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- 2026-06-21 13:47:31
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- New drug Voranigo receives orphan drug designation in Korea
- by Eo, Yun-Ho Sep 04, 2024 05:49am
- Voranigo, the first new malignant brain tumor drug introduced in 20 years, has received an orphan drug designation in Korea. The Ministry of Food and Drug Safety announced so through an official orphan drug designation notice on the 3rd. Specifically, the drug is for the treatment of IDH-mutated diffuse glioma. Voranigo can be used to treat patients with low-grade glioma who are susceptible to isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) mutation. Voranigo (vorasidenib) is an IDH1/2 dual inhibitor class drug developed by the multinational pharmaceutical giant Servier that targets a difficult-to-treat brain tumor, gliomas (including oligodendrogliomas and astrocytomas). The drug received final approval from the U.S. Food and Drug Administration (FDA) on March 6 and is in the process of being approved in Europe and other countries around the world. The efficacy of Voranigo was demonstrated through the Phase III INDIGO trial. The results of the study were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting last year. Results showed that the drug significantly reduced the risk of tumor progression or death by 61% compared with placebo in patients with residual or recurrent grade 2 IDH-mutant glioma, and reduced the risk for further treatment by 74%. These patients had not previously undergone any treatment other than surgery. The trial also showed that Voranigo was well tolerated, and its safety profile was consistent with the results observed in the Phase 1 trial. Glioma is the most common primary malignant brain tumor in adults, and nearly all (grade 2 diffuse glioma) adult patients have IDH1 or IDH2 mutations. The treatments for these patients are all off-label (drugs licensed for other uses) and not formally approved. In addition to Voranigo monotherapy, Servier is currently conducting a clinical trial on Voranigo in combination with MSD's immuno-oncology drug Keytruda (pembrolizumab) in patients with relapsed or advanced IDH1-mutant glioma. The company already owns a pipeline of IDH inhibitors, including Tibsovo (an IDH1 inhibitor) and Idhifa (an IDH2 inhibitor).
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- Yuhan's investment in US subsidiary total KRW 27B over 5 yrs
- by Chon, Seung-Hyun Sep 04, 2024 05:48am
- Yuhan Corporation has invested KRW 3.9 billion additionally to the U.S.-based subsidiary of the company. The company invested KRW 27 billion over the past five years, expanding support for global entry. According to Financial Supervisory Service on September 4th, Yuhan Corporation invested KRW 3.9 billion in the first half of the year and acquired an additional 3 million shares. Yuhan Corporation Headquarter Office buildingEstablished in 2018, Yuhan USA is a U.S.-based regional subsidiary of Yuhan Corporation and and is responsible for investing in potential biotech ventures, conducting global clinical trials, and delivering technology transfers. It is Yuhan Corporation's wholly-owned subsidiary and will serve as a bridgehead for global entry. Yuhan USA operates by having an East Coast office in Boston and a West Coast office in San Diego, United States. Boston is the hub for the world's biotech industry, and San Diego is emerging as a major biotech cluster. It has been two years since Yuhan Corporation invested in Yuhan USA in 2022. In the second quarter of 2022, Yuhan Corporation invested KRW 7.7 billion in Yuhan USA and acquired 6 million shares. Yuhan Corporation invested KRW 1.9 billion when it set up Yuhan USA in 2018. It invested an additional KRW 3.5 billion and KRW 3.6 billion in 2019 and 2020, respectively. In 2021, the company invested KRW 6.4 billion. Including this investment round, Yuhan Corporation has invested a total of KRW 27 billion over the past five years. Yuhan USA's strategy focuses on visiting companies, research centers, and universities in the United States to make direct investments in potential technology and new drug candidates. Its indirect investment strategy involves investing in biotech ventures in the United States or opening its fund to invite U.S.-based biotech ventures and investors. Most of the Yuhan Corporation's investment in Yuhan USA is invested in an investment fund run by 5AM Ventures, a Boston-based biotech venture capital firm. The strategy is continuously investing in overseas biotech funds and seeking new R&D opportunities. Furthermore, Yuhan USA participates in international conferences in the United States and presents clinical data of new drugs developed by Yuhan Corporation to increase chances for out-licensing. In 2020, Yuhan USA successfully out-licensed Yuhan Corporation's gastrointestinal medication. Yuhan Corporation signed an out-licensing agreement with Processa Pharmaceuticals in August 2020 for its ' YH12852,' a candidate for the treatment of functional intestinal disorder. The agreement included exclusive development, manufacturing, and commercialization rights for 'YH12852' worldwide, excluding South Korea. The total agreement amount is up to US$410.5 million (about KRW 500 billion). Yuhan Corporation has secured US$2 million worth of Processa Pharmaceuticals shares for a non-refundable upfront payment. Processa Pharmaceuticals is an R&D company established in Maryland, U.S., in 2016. Yuhan USA identified a potential out-licensing partner in the United States and successfully reached the final agreement with Processa Pharmaceuticals.
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- Generic companies lastly challenge Lixiana patent
- by Kim, Jin-Gu Sep 04, 2024 05:48am
- Pic of Lixiana Generic companies have been filing late patent challenges against Lixiana (edoxaban), the market leader in the direct-acting oral anticoagulants (DOACs) market. This is due to the imminent expiry of the product's formulation patent, which is 2 years away. The strategy of the patent challengers is to avoid the formulation patent and launch generics early upon the expiry of the product patent in November 2026. According to industry sources on the 3rd, Dongkwang Pharmaceutical recently filed a trial to confirm the passive scope of Lixiana's formulation patent against Daiichi Sankyo. Prior to Dongkwang Pharmaceutical, Theragen Etex also filed a challenge to avoid the same patent last month. The interesting fact is that a series of such challenges had ended in the 2020-2021 season. The challenge to the Lixiana formulation patent began in July 2018 when Boryung Pharmaceutical first filed a trial to avoid Lixiana’s patent. Hanmi Pharmaceutical, Chong Kun Dang, Samjin Pharm, Kolmar Korea, Kolmar Pharma, HK. Inno.N, Hutecs Korea followed to receive trial decisions for the same patent. The companies won the first trial after May 2020. In 2021, Dong-A ST and Shinnil Pharmaceutical filed for the same judgment and won the first trial. The original manufacturer of Lixiana, dropped its appeal, and the first-instance victory was finalized as a ruling. This ended the patent challenge, with 10 generic companies avoiding Lixiana's formulation patent once and for all. Now, more than 3 years later, the challenge has resumed with Theragen Etex, Dongkwang Pharmaceutical filing the trials. The analysis is that the companies made the move as the expiry of Lixiana's product patent is now just 2 years away. There are 2 Lixiana patents listed on the MFDS’s green list: a product patent that expires in November 2026 and a formulation patent that expires in August 2028. Generic companies plan to avoid the formulation patent and launch generics of Lixiana early to coincide with the expiration of the product patent. If the companies that won the first trial won the invalidation trial, the patent itself would have been invalidated, rendering no need for latecomers to file separate challenges. However, since the previous companies won the passive scope confirmation trial rather than the invalidation trial, the latecomers must also file individual challenges. Of course, as other generic companies have already won, the chances of success for the latecomers are high. Quarterly DOAC prescriptions (Lixiana, Eliquis, Xarelto, Pradaxa) Industry insiders raised the possibility of additional patent challenges rising in the future due to Lixiana’s long-term lead in the DOAC market with prescription sales of more than KRW 100 billion per year. According to pharmaceutical market research institution UBIST, Lixiana’s prescription sales were KRW 105.3 billion last year. That is up 9% from the KRW 96.7 billion in 2022. In the first half of this year alone, the drug generated KRW 55.7 billion in prescription sales. Lixiana first became the market leader in 2019 and has maintained its lead ever since. The company attributed the rise in prescription sales to the copromotion synergy with Daewoong Pharmaceutical. Moreover, the gap with the second-ranked drug has been widening upon the expiration of the substance patents of its rivals Xarelto (rivaroxaban) and Eliquis (apixaban).
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- Pharma companies jump into developing 'TPD' for cancer
- by Son, Hyung-Min Sep 03, 2024 05:53am
- The global and Korean pharmaceutical industries are focusing on securing Targeted Protein Degradation (TPD) technology, which has emerged following the success of Antibody-Drug Conjugates (ADCs). Recently, major global pharmaceutical companies such as Pfizer, Novartis, and Eli Lilly have successfully acquired TPD technologies, marking TPD as a new anti-cancer drug development strategy, following targeted therapies, immune checkpoint inhibitors, and ADCs. Korean pharmaceutical and biotech industries are also exploring the potential of TPD drug development and have achieved successful technology transfers. According to industry sources on September 3rd, several Korean biopharmaceutical companies, including Yuhan Pharmaceutical, SK Biopharmaceuticals, Daewoong Pharmaceutical, Samjin Pharmaceutical, and Orum Therapeutics, have jumped into developing novel TPD drugs. TPD drugs are the next-generation new drug candidate that can use an intracellular protein degradation system to degrade protein of interest specifically. Unlike conventional small-molecule targeted drugs that inhibit protein function, novel TPD drugs offer superior therapeutic effects and avoid tolerance by directly degrading and eliminating disease-causing proteins. TPD drugs can target over 80% of disease-causing proteins that conventional small-molecule drugs could not modulate. The mechanism of the TPD technology, previously referred to as PROTAC (source=KRICT). SK Biopharmaceuticals has identified TPD as a promising future field and is advancing its development as a follow-up to its epilepsy treatment, Xcopri. Last year, the company invested KRW 62 billion to acquire Proteovant, securing TPD technology. Founded in March 2020 in the U.S., Proteovant is a biotech venture with global-level technology in the TPD field and molecular glue technology. Yuhan Pharmaceutical is also eyeing the opportunity to develop TPD drugs as a follow-up to its non-small cell lung cancer treatment (NSCLC), Leclaza. The company acquired the prostate cancer drug candidate 'UBX-103' in July from Ubix Therapeutics. As a result, Yuhan Pharmaceutical has secured the lead for clinical trials and exclusive rights for the development and commercialization of UBX-103. The recently acquired 'UBX-103' by Yuhan Pharmaceutical is a novel prostate cancer drug candidate based on TPD technology. UBX-103 works by degrading the androgen receptor, overexpressed or hyperactivated in prostate cancer patients. In the non-clinical studies, UBX-103 showed ten times superior androgen receptor degradation and suppression of prostate cancer cell proliferation in wild type and mutant compared to 'ARV-110' of Arvinas, a U.S.-based company. In a castration-resistant prostate cancer mouse model, the drug showed three times more anti-cancer efficacy than ARV-110. Orum Therapeutics is proving its R&D capacity by successfully out-licensing TPD platform to global pharmaceutical companies. In July last year, the company signed an out-licensing agreement with the U.S.-based biotechnology company Vertex Pharmaceuticals for its TPD. Vertex Pharmaceuticals is a company that developed a CRISPR/Cas9 gene-edited therapy, exa-cel. Utilizing Orum Therapeutics' Dual-Precision TPD (TPD2), Vertex Pharmaceuticals plans to discover 'conditioning agents,' which are used to wash bone marrow before injecting patients with gene editing products. TPD, provided by Orum Therapeutics, is a technology that specifically degrades target proteins. Daewoong Pharmaceutical and Samjin Pharmaceutical have signed a strategic business agreement with the Korean TPD discovery company Pin Therapeutics to develop novel drugs. Pin Therapeutics is a novel drug discovery company established in 2017 that conducts global R&D by collaborating with 'PinUS,' a wholly-owned subsidiary in the United States. Global pharmaceutical companies proactively conduct novel TPD drugs Global pharmaceutical companies are also proactively developing novel TPD drugs. AstraZeneca has signed an out-licensing deal with the U.S.-based PineTree Therapeutics for exclusive sales and global rights. PineTree Therapeutics is a company established in 2019 in Boston, U.S., specializing in the development of novel drugs. PineTree Therapeutics' EGFR degrader candidate was developed using its proprietary multi-antibody platform, 'AbRaptor.' Based on the research, this candidate demonstrated anti-tumor activity when used in tumors resistant to drugs such as tyrosine kinase inhibitor (TKI). AstraZeneca has the EGFR drugs Tagrisso and Iressa for the treatment of non-small cell lung cancer (NSCLC). Utilizing the TPD technology, the company plans to develop follow-up drugs for Tagrisso and Iressa. Global pharmaceutical companies like Pfizer and Novartis have invested over KRW 1 trillion in Arvinas' TPD pipeline development. The U.S.-based company Arvinas is a leader in the TPD field. Arvinas' platform PROTAC was previously referred to as TPD technology. The company is the only company in the world to own a proprietary novel TPD candidate that has entered the Phase 2 trial. In 2021, Arvinas signed an out-licensing deal with Pfizer for its novel TPD drug, 'ARV-471,' for breast cancer treatment. It also transferred androgen receptor degrader 'ARV-766' to Novartis. With the agreement, Novartis will be responsible for the global clinical trial development and commercialization of ARV-766. Last year, Arvinas announced ARV-766's interim data from dose escalation research. Based on the clinical results, the drug demonstrated a 50% reduction of prostate-specific antibody (PSA) in 41% of patients with mutations in the ligand-binding domain in the androgen receptor. Novartis will aim to commercialize ARV-766 as a prostate cancer treatment and enter the later stage of clinical trials. Additionally, various global companies like Novo Nordisk, Astellas, and Eli Lilly have jumped into this field by investing in companies developing novel TPD drugs.
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- Biological drug options for psoriasis treatment increase
- by Son, Hyung-Min Sep 02, 2024 05:48am
- Domestic and foreign pharmaceutical companies are expanding psoriasis treatment options through the development of biological agents. Recently, Korea's UCB Pharma succeeded in obtaining domestic marketing authorization for a biological drug with a new mechanism of action, sparking competition in the field. Other domestic pharmaceutical and biotech companies such as HK Inn.N and AprilBio have also entered the market by developing new biologics. Celltrion, Samsung Bioepis, and others are planning to expand their influence in the psoriasis treatment market by manufacturing biosimilars of biological drugs. #According to industry sources, the Ministry of Food and Drug Safety approved Korea's UCB Pharma’s interleukin-17 dual inhibitor Bimzelex on the 29th. Bimzelex is the first biologic to simultaneously target interleukin (IL)-17A and F. While biologics targeting IL-17A, such as Lilly's Taltz and Novartis' Cosentyx, have been available in the market, Bimzelex is the first drug to target IL-17F as well. IL-17 is an inflammatory cytokine that causes psoriasis. By targeting both IL-17A and IL-17F simultaneously, it is believed to be able to inhibit the inflammatory cytokines in higher doses and with greater potency. Psoriasis is a chronic, systemic skin disease caused by an abnormality in the immune system, and is characterized by erythema, a reddening of the skin, and psoriasis, which is white, scaly patches of the skin. Bimzelex’s approval is based on the Phase III BE READY study. The study compared the efficacy and safety of Bimzelex versus placebo in patients with plaque psoriasis. Results showed that the primary endpoint, a Psoriasis Area and Severity Index (PASI) score of 90 or greater at Week 16, was 90.8% in the Bimzelex arm. The proportion of patients achieving a PASI score of 100 was 68.2%, and the proportion of patients achieving an overall clinical response (IGA) score of 0 or 1 was 92.6% in the Bimzelex arm, significantly higher than the 1.2% in the placebo arm. Bimzelex also achieved significant PASI score improvements compared to other biologics. Bimzelex achieved significantly higher PASI 100 rates compared to Janssen's Stelara, AbbVie's Humira, and Cosentyx. Bimzelex’s PASI 100 achievement rate was also shown to have been maintained at a high level for 3 years in the BE BRIGHT open-label extension study. Bimzelex is the only IL-17 biologic introduced in Korea that can be dosed once every 8 weeks as maintenance therapy. It can also be self-injected by patients with education. Development of biologics active...competition heats up for psoriasis The domestic pharma and biotech industry is also developing biologics for psoriasis. Currently, biologics with psoriasis treatment indications include Abbvie’s Humira-Skyrizi, Cosentyx, and Taltz. Domestic biotech companies have also signaled their entry into the market by developing the drugs’ biosimilar versions. Celltrion recently received approval from the U.S. Food and Drug Administration (FDA) for a global Phase III trial of Cosentyx’s biosimilar, ‘CT-P55.’ Cosentyx is a biological drug developed by Novartis that inhibits IL-17A and is effective in a variety of inflammatory diseases, including psoriasis and ankylosing spondylitis. The study will enroll a total of 375 patients with plaque psoriasis. A comparative study will be conducted to demonstrate equivalence in efficacy and safety between the original drug and CT-P55. CT-P55 received Phase I IND approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) in December of last year. In addition to Cosentyx, Celltrion has developed a number of other biologics, including biosimilars of Humira and Stelara. The company plans to expand its footprint in inflammatory diseases such as psoriasis with the Cosentyx biosimilar. Samsung Bioepis is challenging this market with the commercialization of its Stelara biosimilars. In April, Samsung Bioepis received approval from the European Medicines Agency (EMA) for Pyzchiva, a biosimilar of Janssen's autoimmune disease treatment Stelara. Pyzchiva is a biologic that treats plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, with annual global sales near KRW 14 trillion. HK Inno.N and AprilBio will develop biologics targeting novel mechanisms of action. HK Inno.N, YBiologics, and IMBiologics recently licensed-out IMB-101, a new drug candidate for autoimmune diseases, to US pharmaceutical company Navigator Medicines. MB-101 is a dual antibody drug candidate that simultaneously controls innate and adaptive immune responses by dual-targeting OX40L and tumor necrosis factor (TNF). The OX40L pathway is involved in the activation of T-cells, and immune cells, and TNF is a cell signaling protein involved in inflammatory responses. IMBiologics received IND approval from the U.S. Food and Drug Administration (FDA) in August last year and is currently conducting Phase I clinical trials. AprilBio has also successfully licensed out its technology for its autoimmune disease drug candidate 'APB-R3' to U.S. new drug developer Evommune. APB-R3 is a biological drug candidate that targets interleukin (IL)-18. IL-18-targeting candidates are known to be effective in various diseases including psoriasis, inflammatory bowel disease, atopic dermatitis associated with metabolic syndrome-related steatohepatitis, and sepsis. AprilBio has confirmed the tolerability and safety of APB-R3 in a Phase I clinical trial. Evommune plans to initiate a Phase II clinical trial for APB-R3 in the first half of next year.
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- Yuhan’s Leclaza targets US mkt based on its clinical effect
- by Hwang, Byung-woo Sep 02, 2024 05:48am
- The non-small cell lung cancer drug Leclaza (lasertinib) in combination with Ryvrevant(amivantamab) has gained competitivity in the U.S., based on data presented at the World Congress on Lung Cancer (WCLC 2024). Additional data on Leclaza monotherapy and Leclaza in combination with Ryvrevantare is expected to be presented to further increase the drug’s clinical value. WCLC 2024 will be held from September 7 in San Diego, U.S. According to industry sources on the 31st, results from a study comparing the efficacy and safety of Leclaza+Ryvrevant and Leclaza monotherapy to Tagrisso monotherapy will be presented at WCLC 2024, which will be held from September 7 in San Diego, U.S. The data to be presented at WCLC 2024 are from the interim follow-up results of the study, which evaluated the clinical efficacy of Leclaza monotherapy (216 patients) versus Tagrisso monotherapy (429 patients) and Leclaza+Ryvrevant combination therapy (429 patients). In the results that were first disclosed through its abstract, the study showed that Leclaza monotherapy achieved a median progression-free survival (PFS) of 18.5 months by a blinded independent centralized review (BICR) over a median follow-up of 22 months. Also, the Leclaza monotherapy arm was associated with a 2% reduction in the risk of disease recurrence, progression, or death compared with the 16.6 months confirmed in the Tagrisso arm. In addition, an analysis of a high-risk subgroup showed that Leclaza improved PFS even further compared with Tagrisso. In patients with a history of brain metastases, the median PFS was 16.4 months with Leclaza versus 13.0 months with Tagrisso. The median PFS of patients with circulating tumor DNA (ctDNA) was also superior with Leclaza (18.4 months) versus Tagrisso (14.8 months). While more detailed results will be presented at WCLC 2024, experts believe that these results will support the drug settle in the U.S. market. “I think the argument for Janssen will be in providing a stronger rationale for why they chose Leclaza for combination therapy,” said Professor A, a hematologist-oncologist at a Big 5 hospital who asked for anonymity. ”The abstract shows that the efficacy was as expected and that Leclaza was better in terms of side effects, which is one reason why the company chose to use Leclaza as its partner.” Pic of Leclaza With the rising need to prescribe new treatments, the research presented at WCLC 2024 is expected to support the use of Leclaza. The congress will also feature a follow-up of the MARIPOSA trial presented at the European Society of Clinical Medical Oncology Annual Congress (ESMO 2023) last year. According to the abstract, at a median follow-up of 31.1 months, 44% (185/421) of patients in the Leclaza+Ryvrevant arm and 34% (145/428) in the Tagrisso arm were still on treatment. Overall survival (OS) data at a median follow-up of 31.1 months were also presented. At 24 months, 75% and 70% of patients were alive in the Leclaza+Ryvrevantand Tagrisso arms, respectively, and at 36 months, the corresponding figures were 61% and 53%, respectively. the interim analysis of the OS results showed a positive trend in favor of the Leclaza+Ryvrevantarm over the Tagrisso monotherapy arm as in last year but showed no statistical significance. On this, the researchers commented, “OS continues to show a trend toward improvement in the Leclaza+Ryvrevant arm compared to Tagrisso, reaffirming how the Leclaza+Ryvrevant combination is the standard first-line therapy for advanced EGFRm NSCLC.”
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- Tevimbra may be prescribed in general hospitals in KOR
- by Eo, Yun-Ho Sep 02, 2024 05:48am
- The immuno-oncology drug 'Tevimbra' may now be prescribed in general hospitals in Korea. According to industry sources, BeiGene Korea's PD-1 inhibitor Tevimbra (tiselizumab) has passed the drug committees (DCs) of tertiary hospitals, including Samsung Medical Center and Seoul National University Hospital. In addition, the company succeeded in reapplying for Tevimbra’s reimbursement to the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee, raising the possibility of its insurance reimbursement. Tevimbra had previously received the ‘reimbursement standards not set' decision by the CDDC in March. The company had resubmitted its reimbursement application in May. Tevimbra (tiselizumab), which was approved in Korea last November, is an immuno-oncology drug indicated as a monotherapy for patients with unresectable, relapsed, locally advanced, or metastatic oesophageal squamous cell carcinoma who are unable to continue platinum-based chemotherapy or who have relapsed or progressed after receiving prior platinum-based chemotherapy. In the global Phase III RATIONALE-302 trial, Tevimbra prolonged median overall survival (OS) by 2.3 months compared to chemotherapy (8.6 months vs. 6.3 months), with a statistically significant 30% reduction in the risk of death, and did not show any crossover, unlike existing immuno-oncology monotherapies in the OS graph. In the trial, Tevimbra’s OS improvement was consistent across predefined subgroups, including baseline PD-L1 status, region, and race. Compared to chemotherapy, Tevimbra resulted in more than twice as many patients responding to treatment (20% vs. 10%), and showed an improvement in the median duration of response of approximately 3 months, from 4.0 months to 7.1 months, with sustained responses and a reduction in tumor size, which is directly related to quality of life for esophageal cancer patients. Furthermore, Tevimbra was associated with a 17% lower risk of disease progression or death in progression-free survival (PFS) (HR=0.83, 95% CI 0.67-1.01) and improved health-related quality of life (HRQoL) compared to chemotherapy. In April, the U.S. National Comprehensive Cancer Network (NCCN) revised its guidelines to recommend Tevimbra as a Category 1, preferred option for second-line treatment of esophageal squamous cell carcinoma.
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- API competition↑ with entry of Chinese and Indian pharmas
- by Son, Hyung-Min Aug 30, 2024 05:50am
- Chinese and Indian companies developing active pharmaceutical ingredients (APIs) are accelerating their entry into Korea. Numerous Chinese and Indian companies as well as domestic companies participated in 'CPHI Korea 2024,' an exhibition for the global pharmaceutical, bio, and health functional food industry that was held at COEX in Samseong-dong, Seoul for 3 days from the 27th, to promote their API development capabilities. Domestic companies also participated in the event to showcase their technology. Domestic API companies highlighted the quality of their products as a strategy to differentiate themselves from overseas companies. A large number of Chinese and Indian API companies participate in CPHI China was the largest participating country at CPHI Korea 2024. More than 140 Chinese pharma and biotech companies participated in the event, which accounted for almost half of the 340 exhibitors. (Clockwise from the top left) Jiangxi Synergy, Bloomage Biotechnology, Zhejiang Biosan, Hubei Honch Pharmaceutical, Xieli Pharmaceutical from China As China supplies nearly half of the world's APIs, these companies are highly influential in the API market. Korea also imports the largest amount of APIs from China. These companies plan to actively target the domestic market to further increase their influence in Korea. China has been turning its eye to markets outside the U.S. after the U.S. strengthened sanctions against China. The U.S. has been implementing biosecurity legislation that would ban Chinese biotech companies from doing business with the U.S., favoring its own biotech companies. In response, Chinese companies have been eyeing the Korean market, which was why many Chinese companies participated in BIO KOREA 2024 in May to promote their company and technologies. The second largest overseas participant after China was India. India owns the second-largest API market following China. India accounts for 20% of the world's supply of APIs. India's pharmaceutical industry has been growing rapidly, focusing on biopharmaceuticals and contract development manufacturing organizations (From the left) Krishna Enzytech, Ashwagandha, Anupam Rasayan, Oceanic Pharmachem from India Various API, health functional food, and additive developers such as Krishna Enzytech, KSM-66 Ashwagandha, Anupam Rasayan, and Oceanic Pharmachem attended the event. In particular, the health functional food company Ashwagandha, participated as a title sponsor of the event. Korean API companies, including Novarex and Samoh Pharm participated at the event..."secured competitivity with quality" Many domestic companies also participated in CPHI Korea 2024. The second largest amount of companies that participated in the event were Korean companies, following China. Kukjeon Pharmaceutical, Samoh Pharm, Inist ST, Seoheung, and Novarex, among others, promoted their technologies for developing various APIs. (Clockwise from top left) Inist ST, Rihu Healthcare, Samoh Pharm, Suheung from Korea Domestic companies expressed high hopes based on the quality of their products. Currently, China and India dominate the global API market. Korea also imports most of its APIs from these countries. The problem is that domestic synthetic drugs are significantly less competitive in price than their Chinese and Indian counterparts, and the high dependence on overseas APIs limits the opportunities for domestic companies. “It is virtually impossible to keep up with China and India in terms of price competitiveness,” said an official from a domestic API company. “Domestic companies need to differentiate themselves in quality through superior manufacturing facilities and quality development capabilities to stand a chance.” However, the government's support is urgently needed to overcome the price competitiveness of overseas companies, and the industry's opinion is that no significant policies have been implemented up to now. The government's policy direction seeks to advance the self-sufficiency rate of APIs for pharmaceuticals, but the policies have not shown a significant impact until now. In particular, there has been a history of disruptions in the production of essential medicines due to difficulties in the supply of raw materials, including the deployment of THAAD, the valsartan crisis, COVID-19, and trade wars, but even after the pandemic turned endemic, the self-sufficiency rate of APIs has not improved. According to the Ministry of Food and Drug Safety, 31 of the 567 finished drugs reported to have been suspended from production, import, and supply from 2017 to June 2022 due to problems in the supply of APIs. 17 of these were national essential medicines. “To compete not only with the U.S. and Europe, but also with China, India, and Southeast Asia, that own prices competitivity, we need support policies at the finished drug level,” said an official from another domestic API company. ”The government has not clearly presented measures to support for self-sufficiency of APIs in Korea. The goal should not be to maintain a certain level of self-sufficiency, but to support the domestic pharmaceutical industry to compete with the global market.”
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- Anti-cancer drug trends changes from IV→SC
- by Moon, sung-ho Aug 30, 2024 05:50am
- Global pharmaceutical companies speed up the development of subcutaneous (SC) formulations of their proprietary intravenous (IV) medications. To overcome the disadvantage of IV formulation medications that have long administration duration, more anti-cancer drugs are shifting to SC formulations. Following the trend, Korean companies with SC formulation technology are gaining attention. Then, what can we predict about the success in real-world clinical practices? While the shift to SC formulation of anti-cancer drugs is trending, pharmaceutical‧biotech industries focus on real-world clinical practices. Global pharmaceutical companies with IV formulations of anti-cancer drugs are proactively conducting clinical trials to transition to SC formulation products. (Table) RocheAccording to pharmaceutical and biotech companies on August 24th, global pharmaceutical companies with proprietary IV formulations of anti-cancer drugs are proactively conducting clinical trials to transition to SC formulation products. SC formulation products are injected into the subcutaneous layer of the skin. Injection sites are typically arms, thighs, and abdominal region. Until now, anti-cancer drugs were available primarily as IV formulations, which inject medications into veins. IV formulation has the advantages of fast absorption and accurate administration but has the disadvantage of taking a long time. For IV injection of anti-cancer drugs, patients were burdened by having to visit hospitals and withstand four to five hours of needle insertion. In contrast, developing anti-cancer drugs as SC formulations has the advantage of substantially improving patient convenience of administration. The administration duration was reduced from a couple of hours to a maximum of ten minutes. Therefore, patients do not need to stay in the hospital for a long time for anti-cancer drugs. As a result, global pharmaceutical companies with immune checkpoint inhibitors are proactively conducting clinical trials and applying for approvals to transition to SC formulations. Following Roche's 'Tecentriq (atezolizumab)' SC obtaining marketing authorization from the European Medicines Agency (EMA) in January, BMS and Ono Pharmaceutical's R&D of 'Opdivo (nivolumab)' and 'Rybrevant (amivantamab)' is nearing the end. These immune checkpoint inhibitors share the same goal to defend against their sales decrease due to patent expiration. Furthermore, the development of SC formulation products has gained more attention since SC formulations have a greater advantage in patient access in the global market, especially in the U.S. market. Recently, J&J confirmed the non-inferiority of SC formulations compared to IV formulations through the Phase 3 PALOMA-3 study, presented at the American Society of Clinical Oncology (ASCO) meeting. Based on the results, J&J has recently applied for additional U.S. FDA approval on Rybrevant SC formulation. Professor Byoung Chul Cho (Director of the Lung Cancer Center at Yonsei Cancer Hospital) said, "The United States provides incentives to using injections, and the amount of incentives is the same between IV injectable or SC injectable," and explained, "There is no need to maintain IV formulation injectables, which commonly induce injection-associated adverse reactions." Professor Sun Min Lim (Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Hospital) also said, "SC injectables only take 1-2 minutes for Rybrevant administration. The common adverse reactions of IV injectables are fever and lowered blood pressure," and added, "In my opinion, SC injectables can reduce such adverse reactions." In the global market trend, clinical practices in South Korea are accelerating the introduction of SC formulation products, which overcome the previous disadvantages of IV formulation. For example, Roche's Phesgo has been recently introduced with reimbursement. Phesgo is an anti-cancer drug developed by changing the IV formulations of Herceptin (trastuzumab) and Perjeta (pertuzumab) to SC formulations. It received approval in September 2021 as the first investigational biopharmaceutical. Phesgo was developed by combining two IV formulation products into SC formulation. It is known to decrease the administration duration for patients with breast cancer substantially. It has been designated as an innovative new drug (IND) and is reimbursable, leading to its recent use in clinical practices. If patients with metastatic HER2-positive breast cancer who have been receiving the maintenance therapy, IV formulations of Herceptin plus Perjeta every three weeks, were to change to Phesgo SC, administration and monitoring duration is expected to decrease from over four hours to 20 minutes. The remaining step is whether the SC formulation can be used in clinical practices in South Korea. While there are clear advantages in patient administration, there are opinions that, unlike in the global market, such as the U.S., it is challenging to quickly replace the existing market in South Korea due to geographic accessibility. Additionally, many believe it will be challenging for healthcare professionals to readily switch to the SC formulation, which they have yet to experience. However, some argue that the fact that most cancer drug administrations are carried out primarily in large hospitals and are performed in the same way in injection rooms is more positive. The large number of patients who can receive treatment may facilitate the rapid establishment of the SC formulation. Professor Park Yeon Hee (Division of Hematolology-Oncology at Samsung Medical Center) said, "Korean patients tend to wait in the hospital, and there are long waits in large hospitals. Therefore, patients may prefer switching to SC formulations," and stated, "In clinical practices, patients may prefer IV injection despite the wait as SC prescriptions, other than clinical studies, have only been made recently."
- Company
- K-bio jumps into developing new drugs for pancreatic cancer
- by Son, Hyung-Min Aug 30, 2024 05:50am
- Korean pharmaceutical and biotech companies have jumped into the development of new drugs for pancreatic cancer, which is categorized as refractory cancer. Prestige Biopharma, New Cancer Cure Bio (NCC-Bio), LigaChem Biosciences, and Aptamer Sciences are conducting clinical trials to challenge the field. These companies plan to investigate the commercialization potential of their candidates through antibody-drug conjugates (ADCs), targeted anti-cancer agents, and new antibody drugs. New ADC drugs target TROP2 for treating pancreatic cancer According to industry sources on August 29th, Aptamer Sciences applied for a patent for its 'Aptamer-Drug Conjugate (ApDC)' and commenced treatment development. ApDC is a next-generation ADC new drug development platform with its proprietary branched linker-payload technology. Pancreatic cancer is known to have the lowest survival rate among cancer disorders. The five-year survival rate of pancreatic cancer is merely 15.9% from 2017 to 2021, according to the National Cancer Center. The early detection rate of pancreatic cancer is less than 10% due to the location of the organ, and the cancer readily metastasizes to peripheral organs. Until now, several domestic and global companies have jumped into developing new drugs for pancreatic cancer but mainly failed in clinical trials. Aptamer Sciences and latecomer companies plan to develop new drugs for pancreatic cancer using their new drug candidates, such as ADC. Aptamer Sciences derived 'AST-203' using the ApDC platform. AST-203 is made by conjugating TROP2-targeting antibody with 'MMAE,' a microtubule disruption agent, with linker 'VC-PAB.' TROP2 is an intracellular calcium signal transducer that regulates cell proliferation and survival. Although this protein is found in healthy cells, it is often overexpressed in cancer cells and is associated with drug resistance. The only TROP2-targeting new drug available in the market is Gilead Sciences' ADC Trodelvy, which is approved for treating triple-negative breast cancer. TROP2 is commonly found in breast cancer, non-small cell lung cancer (NSCLC), colorectal cancer, and pancreatic cancer. The clinical trials for latecomer agents are being conducted to target major solid cancers. In pre-clinical trials, Aptamer Sciences has confirmed the potential of AST-203 in a tumor spheroid model (3D cell culture of spheroids). According to the company, AST-203 showed a 6.7-fold higher tumor penetration rate than an existing therapy, Trodelvy. Additionally, in a pancreatic cancer animal model, AST-203 demonstrated dose-dependent tumor growth suppressive effects and tumor regression, reducing tumor sizes in all experimental animal groups. Aptamer Sciences aims to commence a clinical trial for AST-203 in two years. LigaChem Biosciences (hereafter referred to as LigaChem Bio) is developing TROP2-targeting ADC LCB84. Last year, LigaChem Bio successfully signed a deal with Janssen, a subsidiary of U.S.-based Johnson & Johnson (J&J) to license-out its LCB84. LCB85 consists of LigaChem Bio's proprietary ConjuAll linker and four MMAE, a microtubule disruption agent. ADC consists of a linker, payload (drug conjugate), and antibody. The ConjuAll linker is known to overcome the issue of releasing cytotoxic drugs into the blood and attacking healthy cells. In preclinical studies, LCB84 demonstrated effects in solid tumors not responding to topoisomerase enzymes-based TROP2 ADC payloads. Major ADCs like Enhertu (trastuzumab deruxtecan) incorporate the technology of topoisomerase enzymes. LigaChem Bio received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) in June, and the company is currently conducting Phase1/2 studies in the United States. In clinical trials, LigaChem Bio plans to investigate the preventive efficacy of LCB84 monotherapy and the combination therapy of LCB84 plus immune checkpoint inhibitor. Prestige Biopharma·NCC-Bio successfully enter clinical trials In addition to ADCs, various new drug candidates are being investigated for potential treatment of pancreatic cancer. Prestige Biopharma is developing a new antibody drug candidate, PBP1510. PBP1510 works by neutralizing pancreatic adenocarcinoma upregulated factor (PAUF), a protein target for the treatment of pancreatic cancer. The PBP1510 Phase 1/2a trials are being conducted in Spain, the United States, Singapore, and Australia. Through the trials, Prestige Biopharma plans to investigate the safety and tolerability of PBP1510 plus gemcitabine combination therapy. Prestige Biopharma aims to expand PBP1510's indication to ovarian cancer and prostate cancer in addition to pancreatic cancer. PAUF is known to be associated with ovarian cancer and prostate cancer. NCC-Bio will commence the development of a new drug for treating pancreatic cancer using 'KN510713,' a targeted anti-cancer agent and fatty acid oxidation (FAO) inhibitor. The company is conducting clinical trials after receiving approval for the KN510713 Phase 1 trial last year. NCC-Bio, founded by Kim Soo Youl, who used to work at the National Cancer Center, is a biotech company specializing in developing new anti-cancer drugs. KN510713 is being developed as an anti-cancer drug candidate that inhibits catabolism. Its clinical trial is the first anti-cancer agent trial to target inhibiting fatty acid oxidation (FAO) metabolism in cancer. KN510713 works by decreasing cancer cell growth by blocking the energy supply to tumor cells without affecting healthy ones. NCC-Bio is studying the last cohort of the Phase 1 trial and plans to enter the Phase 2 trial next year.
