Kaito Pharmaceuticals Passes HKEX Listing Hearing; Suoyuan Biopharma Acquires Tocagen's Gene Therapy Platform and First-in-Class Oncology Drug

Oncology Therapeutics Company Erasca Secures $200 Million in Series B Funding to Support Clinical Development of Multiple Oncology Therapies

On April 28, oncology therapeutics company Erasca announced the completion of a $200 million Series B financing round, co-led by ARCH Venture Partners and Cormorant Asset Management. EDBI, Invus, Terra Magnum Capital Partners, other private and strategic investors, as well as existing investors City Hill Ventures, Colt Ventures, and LifeSci Venture Partners, participated in the round. The proceeds will be used to support the clinical development of its multiple oncology therapies.

Biopharmaceutical Company ROME Therapeutics Completes $50 Million Series A Financing

On April 28, biopharmaceutical company ROME Therapeutics announced the completion of a $50 million Series A financing round, led by GV and ARCH Venture Partners, with participation from Partners Innovation Fund. ROME is dedicated to developing novel therapies for cancer and autoimmune diseases by leveraging repetitive genomic elements.

Kintor Pharmaceutical Passes HKEX Listing Hearing

On April 27, according to disclosures by the Hong Kong Stock Exchange (HKEX), Kintor Pharmaceutical passed the HKEX listing hearing, with Huatai Financial Holdings (Hong Kong) Limited serving as its sole sponsor. Kintor Pharmaceutical is a company dedicated to the research and development of potential first-in-class and best-in-class drugs, focusing on the development of androgen receptor (AR)-targeted therapies for disease areas lacking effective treatments, including prostate cancer, breast cancer, liver cancer, and alopecia.

Novartis’ Secukinumab Receives NMPA Approval for New Indication in Ankylosing Spondylitis

On April 28, Novartis Pharmaceuticals (China) announced that Cosentyx (secukinumab) had been approved by the National Medical Products Administration for the treatment of adult patients with ankylosing spondylitis who have had an inadequate response to conventional therapy. This marks the first and only interleukin inhibitor currently approved in China for the treatment of ankylosing spondylitis. Results from the MEASURE 2 study demonstrated that Cosentyx rapidly alleviates symptoms of back pain, morning stiffness, and fatigue; it also inhibits new bone formation and prevents structural damage.

Biopharmaceutical Company Neurocrine’s New Parkinson’s Drug Ongentys Approved by FDA for Market Launch

On April 27 local time, Neurocrine Biosciences (NBIX) announced that the U.S. Food and Drug Administration (FDA) has approved its oral medication Ongentys (opicapone) as an adjunctive therapy to levodopa/carbidopa for the treatment of Parkinson’s disease patients experiencing “off” episodes. The recommended dosage is one 25 mg or 50 mg capsule taken orally once daily.

Zhifei Biological's Recombinant Mycobacterium tuberculosis Fusion Protein Completes Approval

On April 27, Zhifei Biological Products issued an indicative announcement stating that the drug registration status of the Recombinant Mycobacterium tuberculosis Fusion Protein (EC), developed by its wholly-owned subsidiary Anhui Zhifei Longcom Biopharmaceutical Co., Ltd., had been updated to “Approval Completed – Pending Certificate Issuance” on the website of the National Medical Products Administration. It is reported that this drug is a nationally classified Class I new drug and a world-leading agent for the diagnostic screening of tuberculosis infection. The product is expected to be used for screening Mycobacterium tuberculosis infection; it can be used in conjunction with Tuberculin Purified Protein Derivative (PPD) primarily to differentiate between Bacillus Calmette-Guérin (BCG) vaccination and Mycobacterium tuberculosis infection. It helps distinguish among three populations: those who are BCG-vaccinated but negative or uninfected with Mycobacterium tuberculosis, those who remain positive after BCG vaccination, and those infected with Mycobacterium tuberculosis. This differentiation facilitates the administration of different types of vaccines to each group and supports the clinical auxiliary diagnosis of tuberculosis.

Sinopharm’s Second Inactivated COVID-19 Vaccine Receives Clinical Trial Approval

On April 27, China National Biotec Group (CNBG), a subsidiary of Sinopharm, announced that the inactivated COVID-19 vaccine developed by its Beijing Institute of Biological Products had received clinical trial approval from the National Medical Products Administration (NMPA). A representative from CNBG stated that clinical trials for this newly approved inactivated vaccine were officially launched in Henan Province on April 28. It is understood that this is the second inactivated COVID-19 vaccine from CNBG to receive clinical trial approval. Together with the adenovirus-vector recombinant COVID-19 vaccine developed by Academician Chen Wei’s team at the Academy of Military Medical Sciences of the Academy of Military Sciences, and the inactivated COVID-19 vaccine developed by Beijing Sinovac Biotech, China now has four COVID-19 vaccines approved for clinical trials.

Biotech Company Moderna Submits IND Application for Phase 2 Clinical Trial of COVID-19 Vaccine

Recently, biotechnology company Moderna announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA), planning to initiate Phase 2 clinical trials for its novel coronavirus vaccine, mRNA-1273. Moderna has already received feedback from the FDA on the design of the Phase 2 clinical study. If approved by the FDA and supported by safety data from Phase 1 studies, the company expects to launch the Phase 2 clinical trial in the second quarter of this year. The Phase 2 clinical study is expected to enroll 600 healthy volunteers. Participants will receive two doses of the mRNA-1273 vaccine (or placebo) administered 28 days apart, at dosages of either 50 micrograms or 250 micrograms.

Johnson & Johnson’s CD38-Targeted Anti-Cancer Drug Darzalex Subcutaneous Injection Files for Marketing Approval in Japan

Recently, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (JNJ), submitted a New Drug Application (NDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) seeking approval for the subcutaneous (SC) formulation of Darzalex (daratumumab) for the treatment of patients with multiple myeloma (MM). This formulation was developed using Halozyme’s ENHANZE drug delivery technology and contains recombinant human hyaluronidase PH20 (rHuPH20). In July 2019, Janssen also filed supplemental applications for Darzalex SC with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The currently marketed Darzalex product is an intravenous (IV) formulation.

Nektar’s Immuno-Stimulatory Therapy Bempeg Granted FDA Orphan Drug Designation

Recently, the FDA granted orphan drug designation (ODD) to Nektar Therapeutics’ immunostimulatory therapy bempegaldesleukin (bempeg, NKTR-214) for the treatment of stage IIB–IV melanoma. Currently, Bristol Myers Squibb (BMS) is collaborating with Nektar Therapeutics to develop an immuno-combination regimen of bempeg and the anti-PD-1 therapy Opdivo (nivolumab) for the treatment of various types of tumors.

Kangyuan Pharmaceutical’s Reduning Granules Approved for Clinical Trials

On April 27, Kanion Pharmaceutical issued an evening announcement stating that the company had received the "Clinical Trial Approval Notice" for Reduning Granules, approved and issued by the National Medical Products Administration (NMPA), granting permission to conduct clinical trials. Reduning Granules are an oral formulation developed by the company as an exclusive variant of its proprietary product, "Reduning Injection," featuring a changed route of administration and dosage form. Reduning Injection has been included in multiple diagnostic and treatment guidelines, protocols, or expert consensus statements for viral infectious diseases, such as the "Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 7)." Among currently marketed domestic drugs in the same category, the top-selling traditional Chinese medicines primarily include Lianhua Qingwen Capsules (Granules).

Fosun Pharma’s FCN-011 Capsule Clinical Trial Application Accepted

On April 27, Fosun Pharma announced that its controlled subsidiary, Chongqing Fuchuang Pharmaceutical Research Co., Ltd., had received a “Notice of Acceptance,” indicating that the National Medical Products Administration (NMPA) had accepted for review and registration the clinical trial application for FCN-011 capsules for the treatment of solid tumors. The announcement stated that this new drug is an innovative small-molecule chemical drug independently developed by Fosun Pharma.

Sanofi/Regeneron IL-6R Monoclonal Antibody Reduces Mortality in Critically Ill COVID-19 Patients

On April 27, Sanofi and Regeneron announced the preliminary Phase II results from the Phase II/III study of their IL-6 receptor monoclonal antibody, Kevzara (sarilumab), in hospitalized COVID-19 patients with “severe” or “critical” respiratory disease. The preliminary analysis showed that treatment with Kevzara rapidly reduced C-reactive protein levels, thereby meeting the primary endpoint. Increases in IL-6 levels from baseline were observed in all treatment groups, with a more pronounced rise in critically ill patients compared to those with severe disease. No unexpected safety events related to Kevzara treatment were identified. Based on recommendations from the Independent Data Monitoring Committee (IDMC) following its review of the available Phase II and Phase III data, the trial protocol will be immediately amended so that only “critical” patients continue to receive either 400 mg of Kevzara or placebo.

Pharmaceutical Company Axsome Announces That AXS-05 Met Primary Endpoint in Phase II/III Trial for Agitation Associated with Alzheimer’s Disease

On April 27, 2020, biopharmaceutical company Axsome Therapeutics announced that its Phase II/III ADVANCE-1 trial of AXS-05 for the treatment of agitation in patients with Alzheimer’s disease (AD) had met its primary endpoint. The primary endpoint of the study was a statistically significant reduction in the total score on the Cohen-Mansfield Agitation Inventory (CMAI) at Week 5 compared with placebo. Patients receiving AXS-05 experienced a mean decrease of 15.4 points from baseline, whereas those receiving placebo experienced a mean decrease of 11.5 points, corresponding to mean reductions of 48% and 38%, respectively. AXS-05 also demonstrated superiority over bupropion in reducing CMAI total scores, thereby improving agitation symptoms.

Avadel Pharmaceuticals’ Once-Nightly Narcolepsy Drug Meets All Three Co-Primary Endpoints in Late-Stage Trial

On April 27, 2020, Avadel Pharma, headquartered in Dublin, Ireland, announced positive top-line results from the pivotal Phase III REST-ON clinical trial of FT218 for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy. Under a special protocol assessment, the trial met all three co-primary endpoints across all three dosage levels (9 g, 7.5 g, and 6 g). The endpoints were the Maintenance of Wakefulness Test (MWT), the Clinical Global Impression of Improvement (CG-I), and the mean weekly number of cataplexy attacks.

Saisheng Pharmaceutical's Humanized Anti-VEGF Monoclonal Antibody Injection Approved for Clinical Trials

On April 27, Saisheng Pharmaceutical announced that its developed “Humanized Anti-VEGF Monoclonal Antibody Injection” had received approval for clinical trials and research. Bevacizumab is a recombinant humanized monoclonal antibody that was approved by the U.S. Food and Drug Administration (FDA) in 2004, becoming the first anti-tumor angiogenesis drug approved for marketing in the United States. Its clinical indications include a range of malignant tumors such as colorectal cancer, non-small cell lung cancer, renal cell carcinoma, and liver cancer.

Hansoh Pharma Announces Latest Phase II Clinical Trial Results of Almonertinib in Patients with NSCLC

On April 27, the 111th Annual Meeting of the American Association for Cancer Research (AACR) kicked off in San Diego. At this year’s AACR meeting, Hansoh Pharma announced the latest Phase II clinical study results of Ameile (almonertinib mesylate tablets) in patients with EGFR T790M mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC), and presented efficacy data in patients with brain metastases for the first time. The report showed that the overall response rate (ORR) in the total population was 68.9% (approximately 61% in patients with brain metastases); the disease control rate (DCR) in the total population was 93.4%; the median progression-free survival (PFS) in the overall population was 12.3 months (approximately 10.8 months in patients with brain metastases); and the median duration of response (DoR) in the overall population was 12.4 months (approximately 11.3 months in patients with brain metastases).

Novartis’ PI3Kα Inhibitor BYL719 for Breast Cancer Approved for Clinical Trials in China

On April 27, Novartis’ PI3Kα inhibitor BYL719 received clinical trial approval in China. It is indicated for use in combination with fulvestrant to treat postmenopausal women and male patients with hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced breast cancer who have experienced disease progression during or after endocrine therapy.On April 27, Angelacell’s Mesenchymal Stem Cells (Umbilical Cord) for Injection Received Clinical Trial Approval: According to the website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration, Tianjin Angelacell Gene Engineering Co., Ltd.’s new drug clinical trial application for Mesenchymal Stem Cells (Umbilical Cord) for Injection has been approved for the treatment of refractory acute graft-versus-host disease (GvHD).

Takeda’s Potent EGFR Small-Molecule Tyrosine Kinase Inhibitor Mobocertinib Receives FDA Breakthrough Therapy Designation

Recently, Takeda announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to mobocertinib (TAK-788) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations, whose disease has progressed during or after platinum-based chemotherapy. Currently, there are no approved therapies for this specific subtype of NSCLC. Mobocertinib is a small-molecule tyrosine kinase inhibitor (TKI) designed to selectively target EGFR and human epidermal growth factor receptor 2 (HER2) exon 20 insertion mutations.

Sanofi/Regeneron: Libtayo Monotherapy as First-Line Treatment Significantly Prolongs Survival in Phase III Trial for PD-L1 High-Expression Lung Cancer

Recently, Sanofi and its partner Regeneron announced that a Phase III trial evaluating the anti-PD-1 therapy Libtayo (cemiplimab) for the treatment of non-small cell lung cancer (NSCLC) had met its primary endpoint of overall survival (OS). Following the recommendation of the Independent Data Monitoring Committee (IDMC) to stop the trial early, the protocol will be amended to allow all patients to receive Libtayo. These data will form the basis for regulatory submissions in the United States and the European Union in 2020.

Merck Announces First Clinical Results for Keytruda 400 mg Dosing Every 6 Weeks

Recently, Merck & Co. announced interim data from Cohort B of the Phase I KEYNOTE-555 study evaluating Keytruda (pembrolizumab), an anti-PD-1 therapy, for the treatment of metastatic melanoma. The data demonstrated that the efficacy and safety profile of the 400 mg every 6 weeks (400 mg Q6W) dosing regimen of Keytruda were comparable to those of the currently approved 200 mg every 3 weeks (200 mg Q3W) regimen. Interim results showed an overall response rate (ORR) of 38.6% in patients treated with Keytruda 400 mg Q6W. These findings represent the first clinical results assessing the Q6W dosing regimen of Keytruda.

Major Breakthrough Achieved in Clinical Trial of Boshengji's Autologous CD7-CAR-T Cell Therapy

Recently, Gracell Biotechnologies announced on its official WeChat account that its autologous CD7-CAR-T cell therapy has achieved a breakthrough in the clinical trial for treating refractory and relapsed T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/LBL). In the clinical study, CD7-CAR-T cells prepared from patients' peripheral healthy T cells demonstrated superior cytotoxic activity against CD7+ malignant target cells, effectively killing tumor cells even at an effector-to-target ratio as low as 1:100. According to PDX models constructed from patients' primary T-ALL cells, treatment with CD7-CAR-T significantly extended survival; analysis of major organs with tumor burden showed that tumor cells were essentially cleared. Gracell Biotechnologies stated that larger-scale clinical trials of the CD7-CAR-T cell therapy are underway, and the Investigational New Drug (IND) application is entering its final countdown.

Akeso Announces Preliminary Results from Phase 1b/2 Study of Investigational New Drug AK104 in Combination with Chemotherapy

On April 27, the 111th Annual Meeting of the American Association for Cancer Research (AACR) kicked off in San Diego. At this year’s AACR meeting, preliminary results from a Phase 1b/2 study of Akeso Biopharma’s investigational new drug AK104 in combination with chemotherapy as first-line treatment for advanced gastric cancer or gastroesophageal junction adenocarcinoma were presented. The data showed an objective response rate (ORR) of 57.9% (11/19) and a disease control rate (DCR) of 94.7% (18/19). The longest duration of treatment exceeded 42 weeks in some patients, with 13 patients still receiving ongoing therapy. These findings indicate that AK104 combined with chemotherapy demonstrates favorable safety and antitumor efficacy, holding promise as a next-generation cancer immunotherapy superior to PD-1 antibody monotherapy.

Zhixiang Pharmaceutical Initiates Phase Ib/II Clinical Study of GR1405 for Advanced Triple-Negative Breast Cancer

On April 26, Zhixiang Pharmaceutical registered the initiation of a Phase Ib/II clinical study evaluating GR1405 in combination with gemcitabine and cisplatin as first-line treatment for advanced triple-negative breast cancer (TNBC). The study aims to assess the preliminary efficacy of GR1405 injection combined with gemcitabine and cisplatin (GP regimen) as first-line therapy in patients with advanced TNBC. It also seeks to evaluate the safety, immunogenicity, and pharmacokinetic profile of GR1405 injection in combination with the GP regimen as first-line treatment for these patients. This is an open-label, randomized, parallel-group domestic trial planned to enroll 60–100 patients with pathologically confirmed locally advanced or metastatic TNBC.

Innovent Biologics’ Parsaclisib for the Treatment of Indolent Lymphoma Completes First Dosing in Pivotal Registration Clinical Trial in China

On April 28, Innovent Biologics announced that the first patient in China had been dosed in a pivotal Phase 2 registration-enabling clinical study of parsaclisib (development code: IBI-376), its PI3Kδ-specific inhibitor. The study aims to evaluate the efficacy and safety of parsaclisib in patients with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL).

Antengene’s ATG-008 in Combination with Toripalimab Completes First Dosing in Patients with Advanced Solid Tumors and Hepatocellular Carcinoma

On April 28, Antengene announced that the first patient with advanced solid tumors and hepatocellular carcinoma (HCC) had been dosed in China in a clinical trial evaluating the combination therapy of its dual mTOR1/2 inhibitor ATG-008 and Junshi Biosciences’ anti-PD-1 monoclonal antibody toripalimab (brand name: Tuoyi). Including ATG-008, Antengene is actively advancing clinical trials of multiple investigational products in combination with anti-PD-1 monoclonal antibodies for the treatment of various solid tumors and hematologic malignancies.

AI Drug Discovery Company Insilico Medicine Enters New Drug R&D Collaboration with Astellas

On April 28, AI-driven drug discovery company Insilico Medicine and Astellas Pharma announced a collaboration to jointly develop drug candidates for Astellas’ new drug pipeline. Under the partnership, the two parties will leverage Insilico Medicine’s novel generative AI system to accelerate the development of drug candidates targeting traditionally challenging target families. According to the agreement terms, Insilico Medicine will receive upfront payments and milestone payments, and will share intellectual property rights arising from the collaboration. Specific financial details were not disclosed.

Sorrento Therapeutics Acquires Tocagen’s Gene Therapy Platform and First-in-Class Anti-Tumor Drug

On April 28, Sorrento Therapeutics announced the acquisition of core assets from Tocagen, a pioneer in gene therapy. The acquired assets include the gene therapy platform (the Replicating Retroviral Vector platform, RRV) and global rights to all related product pipelines (with the exception of Greater China rights for one product). The acquisition encompasses Toca 511 and Toca FC (now named DB107), a drug combination in Phase III clinical trials for the treatment of recurrent high-grade glioma, as well as several early-stage projects in tumor immunotherapy, such as a gene therapy program targeting PD-L1.

Yuheng Pharmaceutical’s General Manager Zhang Dayong Resigns; Long Wancheng Appointed as New General Manager

On April 27, the Board of Directors of Harbin Yuheng Pharmaceutical Co., Ltd. received a written resignation letter from Mr. Zhang Dayong, the General Manager. Due to personal reasons, Mr. Zhang applied to resign from his positions as General Manager of the Company and all roles in its subsidiaries. Upon completion of the resignation process, Mr. Zhang will no longer hold any position within the Company. As of the date of this announcement, Mr. Zhang holds 307,800 shares of the Company’s stock. On the same day, Yuheng Pharmaceutical approved the appointment of Mr. Long Wancheng as General Manager, with his term lasting until the expiration of the Fourth Board of Directors.

Digital Cell Biology Company Berkeley Lights Launches New Features to Accelerate the Development of Effective Cancer Immunotherapies

Recently, Berkeley Lights, a leader in digital cell biology, announced the launch of new features empowering its Opto Cell Therapy Development 1.0 workflow. This workflow, comprising a suite of software capabilities, reagents, and protocols, operates on the Beacon® and Lightning™ systems. With these newly introduced features, researchers can now perform multiparametric analysis on thousands of T cells within just a few days, enabling them to recover live cells for downstream genomic analysis. This ultimately allows Berkeley Lights’ customers to link T cell phenotype and function with the genotype of individual cells, integrating T cell functional analysis into an innovative platform.

Immunotherapy Company Harpoon Receives $50 Million Milestone Payment for HPN217 Multiple Myeloma Clinical Trial

On April 27, 2020, immunotherapy company Harpoon Therapeutics announced that the first patient had been dosed in the Phase 1/2 clinical trial of HPN217 for the treatment of relapsed/refractory multiple myeloma (RRMM). HPN217 was developed under a global license and option agreement with AbbVie. The dosing of the first patient in this clinical trial will trigger a $50 million milestone payment to Harpoon.