Six Therapies Including China's First TIL Therapy Receive IND Approval; Lingkang Pharma Files for IPO

According to the announcements from various companies and the information from the CDE official website, 6 drugs/therapies have been approved for clinical trials! They areSuzhou Gravel Biotechnology Co., Ltd.'s TIL Therapy,LNK01004, a Class 1 new drug developed by Lingke Pharmaceuticals,VGB-R04 Injection by Tianze Yuntai,LX101 Injection by Longxin Bio,Two Oncolytic Virus Products from Virogin BioVG201 andVG161。

Gravel Bio: TIL Therapy

According to the CDE official website, GT101 Injection independently developed by Suzhou Gravel Biotechnology Co., Ltd. has officially received the clinical trial implied permission from the National Medical Products Administration (NMPA). This is the first TIL therapy approved for clinical trials in China.

GT101 Injection demonstrated favorable drug safety and significant tumor-killing effects as well as clinical efficacy in the investigator-initiated clinical trial (IIT), potentially becoming an important treatment option for patients with solid tumors such as melanoma, cervical cancer, and non-small cell lung cancer in China.

GT101 is based on Gravel Biotechnology's proprietary TIL cell stemness expansion platform, StemTexp®, which expands and prepares TIL cell drugs with a high proportion of memory phenotype from patient tumor tissue samples, meeting clinical infusion requirements.

Lingke Pharmaceuticals: Class 1 New Drug LNK01004

According to official news from Lingke Pharmaceuticals, its self-developed Class 1 innovative drug LNK01004 has been approved by the National Medical Products Administration (NMPA) for clinical trial permission for the treatment of psoriasis.

LNK01004 is a novel kinase inhibitor for the treatment of psoriasis. LNK01004 can simultaneously inhibit multiple inflammatory cytokines and disease-inducing signaling pathways associated with psoriasis, demonstrating the potential for optimal efficacy. In preclinical studies, LNK01004 exhibited skin-restricted advantages, with the drug primarily distributed in the affected skin tissue and minimal exposure in the bloodstream, thus avoiding safety issues related to potential systemic immune suppression caused by systemic drug exposure. LNK01004 demonstrated favorable efficacy and safety in animal trials.

Tianze CloudTech: VGB-R04 Injection

According to the CDE official website, VGB-R04 Injection, the first gene replacement therapy drug independently developed by Tianze Cloud Therapeutics, has obtained clinical trial implied permission. The indication is hemophilia B caused by congenital coagulation factor FIX deficiency.

Hemophilia is a type of X chromosome-linked recessive hereditary bleeding disorder, which can be divided into two subtypes: Hemophilia A and B. The former is characterized by a deficiency in coagulation factor VIII (FVIII), while the latter involves a deficiency in coagulation factor IX (FIX), both caused by mutations in the respective coagulation factor genes.

After intravenous injection, VGB-R04 injection delivers the expression cassette to the nucleus through AAV capsid protein-mediated transduction of liver cells. The VGB-R04 expression cassette exists in the form of episomal DNA and expresses the high-activity natural variant (hFIX Padua) of coagulation factor IX in liver cells. The hFIX Padua protein, expressed and secreted into the blood by liver cells, substitutes for the missing congenital coagulation factor IX to correct the coagulation disorder in patients with hemophilia B.

Langxin Bio: LX101 Injection

According to the CDE official website, LX101 Injection, a Class 1 new drug developed by Shanghai Langsheng Biotechnology Co., Ltd. under Langxin Biotechnology, has received tacit approval for clinical trials. It is intended for treating patients with inherited retinal degeneration (IRD) associated with RPE65 biallelic mutations.

Inherited Retinal Degeneration (IRD) caused by RPE65 gene mutations is a typical blinding rare disease. Common IRDs include retinitis pigmentosa, choroideremia, Leber's Hereditary Optic Neuropathy (LHON), Leber Congenital Amaurosis (LCA), Stargardt disease, achromatopsia (ACHM), and X-linked retinoschisis (XLRS), which occur due to the death of retinal photoreceptor cells caused by mutations in one or more genes.

LX101 Injection is a gene therapy using rAAV as a vector. By optimizing the design of the RPE65 gene coding sequence, it efficiently expresses the human RPE65 protein, compensating for the loss of protein function caused by mutations in this gene. After intravitreal administration, it can effectively treat patients with inherited retinal degeneration (IRD) related to biallelic RPE65 mutations.

Virogin Bio: Two Oncolytic Virus Products Approved for Clinical Trials in China

Virogin Biotech announced that its next-generation oncolytic virus product VG201, based on a dual-regulation backbone of transcription and translation, has been approved by the China National Medical Products Administration (NMPA) to enter clinical trials. At the same time, the NMPA also approved a Phase 1/2 clinical study of the company’s immune-enhanced oncolytic virus product VG161 in combination with the anti-PD-1 monoclonal antibody nivolumab for the treatment of advanced gastric cancer. This project will be led by Sinopharm Virogin (a joint venture between Virogin Biotech and China National Biologic Products Corporation).

VG201 (Recombinant Human IL12/15 Herpes Simplex Type I Dual-Regulated Oncolytic Virus Injection) is a potential “first-in-class” oncolytic virus investigational product based on the Transcription and Translation Dual Regulation (TTDR) mechanism. According to a press release from Virogin Biotech, the company’s exclusive TTDR viral backbone achieves tumor-specific oncolysis by regulating, rather than deleting, essential genes for viral replication. VG201 also carries multiple exogenous genes, aiming to synergistically activate innate and adaptive anti-tumor immunity. Additionally, this product holds promise for enabling precision oncolytic virus therapy based on tumor biomarkers.

VG161 (Recombinant Human IL12/15-PDL1B Herpes Simplex Virus Type I Oncolytic Virus Injection) is a novel anti-tumor immune-enhanced herpes simplex virus type I oncolytic virus used for the treatment of solid tumors. According to earlier press releases from Virogin Biotech, VG161 enters tumor tissue through intratumoral injection. While the virus replicates and lyses tumor cells, the four immune-stimulating factors it carries are effectively expressed, achieving synergy between oncolytic activity and immune stimulation. Additionally, further synergistic enhancement occurs among the four immune-stimulating factors expressed by the virus, converting the antiviral immune response into a specific anti-tumor immune response. In multiple tumor models, particularly in liver cancer, soft tissue sarcoma, and pancreatic cancer models, this product has demonstrated favorable anti-tumor efficacy characteristics.

Editor: Qijin

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