Currently,A Total of 30 AAV Gene Therapy Drugs Granted IND Approval in China, of which 3 have entered Phase III clinical trials.According to its INDSummary of Approval Timeline in Chronological Order:
1、Frontera Therapeutics' FT-002
On November 6, 2023, FT-002 Injection, an innovative gene therapy drug independently developed by Frontera Therapeutics, Inc. (referred to as "Frontera Therapeutics"), received clinical trial approval from the CDE for the treatment of X-linked Retinitis Pigmentosa (XLRP) caused by RPGR (Retinitis Pigmentosa GTPase Regulator) gene mutations.
FT-002 Injection is aRecombinant Adeno-Associated Virus (rAAV)Gene therapy drugs using rAAV as a vector to carry the target gene are administered via intravitreal injection, enabling retinal cells to express active RPGR protein. This protein participates in the ciliary transport function of photoreceptors, rescuing photoreceptor cell loss caused by RPGR gene mutations and improving patients' visual function or slowing the progression of vision loss. The preliminary results of the IIT study on FT-002 injection are encouraging, showing significant improvements in objective indicators such as macular retinal thickness, visual field, and visual acuity after administration. Notably, some patients exhibited a marked increase in best-corrected visual acuity (BCVA) two months post-treatment compared to baseline (measured by the ETDRS chart).
2、RRGENER's RRG001
On November 6, 2023, Shanghai RRGENER Biotechnology Co., Ltd. ("RRGENER") announced that the Investigational New Drug (IND) application for its self-developed and produced RRG001 intravitreal injection has been approved by the CDE.RRG001 Intravitreal InjectionRRGENER's first injectionApplicable toAge-related Wet Macular Degeneration (nAMD)TheGene therapy drugs.
RRG001 Intravitreal Injection is a recombinant adeno-associated virus (rAAV) gene therapy drug independently developed by RRGENER, which delivers the epidermal growth factor receptor (VEGFR) fusion protein gene into the fundus of nAMD patients through subretinal administration. This enables the fundus cells to act as protein factories, continuously expressing the VEGFR fusion protein needed by patients, avoiding the drawbacks of frequent dosing associated with traditional antibodies, with the aim of achieving a "one-time administration, long-term efficacy" treatment for macular degeneration. The drug has already initiated an investigator-initiated clinical trial (IIT study) at the Jiangsu Provincial People's Hospital in February 2023. Preliminary clinical research data shows that subjects experienced significant clinical benefits, with no serious adverse events reported.
3. SKG0106 by Skyline THERAPEUTICS
In October 2023, the AAV ophthalmic gene therapy SKG0106 developed by Skyline Therapeutics was approved for clinical trials by the National Medical Products Administration (NMPA) in China for the treatment of neovascular age-related macular degeneration (nAMD). Additionally, SKG0106 received FDA approval in June this year to initiate a global Phase I/IIa clinical trial for the treatment of nAMD.
SKG0106 is an innovative ophthalmic gene therapy drug under research. This therapy uses recombinant AAV as a vector to express a unique anti-vascular endothelial growth factor (VEGF) protein, administered via intravitreal injection, offering long-term effects with a single dose.Potential for effective periods.
4、Janssen's JNJ-81201887
In early August 2023, JNJ-81201887 (AAVCAGsCD59), an AAV gene therapy developed by Janssen, a subsidiary of Johnson & Johnson, received the CDE's tacit approval for clinical trials. It is intended to be developed for treating adult patients with geographic atrophy secondary to age-related macular degeneration.
JNJ-81201887 (JNJ-1887, AAVCAGsCD59) is an investigational gene therapy based on an AAV vector, designed to increase the expression of soluble CD59 (sCD59) to protect retinal cells, thereby slowing and preventing disease progression.
5、Shanghai Belief-Delivery BioMed Co.,Ltd.TheBBM-H803
On July 24, 2023, the clinical trial application for "BBM-H803 Injection" submitted by Shanghai Belief-Delivery BioMed Co., Ltd. and Shanghai Mianyi Biotechnology Co., Ltd., wholly-owned subsidiaries of Belief BioMed (BBM), received tacit approval for clinical trials. The indication is Hemophilia A.
BBM-H803 is an AAV gene therapy drug independently developed by Belief BioMed. It delivers the human coagulation factor VIII gene into patients with hemophilia A through intravenous administration, thereby increasing and maintaining the level of coagulation factor in patients for a long term.
6. VGM-R02b by Shanghai Tianze Yuntai Biomedical Co., Ltd.
On July 13, 2023, Shanghai Tianze Yuntai Biomedical Co., Ltd. (referred to as "Shanghai Tianze Yuntai Biomedical Co., Ltd.VGM-R02b, independently developed by R&B Bio, has been approved by the National Medical Products Administration to conduct clinical trials for the treatment of Glutaric Acidemia Type I.
VGM-R02b is a potential treatment to prevent severe or life-threatening disease progression caused by glutaric acidemia in infants and children. It is also the world's first gene therapy product for Glutaric Acidemia Type I (GA-I). This therapy is based on the principle of gene replacement.Recombinant Adeno-Associated Virus (rAAV) as a vector`, the therapy was introduced in`On May 25, 2022, it was granted the FDA's Rare Pediatric Disease Designation (RPDD) for the treatment of GA-I.
7、 Frontera Therapeutics' FT-004
On July 12, 2023, Frontera Therapeutics, Inc. developed a treatment targetingHemophilia B(Endogenous FIX activity ≤2%)) ofAAV Gene Therapy Drug FT-004 Receives CDE Clinical Trial Approval
FT-004 is a gene therapy drug based on the AAV vector. Preclinical data shows that FT-004 can efficiently enter liver cells, sustainably and stably express and secrete functional hFIX protein into the blood, effectively enhance the coagulation ability of model animals over the long term, and has demonstrated good safety.On June 28, 2023, Sichuan Real&Best Biotech Co., Ltd. (hereinafter referred to as "R&B Bio") received CDE approval for its AAV gene therapy drug "ZS802 Injection" targeting Hemophilia A, and will soon commence clinical Phase I/II trials.
ZS802 is an AAV gene therapy drug independently developed by R&B Bio. It utilizes the company's self-developed smallest liver-specific promoter globally, solving the challenge of packaging large gene capacity and significantly improving product quality. Additionally, ZS802 incorporates an optimized and modified FVIII gene sequence developed by R&B Bio, effectively enhancing its efficacy. Currently, the ZS802 project has initiated IIT research at the Hematology Hospital of the Chinese Academy of Medical Sciences, with preliminary results demonstrating the drug’s safety and efficacy.9. EXG102-031 by JiaYin Bio
On June 1, 2023, the AAV gene therapy drug EXG102-031 ophthalmic injection developed by Hangzhou Jiayin Biotechnology Co., Ltd. ("Jiayin Bio") was approved by the CDE for the indication of wet age-related macular degeneration (wAMD).
This therapy uses AAV as a vector to overexpress a therapeutic fusion protein, which can bind/neutralize all known vascular endothelial growth factor (VEGF) and angiopoietin-2 (ANG2) subtypes, theoretically providing long-term efficacy with a single administration.On April 27, 2023, Anlong (Beijing Anlong Biomedical Co., Ltd.) announced that the IND for its ophthalmic gene therapy product "AL-001 Ophthalmic Injection" had been approved by the CDE, with the indication being: wet age-related macular degeneration (wAMD).On May 29, 2023, Anlong announced that the project had received approval from the institutional project initiation of Beijing Union Medical College Hospital, the leading research unit, and its Ethics Committee, marking the official entry of this project into the clinical trial phase.。
This therapy is the first in China forwAMDThe first approved gene therapy administered via suprachoroidal space (SCS) injection,This therapyOverexpression of anti-VEGF protein using AAV as a vector is theoretically effective for a long term with a single administration. This product adopts an advanced, self-developed rAAV production process using Sf9 suspension cells free of helper viruses.11、Frontera Therapeutics' FT-003
On April 26, 2023, Frontera Therapeutics announced that the Investigational New Drug (IND) application for FT-003 injection was approved by the CDE.LinClinical Trial PermitThe indication for this product is neovascular age-related macular degeneration (nAMD).
FT-003 Injection is a novel recombinant adeno-associated virus gene therapy drug. Preclinical study data show that after the injection of FT-003, it can efficiently infect multiple layers of retinal cells in animals, enabling sustained expression and secretion of anti-angiogenic factors, reducing vascular endothelial permeability, and inhibiting the formation of new blood vessels. A single injection in patients is expected to achieve long-term efficacy.
Moreover,FT-003 Treatment for Diabetic Macular Edema (DME) IND Application Also SubmittedObtainCDELinClinical Trial Approval.
On May 19, 2023, the team led by Professor Li Xiaorong from the Ophthalmology Hospital of Tianjin Medical University successfully completed the first patient dosing in China for the treatment of DME with FT-003.
12. Hui-Gene TherapeuticsTheHG004
On April 18, 2023, Hui-Gene Therapeutics (Shanghai) Biotechnology Co., Ltd. (referred to as "Hui-Gene Therapeutics") announced thatThe IND for HG004, the company's first self-developed ophthalmic AAV gene therapy drug, has been approved by the CDE. The indication is Type 2 Leber's Congenital Amaurosis (LCA2). Additionally, in January this year, HG004 received IND approval from the FDA.
HG004 is an AAV-mediated gene replacement therapy designed to treat RPE65 mutation-associated retinopathy. Mutations in the RPE65 gene may lead to severe early-onset childhood retinal dystrophy, early-onset severe retinal dystrophy, Leber congenital amaurosis (LCA), or retinitis pigmentosa (RP). The AAV vector used in HG004 achieves a transduction efficiency in retinal pigment epithelium that is at least 10 times higher than that of AAV2, with an initial effective dose significantly lower than the marketed AAV2-hRPE65 (LUXTURNA). In the IIT clinical study conducted at Xinhua Hospital in Shanghai, China, HG004 demonstrated excellent clinical efficacy, resulting in substantial and significant recovery of patients' vision.April 14, 2023Neurophth Biotechnology Co., Ltd.The IND application for NFS-02 ophthalmic injection, an AAV gene therapy drug, has received tacit approval from the CDE, with the indication being Leber's hereditary optic neuropathy (G3460A). Additionally, last year, NFS-02 received FDA approval for a new drug clinical trial (IND).NFS-02 is a novel intravitreal gene therapy drug based on AAV2. The therapeutic gene can be delivered to the patient's damaged retinal ganglion cells through a single intravitreal injection of the drug, repairing the mitochondrial bio-respiratory chain impaired by genetic mutations, thereby restoring visual function in retinal ganglion cells.On January 16, 2023, the clinical trial application for GS1191-0445 Injection, an AAV gene therapy drug for the treatment of Hemophilia A developed by Gritgen Therapeutics Co., Ltd. (Suzhou Huayi Lejian Biotechnology Co., Ltd.), was approved by the CDE.Gritgen officially submitted the IND application for this therapy to the CDE in November 2022 and received acceptance, becoming the hemophilia A treatment drug in China to enter the IND stage. In addition, the drug has conducted IIT research at the Tianjin Blood Disease Research Institute., with 9 patients enrolled, showing good safety and encouraging efficacy data after medication.15、Innostellar BiotherapeuticsLX102On December 23, 2022, Innostellar Biotherapeutics announced that its subsidiary, Innostellar Biotherapeutics Co., Ltd. (Suzhou)(Innostellar Biotherapeutics)The IND application for the AAV gene therapy product LX102 injection has been approved by the CDE for the treatment ofWet Age-related Macular Degeneration (wAMD).This therapy is based on AAV vector-mediated in vivo gene therapy.Method, can express anti-VEGF fusion proteinThe target gene is introduced into the patient's retinal cells, and theoretically, a single administration can have long-term effects. In previously conducted IIT clinical studies, this therapy demonstrated good safety and efficacy.。On December 20, 2022, the IND application for GC301 Adeno-Associated Virus Injection, an AAV gene therapy drug developed by Beijing Genecradle Therapeutics Co., Ltd. (Genecradle), received tacit approval from the CDE, with the indication being Infantile-Onset Pompe Disease (IOPD).On June 2, 2023, the Phase I/II clinical trial kick-off meeting for GC301 was successfully held at Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, marking the official launch of the clinical trial for GC301 injection in the treatment of infantile Pompe disease at the main research center.。Its treatment strategy is: after a single intravenous infusion, the therapeutic gene can be widely expressed throughout the body, aiming to compensate for the GAA enzyme gene defect in tissues such as the liver, muscles, and central nervous system. GC301 has demonstrated good safety and efficacy in an investigator-initiated clinical study (IIT).2022On December 6, CHIGENOVO Co., Ltd. (referred to as "CHIGENOVO") "ZVS101e Injection"IND Application Granted CDE Tacit Approval, Indication: Crystalline Retinopathy (with CYP4V2 biallelic mutations)）。On February 20, 2023, the first subject was successfully enrolled and dosed in the Phase I/II clinical trial of ZVS101e Injection at Tianjin Medical University Eye Hospital.。ZVS101e is a gene replacement therapy based on AAV8 vector.The therapy, which targets the same indications and treatment principles as VGR-R01 developed by Shanghai Tianze Yuntai Biomedical Co., Ltd. that was approved for clinical trials in November 2022.November 2022, Beijing GenecradleBeijing Genecradle Therapeutics Co., Ltd. (Genecradle)'s AAV gene therapy drug GC304 Adeno-Associated Virus Injection ("GC304 Injection") IND application has received tacit approval from the CDE for the treatment of patients with hypertriglyceridemia accompanied by recurrent acute pancreatitis.GC304 Gene Drug-Loaded Therapeutic BaseBecause of the lipoprotein lipase (LPL) gene, LPL is a key enzyme in hydrolyzing triglycerides (TG) in plasma lipoproteins.19. KH631 by Chengdu Hongji Biotechnology Co., Ltd.November 15, 2022Chengdu Hongji Biotechnology Co., Ltd. (Hongji Bio), a subsidiary of Kanghong Pharmaceutical, has received tacit approval from the National Medical Products Administration (NMPA) for five IND applications for its AAV gene therapy drug "KH631 Ophthalmic Injection," intended for the treatment of neovascular (wet) age-related macular degeneration (wetAMD).Early May 2023，The team of Professor Wei Wenbin from Beijing Tongren Hospital, Capital Medical University, has completedKH631 for the Treatment of AMDFirst Patient Dosed in Phase I Clinical Trial。20. VGR-R01 by Shanghai Tianze Yuntai Biomedical Co., Ltd.On November 1, 2022, the IND application for VGR-R01 injection, an AAV gene therapy drug developed by Shanghai Tianze Yuntai Biomedical Co., Ltd. (Tianze Yuntai), received tacit approval from the CDE. Its indication is crystalline retinal dystrophy (Bietti crystalline dystrophy, BCD) caused by mutations in the CYP4V2 gene.(Full text link:Shanghai Tianze Yuntai Biomedical Co., Ltd.'s BCD Gene Therapy Drug IND Approved）。In October 2022, the AAV gene therapy drug GC101 Adeno-Associated Virus Injection ("GC101 Injection") developed by Beijing Genecradle Therapeutics Co., Ltd. received implied permission for clinical trials from the CDE, with the clinical indication being Type 1 Spinal Muscular Atrophy (Type 1 SMA). On November 15 of the same year, the IND application for "GC101 Injection" for Type 2 SMA indications received implied permission from the CDE.22. Frontera Therapeutics' FT-001In September 2022, Frontera Therapeutics received the CDE’s tacit approval for the Investigational New Drug (IND) application of FT-001 injection, a gene therapy drug targeting RPE65 biallelic variant hereditary retinal degeneration. On January 9, 2023, Frontera Therapeutics announced that the first patient dosing of FT-001 injection was completed at Peking Union Medical College Hospital (Full text link:Frontera Therapeutics' FT-001 Injection Completes First Patient Dosing）。On September 1, 2022, the clinical application of ZS801 Injection from Sichuan Real&Best Biotech Co., Ltd. was approved by the CDE for the control and prevention of bleeding in male patients aged 18 years and above with severe or moderately severe Hemophilia B (congenital Factor IX deficiency, Factor IX < 2%).This is an AAV gene therapy. The serotype of the AAV vector used in this therapy has very low pre-existing neutralizing antibodies in patients, allowing it to cover more Chinese patients.。24. EXG001-307 by JiaYin BioOn June 21, 2022, CHIGENOVO announced that the clinical trial application for its self-developed AAV gene therapy EXG001-307 injection had been approved by the CDE for the treatment of Type 1 Spinal Muscular Atrophy (Type 1 SMA) with bi-allelic mutations (deletions) in the Survival Motor Neuron 1 (SMN1) gene.This is the first gene therapy product for the treatment of Type 1 SMA via intravenous injection approved for registration clinical trial in China (Full text link:Another AAV Gene Therapy IND Clinical Trial Approved by CDE in China）。EXG001-307 is an AAV-based gene therapy with the potential for long-term efficacy from a single administration. Its mechanism of action and usage are similar to Novartis' Zolgensma. Hangzhou Jiayin has adopted an innovative design for EXG001-307, aiming to reduce side effects on the heart and liver, thereby enhancing its therapeutic effectiveness.25. Shanghai Tianze Yuntai Biomedical Co., Ltd.VGB-R04In April 2022, VGB-R04 Injection, the first AAV gene therapy candidate drug independently developed by Shanghai Tianze Yuntai Biomedical Co., Ltd., received clinical trial approval for the treatment of Hemophilia B caused by congenital deficiency of coagulation Factor IX.VGB-R04 is administered intravenously, delivering the target gene (therapeutic gene) to the liver cell nucleus mediated by the AAV capsid. It expresses a variant of coagulation factor IX (hFIX Padua) protein in liver cells. FIX-Padua is a naturally occurring, highly active FIX variant (R338L), with activity approximately eight times that of normal wild-type FIX. This means it can achieve normal blood clotting function at lower expression levels, thereby reducing the dosage of the viral vector and enhancing the safety and efficacy of the viral vector administration.26、Innostellar BiotherapeuticsLX101In April 2022, LX101 Ophthalmic Injection, an AAV2-RPE65 gene therapy formulation independently developed by Shanghai Innostellar Biotherapeutics Co., Ltd. (under Innostellar Biotherapeutics), received clinical trial approval for the treatment of patients with inherited retinal degeneration (IRD) associated with biallelic RPE65 mutations.The gene therapy LX101, using AAV2 as a vector, delivers the functionally normal and optimized coding sequence of the RPE65 gene into retinal cells in the body, compensating for the loss of protein function caused by mutations in this gene and restoring vision. In previously conducted investigator-initiated clinical studies, this gene therapy demonstrated good safety and efficacy.27. Novartis' OAV101 (already entered Phase III clinical trials)In January 2022, Novartis (Novartis, NYSE: NVS) received clinical trial approval in China for its SMA gene therapy drug OAV101 injection (Zolgensma). On April 29, 2022, relevant databases showed that this therapy had initiated clinical trials in China for the first time, planning to enroll 20 participants in China as part of the global Phase 3 clinical STEER study. On the afternoon of June 20, 2022, Novartis (Novartis) commenced the clinical trial in China for its gene therapy (OAV101).The kick-off meeting of the research center was successfully held at Peking University First Hospital, the leading institution. This clinical trial is the China segment of the global Phase III clinical STEER study, led by Professor Xiong Hui from the Department of Pediatrics at Peking University First Hospital. It targets treatment-naive patients aged 2 to 18 with Type 2 Spinal Muscular Atrophy (SMA).。
Zolgensma is a gene replacement therapy for treating Type 1 SMA, which theoretically offers long-term or even lifelong efficacy with a single administration, providing a one-time treatment option addressing the root cause of the disease. This gene therapy uses an scAAV9 vector delivered intravenously to introduce the normal SMN1 gene into the patient’s body, producing normal SMN1 protein and thereby improving the function of affected cells such as motor neurons. In contrast, Spinraza and Evrysdi, drugs used to treat SMA, require repeated long-term dosing. Spinraza is administered via spinal injection every four months, while Evrysdi is an oral medication taken daily.28. Shanghai Belief-Delivery BioMed Co.,Ltd.BBM-H901 (Entered Phase III Clinical Trial)In August 2021, BBM-H901 Injection, a gene therapy drug for the treatment of Hemophilia B independently developed by Shanghai Belief-Delivery BioMed Co., Ltd., a wholly-owned subsidiary of Belief BioMed, received clinical trial approval. By the end of December 2021, the clinical trial had successfully completed the first dosing of a participant.Currently in Phase III clinical trials，Expected to be launched for sale in the second half of 2024 to the first half of 2025.。
BBM-H901 is an intravenously administered AAV gene therapy, where the AAV carries the target gene (therapeutic gene) that overexpresses human coagulation factor IX (hFIX), thereby increasing and maintaining the patient's coagulation factor levels long-term.For the prevention of bleeding in adult male patients with hemophilia BBBM-H901 is one of the earliest AAV gene therapy drugs in China to enter clinical trials, having started IIT clinical research (NCT04135300) in 2019. The results of the IIT clinical research showed that this therapy has good safety and efficacy. After administration, the level of clotting factor IX (hFIX) in the subjects significantly increased, with hFIX levels remaining stable in the blood over the long term. The annualized bleeding rate of patients was significantly reduced, with no significant adverse reactions observed.29. NeurophthNR082 (Entered Phase III Clinical Trials)In March 2021, Neurophth's NR082 ophthalmic injection received the Investigational New Drug (IND) approval from the National Medical Products Administration. On June 28, 2021, Neurophth announced that the first patient was enrolled and dosed in the Phase I/II/III first-stage clinical trial of NR082, China’s first in vivo AAV gene therapy drug for ophthalmology at the clinical stage. On February 22, 2023, Neurophth announced that all patients had been enrolled and dosed in the Phase III clinical trial of NR082 ophthalmic injection for the treatment of Leber Hereditary Optic Neuropathy caused by ND4 mutations in China.。
NR082 Gene Therapy Drug Uses AAV as a Vector for Leber's Hereditary Optic Neuropathy (LHON) Caused by ND4 Mitochondrial Gene Mutation. The Administration Method is a Single Intravitreal Injection, Delivering the Therapeutic Gene to the Patient’s Damaged Retinal Ganglion Cells Through the Vitreous Cavity, Repairing the Mitochondrial Bioenergetic Respiratory Chain, and Restoring Vitality and Visual Function to the Retinal Ganglion Cells.In mid-June 2019, the hepatitis B AAV gene therapy STSG-0002 applied for clinical trial by Staidson(Beijing)Biopharmaceuticals Co.,Ltd., and was approved by the National Medical Products Administration in mid-September 2019 for clinical trials targeting chronic hepatitis B treatment. In August 2020, the first subject was dosed.STSG-0002 is an AAV vector-based DNA gene therapy drug utilizing RNA interference technology, developed by Staidson. Compared to non-viral vector small nucleic acid RNA drugs, this drug demonstrates significantly longer efficacy and is expected to provide long-term effectiveness with a single administration.In addition, there are currently 7 AAV gene therapies on the market worldwide., as shown in the figure below:Among them, (1)ZolgensmaLaunched in May 2019, with first-year sales reaching 361 million USD; 920 million USD in 2020; 1.351 billion USD in 2021; and 1.37 billion USD in 2022.。（2）Luxturna，As of September 2019, net sales totaled $55 million (September 2018-2019: $27 million and $28 million). In October 2019, Roche announced the acquisition of Spark, after which the sales performance of Luxturna was no longer reflected in Roche's financial reports.Source: Official Account "Cell and Gene Therapy Field", official reports from listed companies
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