Introduction:Women are 22% more likely than men to suffer from long COVID; Nabriva's stock price fell 87% after layoffs of 40%; PD-1/VEGF bispecific antibody receives third Breakthrough Therapy Designation… BioExploration brings you the "pharma" news and explores the value of biotechnology!
01
Female Patients Suffer from Long COVID
The risk is 22% higher for women than for men.
Recently, researchers from Johnson & Johnson analyzed data from over 1.3 million COVID-19 patients and found that women are more likely to suffer from post-COVID conditions than men, with a 22% higher risk, and exhibit different types of symptoms. Specifically, female patients are more prone to mood disorders such as depression, as well as ear, nose, and throat symptoms, musculoskeletal pain, and respiratory issues, while male patients are more susceptible to diabetes and kidney diseases.
Researchers say differences in immune system function between females and males may be a key driver of the gender differences in long COVID. This study uncovers the gender disparities in long COVID, which is crucial for identifying and rationally designing effective therapies.
02
Layoffs 40%
Nabriva's Stock Price Drops by 87%
In the third-quarter report, Nabriva stated that it would streamline the research team for the treatment of acute bacterial skin and skin structure infections (known as Sivextro) and lay off approximately 40% of its workforce. Since the beginning of this year, the company's stock price has fallen by 87%.
Nabriva's CEO Ted Schroeder said in a statement: "Given the pressure of the macro environment, as evidenced by the continued growth in demand for prescription drugs, maintaining cash flow is the most effective way to preserve optionality and value for shareholders as we build on our commercial success with Sivextro. To align with the shift in our strategic focus, extend our cash runway, and maximize the value of the products in our portfolio, we have paused early-stage R&D activities and reduced our global workforce by approximately 40%."
03
PD-1/VEGF Bispecific Antibody
Received Third Breakthrough Therapy Designation
Recently, Akeso Biopharma announced that its self-developed globally pioneering bispecific antibody new drug, Evecan (PD-1/VEGF bispecific antibody, AK112), has been included in the list of proposed breakthrough therapies by the Center for Drug Evaluation of the National Medical Products Administration. This is the third breakthrough therapy designation received by Evecan, which can be used in combination with docetaxel to treat locally advanced or metastatic non-small cell lung cancer that is resistant to prior PD-1/L1 inhibitors and platinum-based chemotherapy.
Currently, the innovative drug Evecan developed by Akeso Biopharma not only received the only Breakthrough Therapy Designation in China for the treatment of lung cancer in the field of PD-1/L1 resistance, but it is also the only drug in China's lung cancer field to have obtained three Breakthrough Therapy Designations.
04
Harbour BioMed Reaches Agreement with WuXi Biologics
Build a Vaccine CDMO Service Base in China
On November 15, WuXi Vaccines, a wholly-owned subsidiary of WuXi Biologics, a global leading contract research, development and manufacturing organization (CDMO), announced an agreement with Harbour BioMed to take over its industrialization base located in Suzhou.
According to the agreement, Harbour BioMed agrees to sell the industrial base for a total consideration of RMB 1.46 billion. Both parties will leverage their respective strengths in innovative R&D and production services to further promote the rapid development of the innovative drug sector. As a deeply strategic partner, WuXi Biologics will provide integrated services to Harbour BioMed, ensuring the development and production needs of its global innovative pipeline.
This industrialization base covers an area of 8,500 square meters, including multiple single-use bioreactors of different scales such as 250 liters, 500 liters, and 1,000 liters, as well as aseptic biopharmaceutical production lines. WuXi Hede plans to develop it into a vaccine development and GMP manufacturing service base with industry-leading service standards, providing better vaccine CDMO services for global partners. This will also become WuXi Hede's first independent vaccine development and GMP manufacturing service base in China.
05
CGT Products by JingShan Bio
GC101 Approved for Clinical Use
JingShan Technology's GC101 Receives Approval for Clinical TrialThe clinical trial application for GC101, a cell and gene therapy product independently developed by HaijingShan Biotechnology Co., Ltd. ("JingShan Technology"), was recently approved by the National Medical Products Administration. This product is classified as a Class 1 therapeutic biological product (innovative biological product) and can be used for transplant treatment of hard-to-heal surface wounds in patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB). JingShan Technology plans to initiate Phase I clinical trials within China (excluding Hong Kong, Macao, and Taiwan regions) once conditions are met. To date, no similar products or drugs for RDEB treatment have been approved for marketing worldwide.
RDEB is a monogenic hereditary disease. According to the "Notice on the Publication of the First List of Rare Diseases" (Guo Wei Yi Fa [2018] No. 10), RDEB is listed as a rare disease. RDEB has an autosomal recessive inheritance pattern, and patients' skin, eyes, oral cavity, esophagus, respiratory tract, and other mucosal tissues develop blisters or blood blisters after minor friction, leading to ulceration. The skin is "as fragile as butterfly wings," and thus patients are often referred to as "butterfly children."
Genescript Biotech is one of the first biotechnology companies to join the Fosun Intelligence incubation platform. As of October 2022, Genescript Biotech's cumulative R&D investment in GC101 has been approximately 33 million RMB.
