Search Results for “ breast cancer ” – Page 19 – media

BioDuro-Sundia’s Partner, DigmBio Announced IND Clearance from Korea MFDS for its Selective PARP1 Inhibitor DM5167

SHANGHAI, March 26, 2024 /PRNewswire/ — BioDuro-Sundia’s partner, DigmBio, a South Korean biotechnology company, announced its selective PARP1 inhibitor for the treatment of triple-negative breast cancer has been approved by Korea Food and Drug Administration (MFDS) for Investigational New Drug (IND) application. Founded in April 2020, DigmBio is a pioneering biotech company discovering and developing novel therapies to treat oncology, neurodegeneration, and fibrosis. The lead program DM5167 is the 2nd generation PARP1 selective inhibitor. According to preclinical study results, DM5167, a novel selective PARP1 inhibitor, exhibits superior in vivo safety, particularly in terms of hematotoxicity and demonstrates enhanced selectivity in enzyme assays, and possesses a more efficient DNA trapping capability. Notably, DM5167 showcases excellent brain permeability, rendering it suitable for treating brain metastasis and brain cancer. DigmBio CEO Kim Jung-min stated, “We are pleased to receive official approval from the Food and Drug Safety Department without the need for any ...
- Source: drugdu
- 82
- April 1, 2024
Henlius’ Trastuzumab Approved in Brazil, a Semi-Exclusive License Area, in Latin America

Recently, HANQUYOU (trastuzumab, trade name in Europe: Zercepac®), independently developed and manufactured by Henlius, has been approved to be marketed in Brazil for the treatment of HER2-positive breast cancer and gastric cancer. To date, the product has been approved for marketing in more than 40 countries and regions worldwide. Following the commercialization of HANQUYOU in Argentina, the approval of HANQUYOU in Brazil, the largest economy and the most populous country in Latin America, has become another anchor point for Henlius’ continuous global commercial expansion. Latin America and the Caribbean comprises 33 countries and regions with a total population of close to 660 million as of 2022 and a per capita GDP of close to $10,000 per capita [1]. In Latin America, breast and gastric cancers are the most and fifth most prevalent malignancies, respectively. The total number of new cases of breast and gastric cancer in the region in 2022 ...
- Source: drugdu
- 96
- March 22, 2024
Achieving first full year of profitability, and ushering in a new phase of high-quality development

Henlius (2696.HK) released a positive profit forecast. Based on the preliminary assessment of the unaudited consolidated management accounts for the year ended 31 December, 2023 (the “Reporting Period”) and the information currently available to the Board, it is expected that the company will record a profit for the year of no less than RMB500 million for the Reporting Period. This is the first time for Henlius to achieve full-year profits following the company’s achievement of its first half-year profits for the six months ended 30 June 2023. The full year of profitability is primarily contributed by the continuous growth in sales revenue of the company’s core products HANQUYOU and HANSIZHUANG, as well as cost reduction and efficiency improvement through refined management. Wenjie Zhang, Chairman and Executive Director of Henlius, said: “2023 is a milestone as we reported a full-year profit for the first time. Benefiting from the efficient synergy and ...
- Source: drugdu
- 125
- March 10, 2024
Henlius’ Trastuzumab Plots Southeast Asia Expansion, to Enter Thailand and Philippines

Recently, Henlius’ self-developed and manufactured HANQUYOU (trastuzumab, trade names: Zercepac® in Europe, Tuzucip® and Trastucip® in Australia) has been approved for marketing in Thailand and the Philippines under the trade names of TRAZHER® and Hertumab®, respectively, for the treatment of HER2-positive breast cancer and gastric cancer. Up to now, HANQUYOU has been successfully approved in Southeast Asian countries, including Singapore and Cambodia, and in a total of more than 40 countries and regions. Breast cancer is the most prevalent malignancy in Southeast Asia, with nearly 170,000 new cases of breast cancer in the region in 2022. About 15% to 20% of breast tumours are HER2-positive breast cancers. On the other hand, the reported rates of HER2 positivity in patients with gastric cancer range from 12% to 23%. Trastuzumab has long been a cornerstone of therapy for the treatment of HER2-positive breast and gastric cancers, and has been included as a ...
- Source: drugdu
- 131
- March 8, 2024
Biotheus’s PD-L1/VEGF dual antibody is planned to be included in breakthrough therapeutic category and has reached a licensing cooperation of over US$1 billion

Today (1st March), the official website of the Center for Drug Evaluation (CDE) of the NMPA announced that the PM8002 injection applied by Biotheus is planned to be included in the breakthrough therapy category, and the indication is the first-line treatment of inoperable locally advanced/recurrent metastatic triple-negative breast cancer with albumin-bound paclitaxel for combined injection. Public information shows that PM8002 is an anti-PD-L1/VEGF bispecific antibody independently developed by Biotheus. BioNTech has reached a cooperation agreement of more than US$1 billion with Biotheus to obtain the development, production and commercialization rights of this product worldwide (except Greater China). PM8002 is a bispecific antibody drug candidate consisting of a humanized anti-PD-L1 mono-antibody (VHH) fused to an anti-VEGF-A IgG1 antibody containing an Fc-silent mutation. This design can enrich PM8002 molecules into the tumor environment and reduce the systemic side effects caused by systemic VEGF blockade. According to an earlier press release fromBiotheus, PM8002 ...
- Source: drugdu
- 128
- March 5, 2024
Jacobio Pharma Receives IND Approval for P53 Y220C Activator JAB-30300 in the U.S.

BEIJING, SHANGHAI and BOSTON, March 1, 2024 /PRNewswire/ — Jacobio Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, today announced it received IND (Investigational New Drug) approval of its self-developed drug JAB-30300 (P53 Y220C activator) from the FDA of the U.S. Jacobio plans to initiate a Phase I/IIa advanced solid tumors clinical trial in the U.S., to evaluate safety and efficacy of JAB-30300. Jacobio also plans to submit IND in China, and will conduct clinical studies once receives the IND approval. P53 is the single most frequently altered gene in human cancers, with mutations being present in approximately 50% of all invasive tumors. JAB-30300 is an orally bioavailable small molecule activator for the treatment of patients with solid tumors harboring P53 Y220C mutation. Studies shows that, JAB-30300 has shown very high binding affinity to P53 Y220C mutant proteins. Tumor regression was achieved in multiple cancer models covering various ...
- Source: drugdu
- 150
- March 5, 2024
AstraZeneca’s “CD19/CD3 dual antibody” receives clinical approval in China

According to the CDE official website, AstraZeneca’s Class 1 therapeutic biological product AZD0486 has obtained implicit approval for clinical trials and is intended to be used to treat relapsed or refractory B-cell acute lymphoblastic leukemia. AZD0486 (TNB-486) is a new, fully human CD19xCD3 IgG4 bispecific antibody, originally developed by TeneoTwo. In 2022, AstraZeneca acquired TeneoTwo for US$1.265 billion and also obtained its clinical-stage drug TNB-486. According to public information, AZD0486 can bind to CD19 on the surface of B lymphocytes and CD3 receptors on the surface of T lymphocytes, thereby initiating the immune response of T lymphocytes. A Phase I clinical study (NCT04594642) published in the journal “OncLive” in August 2023 showed that AZD0486 has a durable tumor inhibitory effect on relapsed/refractory follicular lymphoma, regardless of the expression level of CD20, and it is also independent of the type and dosage of existing drugs. Currently, AZD0486 has entered the Phase ...
- Source: drugdu
- 98
- March 2, 2024
Gilead signs antibody deal with Biocytogen amid ADC buzz

Biocytogen Pharmaceuticals shared plans for its new antibody evaluation and option agreement with Gilead Sciences. In the deal, Gilead will gain access to Biocytogen’s fully human antibody library. The agreement gives Gilead a three-year nomination period to choose its targets of interest and assess the selected antibodies, with the option of acquiring selected antibodies for worldwide therapeutic development. Biocytogen owns four genetically engineered RenMice platforms for the discovery of multiple antibody types. This includes bispecific antibody-drug conjugates (ADC), TCR-mimic antibodies and more. As of June 2023, the China-based company was part of 50 therapeutic antibody and multiple clinical asset co-development, out-licensing and transfer agreements. Earlier this year, Biocytogen partnered with Radiance Biopharma to share its bispecific ADC expertise. The company also signed deals with Ona Therapeutics in December 2023 and Myricx Bio in September 2023 to develop ADCs. This correlates with an uptick in high-value deals recently seen in the ...
- Source: drugdu
- 86
- February 21, 2024
Yet another clinical hold for Gilead’s magrolimab trials

Gilead Sciences had paused enrolment in the magrolimab solid tumour trials, with the FDA requesting a partial clinical hold on these studies. Earlier this month, the US regulatory agency placed a full clinical hold on all the clinical trials of magrolimab for myelodysplastic syndromes (MDS) and acute myeloid leukaemia (AML). “Gilead will likely decide to deprioritise the magrolimab programme entirely,” said Sakis Paliouras, associate director for oncology research and analysis at GlobalData. Adding: “it is less likely, but still possible, that the company will come back from the clinical hold and continue the programme.” The latest partial clinical hold affects the Phase II trials of magrolimabin multiple solid tumour conditions such as head and neck squamous cell carcinoma (NCT04854499), triple-negative breast cancer (NCT04958785), and colorectal cancer (NCT05330429). In addition to Gilead-sponsored trials, the partial clinical also applies to Investigator Sponsored Studies with magrolimab in solid tumours. Paliouras said the blood ...
- Source: drugdu
- 155
- February 21, 2024
Daiichi Sankyo again dials up Enhertu sales forecast, advances 2nd AstraZeneca-partnered ADC

AstraZeneca-partnered Enhertu has become a bright spot in Daiichi Sankyo’s business, and the Japanese pharma has again increased its sales projection for the HER2-directed antibody-drug conjugate. But this time, the rosier outlook reflects developments outside the U.S. Daiichi now expects Enhertu sales to come in at 383.9 billion Japanese yen (about $2.6 billion) for the 12 months ending March 31. The number includes profits from regions where AstraZeneca books Enhertu sales. Daiichi had already once dialed up its Enhertu forecast for its current fiscal year. The drugmaker’s projection was originally 320 billion yen back in April 2023, then Daiichi raised it to 381.7 billion yen in October. Despite rolling out the higher global forecast, Daichii actually reduced Enhertu’s 12-month sales estimate in the U.S. by $30 million to $1.58 billion. For the first nine months of the company’s fiscal year, Enhertu generated $1.14 billion in the U.S., an increase of ...
- Source: drugdu
- 131
- February 2, 2024

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