China Approves First Long-Acting Injectable HIV Treatment; FDA to Review Safety of CRISPR-Based Gene Editing Therapy

Oct 31, 2023 19:58 CST Updated 19:58

Immuxell Biotech

Developer of Immune Cell Therapeutic Drugs

1. ImmuXell Biotech Completes Over 100 Million Yuan in Series A Financing

Recently, ImmuXell Biotech LtD. (referred to as "ImmuXell Biotech") announced the completion of an over 100-million-yuan Series A round of financing. This round of financing was led by SDIC Venture Capital, with co-investment from Huangpu Pharmaceutical Fund, Yuanxi Haihe Fund, and others, supporting ImmuXell Biotech in promoting new technology research and development, commercial production implementation, and international business strategic layout. The funds raised in this round will be used to accelerate the advancement of the registration clinical trial application for a novel TCR-T cell therapy product targeting the KRAS G12V mutation, as well as the product development and international cooperation for multiple subsequent innovative pipelines.

2. The U.S. FDA Will Evaluate the Safety of Genome Editing Therapies

Sickle cell anemia is caused by structural abnormalities in hemoglobin, leading to deformation and aggregation of red blood cells, which can block blood vessels and cause tissue hypoxia. Previously, the CRISPR gene-editing therapy for sickle cell anemia developed by CRISPR Therapeutics and Vertex Pharmaceuticals showed promising results in clinical trials, and its marketing application was accepted by the U.S. Food and Drug Administration (FDA) in January this year. According to a report by Nature News, the FDA will hold a meeting on October 31st local time, where the Cellular, Tissue, and Gene Therapies Advisory Committee, composed of external experts, will provide recommendations on the Exa-cel therapy. If approved, Exa-cel will become the first CRISPR-Cas9 genome-editing therapy to be marketed.

3. Simcere Zaiming: Trilaciclib, a chemotherapy bone marrow protection drug, receives routine approval from the National Medical Products Administration (NMPA).

On October 30, Simcere Pharmaceutical Group's subsidiary, Simcere Zaiming Pharmaceutical Co., Ltd., announced that the first indication for Cosela® (Trilaciclib Hydrochloride for Injection) has been granted full approval by the National Medical Products Administration (NMPA), transitioning from conditional to regular approval. According to reports, Cosela® is a globally innovative drug co-developed by Simcere Pharmaceutical and G1 Therapeutics. It is administered prior to chemotherapy and provides comprehensive bone marrow protection.

4. Brain-computer interface "unfreezes" control ability in ALS patients, requires no recalibration after three months of use

A study published in the latest issue of *Science Advances* shows that researchers at Johns Hopkins University in the U.S. have developed a brain-computer interface (BCI) for treating ALS, which maintains 90% accuracy for three months without the need for retraining or recalibrating the algorithm. The study shows that patients' responses remain very stable over time, eliminating the need to retrain the BCI algorithm. In the near future, ALS patients may be able to start their day by turning on lights or playing TV news using only their brain signals.

5. Pfizer to Cut Nearly 800 Jobs in New Jersey

According to local notices in New Jersey, USA, Pfizer will lay off 791 employees at its Gladstone production base in New Jersey. This layoff plan is expected to take effect in February 2024. Earlier this month, Pfizer reduced its 2023 revenue forecast by $9 billion and stated that it would carry out cost-cutting activities across the entire company.

6. Replacing Daily Oral Medications, the First Long-Acting Injectable HIV Treatment Approved in China

Recently, British pharmaceutical company GlaxoSmithKline (GSK) announced that ViiV Healthcare, its HIV (Human Immunodeficiency Virus, which causes the disease known as "AIDS") specialized joint venture, has received approval from China's National Medical Products Administration (NMPA) for the combined use of its product Vocabria® (generic name: cabotegravir injection) with Janssen Pharmaceuticals, a subsidiary of U.S.-based Johnson & Johnson, for their product Rekambys® (generic name: rilpivirine injection). This combination is approved for treating HIV-1 infected individuals who have achieved viral suppression.

This is the first long-acting injectable HIV treatment regimen, which can replace daily oral medications, allowing for once-monthly or once every two months administration. It is also the first complete HIV-1 long-acting (up to every two months) injectable treatment regimen approved by the NMPA. Additionally, the tablet form of cabotegravir has been approved for use in combination with rilpivirine tablets, serving as an optional oral lead-in therapy before initiating the injectable treatment or as an oral treatment option for individuals who miss scheduled injections.

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