Johnson & Johnson's Class 1 Anti-Prostate Cancer Drug JNJ-78278343 Receives IND Approval in China

PharmSnap Weekly Selection (October 7th ~ October 13th): Latest Developments in New Drug R&D, Including Progress Updates and Significant Drug Transactions – All in One Quick Read.

Source: PharmaGo Enterprise Edition – Global Drug Analysis System Database, official websites of various enterprises

Johnson & Johnson:
JNJ-78278343 Injection

On October 12, according to the CDE official website, Johnson & Johnson's Class 1 new drug JNJ-78278343 injection received implied clinical trial approval for the treatment of adult male patients with advanced prostate cancer.

Image Source: CDE Official Website

According to publicly available data, JNJ-78278343 is a KLK2-CD3 bispecific antibody and T-cell redirection product designed to target KLK2 and induce T-cell activation by binding to CD3 on T cells. This product has potential immunomodulatory and anti-tumor activity. After administration, it can bind to CD3 on T cells and KLK2 on KLK2-expressing tumor cells, thereby redirecting T cells to KLK2-expressing tumor cells and generating T-cell-mediated lysis of KLK2-expressing tumor cells.

Currently, Johnson & Johnson has launched several international studies on JNJ-78278343 for prostate cancer. Among them, the Phase 1 study of JNJ-78278343 as a monotherapy for advanced prostate cancer is expected to be preliminarily completed by November 30, 2024.

Image Source: clinicaltrials.gov

The clinical trial application for JNJ-78278343 injection has been successfully approved by the NMPA, and Johnson & Johnson may conduct further research on it in China.

Progress in the Development of Other New Drugs

1.Biogen's "Tofersen Injection" Approved for Marketing in China

On October 8, according to the NMPA official website, Biogen's Tofersen Injection was approved for marketing in China, indicated for treating adult Amyotrophic Lateral Sclerosis (ALS) with SOD1 gene mutations. This is the world’s first causative treatment for SOD1-ALS, and it was approved in China through a clinical trial exemption pathway. The drug has also been shortlisted for the "Best Rare Disease Product Award" in the 2024 Prix Galien USA Awards, which were announced in August this year.

2. AstraZeneca "AZD9592" Approved for Clinical Trials

On October 8, according to the CDE official website, AstraZeneca's Class 1 new drug AZD9592 received two clinical trial implied permits for the following indications: combination therapy with osimertinib for the treatment of advanced solid tumors; combination therapy with 5-fluorouracil (5-FU), leucovorin, and bevacizumab for the treatment of advanced solid tumors. Public data indicates that AZD9592 is a bispecific antibody-drug conjugate (ADC) targeting EGFR and c-MET, currently in Phase 1 clinical research internationally.

3.索元生物 "DB104" Receives FDA Fast Track Designation

On October 9, Denovo Biopharma announced that its potential "first-in-class" innovative drug DB104 (liafensine) for treatment-resistant depression (TRD) has been granted Fast Track designation by the U.S. FDA. The drug is a triple reuptake inhibitor that simultaneously inhibits the reuptake of serotonin, norepinephrine, and dopamine, which play important roles in depression. Using its proprietary DGM™ biomarker big data/AI discovery platform, Denovo Biopharma discovered a novel biomarker, DGM4, which can predict the efficacy of DB104 and is being used to guide the ENLIGHTEN international multicenter clinical trial.

4. Bintie Bio "IX001 TCR-T Injection" Approved for Clinical Trials

On October 9, according to the CDE official website, Bentie Bio's Class 1 new drug IX001 TCR-T injection received implied permission for clinical trials. The indication is for advanced pancreatic cancer with the HLA-A*11:01 genotype and positive expression of the tumor antigen KRAS G12V. Public information indicates that the IX001 TCR-T injection is a TCR-T cell therapy targeting the KRAS G12V mutation.

5. Clinical Progress Update of InnoCare Pharma's "ICP-488"

On October 9, InnoCare announced that its self-developed novel Tyrosine Kinase 2 (TYK2) inhibitor ICP-488 reached the primary endpoint in a Phase 2 clinical study for the treatment of moderate to severe plaque psoriasis. After 12 weeks of treatment, ICP-488 demonstrated favorable efficacy and safety in patients. ICP-488 achieved multiple efficacy endpoints in the once-daily 6 mg and once-daily 9 mg dose groups, including Psoriasis Area and Severity Index (PASI) 75, PASI 90, PASI 100 (PASI score improvement of ≥75%, ≥90%, and ≥100% from baseline), as well as Static Physician's Global Assessment (sPGA) 0/1 (indicating complete or near-complete skin clearance).

6. China Resources Tianqing "Bemarituzumab Injection" Combined with "LM-108 Injection" Therapy Approved for Clinical Trials

On October 9, according to the CDE official website, the combination of Zhengda Tianqing's Bemarituzumab Injection and Limin Pharmaceutical's LM-108 Injection received clinical trial implied permission. The indication is: LM-108 in combination with Bemarituzumab/Penpulimab and chemotherapy for the treatment of advanced solid tumors (gastric cancer, pancreatic cancer, esophageal squamous cell carcinoma). According to publicly available information, Bemarituzumab is an innovative anti-PD-L1 humanized monoclonal antibody; Penpulimab is a novel differentiated anti-PD-1 monoclonal antibody; LM-108 is a CCR8-targeted monoclonal antibody independently developed by Limin Pharmaceutical.

7. Hengrui Medicine "SHR-6934 Injection" Approved for Clinical Trials

On October 9, according to the CDE official website, Hengrui Medicine's Class 1 new drug SHR-6934 Injection obtained clinical trial implied permission, intended for the treatment of heart failure. According to the latest epidemiological survey results on heart failure in China, the prevalence rate of heart failure among residents aged 35 and above in China is 1.3%; it is estimated that the domestic heart failure market has reached a scale of hundreds of billions of yuan. It is understood that chronic heart failure is also one of the few cardiovascular diseases with an incidence rate still rising significantly.

8. Lilly's "Mirikizumab" Submitted for Marketing Approval in China

On October 9, according to the CDE website, Eli Lilly's mirikizumab intravenous injection and subcutaneous injection formulations were submitted for marketing authorization in China. Mirikizumab is a monoclonal antibody targeting the IL-23p19 subunit, which was first approved for marketing in Japan in March 2023 under the trade name Omvoh. Its indications include induction and maintenance treatment for moderate to severe ulcerative colitis (UC) that has shown an inadequate response to existing therapies.

9. Bayer "Elinzanetant" Submitted for Marketing Approval in the U.S.

On October 9, Bayer announced that the U.S. FDA has accepted the New Drug Application (NDA) for Elinzanetant, a dual NK-1/NK-3 receptor antagonist, for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause, commonly known as hot flashes. Elinzanetant is the first dual NK-1 and NK-3 receptor antagonist, which works by modulating a group of estrogen-sensitive neurons (KNDy neurons) in the hypothalamus of the brain.

10. Derui Zhiyao "MDR-001" Phase 2b Clinical Trial Completes First Participant Dosing

On October 10, Derui Zhiyao announced that the first dosing group of the Phase 2b clinical trial for MDR-001, a novel small-molecule oral GLP-1RA drug, has been completed. This marks the official entry of the MDR-001 project into the registration clinical research phase. MDR-001 is a β-arrestin 2 highly selective GLP-1R agonist developed by Derui Zhiyao. The drug not only retains the islet cell repair and protection function brought by β-arrestin recruitment but also avoids the restricted insulin secretion and mediated endocytosis desensitization caused by β-arrestin 1 recruitment, demonstrating distinct differentiation characteristics and potential clinical advantages.

11. Roche's "Inavolisib" Combination Therapy Receives FDA Approval

On October 10, according to the FDA's official website, Roche's PI3Kα inhibitor inavolisib (Itovebi), in combination with palbociclib and fulvestrant for the treatment of endocrine therapy-resistant, PIK3CA-mutated hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in adult patients who have relapsed during or after adjuvant endocrine therapy, has been approved. It is understood that inavolisib is an oral, highly selective PI3Kα inhibitor with higher selectivity and potency for PI3Kα than other subtypes (PI3Kβ/δ/γ) and can specifically trigger the degradation of mutated PI3Kα protein.

12. Hengrui Medicine "SHR2554 Tablet" Submitted for Market Approval

On October 11, according to the CDE official website, the marketing application for SHR2554 tablets, a Class 1 new drug developed by Hengrui Medicine, was accepted. At the same time, the drug is proposed by the CDE to be included in the priority review for use in patients with relapsed or refractory peripheral T-cell lymphoma who have previously received at least one line of systemic treatment. SHR2554 is a novel, potent, and selective oral EZH2 inhibitor developed by Hengrui Medicine. It can selectively inhibit the activity of both wild-type and mutant EZH2 enzymes, thereby suppressing the trimethylation of H3K27 within cells, which leads to cell cycle arrest in the G1 phase, induces early apoptosis, and ultimately achieves the goal of inhibiting the growth of various malignant tumors, including lymphoma.

13.Junshi Biosciences "Angoriximab Injection" Approved for Marketing in China

On October 11, according to the NMPA official website, Junshi Biosciences' Angoreximab Injection has been approved for marketing. The indication is: on the basis of dietary control, in combination with statins, or with statins and ezetimibe, for adult patients with primary hypercholesterolemia (non-familial) and mixed dyslipidemia who are unable to reach low-density lipoprotein cholesterol (LDL-C) goals despite receiving moderate or higher doses of statin therapy. It is reported that Angoreximab (JS002) is a recombinant humanized anti-PCSK9 monoclonal antibody injection developed by Junshi Biosciences.

14. Hengrui Medicine "RGL-193 Injection" Approved for Clinical Trials

On October 11, according to the CDE official website, the Phase 1 new drug RGL-193 injection submitted by Shanghai Ruihongdi Pharmaceutical was approved for clinical trials and is expected to be developed for the treatment of Parkinson's disease. It is reported that the company is a subsidiary of Hengrui Pharmaceutical. RGL-193 injection is an AAV dual-gene drug targeting Parkinson’s disease, which can improve the conversion efficiency of levodopa while also playing a role in protecting and repairing damaged dopaminergic neurons. It has the potential effect of slowing disease progression and reducing the dosage of oral anti-Parkinson's drugs.

15. Kangkang Bio "Injectable Tumor-Specific Recombinant IL-12 Fc Fusion Protein" Approved for Clinical Trials

On October 12, according to the CDE official website, Kang抗 Bio's injectable tumor-specific recombinant IL-12 Fc fusion protein, a Class 1 new drug, was approved for clinical trials. It is being developed for advanced or metastatic solid tumors. Public information indicates that this is the company’s investigational product KGX101, a next-generation cytokine IL-12 prodrug, which has already received IND approval in the United States.

16. Pfizer "Hympavzi" Receives FDA Approval

On October 12, the U.S. FDA approved Pfizer's Hympavzi (marstacimab) for routine prophylaxis or reduction of bleeding in adults and pediatric patients aged 12 years and older with hemophilia A and hemophilia B who do not have inhibitors (neutralizing antibodies) against coagulation factors VIII and IX. According to publicly available information, this therapy can treat hemophilia A and hemophilia B by targeting tissue factor pathway inhibitor (TFPI).

17. Capricor's "Deramiocel" Clinical Research Makes New Progress

On October 12, Capricor announced the three-year positive results of its HOPE-2 open-label extension (OLE) trial, which focused on non-ambulatory patients with advanced Duchenne muscular dystrophy (DMD). The analysis of the OLE trial showed that cardiac and skeletal muscle function in patients treated with its lead cell therapy, deramiocel (CAP-1002), remained stable over the three-year period. Capricor stated that it expects to complete the submission of the biologics license application (BLA) for this therapy to treat DMD-related cardiomyopathy by the end of this year.

18. BeiGene's "BG-C137 Injection" Submitted for Clinical Trial in China

On October 12, according to the CDE official website, BeiGene's Class 1 new drug "BG-C137 Injection" clinical trial application was accepted. Public information shows that BG-C137 is an FGFR2b ADC drug developed by BeiGene, which registered a clinical trial overseas earlier this month. The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary anti-tumor activity of BG-C137 in subjects with advanced solid tumors. The study is planned to commence on November 20, 2024.

19. Novartis "Brolucizumab" New Indication Submitted for Marketing Approval in China

On October 12, according to the CDE official website, Novartis' Brolucizumab new indication marketing application has been accepted. Public data shows that Brolucizumab, developed by Novartis, is a full VEGF-A inhibitor and a novel humanized single-chain antibody fragment with a molecular weight of only 26kDa, high affinity, strong tissue penetration, and minimal systemic side effects. The first marketing application in China was submitted in August 2023, and this is its second marketing application in China.

20. Hengrui Medicine "Hetrombopag Ethanolamine Tablets" New Indication Submission for Market Approval

On October 13, according to the CDE official website, Hengrui Medicine's Hetrombopag Ethanolamine Tablets new indication marketing application has been accepted. Public data shows that Hetrombopag Ethanolamine is a new generation TPO-R agonist, which can promote platelet production by activating the TPO-R mediated STAT and MAPK signaling pathways. Previously, this drug has been approved in China for two indications: treating adult patients with chronic primary immune thrombocytopenia who have had an inadequate response to treatments such as corticosteroids and immunoglobulins, and treating adult patients with severe aplastic anemia who have had an inadequate response to immunosuppressive therapy.

Global Pharmaceutical Trading Dynamics

1.AstraZeneca Collaborates with CSPC on Lp(a) Inhibitor

On October 7, AstraZeneca China announced an exclusive licensing agreement with CSPC Pharmaceutical Group to advance the development of a preclinical innovative small molecule lipoprotein(a) (Lp(a)) inhibitor. Under the agreement, AstraZeneca will acquire CSPC’s preclinical candidate small molecule drug YS2302018, an oral lipoprotein(a) inhibitor, for the development of a novel lipid-lowering therapy, as well as for use as monotherapy or combination therapy for various cardiovascular diseases, including in combination with the oral small molecule PCSK9 inhibitor AZD0780. CSPC will receive an upfront payment of $100 million and is also eligible to receive up to $1.92 billion in development and commercialization milestone payments, along with tiered royalties.

2. Zhengda Tianqing and Youzhiyou Reach Cooperation

On October 7, China Biologic Products announced that its subsidiary, Zhengda Tianqing, signed an exclusive licensing and cooperation agreement with Youzhiyou Biotech. Zhengda Tianqing has obtained the exclusive, sublicensable license for the development, registration, manufacturing, and commercialization of M701, a product developed by Youzhiyou Biotech, in mainland China. Zhengda Tianqing will pay Youzhiyou Biotech an upfront payment and research and development milestone payments totaling approximately RMB 315 million based on the progress of the research and development. Additionally, Zhengda Tianqing will pay sales milestone payments of up to RMB 700 million and tiered royalties ranging from single-digit to low double-digit percentages of annual net sales to Youzhiyou Biotech.

3. Yilian Biologics and Amgen Reach Cooperation

On October 8, Yilian Biotech announced a global clinical research and drug supply collaboration agreement with Amgen. Under the agreement, Amgen will lead a global clinical study to evaluate the potential of Yilian Biotech's B7-H3-targeted antibody-drug conjugate YL201 in combination with Amgen’s DLL3 and CD3-targeted bispecific T-cell engager (BiTE®) IMDELLTRA™ (generic name: tarlatamab) for the treatment of extensive-stage small cell lung cancer (ES-SCLC). Yilian Biotech will provide the investigational drug YL201 for this combination study.

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Editor: Muyan

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