy and safety of the drug in 31 patients with APDS aged 12 years and older. Open label extension data of 38 patients receiving Joenja for an average of two years were also submitted. Randomized and placebo-controlled clinical results at 12 weeks demonstrated the clinical effects of Joenja 70 mg administered twice daily. It obtained a significant finding from the co-primary endpoints, which evaluated lymphoproliferation as measured by the reduction in lymph node size and increase in naïve B cells. It reflected the impact on immune dysregulation and normalization of immunophenotype. The change between Joenja and placebo for lymph node size was –0.25, and for the percentage of naïve B cells was 37.30. The most common adverse reactions were headache, sinusitis, and atopic dermatitis. Meanwhile, Pharming Group signed a license agreement with Novartis for Joenja in 2019. Novartis received US$10.5 million from Pharming Group when Joenja launched in the United States in April last year, as well as additional milestone and recurring royalty revenue.
- Company
- A growing trend of SC injections heats up competition
- by Son, Hyung-Min Jun 13, 2024 05:48am
- Pharmaceutical and biotech companies in Korea and worldwide focus on developing formulation modifications for anticancer agents. Following 'Tecentriq (atezolizumab)' SC (subcutaneous injection obtaining marketing authorization from the European Medicines Agency (EMA) in January, the R&D of 'Opdivo (nivolumab)' and 'Rybrevant (amivantamab)' is nearing the end. The industry attributes the recent booming development of SC formulations to their advantages over IV (intravenous) formulations, such as shortened administration time, improved convenience of administration, and reduced injection-related side-effects. According to the industry sources on June 11th, Bristol Myers Squibb (BMS)·ONO Pharmaceutical and Janssen disclosed the research outcomes of their SC formulations products, Opdivo and Rybrevant, respectively. Opdivo, an immunotherapy for cancerOpdivo, developed by BMS and ONO Pharmaceutical, is a PD-1-targeting immunotherapy for cancer. BMS conducted a clinical trial involving patients with renal cell carcinoma to change the Opdivo IV formulation to an SC formulation, and they obtained successful outcomes. The Phase 3 CheckMate-67T trial enrolled 495 patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior therapy. For safety profile, the percentage of patients with topical adverse reactions of all grades in the Opdivo SC group was 8.1%, and in the IV group, it was 2.0%. Among the patients who were anti-drug antibodies (ADA)-positive, 15.2% of the patients in the SC group experienced mild topical adverse reactions of Grade 1-2, which resolved without the need of treatment. SC formulation of Rybrevant, a targeted therapy for cancer, has also shown effects in a clinical trial. Rybrevant, developed by Janssen, is a treatment for patients with non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. A recently disclosed Phase 3 PALOMA-3 study demonstrated the non-inferiority of SC formulation Leclaza plus Rybrevant therapy to IV formulation Leclaza plus Rybrevant therapy. At a median follow-up of 7 months, SC formulation of Leclaza plus Rybrevant therapy was non-inferior to IV formulation Leclaza plus Rybrevant therapy. Yuhan SC formulation of Leclaza plus Rybrevant therapy had an ORR of 30.1% compared to 32.5% in IV formulation Leclaza plus Rybrevant therapy, meeting the standard for non-inferiority. For injection-related reactions (IRR), SC formulation of Leclaza plus Rybrevant therapy showed 13% IRR, which was significantly lower than 66% in IV formulation Leclaza plus Rybrevant therapy. The analysis suggests that improving Rybrevant’s administration will lead to greater synergy when combined with Leclaza. One of the concerns about combining oral Leclaza with IV formulation Rybrevant is that it may be less convenient due to the increased number of hospital visits. Since oral formulations for targeted therapy for lung cancer, such as Tagrisso (osimertinib) and Giotrif (afatinib), have been approved, Rybrevenat’s injectable formulation poses a weakness. Therefore, whether SC formulation of Rybrevant would be commercialized is attracting attention. Latecomers have started developing SC formulations Latecomers to developing anticancer agents are working to change formulations to reduce the administration time. Roche has succeeded in developing SC formulation of Tecentriq, an immunotherapy for cancer, and MSD is conducting a phase 3 clinical trial of SC formulation of Keytruda. Alteogen, which has a SC formulation modification technology, plans to develop technology for ADC SC platform. Alteogen expects the SC formulation of ADC to reduce adverse reactions. The company aims to launch the SC formulation of ADC into the market by 2028. The Korean pharmaceutical biotech industry is working on developing potential SC formulations of anticancer candidates. GI Innovation is developing a SC formulation of GI-102, a candidate immunotherapy for cancer. According to GI Innovation, the SC formulation of GI-102 has a bioavailability (BA) of up to 60% compared to an IV formulation. A clinical trial for the SC formulation of GI-102 will be conducted by confirming an appropriate dose in patients with various solid cancers. Once a proper dose of the SC formulation of GI-102 is determined, GI Innovation plans to conduct a clinical trial for an incremental dose in patients with solid cancer who have failed systemic therapies. Additionally, several companies are working on a new formulation modification other than IV to SC. Daehwa Pharmaceutical is developing an oral paclitaxel formulation, Liporaxel Sol. In a phase 3 clinical trial conducted by Daehwa Pharmaceutical’s partnering company in China, Haihe Biopharma, the efficacy and safety of Liporaxel have been confirmed to be non-inferior to paclitaxel injection.
- Company
- ‘Verify safety when using botulinum toxin for hair loss'
- by Nho, Byung Chul Jun 12, 2024 05:45am
- Dr. Jae-Hong Kim, Director of Planning and Policy at the Association of Korean Dermatologists (Chief Director, Yonsei Joeun Dermatology Clinic Gwangmyeong Branch)The market for hair loss treatment is growing day by day as hair loss, once considered a typical condition of middle-aged men, has become a general condition across all genders and ages. In particular, the market is being segmented across a wide age range and various lifestyles, and new treatments that complement the limitations of existing treatments are being actively developed. Dr. Jae-Hong Kim, Director of Planning and Policy at the Association of Korean Dermatologists, said, "Androgenetic alopecia (AGA), the most common type of hair loss, is generally treated with oral medications, but if the patient has inadequate drug response, the treatment’s effect decreases after a certain period of time. In recent years, procedures with different mechanisms of action, such as botulinum toxin, have emerged as a new alternative to treat hair loss." Botulinum toxin is a neurotoxin that inhibits the release of acetylcholine, a neurotransmitter that prevents muscles from contracting. It causes a temporary relaxation and shrinkage response in the muscle and is commonly used to treat wrinkles such as crow's feet and frown lines or to shrink overdeveloped muscles such as trapezius and calves. Kin explained, "When injected into the dermis, botulinum toxin has been shown to reduce the activity of TGF-ß1, which is responsible for hair loss. It is known to improve hair loss by increasing blood circulation by relaxing of the muscles around the scalp when injected intramuscularly." Research and publications on the effectiveness of botulinum toxin in treating hair loss are actively being conducted and published in the field. "There was a case of a man in his 30s and 40s who had advanced hair loss with thinning hair in the crown area along with scalp heat. He did not see any significant effect from oral medications, but experienced symptom improvement after receiving botulinum toxin injections in the balding areas.” However, as hair loss can have a significant impact on a patient's social and interpersonal life, it is important to carefully check the safety of the administered products. The safety and product history can be checked through the product’s FDA approval status and proven titer in the global market. In Korea’s botulinum toxin market, products such as Botulax have been approved by the FDA and have entered big markets such as Europe and China, and have been recognized for both its efficacy and stability. Accurate diagnosis and proper treatment by a medical professional are also important to achieve the best results. He added, "Patients tend to rely on arbitrary treatments or folk remedies, fearing side effects of oral medications or painful injections, which can cause them to miss the right timing to receive treatment. As various treatment methods are now available, patients should consult with a medical team to develop a treatment plan that takes into account each patient’s individual characteristics and the mechanism of action of the drug."
- Company
- Autotelic Bio signs licensing agreement with Chinoin
- by Nho, Byung Chul Jun 12, 2024 05:45am
- (From the left) Fernando Torres Navarrete, BD Director at Chinoin Productos Farmaceuticos in Mexico , Tae-Hun Kim, CEO of Autotelic Bio Autotelic Bio announced on the 7th that it has signed an exclusive license and supply agreement with Chinoin Productos Farmaceuticos in Mexico to distribute ATB-101, a novel combination drug for the treatment of hypertension and diabetes. ATB-101 is a fixed-dose combination product comprising of the hypertension drug ‘olmesartan’ and the oral diabetes drug ‘dapagliflozin.’ It is the world's first combination drug that treats both hypertension and Type 2 diabetes, making it easier for patients with both chronic diseases to take their medication. The company has received Phase III IND approval from the Ministry of Food and Drug Safety for ATB-101 and is currently conducting Phase III clinical trials in patients with essential hypertension and type 2 diabetes at more than 35 major hospitals in Korea, including Seoul National University Bundang Hospital. Autotelic Bio is planning to launch the product globally after proving safety and efficacy through the ongoing Phase 3 clinical trial. For this, the company has registered composition patents in the U.S., Japan, Russia, Mexico, and Brazil, in addition to Korea, and is expanding its patent to other countries such as China. The exclusive license and supply agreement it signed in Mexico is to supply more than 30 million ATB-101 tablets over 5 years. The agreement demonstrates the company's potential to expand into neighboring Latin American countries through Chinosa and is expected to serve as a bridgehead for future global expansion. In addition to the upfront payment, Autotelic Bio will receive additional payments based on development, licensing, and commercialization milestones. Mexico's hypertension and diabetes market is the second largest in Latin America after Brazil and has significant potential. Autotelic Bio plans to grow sales in the Mexican market and reinvest the proceeds in the continued development of innovative new medicines. Chinoin Productos Farmaceuticos is a Mexican pharmaceutical company founded in 1924. It owns a pharmaceutical R&D, manufacturing, licensing, sales, and marketing division, and is regarded to have excellent sales and marketing capabilities, ranking among the top 10 pharmaceutical sellers in Mexico. Autotelic Bio recently completed a pre-IND meeting with the U.S. Food and Drug Administration (FDA) to advance ATB-101 into the United States. During the meeting, the company received a positive response from the FDA regarding the ongoing Phase III clinical trial, and that an additional local Phase I clinical trial will be sufficient for approval in the U.S. based on the results of the domestic Phase III trial. Based on the results of the pre-IND meeting, the company will be meeting with more than 10 pharmaceutical companies at Bio USA to discuss global rights agreements for ATB-101, including in the US. This year, Autotelic Bio has joined the Boston C&D Incubation Office, a blockbuster global expansion program organized by the Korea Health Industry Development Institute (KHIDI), to strengthen its network for ATB-101’s clinical development and licensing-out activities and create results in the U.S. market. In addition to the incrementally modified drug, Autotelic Bio is developing two other RNA-based anti-cancer drugs, ATB-320 (a dual-mechanism of action anti-cancer RNA drug that works on the TME and inhibits angiogenesis) and ATB-350 (a next-generation KRAS mutation-targeting anti-cancer RNA drug that targets specific tissue). Also, its ATB-610 (ALK5 inhibitor), an inhaler in the company’s anti-fibrosis drug pipeline, has been selected as a project of the National New Drug Development Project in Korea, adding momentum to the company’s development of new drugs.
- Company
- Failed reimb negotiations for Lorviqua, was it for the best?
- by Eo, Yun-Ho Jun 12, 2024 05:45am
- After a long wait, the result was still a ‘no go.’ A solution does exist, but hesitation seems to be holding them back. The insurance reimbursement expansion for the 3rd-generation ALK anticancer drug Lorviqua to first-line therapy has become unclear again. Negotiations between Pfizer Korea and the National Health Insurance Service on the drug price of the ALK-positive NSCLC treatment Lorviqua (lorlatinib), which passed the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee review in January and began in March, recently broke down. This is the first time negotiations have broken down for a drug seeking reimbursement expansion risk-sharing agreement (RSA) scheme. The reason for the breakdown is believed to be related to the ‘expenditure cap amount’ rather than 'drug price'. Lorviqua was granted pharmacoeconomic evaluation exemptions when it was first listed. Such PE exemption drugs are required to be reimbursed through the RSA Expenditure Cap Type scheme. As such, a new cap amount would have been derived to account for the increased usage due to the expanded reimbursement during negotiations, and it is likely that Pfizer was unable to accept it. Pfizer's unacceptance may be seen as greed on the pharmaceutical company’s part. However, negotiations are always conducted within a set framework. Pfizer did conduct a pharmacoeconomic evaluation as part of the reimbursement expansion process. So the solution would be to eliminate the disputed expenditure cap requirement and convert Lorviqua to a drug listed through the general process. The other ALK anticancer drugs available in the market - the 1st generation drug ‘Xalkori (crizotinib),’ 2nd generation drug ‘Alecensa (alectinib),’ ‘Zykadia (ceritinib)’ – were all listed through the general track. In fact, Pfizer offered to switch Lorviqua’s reimbursement path to general listing during negotiations, but the government turned it down as it was "unprecedented," and that hesitation led to the breakdown of negotiations. However, patients are left to suffer the damage. It's important to make things work. If necessary, there's no reason not to take the road less traveled. Moving RSA drugs to the general track will also ensure additional price transparency. Pfizer quickly announced plans to reapply for reimbursement expansions. A company spokesperson said: "We are disappointed that final negotiations were unsuccessful. We plan to reapply for first-line reimbursement as soon as possible to ensure patient access to the treatment and we will do our best to engage in effective discussions with the government and facilitate a forward-looking review.” As such, its progress upon reapplication will also be interesting to watch. This was the e first time RSA negotiations have failed. After the unprecedented event, starting the process all over again would be a lengthy process. Regardless of whether reimbursement is expanded or not, the government would need to be flexible in its administration to achieve a quick result. Lorviqua was specifically designed and developed by Pfizer to penetrate the blood-brain barrier (BBB). The drug’s high clinical value as a first-line treatment was recognized in the 5-year long-term follow-up results of the CROWN study that was presented at ASCO. Results showed that Lorviqua reduced the risk of disease progression or death by 81% compared to crizotinib, with 60% of patients surviving without disease progression at 5 years. The risk of brain metastasis progression was reduced in 94% of patients, with only 4 of 114 Lorviqua-treated patients without brain metastases developing brain metastases.
- Company
- Boryung wins the Pomalyst patent challenge for the 2nd time
- by Kim, Jin-Gu Jun 11, 2024 03:25pm
- Boryung has once again challenged the Pomalyst patent and won. Boryung won the second attempt to avoid the substance patent of ‘Pomalyst (pomalidomide),‘ a treatment for multiple myeloma. Despite winning the infringement trial for the same patent in 2021, Boryung had not released generic versions. It seems that Boryung changed the method of generic development and rechallenged the patent. The analysis suggests that Boryung is on a countdown to releasing Pomalyst generic following the second-time success of the patent infringement challenge. It has been confirmed that Boryung has already applied for marketing approval for four doses of pomalidomide. According to pharmaceutical industry sources on June 10th, Boryung received the decision in its favor regarding the claims to confirm the scope of a right for the Pomalyst substance patent. Interestingly, Boryung has already won the previous challenge for the same patent. In July 2020, Boyung filed claims to confirm the scope of a right for the Pomalyst substance patent and won the claim in February. At that time, Kwang Dong Pharmaceutical also challenged the patent and won. However, Kwang Dong Pharmaceutical and Boryung have not released the generic version. Although the patent holder did not appeal the loss of the first trial, neither company released the generics. In three years, Boryung filed a claim with the Intellectual Property Trial and Appeal Board (IPTAB) again. The target for claiming a trial and the type of claim were the same as before. Regarding this, the pharmaceutical industry suggested that both companies attempted to develop Pomalyst generics using a method approved by the IPTAB but faced challenges. Boryung might have developed a generic using a different method. Developing a generic with a new method may have required a new trial decision to confirm whether it does not fall under the scope of the rights of the Pomalyst patent. Consequently, the company may have rechallenged the same patent and won. It has been confirmed that Boryung has already applied for marketing approval for its four doses of generics. The pharmaceutical industry anticipates that Boryung will secure a right to priority of sale for Pomalyst generic exclusively. Celgene’s Pomalyst was approved in 2014 for the treatment of multiple myeloma. According to a pharmaceutical market research firm IQVIA, Pomalyst’s sales reached KRW 22.8 billion last year, up 17% from KRW 19.5 billion in 2022.
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- GC's Sanfilippo syndrome drug receives fast-track status
- by Son, Hyung-Min Jun 11, 2024 05:47am
- GC Biopharma announced on Tuesday that the U.S. FDA has granted Fast Track Designation for GC1130A, a treatment for Sanfilippo syndrome type A (MPS IIIA) that it has been co-developing with Novel Pharma. The fast-track designation follows the FDA's clearance of the Phase I investigational new drug (IND) application for GC1130A last month and is expected to further accelerate the development of GC1130A. Sanfilippo syndrome (type A) is a rare genetic disorder that causes central nervous system damage through the accumulation of heparan sulfate, leading to progressive neurological decline. Without treatment, patients face life-threatening complications by the age of 15. GC1130A is a new biological drug that is being developed using GC Biopharma’s high-concentration protein formulation technology, designed for administration to the central nervous system. It is delivered directly into the brain's ventricles through intracerebroventricular (ICV) injection, a method first applied globally by GC Biopharma's Hunter syndrome treatment, 'Hunterase', which has received marketing authorization in Japan. The potential of GC1130A to meet the unmet medical needs of Sanfilippo syndrome has been recognized by major drug regulatory agencies; in 2023, the FDA granted GC1130A Rare Pediatric Disease Designation (RPDD) and Orphan Drug Disease (ODD), and earlier this year, the European Medicines Agency (EMA) also granted GC1130A ODD status. Currently, GC Biopharma and Novel Pharma are preparing to initiate a multinational clinical trial to evaluate the safety and tolerability of GC1130A in Korea, the US, and Japan. A GC Biopharma official said, “With no approved treatment available for Sanfilippo syndrome, we are pleased that the FDA has granted GC1130A Fast Track designation. This designation will allow us to accelerate the development of our drug to bring hope to patients suffering from Sanfilippo syndrome.” The FDA's Fast Track program is designed to expedite the development and review of drugs intended to treat serious or unmet medical needs. The Fast Track designation provides extensive support, including frequent meetings with the FDA throughout the drug development, clinical, and approval stages.
- Company
- 'Novel drugs·CDMO competitiveness↑'
- by Son, Hyung-Min Jun 10, 2024 05:41am
- Major biotech companies in Korea participated in the BIO International Convention (BIO USA 2024) and introduced their in-house competitiveness. Over 50 Korea-based companies attended the BIO USA 2024, held between June 3-6 in San Diego, United States. They sought opportunities to expand partnerships along with discussions for technology transport. Samsung Biologics showcased its new platform, showing a strong directive to expand the company’s growth related to intensified cell-culture with improved manufacturing capacity. Lotte Biologics, ST Pharm, and Prestige Biologic introduced their contract development and manufacturing organization (CDMO) capacities and held partnering meetings for contract orders. Korean companies have made significant achievements in novel drug development. VaxCell Biotherapeutics showcased positive results of its novel candidate under a phase 2 clinical trial for hepatocellular carcinoma. Genome & Company won a technology transport contract for its antibody-drug conjugate (ADC), confirming its competitiveness. China absent from the BIO USA…all eyes on K-bio According to industry sources on June 9th, 47 Korean companies ran booths during the BIO USA, which was 6 more companies than last year. BIO USA is the world’s largest biopharmaceutical convention, with more than 20,000 leaders in the biopharmaceutical industry participating. Continuing from last year, Korean CDMO companies have gathered attention this year. Notably, due to the introduction of the Biosecure Act by the United States, all eyes were drawn to the Korean companies in the absence of WuXi Biologics, China’s largest CDMO. The United States aims to limit the business with the Chinese biotech companies. Therefore, the analysis suggests that along with Swiss-based Lonza and Japan-based Fujifilm, Korean CDMO companies will have more opportunities. The Korea booth at the BIO International Convention (BIO USA 2024) (photo=KoreaBio). Samsung Biologics launched a new CDO platform called S-Tensify, bolstering CDO competitiveness. S-Tensify supports high-intensity biomedicine development with the latest cell-culture technology. The company shared that S-Tensify’s adoption of N-1 perfusion technology has increased its cell-culture concentration by 30-fold, significantly boosting manufacturing capacity during inoculation at the seed stage (N-1). ST Pharm has started CDMO of CRISPR/Casx, used in gene editing technology. Gene editing is a biomolecular tool for editing precise locations within DNA using zinc finger nucleases, TALEN, or CRISPR/Cas9. CRISPR/Casx is an innovative technology for precisely editing DNA sequences, enabling deletion, addition, or correction of genetic material. Novel drug development using gene editing is currently underway. The U.S. FDA approved exa-cel (U.K.-authorized product name: Casgevy), a CRISPR/Cas9 gene-edited therapy developed by the United States biotech company Vertex Pharmaceuticals and SWISS-based CRISPR Therapeutics. ST Pharm showcased its manufacturing process of sgRNA, which precisely targets the genome. More than 100 mer high-purity sgRNA production is needed to develop medicines, and this manufacturing technology is more difficult than ASO or siRNA oligonucleotides ingredients. During the event, Prestige Biologics shared new CDMO business opportunities due to the imminent passing of the Biosecure Act by the United States. According to the company, over 30 companies have requested meetings, and 6 offers have been received. Prestige Biologics emphasized that the company is equipped with cost competitiveness and quality for a single-use approach. K-bio showcased novel drug development competitiveness In addition to CDMO orders, Korean biopharmaceutical companies also showcased their capabilities in the development of novel drugs. VaxCell Biotherapeutics presented the outcomes of Phase 2a ‘Vax-NK/HCC’ clinical trials for hepatocellular carcinoma. This trial evaluated the efficacy of Vax-NK/HCC plus HAIC combination therapy involving 16 patients with advanced hepatocellular carcinoma who did not respond to conventional treatments. The clinical results demonstrated that Vax-NK/HCC plus HAIC combination therapy had an objective response rate (ORR) of 68.8% and a progression-free survival (PFS) of 16.8 months. Genome & Company has confirmed the competitiveness of its ADC candidate. Earlier this month, the company signed a technology transfer contract with Swiss-based Debiopharm for its ADC candidate, GENA-111. Including the upfront payment of approximately KRW 6.9 billion, the contract size amounts to a maximum of KRW 586.4 billion. GENA-11 is an ADC candidate with a novel mechanism for targeting CD239. CD239 is known to be highly expressed in cancer cells than in healthy cells, and no ADC has been commercialized for targeting this. Genome & Company is considering targeting GENA-111 to treat gynecologic cancer. After assessing which payload would be more effective, the company stated that the final target indication would be decided. Bridge Biotherapeutics shared directives for developing novel drug candidates to treat idiopathic pulmonary fibrosis (IPF). BBT-887 is an innovative new candidate under development in a phase 2 trial. It is a selective inhibitor of autotaxine enzyme. Autotaxine is a protein known to bind to receptors in cells and induce various physiological activities, such as sclerosis and tumorigenesis. Bridge Biotherapeutics presentation (photo=Bridge Biotherapeutics). Last month, Bridge Biotherapeutics received authorization from the Independent Data Monitoring Committee (IDMC) to continue the clinical trial. After evaluating the efficacy and safety data of 75 clinical subjects, there were no concerns related to the drug safety or effects.
- Company
- Chronic kidney disease drug ‘Kerendia’ can be prescribed
- by Eo, Yun-Ho Jun 10, 2024 05:41am
- Bayer’s new chronic kidney disease drug ‘Kerendia.’ ‘Kerendia,’ a treatment for chronic kidney disease, is now available for prescription after receiving approval for insurance reimbursement. According to industry sources, Bayer’s Kerendia (finerenone) has passed the drug committee (DC) of Big 5 tertiary general hospitals, including Seoul National University, Seoul Asan Hospital, and Sinchon Severance Hospital. Additionally, 49 hospitals in Korea have assigned Kerendia’s prescription code. Kerendia is a treatment for chronic kidney disease accompanying type 2 diabetes. It has been listed for reimbursement since February last year. With Chon Kun Dang becoming a marketing partner in South Korea, rapid landing and promotional activities are underway. Kerendia received approval in Korea last year. It is indicated for the treatment to reduce the risk of sustained eGFR (estimated Glomerular Filtration Rate, eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes. CKD is one of the most common complications in type 2 diabetes and is an independent risk factor of cardiovascular diseases. While CKD is a progressive disease, it can be difficult to detect because the disease can progress without showing obvious signs until just before the late-stage renal failure occurs. With late-stage renal failure, patients require dialysis or kidney transplants to sustain life. This can pose a socio-economic burden and have a profound impact on a patient’s quality of life. For patients with type 2 diabetes, frequent monitoring and assessment of kidney damage and kidney function are essential. Early detection and appropriate treatment are critical to slowing down the progression of the disease and reducing the risk of cardiovascular diseases. In type 2 diabetes, the three key factors causing kidney disease are hemodynamic changes, metabolic abnormalities, and inflammation or fibrosis. However, in current therapy, treatments targeting hemodynamic and metabolic factors are only available, while treatments targeting inflammation and fibrosis are lacking, highlighting the need for new treatment approaches. Kerendia is a novel therapeutic approach targeting inflammation and fibrosis in adult chronic kidney disease patients with type 2 diabetes. It is the first non-steroidal, selective mineralocorticoid receptor antagonist. Overactivation of the mineralocorticoid receptor (MR) can lead to inflammation and fibrosis, which can result in permanent damages to kidney. Kerendia inhibits the overactivation of the mineralocorticoid receptor, reducing inflammation and fibrosis, and thereby preventing kidney damage. Kerendia demonstrated its effectiveness in the Phase 3 FIDELIO-DKD trials. FIDELIO-DKD trials enrolled approximately 5,700 patients from 48 countries globally, and Kerendia is indicated to inhibit the progression of chronic kidney disease and reduce the risk of cardiovascular events in adult patients with chronic kidney disease accompanying type 2 diabetes. Patients participating in the study received either Kerendia at doses of 10mg or 20mg in addition to standard therapy or a placebo. Clinical outcomes demonstrated that primary composite endpoint consisted of end-stage kidney disease, a sustained decline of more than 40% in eGFR, reduction by approximately 18% compared to the placebo in renal death. In addition, it reduced the secondary endpoints consisting of cardiovascular death, nonfatal myocardial infarction, stroke, or heart failure leading to hospitalization by approximately 14%. The outcomes of major adverse events or the rate of adverse events related to acute kidney damage were comparable between the two groups. Meanwhile, the European Society of Cardiology (ESC) revised its ‘2021 ESC Guidelines for the Diagnosis and Treatment of Acute or Chronic Heart Failure’ and listed Kerendia as a Class 1A recommendation to prevent hospitalization due to heart failure in patients with chronic kidney disease accompanying type 2 diabetes. Additionally, the ESC recommended annual assessment of eGFR and urinary albumin levels to screen for the development of chronic kidney disease in patients with diabetes.
