1. Gene-editing therapy new drug receives FDA approval for clinical trials

Recently, GEB-101, a novel gene-editing therapeutic for hereditary corneal dystrophy independently developed by the team of Hong Jiaxu and Zhou Xingtao from the Eye & ENT Hospital of Fudan University, has received FDA approval for new drug clinical trials in the United States. This drug is the world’s first in vivo genome editing therapy targeting TGFBI-related corneal dystrophy, which is caused by mutations in the TGFBI gene, and cannot be prevented from recurring at the genetic level through traditional surgery. Based on ribonucleoprotein, GEB-101 is "ready-to-use and rapidly degradable," capable of addressing the root cause of the disease with high-efficiency targeted editing and low off-target risk. Clinical trials are expected to begin patient enrollment in the U.S. in Q2 2026, with plans to initiate trials in China at an appropriate time. The trial will adopt a sequential enrollment approach to evaluate the safety, tolerability, and preliminary efficacy of a single intrastromal corneal injection in patients.

2. 30,000 Yuan: Sun Yat-sen University Plans to Commercialize a New Ganoderma Spore Component Extraction Technology

Sun Yat-sen University Plans to Transfer a New Ganoderma Spore Component Extraction Technology for 30,000 Yuan; Recipient is Guizhou Huahong Biotechnology Co., Ltd. The technology inventors are Professor Ge Fahuan and his team. This patent successfully extracts and isolates a novel compound from Ganoderma spore oil using multi-step purification processes such as extraction and defatting. Ganoderma, a traditional medicinal fungus in Chinese medicine, is often used to treat debilitating diseases. Modern research shows its potential in the field of adjuvant cancer therapy. Ganoderma spore powder, the seed of Ganoderma, requires breaking its double-wall structure to release active components. Ganoderma spore oil, the concentrated essence extracted from Ganoderma spores, can enhance immunity and alleviate adverse effects of radiotherapy and chemotherapy. However, current clinical solutions have shortcomings, as its chemical composition has not been fully identified, affecting product standardization and efficacy stability. This patented technology may help address these issues.

3. NewDEL Biotech Completes Additional A+ Round Financing Worth Tens of Millions, DEL+AI Dual-Driven Innovation in Drug Development

On January 21, 2026, it was reported that Shenzhen NewDEL Biotech Co., Ltd. recently completed a multi-million yuan Series A+ strategic financing round, with this round of investment being contributed by XtalPi, a Hong Kong Stock Exchange-listed company and returning shareholder. This marks an important capital boost for NewDEL Biotech within half a year following an earlier investment by XtalPi. The proceeds from this financing will primarily be used to further develop and upgrade NewDEL Biotech’s "DEL+AI" integrated technology platform, accelerate the advancement and clinical development of its innovative drug pipeline, and further enhance the efficiency and success rate during the early drug discovery stage. Through this strategic partnership, both parties will continue to collaborate deeply on key R&D processes such as target discovery, molecular design optimization, and preclinical research, establishing a closed-loop R&D process of "DEL high-throughput screening + AI intelligent analysis and optimization." This collaboration is expected to overcome the traditional bottlenecks of long drug development cycles, high costs, and low success rates, ushering in a more efficient and precise new drug discovery model.

4. Roche's Oral Obesity Class 1 New Drug Approved for Clinical Trials in China

On January 20, the CDE official website showed that Roche's Class 1 new drug RO7795081 (CT-996) was approved for clinical trials in China for the first time, intended for long-term weight management in overweight or obese patients. This drug is an oral small-molecule GLP1R agonist, initially developed by Carmot Therapeutics. At the end of 2023, Roche acquired this drug for $3.1 billion after purchasing Carmot. Overseas, Roche is conducting clinical research on its use in treating obesity and type 2 diabetes. On January 20, two Phase III clinical trials evaluating RO7795068 (CT-388) for the treatment of obesity or overweight patients were registered on ClinicalTrials.gov. Additionally, obesity is a key focus area for Roche. In March 2025, Roche also licensed the long-acting amylin analog Petrelintide from Zealand Pharma, which has significant potential for combination with CT-388 and is expected to become the best-in-class therapy.

5. $16 Million! First Custom Gene Therapy Team Secures Seed Round, Fires the First Shot in the "Democratization" of Rare Disease Treatment

In January 2026, biotech startup Aurora Therapeutics secured $16 million in seed funding, with the investment led by Menlo Ventures of Silicon Valley; no financial advisor was mentioned. The company was co-founded by Jennifer Doudna, co-inventor of CRISPR gene-editing technology and Nobel Chemistry Prize laureate, along with Fyodor Urnov, a scientist involved in developing the world’s first personalized CRISPR therapy. Edward Kaye, the CEO, has extensive experience in the development and commercialization of orphan drugs. In February 2025, a 7-month-old infant named KJ successfully underwent the world’s first fully customized CRISPR gene-editing treatment, demonstrating the feasibility of personalized gene therapy. Aurora's mission is to scale this "one patient, one drug" model, providing millions of rare disease patients worldwide with access to treatment. This funding marks a significant step for CRISPR technology transitioning from academic research to commercial application.