On September 12, 2023, the official website of the China Securities Regulatory Commission disclosed that Beijing Qingke Biotechnology Co., Ltd. had completed the acceptance of IPO coaching and filing. The coaching institution was CITIC Securities Co., Ltd., and the dispatched institution was the Beijing Securities Regulatory Bureau. The official website information showed that Qingke Biotechnology was established in 2017 as a gene synthesis platform enterprise with an independent whole industry chain. Its business scope covered three major directions: synthetic genomics products and services, life science raw materials and equipment, and bio-manufacturing CXO.

2. WECARE MEDICAL Completes Tens of Millions of Yuan in Pre-A Round Financing, Led by Noyou Capital

Today, Hangzhou Ruier Weikang Technology Co., Ltd. (hereinafter referred to as "WECARE MEDICAL") announced that it had completed a Pre-A round of financing worth tens of millions of RMB several months ago, led by Noyou Capital, with follow-up investment from the existing shareholder, renowned angel investor Mr. Ye Huahua. The funds raised from this round of financing will be used to advance the development of non-invasive deep brain stimulation neuromodulation products based on Temporal Interference (TI), expand the pipeline of brain science diagnosis and treatment products, upgrade and iterate the Biovital digital health general technology platform, and build production, sales, and marketing teams.

3. BioLineRx, a biopharmaceutical company, announces FDA approval of Aphexda in combination with filgrastim for mobilizing hematopoietic stem cells to peripheral blood.

On September 12, 2023, biopharmaceutical company BioLineRx announced that the U.S. FDA had approved Aphexda (motixafortide) in combination with filgrastim (granulocyte colony-stimulating factor, G-CSF) to mobilize hematopoietic stem cells into peripheral blood for autologous stem cell mobilization (SCM) in multiple myeloma patients undergoing transplantation. Aphexda is reported to be the first innovative drug approved by the FDA for stem cell mobilization in multiple myeloma in a decade. The FDA’s approval was primarily based on results from the two-part GENESIS Phase 3 clinical trial, a randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of Aphexda plus G-CSF compared to placebo plus G-CSF for mobilizing hematopoietic stem cells in multiple myeloma patients undergoing autologous transplantation. The combination regimen of Aphexda and G-CSF generally demonstrated good tolerability and safety profiles.

4. Novartis Stops Development of Ophthalmology AAV Gene Therapy GT005

On September 11, Syncona Investment Management Limited, an investor in Gyroscope Therapeutics (Gyroscope), stated that Novartis has ceased development of the ophthalmic AAV gene therapy GT005.It is reported that GT005, a key investigational product of Gyroscope, is a gene therapy based on the AAV2 vector.GT005 aims to restore the balance of an overactive complement system (a part of the immune system) by increasing the production of complement factor I (CFI) protein.Excessive complement activation is closely related to the development and progression of AMD.CFI protein regulates the activity of the complement system.It is believed that increasing CFI production can alleviate systemic overactivity and reduce inflammation, with the aim of protecting vision.

5. AI may become a powerful tool to solve male infertility.

Recently, a healthy sperm recognition system developed by a team led by biomedical engineer Vasilescu from the University of Technology Sydney (UTS) is preparing to enter the clinical validation stage. Dr. Vasilescu said that this artificial intelligence system, named "Search Sperm," can find healthy sperm in tissue samples of patients with severe infertility, and it is 1,000 times faster than any rigorously trained doctor.

6. Clover Launches Quadrivalent Seasonal Influenza Vaccine in China

On September 12, 2023, Clover Biopharmaceuticals, a global commercial-stage biotechnology company dedicated to unlocking the power of innovative vaccines to save lives and improve health,Hong Kong Stock Exchange Stock Code:02197) announced the launch of the Adimas-S vaccine today.(Clover Biopharmaceuticals, Ltd. (Clover;Hong Kong Stock Exchange Stock Code:02197) is a global biotechnology company at the commercialization stage, dedicated to unleashing the power of innovative vaccines to save lives and improve health worldwide.Today, the company announcedThe AdimFlu-S (QIS) vaccine has been launched in China. This vaccine is the only imported quadrivalent seasonal influenza vaccine approved for use in individuals aged 3 years and above.To date, the QIS vaccine has been launched in 26 provinces and municipalities across China, and is ready for commercialization.Sales are expected to boost Clover's financial performance starting from 2023, with significant growth anticipated in 2024 and beyond.

7. Updated COVID-19 Vaccines from Moderna and Pfizer BioNTech Approved by FDA

The U.S. Food and Drug Administration (FDA) approved two updated COVID-19 vaccines from Pfizer-BioNTech and Moderna on Monday afternoon.Strong injectable, just in time for the autumn vaccination season.These two reformulated mRNA vaccines are specifically designed to provide protection against the prevalent Omicron-related variants, including the XBB.1.5 subvariant, which the FDA recommended in June 2023 to update the vaccines to cover.