1.Over the past 24 hours, VCBeat has monitored eight financing and investment deals and one acquisition in the biopharmaceutical sector.
Tale Biotech Completes Tens of Millions in Pre-A Financing to Accelerate Multi-Omics Liquid Biopsy Layout
On January 10, Tailai Biotech announced the completion of its Pre-A financing round, raising tens of millions of RMB. The round was jointly invested by Ruifu Medical Health Fund, Kindstar Global, and Kunpeng Medical Angel Fund, with Huanghe Capital serving as the exclusive financial advisor. The proceeds will be primarily used to support the construction and layout of the company’s third-party medical testing laboratories, the application for professional qualifications for pan-cancer screening products, and the research and development of clinical products for specific diseases.
Immunotherapy Company TScan Completes $35 Million Series B Financing to Expand Its Development Efforts
On January 9, TScan Therapeutics, a company dedicated to the development of innovative T-cell receptor (TCR) immunotherapies for cancer and infectious diseases, announced the completion of a $35 million Series B financing round. The round saw participation from the Novartis Institutes for BioMedical Research (NIBR) and Astellas Venture Management. The proceeds will be used to expand its development efforts.
Clinical Analytics Firm Covera Health Secures $23.5 Million in Series B Funding to Accelerate Its Data Science R&D Efforts
On January 9, Covera Health, a U.S.-based clinical analytics solutions company, announced the completion of a $23.5 million Series B financing round. The round was led by Insight Partners, with participation from Prism Ventures. The proceeds will be used to accelerate its data science research and development efforts aimed at reducing diagnostic errors through measurement and quantification. Initially, the funding will be directed toward the field of radiology. As the business expands, the company will also leverage the capital to further support and scale its inaugural solution, the “Center of Excellence for Radiology” program, which serves health plans, self-insured employers, and strategic partners.
Biotech Firm Alderaan Completes $20.7 Million Series A Financing to Advance Preclinical Development of Its CD25 Antibody
Alderaan Biotechnology Announces Completion of €18.5 Million ($20.7 Million) Series A FinancingRecently, biotechnology company Alderaan Biotechnology announced the completion of an €18.5 million ($20.7 million) Series A financing round, with investors including Advent France Biotechnology (AFB) and Medicxi. The funds will support the preclinical development of its specific CD25 antibody designed to deplete regulatory T cells (Tregs), with plans to advance it into clinical development in 2022.
Pharmaceutical Company Grey Wolf Completes $14 Million Series A Financing to Develop Its Investigational Immuno-Oncology Therapy
On January 9, pharmaceutical company Grey Wolf Therapeutics announced the completion of a £10 million (approximately $14 million) Series A financing round. The funds will be used to advance its investigational immuno-oncology therapies, which are designed to directly modify tumor cells to facilitate immune system-mediated attack and destruction.
Biotech Firm Jasper Completes $14.1 Million Series A+ Funding Round to Advance JSP191 Development
On January 9, U.S. biotechnology company Jasper Therapeutics announced the completion of a $14.1 million Series A+ financing round, led by Roche Venture Fund, with other investors undisclosed. The funds will further advance the development of JSP191. Next, the company plans to expand its research to patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) undergoing hematopoietic cell transplantation, aiming to position JSP191 as a therapeutic modality for patients with other rare and ultra-rare monogenic diseases as well as autoimmune disorders.
BirthBiotech Company Emergex Completes $11 Million Series A Funding to Advance Its Vaccine Development
On January 9, biotechnology company Emergex Vaccines announced the completion of an $11 million Series A financing round. The proceeds will be used to advance the development of its vaccines against multiple infectious diseases. The company’s development strategy differs from that of traditional vaccines. Rather than focusing on developing antibodies to prevent human viral infection, as is common with conventional approaches, Emergex Vaccines primarily aims to ensure that individuals do not develop disease, rather than preventing viral infection itself.
Biomedical Company Progentec Completes $5 Million Series A Financing to Commercialize Digital Diagnostic Therapeutics for Lupus Treatment
On January 8, Progentec, a U.S.-based biomedical diagnostics company, announced the completion of a $5 million Series A financing round, co-led by Plains Venture Partners, Oklahoma Seed Capital Fund, and Oklahoma Angel Capital Fund II. The proceeds will be used to commercialize the aiSLE DX flare prediction test, conduct new research on digital biomarkers, and provide remote therapeutic services. The company plans to launch its aiSLE DX lupus classification diagnostic test in the market by mid-year.
2.The FDA approved one new drug, and the National Medical Products Administration issued three approvals.
FDA Approves First Targeted Therapy, Ayvakit, for Rare Mutations in Patients with Gastrointestinal Stromal Tumors
On January 9, the FDA approved Ayvakit (avapritinib), developed by Blueprint Medicines Corporation, for the treatment of adult patients with unresectable (not removable by surgery) or metastatic gastrointestinal stromal tumors (GIST). This approval includes GISTs harboring PDGFRA D842V mutations, which are the most common exon 18 mutations. As a kinase inhibitor, Ayvakit blocks cancer cell growth by inhibiting kinase activity.
Bristol Myers Squibb’s Abatacept Injection Approved for Market Launch by China’s National Medical Products Administration
On January 10, Bristol-Myers Squibb’s abatacept injection received marketing approval from the National Medical Products Administration for the treatment of rheumatoid arthritis in patients with an inadequate response to methotrexate. In July 2013, Bristol-Myers Squibb and Jiangsu Simcere Pharmaceutical entered into a collaboration to develop this product for the Chinese market; upon approval, the two parties will share the market revenues.
Hybio’s Atosiban Acetate Injection Approved by China’s National Medical Products Administration
On January 9, Hybio Pharmaceutical announced that it had received the Drug Registration Approval for Atosiban Acetate Injection issued by the National Medical Products Administration (NMPA). Atosiban Acetate Injection is indicated for pregnant women at 24 to 33 completed weeks of gestation, aged ≥18 years, with normal fetal heart rate, who exhibit regular uterine contractions lasting at least 30 seconds each and occurring ≥4 times within 30 minutes; cervical dilation of 1–3 cm (or 0–3 cm in nulliparous women); and cervical effacement/softening of ≥50%, with the aim of delaying imminent preterm birth. Following administration, it dose-dependently inhibits uterine contractions and reduces oxytocin-mediated prostaglandin secretion, thereby achieving tocolytic effects.
Northeast Pharmaceutical's Paracetamol Tablets Pass Consistency Evaluation
On January 10, Northeast Pharmaceutical received the "Drug Supplementary Application Approval" issued and approved by the National Medical Products Administration (NMPA) for its 0.5g specification of Paracetamol Tablets, indicating that this drug has passed the consistency evaluation of quality and efficacy for generic drugs. The announcement stated that Paracetamol Tablets are mainly indicated for fever caused by common cold or influenza, and are also used to relieve mild to moderate pain such as headache, joint pain, migraine, toothache, muscle pain, neuralgia, and dysmenorrhea.
Latest News in the Global Biopharmaceutical Sector
Hengrui Medicine’s PD-1 Inhibitor in Combination with Albumin-Bound Paclitaxel and Apatinib Approved for Clinical Trials, with 31 Concurrent Clinical Studies Underway
On January 9, the Center for Drug Evaluation (CDE) updated its list of clinical trial implicit approvals. Among them, Hengrui Medicine’s PD-1 inhibitor, camrelizumab, received approval for a new clinical trial: in combination with albumin-bound paclitaxel and apatinib, for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer in patients who have not previously received systemic anti-tumor therapy for recurrent or metastatic disease. Furthermore, data from the Insight database shows that there are currently 31 ongoing clinical trials involving camrelizumab (based on clinical trial registration numbers), including 9 Phase III trials and 14 Phase II trials.
Pharmaceutical Company ADC Therapeutics’ Innovative ADC Drug ADCT-402 Meets Key Clinical Trial Endpoints
On January 9, ADC Therapeutics announced that its innovative antibody-drug conjugate (ADC), loncastuximab tesirine (ADCT-402), met the primary endpoint in a pivotal Phase 2 clinical trial involving patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). Loncastuximab tesirine achieved an overall response rate (ORR) of 45.5%, with 20% of patients attaining complete remission (CR). The company stated that it expects to submit a Biologics License Application (BLA) to the U.S. FDA in the third quarter of this year.
Regeneron Announces Positive Phase 2 Trial Results of Garetosmab for the Treatment of Fibrodysplasia Ossificans Progressiva
On January 9, Regeneron announced that its investigational drug garetosmab (REGN2477) reduced the formation of new lesions by nearly 90% and lowered the total number of lesions (pre-existing and newly formed) by 25% compared with placebo in the Phase 2 LUMINA-1 trial in patients with fibrodysplasia ossificans progressiva (FOP). Regeneron stated that it will engage in further discussions with regulatory authorities regarding the submission of a regulatory application and prepare to initiate clinical studies in pediatric patients.
Alphamab Oncology’s KN026 Completes First Patient Dosing in Phase II Clinical Trial for Breast Cancer
On January 9, Alphamab Oncology announced that the first patient had been dosed in its Phase II clinical study of the bispecific antibody KN026 for the treatment of HER2-low or HER2-positive recurrent/metastatic breast cancer.
NIH Launches Clinical Trial of Autologous Stem Cell Therapy for AMD
Recently, researchers at the National Eye Institute (NEI) have been conducting a clinical trial to evaluate the clinical safety of a novel therapy for geographic atrophy (GA) based on patients’ autologous stem cells. GA is an advanced form of dry age-related macular degeneration (AMD) and the leading cause of vision loss among individuals aged 65 and older. Currently, there are no approved treatments for geographic atrophy associated with AMD. The preclinical studies for this trial were supported by the NEI Intramural Research Program and the NIH Common Fund Therapeutic Challenges Award. The trial is being conducted at the NIH Clinical Center in Bethesda, Maryland.
Boji Medicine Signs Project Entry Agreement with Nanchang Science and Technology Innovation City Management Committee
On May 9, Boji Medicine issued a public announcement stating that it had recently signed a Project Entry Agreement with the Administrative Committee of the China (Nanchang) Traditional Chinese Medicine Science and Technology Innovation City. The two parties plan to build a traditional Chinese medicine (TCM) industrial platform in the Innovation City, centered on an incubator plus a high-end shared TCM R&D platform. Specific construction contents include a public service platform for TCM R&D, supporting incubators, and the establishment of special investment funds.
Pharmaron Plans to Inject RMB 1.275 Billion in Capital Increases into Three Wholly-Owned Subsidiaries
On January 9, Pharmaron issued an announcement stating that the Company plans to inject a total of RMB 1.275 billion of its own funds into Pharmaron Tianjin, Pharmaron Shaoxing, and Ningbo Technology. Specifically, the capital injection into Pharmaron Tianjin amounts to RMB 200 million, increasing its registered capital from RMB 420 million to RMB 620 million; the capital injection into Pharmaron Shaoxing amounts to RMB 300 million, increasing its registered capital from RMB 100 million to RMB 400 million; and the capital injection into Ningbo Technology amounts to RMB 775 million, increasing its registered capital from RMB 325 million to RMB 1.1 billion.
Inner Mongolia Health Commission: Average Life Expectancy in Inner Mongolia Rises to 76.9 Years
Recently, the People's Government of Inner Mongolia Autonomous Region held a press conference on safeguarding and improving people's livelihoods. At the conference, Wang Zhanguo, Deputy Director of the Health Commission of Inner Mongolia Autonomous Region, stated that the health status of residents in Inner Mongolia has been improving year by year. The average life expectancy has risen to 76.9 years; the maternal mortality rate has decreased from 32.88 per 100,000 live births in 2009 to the current 10.47 per 100,000 live births; and the infant mortality rate has dropped from 12.99‰ to 3.77‰. The latter two indicators have remained consistently below the national average.