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- 2026-03-14 21:27:04
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- Phase 1/2 of CJ Bio's Microbiome has been applied
- by Dec 28, 2022 05:48am
- CJ Bioscience announced on the 26th that it has submitted an IND of phase 1/2 of the Microbiome immuno-cancer drug "CJRB-101" to the U.S. Food and Drug Administration (FDA). CJRB-101 is a new immuno-cancer drug candidate secured by CJ Bioscience. It was developed through various immunological reviews based on the strain library that CJ has built. It is listed in the EFSA and has high safety for human administration, and unlike existing intestinal microorganisms, process development for mass production of medicines is underway, enabling long-term clinical trials for cancer patients. Phase 1/2 clinical trials evaluate the safety and preliminary efficacy of CJRB-101 in patients with metastatic cancer such as advanced or non-small cell lung cancer, head and neck squamous cell carcinoma, and melanoma. It will be conducted by a number of clinical trial institutions in the United States and Korea and will recruit 46 people in phase 1 and a total of 120 people in phase 2. The drug resistance, safety, and effectiveness of the immuno-cancer drugs Keytruda and CJRB-101 are evaluated in combination. In order to expand the utilization of new drug candidates, CJ Bioscience decided to conduct a clinical efficacy evaluation at the same time for lung cancer as well as other cancers (head and neck cancer and skin cancer) with high marketability and incidence It will submit a clinical trial plan to the Ministry of Food and Drug Safety in the first half of next year. CJ Bioscience was launched earlier this year as a subsidiary of CJ's Red Bio (pharmaceutical and healthcare). An official from CJ Bioscience said, "It is expected that CJRB-101 and immune checkpoint will be used together to increase the low response rate of existing immuno-cancer drugs and provide new treatment opportunities for intractable patients who do not see the effect of immuno-cancer drugs."
- Company
- Kisqali Extends PFS by 1 yr in poor prognosis breast cancer
- by Dec 28, 2022 05:48am
- Novartis Korea announced on the 26th that the progressive and metastatic breast cancer treatment Kisqali has extended the progressive survival period by about one year compared to the first treatment of hormone receptor-positive (HR+)/human epithelial cell growth factor 2 negative (HER2-) breast cancer patients. The results of this study were presented at the San Antonio Breast Cancer Conference (SABCS 2022) held from December 6 to 10. The company's Kisqali RIGHT Choice study is the first phase 2 clinical trial to compare CDK4/6 inhibitor Kisqali and endocrine therapy combinations in aggressive pre-menopausal and transmenopausal HR+/HER2-progressive breast cancer patients. It was conducted on 222 patients with HR+/HER2-progressive breast cancer in premenopausal and menopause transitions that show aggressive characteristics, such as patients with visceral metastasis with symptoms and patients with rapid progression of diseases or symptoms. In particular, more than 50% of patients with intestinal metastasis crises were included in this study. CDK4/6 inhibitors and endocrine therapy are used as standard treatments in the primary treatment of HR+/HER2-progressive breast cancer patients, but combination chemotherapy is still used in patients with rapid disease progression or intestinal metastasis crisis. Kisqali demonstrated an extension of the progression-free survival period (PFS) even in the group of patients who are difficult to treat through a RIGHT Choice study. As a result of phase 2, the median PFS value of the Kisqali combined group was 24.0 months, which was 11.7 months longer than the 12.3 months of the control group (HR=0.54). The median time until treatment failure in the Kisqali combined group was 18.6 months, which was longer than 10 months compared to 8.5 months in the control group (HR=0.45). In terms of safety, the combined Kisqali group had a lower incidence of serious adverse reactions related to treatment and the resulting discontinuation rate of treatment compared to the combined chemotherapy group. Kisqali showed a similar safety profile to existing data. Yoo Byung-jae, CEO of Novartis Korea, said, "Kisqali has confirmed the benefits of extending the progressive survival period in patients with fast cancer progression or poor prognosis, such as visceral metastatic patients with symptoms."
- Company
- Samsung BioLogics did not receive 45.5 billion won
- by Dec 27, 2022 06:10am
- Cytodyn Main Pipeline (Data = Cytodyn)Samsung BioLogics has been in conflict with U.S. bio company Cytodyn over the past year to pay for commissioned production (CMO). Conflicts have continued for a year as Cytodyn is overdue the promised cost of the biopharmaceutical CMO. Late payments more than doubled from $13.5 million (17.2 billion won) in January this year. According to the U.S. Securities and Exchange Commission on the 26th, Cytodyn told Samsung BioLogics in a third-quarter report that the balance of overdue payments related to Leronlimab CMO was $35.7 million. Cytodyn is an American bio company that is developing AIDS, cancer, non-alcoholic fatty hepatitis (NASH), and COVID-19 candidates. In May 2019, Samsung BioLogics signed a contract with Leronlimab CMO for AIDS treatment. At that time, the minimum guarantee amount for the contract was $31 million (39.5 billion won). The minimum guarantee amount increased to $50.22 million (64 billion won) through a change in contract terms in July 2020. It is a contract that guarantees sales of $246 million (313.7 billion won) by 2027 through the production of commercial products if the license is successful. Cytodyn said Samsung BioLogics should pay $35.7 million in arrears. (Data = US Securities and Exchange Commission) Leronlimab is a fully humanized IgG4 monoclonal antibody treatment that targets CCR5 used in the process of the virus penetrating T cells as a mechanism to suppress cell infection of the HIV virus. Clinical trials for severe COVID-19 patients were also conducted through drug re-invention, but there was no significant difference from the placebo group in terms of efficacy. The payment conflict erupted when Cytodyn did not pay $13.5 million (17.2 billion won) to Samsung BioLogics at the end of last year. Samsung BioLogics sent a written notice to Cytodyn earlier this year demanding payment. According to the disclosure, the balance of arrears increased to $38.1 million as of May 31. As of August 31, it was slightly reduced to $35.7 million. The overdue balance seems to have decreased as some of the payments were made. Cytodyn said, "We will make reasonable efforts to fix serious violations. If we do not make reasonable efforts during the correction period, Samsung BioLogics can terminate the contract," and explained, "Cytodyn management is continuously discussing with Samsung BioLogics to solve the problem."
- Company
- LG Chem's Humira biosimilar applies for domestic permission
- by Dec 27, 2022 06:10am
- A researcher at LG Chem is looking at the data.(Source: LG Chem)LG Chem announced on the 23rd that it has applied for permission for Humira biosimilar LBAL items to the Ministry of Food and Drug Safety. Indications include rheumatoid arthritis, psoriatic arthritis, axillary spinal arthritis, adult Crohn's disease, psoriasis, ulcerative colitis, Betchett enteritis, and meningitis in adults. In addition, children (6 to 17 years old) have Crohn's disease, idiopathic childhood arthritis, and childhood plate psoriasis. LG Chem was approved on May 27, 2016, for a phase 3 clinical trial to evaluate the equivalence of LBAL and Humira in patients with active rheumatoid arthritis who responded inappropriately to Methotrexate. After registering the first target on June 23, 2016, the last target visit was completed on February 1, 2018. LG Chem confirmed equivalence in the LBAL and Humira groups as clinical results. In the safety sector, the incidence of adverse reactions (AE) was similar in the LBAL and Humira groups. The incidence of significant adverse reactions (SAE) was 8.3% in the LBAL group and 4.7% in the Humira group, showing no significant difference. There was no adverse reaction that resulted in death. LBAL is a biosimilar developed in a high-concentration formulation like Humira. It is a product that improves patient convenience by removing citrate that can cause pain to patients. An official from LG Chem said, "We expect to provide patients with more options for treating autoimmune diseases through the previously released Eucept and LBAL."
- Company
- Nubeqa, approval for a combination therapy indication
- by Eo, Yun-Ho Dec 23, 2022 06:06am
- It is expected that the prescription of the combination therapy of the prostate cancer treatment Nubeqa will be possible in Korea. According to related industries, Bayer Korea recently submitted an application to the Ministry of Food and Drug Safety to expand the Taxotere combination therapy indication of an oral androgen receptor inhibitor (ARi) Nubeqa for treating vision nmCRPC. Nubeqa is an androgen receptor inhibitor with a unique chemical structure that binds to androgen receptors to inhibit the growth of prostate cancer cells through strong antagonism. The corresponding indication of this drug has been validated through an ARASENS phase 3 study. The metastatic hormone-sensitive prostate cancer patient group with Nubeqa and ADT and Taxotere on ARASENS 3 demonstrated a statistically significant improvement in total survival compared to the control group with ADT and Taxotere. The patient group using Nubeqa, ADT, and Taxotere showed a statistically significant delay in the period required for the pain to progress. The clinical results were announced at the 2022 Urology Cancer Symposium (ASCO GU) of the American Society for Clinical Oncology held in February, and were published in the medical journal "New England Journal of Medicine." Nubeqa has not yet applied for insurance benefits in Korea, so it is expected to take time to lead to actual prescription activation. The drug has not been registered since the HIRA Cancer Disease Review Committee ruled it unsuitable in February 2021.
- Company
- 1 of 2 patent suits filed this year proceed to the 2nd round
- by Kim, Jin-Gu Dec 23, 2022 06:06am
- It seems that the patent disputes in the pharma and bio industry will continue on in the long term. Among the 20 major rulings made during the first trial, 11, over 50% are being retried in a second trial by the Patent Court of Korea. Both the winning and losing parties of the patent suit that had been filed against Boryung Pharmaceutical’s fixed-dose combination for hypertension, ‘Dukarb (fimasartan and amlodipine),’ opted to continue their dispute in a second trial. In the case of the patent dispute over Novartis’s heart failure treatment ‘Entresto (valsartan+sacubitril),’ the original company appealed after the generic drug companies won the first trial. In the case of the dispute over the DPP-4 inhibitor class antidiabetic ‘Galvus (vildagliptin),’ the agenda is being fiercely tried again from square one after the Supreme Court's ruling of remand after reversal, and Novartis is also further countering by filing a trial for the active confirmation of the scope of rights. ◆Generics companies win first trial on Entresto... Novartis appeals According to industry sources on the 23rd, 21 major trial rulings and judgments have been made this year for patents in the industry. The number excludes cases where the company voluntarily withdrew its suit after requesting judgment. 20 of the cases received a ruling from the Intellectual Property Trial and Appeal Board (first trial), and 1 received a ruling from the Patent Court of Korea (second trial). Of the 20 cases that received a ruling in the first trial, 11 cases chose to continue on to the second trial. This means that more than half of the parties of major disputes did not accept the decision of the first trial. Pic of EntrestoEntresto’s patent dispute is one representative example. The dispute was sparked after its generic companies simultaneously filed suits to invalidate and confirm the passive scope of rights on Entresto’s 6 patents. Starting with Elyson Pharm, 13 companies challenged ▲1 use·composition patent ▲ 1 salt·hydrate patent (un-listed in the patent register) ▲1 use patent ▲1 crystalline form patent ▲2 substance patents for Entresto. The first trial was concluded in favor of the generic companies. Generic companies succeeded in challenging 1 use·substance patent, 1 crystalline form patent, and 2 substance patents. The remaining trials for the use patent and salt·hydrate patent have not been concluded yet. The company of the original drug, Novartis, decided to continue on the fight to the second trial for the crystalline form patent and the use·composition patent in March and July of this year. The company has given up the trials for its other 2 substance patents. Entresto has no drug substance patent, and the role is replaced by the use·composition patent and crystalline form patent. Therefore, Novartis plans to focus its defense strategy around these two patents. ◆Both the winning and loser parties appeal to ruling for Dukarb... long-term dispute inevitable Pic of Dukarb Two conflicting rulings were made in the first trial for Boryung’s Dukarb patent. Among 40 generic companies that challenged Dukarb’s patent, 2 won against Boryung, while the others lost. 29 of the companies filed a new trial on the same patent at the same time. If the first trial they attempted was made to avoid the patent by confirming the passive scope of rights, the companies added a patent invalidation strategy after losing the first trial. From the generic company’s perspective, whether it receives a winning decision from the Patent Court of Korea or a new ruling from the Intellectual Property Trial and Appeal Board, the company will be eligible to release its generic early. This is why companies that challenge the patent are mobilizing all available strategies. Boryung Pharmaceutical also filed a lawsuit against the two pharmaceutical companies that won against the company in the first trial to annul the trial decision. As a result, the Dukarb patent dispute, which began in March last year, is expected to be prolonged to even after the substance patent for Kanarb expires in February next year. ◆Galvus dispute to continue to the end...Novartis files active confirmation of the scope of rights # i3 The patent dispute around Galvus was also inconclusive this year. The analysis is that the conflict has been prolonged for more than 5 years due to the sharp differences in the position of the two parties. The situation had also intensified with Novartis' counteract, filing a trial for the active confirmation of the scope of rights. The conflict began in 2017 when Ahn-Gook Pharmaceuticals and Hanmi Pharmaceuticals claimed part of the term extended for the substance patent of Galvus invalid. The generic companies won the first trial. In the second trial, the court overruled the first court’s decision and ruled in favor of the original company. In the third trial, the Supreme court questioned the qualifications of the original company that filed the appeal and remanded it back to the first trial. With the remandment, the dispute resumed in the first instance court. Unlike in the previous first trial, the Intellectual Property Trial and Appeal Board ruled in favor of the original company, and generic companies appealed once again. Currently, Ahn-Gook Pharmaceuticals and Hanmi Pharmaceuticals are waiting for the second trial ruling. Apart from the dispute, Novartis had filed a trial for the active confirmation of the scope of rights against Kyongbo Pharmaceutical, Ahn-Gook Pharmaceuticals, and Korea United Pharm. The active confirmation of the scope of rights is filed by the original companies to protect their patent rights from generic companies. The suit is rarely filed in the domestic pharmaceutical and bio-industry. Kyongbo and the others have already released their generic versions after they won the first trial. The substance patent for Galvus expired in March of this year. However still, Novartis plans to see the dispute to the end and be recognized for the generic companies’ patent infringement. If Novartis wins, it will be possible to claim damages due to patent infringement. All companies that released Galvus generics will be subject to claims for damages. Also, Roche and Alvogen Korea received mixed results over the 3 use patents for Avastin. Alvogen Korea won 2 trials and Roche succeeded in defending 1 claim. Both companies decided to appeal and take the dispute to the second trial. However, Roche withdrew the lawsuit it had filed for cancellation of the trial decision in September and plans to focus on the case appealed by Alvogen Korea. In the patent dispute over Monterizine Cap, Hanmi Pharmaceuticals filed an appeal for the cacellation of the trial decision against 20 pharmaceutical companies after losing the first trial.
- Company
- New HCV drug Epclusa lands in hospitals with reimb
- by Eo, Yun-Ho Dec 22, 2022 05:52am
- The Hepatitis C treatment ‘Epclusa’ is rapidly landing in hospitals for prescriptions after being granted reimbursement in Korea. According to industry sources, Gilead Science Korea’s oral chronic hepatitis C treatment Epclusa (sofosbuvir/velpatasvir) has passed the Drug Committees (DCs) of the Big-5s including the Seoul National University Hospital, Seoul St. Mary’s Hospital, Asan Medical Center, and Shinchon Severance Hospital, as well as other major medical institutions including Ajou University Hospital, Hallym University Sacred Heart Hospital, Pusan National University Hospital, Kyungpook National University Hospital, Chonnam National University Hospital, Chonbuk National University Hospital, Chungnam National University Hospital, and Chungbuk National University Hospital. When considering how the drug has only been listed for reimbursement on the 1st of last month, the drug is quickly landing at hospitals for prescriptions in Korea. Epclusa can be administered with reimbursement in adult and pediatric patients 23 years or older, weighing at least 30 kg, with any genotype of the chronic hepatitis C virus, regardless of the stage of cirrhosis or previous treatment experience. With the approval, Epclusa became the only treatment in Korea that can be prescribed with reimbursement regardless of HCV genotype or stage of fibrosis from November. Epclusa is a fixed-dose combination of sofosbuvir, a nucleotide analog NS5B polymerase inhibitor, and velpatasvir, an NS5A replication complex inhibitor. The drug demonstrated a 99% treatment success rate (SVR12) in the ASTRAL-1 study conducted on patients with chronic HCV infection genotypes 1, 2, 4, 5, and 6 , without cirrhosis or with compensated cirrhosis. Also, in the ASTRAL-4 study, the treatment success rate was 94% in patients with decompensated cirrhosis using Epclusa. Meanwhile, according to the HCV treatment guidelines issued by the Korea Association for the Study of the Liver, Epclusa is recommended for patients with all HCV genotypes, with or without compensated cirrhosis, with or without treatment experience. Also, Vosevi is recommended as a retreatment for patients with chronic hepatitis C that have previously failed DAA treatment.
- Company
- Dong-A ST introduces candidate substance technology
- by Kim, Jin-Gu Dec 22, 2022 05:52am
- Global joint development of immuno-cancer drugs under the mechanism of double fusion antibodies and acquisition of exclusive sales rights Dong-A ST announced on the 21st that it has signed a license agreement with Kanaph Therapeutics to license candidate substances for immuno-cancer drugs under the dual fusion antibody mechanism. Dong-AST will introduce global joint research and development and exclusive sales rights of preclinical immuno-cancer drug candidates held by Kanaph Therapeutics, a domestic pharmaceutical bio-venture. Dong-AST will pay Kanaph 5 billion won in advance and up to 18 billion won in additional payments depending on the development milestone. It also plans to pay up to 180 billion won more depending on sales if it succeeds in commercialization. Royalty is separate and will be paid at a certain rate according to the sales profit after the product is released. According to Dong-AST, the substance is an antibody and cytokine fusion protein. It is a mechanism to activate immunity by transferring cytokines specifically to tumors using antibodies to proteins expressed in the tumor microenvironment. At this time, cytokines are not delivered to normal tissues, so side effects of systemic immune activity can be prevented.
- Company
- PO SMA tx Indication of Evrysdi expands
- by Eo, Yun-Ho Dec 21, 2022 06:05am
- Evrysdi, a PO SMA treatment, can be used for infants under 2 months in Korea. According to related industries, Evrysdi recently obtained approval from the Ministry of Food and Drug Safety to expand the indication. Accordingly, Evrysdi can be administered to newborns before symptoms appear in Korea. The expansion of neonatal indications was based on the results of phase 2 clinical RAINBOWFISH. In the study, the efficacy, safety, pharmacokinetics, and pharmacokinetics of Evrysdi were evaluated for asymptomatic SMA patients who were genetically diagnosed up to 6 weeks of age regardless of the number of SMN2 genes. The primary target point was set as the proportion of patients who could sit without assistance or support for 5 seconds. By the time of the data cutoff, a total of 26 patients were registered. Their age was 28.5 days (central value), and they were diagnosed with SMA based on genetic testing but had no symptoms. Evrysdi, the first PO option as an SMA treatment, has the advantage of being able to be customized according to age and weight. The process of registering insurance benefits is still slow. It is not on the HIRA's public list of any committees. It remains to be seen whether Evrysdi will be able to expand its coverage in 2023 along with the expansion of the indication. Meanwhile, Biogen's Spinraza and Novartis' Zolgensma are currently listed in the SMA area in Korea.
- Company
- Organon sold 3 types of infertility & contraceptives
- by Dec 21, 2022 06:05am
- Organon announced on the 19th that it will conduct direct sales and marketing of infertility and contraceptive products. According to Organon, the company will directly sell and market the infertility treatments Puregon and Organutran, and the implantable contraceptive Impranon in the body from next year. The company explained that it is a strategic business decision to realize the promotion of women's health. The goal is to strengthen competitiveness in infertility and contraception markets, including existing women's health products. Impranon will start direct marketing on January 1, 2023. Puregon and Orgalutran will be in charge of Organon Korea after the co-promotion contract with Han Wha, scheduled for the first half of next year. The three products that are converted to direct sales are representative infertility and contraceptive drugs sold in Korea over the past 20 years. Puregon has established himself as a representative of follicle-stimulating hormone, an ovulation-inducing agent. Orgalutran is a GnRH antagonist and has been used to prevent early ovulation spikes in women undergoing hyperovulation induction for assisted reproduction.Impranon is a long-term persistent reversible contraceptive inserted under the skin, with a 99% contraceptive effect lasting up to three years. CEO Kim So-eun said, "We will make significant progress in promoting women's health by strengthening expertise and differentiating based on various women's health product portfolios."
