Tislelizumab Approved for Urothelial Carcinoma; Three COVID-19 Vaccines Enter Clinical Trials

Beigene’s Tislelizumab Receives Approval for New Indication in Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma

On April 9, tislelizumab (BAIZEAN®), a PD-1 monoclonal antibody independently developed by BeiGene, officially received approval from the National Medical Products Administration (NMPA) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have previously received therapy. With this approval, tislelizumab becomes the first PD-1/PD-L1 monoclonal antibody approved in China for the indication of urothelial carcinoma. This also marks the second indication approved for tislelizumab in China, following its earlier approval for relapsed or refractory classical Hodgkin lymphoma (r/r cHL) after at least two lines of systemic chemotherapy.

Zhenshiming's New Class IV Sodium Hyaluronate Eye Drops Pass Consistency Evaluation

On April 10, Zhen Shiming Pharmaceutical’s new Class 4 application for Sodium Hyaluronate Eye Drops was approved by the National Medical Products Administration (NMPA), deemed as having passed the consistency evaluation. This makes Zhen Shiming the second company in China to achieve consistency evaluation for this product, following Chengdu Pushi Pharmaceutical. Sodium Hyaluronate Eye Drops are a major product in the ophthalmic market, indicated for dry eye disease to alleviate dry eye symptoms.

Kangyuan Pharmaceutical’s Class 6.1 New Traditional Chinese Medicine, Jinguzhi Tong Gel, Approved for Market Launch

On April 13, Jinguzhi Tong Gel, a Class 6.1 new traditional Chinese medicine (TCM) drug submitted by Kanion Pharmaceutical, received marketing approval from the National Medical Products Administration (NMPA). Kanion Group is a large health industry group primarily engaged in the production and distribution of innovative TCM, biopharmaceuticals, and general health products. Its current main product portfolio focuses on TCM-advantaged therapeutic areas, including anti-infectives, gynecology, cardiovascular and cerebrovascular diseases, and orthopedics.

Ministry of Science and Technology: Three COVID-19 Vaccines Have Been Approved for Clinical Trials

On April 14, the Joint Prevention and Control Mechanism of the State Council held a press conference on the progress of scientific research breakthroughs in drug development and vaccine research for COVID-19. In response to questions about China’s current progress in vaccine development, Wu Yuanbin, Director of the Department of Social Development Science and Technology under the Ministry of Science and Technology, pointed out that three vaccines have been approved for clinical trials. Wu noted that the Ministry of Science and Technology is pursuing five technical routes, with vaccines based on other routes also being accelerated. The live attenuated influenza virus vector vaccine has completed the construction of the vaccine strain and the establishment of quality control methods; the recombinant protein vaccine has completed the construction of the seed virus; and nucleic acid vaccines have entered the stage of evaluating efficacy and safety in animals, while simultaneously carrying out the preparation and quality testing of clinical samples.

China's Adenovirus-Vectored Recombinant COVID-19 Vaccine Becomes the First to Enter Phase II Clinical Trials

On April 14, Xinhua News Agency reported that the adenovirus-vectored recombinant COVID-19 vaccine, developed by Academician Chen Wei’s team at the Institute of Biotechnology, Academy of Military Medical Sciences, Chinese Academy of Military Sciences, commenced its Phase II clinical trial on the 12th. According to the World Health Organization’s official website, this is currently the only COVID-19 vaccine worldwide to have entered Phase II clinical trials.

Sinovac Biotech's Inactivated Novel Coronavirus Vaccine Approved for Clinical Trials

On April 13, the National Medical Products Administration (NMPA) approved the entry into clinical studies of the inactivated SARS-CoV-2 vaccine (brand name: CoronaVac) developed by Beijing Sinovac Biotech Co., Ltd., a subsidiary of Sinovac Biotech Ltd. Currently, the investigational inactivated COVID-19 vaccine for clinical trials produced by Sinovac Biotech has passed testing by the National Institutes for Food and Drug Control (NIFDC), and clinical trials are set to commence shortly.

BeiGene’s Baizean Combined with Chemotherapy Meets Primary Endpoint in Phase 3 Trial for First-Line NSCLC Patients

On April 14, BeiGene announced that the Phase 3 clinical trial of its anti-PD-1 antibody, Baizean® (tislelizumab injection), in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of patients with non-squamous non-small cell lung cancer (NSCLC), met its primary endpoint in the planned interim analysis. As assessed by an Independent Review Committee (IRC), the regimen demonstrated a statistically significant improvement in progression-free survival (PFS) compared to pemetrexed and platinum-based chemotherapy alone.

AstraZeneca Launches Large-Scale Clinical Trial of Calquence for Treating Severe COVID-19 Patients

On April 14, AstraZeneca announced the initiation of a randomized, global clinical trial to evaluate the potential of Calquence (acalabrutinib) in treating severe COVID-19 patients with hyperimmune responses (cytokine storm). This trial, named CALAVI, is based on early clinical data for Calquence, which suggested that inflammation reduction resulting from BTK inhibition appears to mitigate the severity of COVID-19-induced respiratory distress.

Hengrui Medicine Initiates Phase III Clinical Trial of PD-1 Combination Therapy for Triple-Negative Breast Cancer

On April 13, Hengrui Medicine registered the initiation of a Phase III clinical study evaluating camrelizumab in combination with albumin-bound paclitaxel and apatinib for the treatment of advanced triple-negative breast cancer (TNBC). The study plans to enroll 780 patients with TNBC. The primary objectives are to assess the efficacy of the experimental group versus the control group in the PD-L1-positive population, as well as in the overall intention-to-treat (ITT) population. Secondary objectives include evaluating the safety of the experimental group compared to the control group, along with pharmacokinetic and immunogenicity analyses. The primary endpoints are progression-free survival (PFS) in the PD-L1-positive population and PFS in the overall ITT population.

Approval Granted for Clinical Trial Application of Ascletis' New HIV Drug ASC09F

On April 13, Ascletis Pharma Inc. announced that the National Medical Products Administration (NMPA) had approved its investigational new drug application for ASC09F, an HIV protease inhibitor (a fixed-dose combination tablet of ASC09 and ritonavir). ASC09 features a high genetic barrier to resistance. Completed Phase I and Phase IIa clinical trials have demonstrated that ASC09 possesses potent antiviral activity. Studies indicate that more than seven mutations are required for HIV to develop resistance to ASC09, suggesting that ASC09 has a higher genetic barrier to resistance compared with other protease inhibitors. This profile positions ASC09 as a preferred therapeutic option for both treatment-naïve and treatment-experienced patients with HIV.

Clinical Trial Application for Aosaikang's Oncology Biologic ASKB589 Injection Accepted

On April 13, AskPharm announced that its wholly-owned subsidiary, Jiangsu AskPharm Pharmaceutical Co., Ltd., and its wholly-owned subsidiary, Jiangsu AskPharm Biopharmaceutical Co., Ltd., recently received the "Notice of Acceptance" from the National Medical Products Administration (NMPA) for the investigational new drug (IND) application of ASKB589 injection. ASKB589 injection is an anti-tumor biologic novel drug independently developed by Jiangsu AskPharm with independent intellectual property rights. It primarily exerts its antitumor effects through antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), and is intended for the treatment of indications such as gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, and pancreatic cancer.

Tagri Bio’s IND Application for TGRX-678 in the Treatment of Chronic Myeloid Leukemia Accepted

On April 11, the official website of the Center for Drug Evaluation (CDE) announced that Shenzhen Tagrisso Biopharmaceuticals, a domestic pharmaceutical company, had submitted an Investigational New Drug (IND) application for its investigational new drug, TGRX-678 tablets. The application, which has been accepted for review, proposes the use of TGRX-678 for the treatment of chronic myeloid leukemia (CML). This investigational agent is a fourth-generation Bcr-Abl inhibitor designed to compete with leading global drugs in its class and holds promise for transforming the clinical management of chronic myeloid leukemia (CML).

Gracell Biotechnologies to Report First-in-Human Trial Results of Universal TruUCAR™ GC027 Therapy

Recently, Gracell Biotechnologies announced that it will deliver a platform presentation at the American Association for Cancer Research (AACR) Annual Meeting, reporting data from a Phase 1 clinical trial of its universal TruUCAR™ GC027 product. This first-in-human trial aims to evaluate the feasibility of treating relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL).

Generic Drug Company Bausch Health Launches Clinical Trial Program for Virazole in the Treatment of COVID-19

On April 13, 2020, the Canadian generic pharmaceutical company Bausch Health announced that it had launched a clinical trial program in Canada to investigate the use of Virazole for the treatment of COVID-19. Virazole, marketed by Bausch Health, is currently approved in the United States, Canada, and other countries/regions worldwide for the treatment of hospitalized infants and young children with severe lower respiratory tract infections caused by respiratory syncytial virus (RSV).

Arrowhead Pharmaceuticals Officially Submits Phase 1/2a Study of RNAi Therapy for Different Indications

On April 10 (U.S. time), RNAi therapeutics company Arrowhead Pharmaceuticals announced that it had submitted an application to regulatory authorities for approval to initiate a Phase 1/2a clinical study of its candidate RNAi therapy, ARO-ENaC, targeting non-hepatic indications for the treatment of cystic fibrosis (CF). Preclinical studies of Arrowhead’s cystic fibrosis program have yielded promising results, prompting the company to seek authorization for subsequent human trials to evaluate the drug’s efficacy and safety.

BlackRock Strikes $2 Billion Strategic Partnership with RNAi Therapeutics Company Alnylam

Recently, Blackstone Life Sciences and RNAi therapeutics company Alnylam Pharmaceuticals announced that they have entered into a strategic partnership. Under this agreement, Blackstone Life Sciences will provide up to $2 billion in funding to support Alnylam in advancing the development of innovative technologies. This round of financing was led by Blackstone Life Sciences and GSO Capital Partners, Blackstone’s credit platform, aiming to help Alnylam achieve financial sustainability without the need for further fundraising, thereby accelerating its commercialization process. The deal also set a new record for the largest private equity investment in a biotechnology company.

GlaxoSmithKline Announces Merger of Respiratory Business Effective May 1

On April 14, GlaxoSmithKline China formally notified its employees that, effective May 1, the Respiratory Business Unit would undergo a structural reorganization. Specifically, the former Innovative Products and Established Products divisions will be merged, and the entire respiratory team will be divided into two regional management centers: North China and South China. The respective leaders have also been announced: Li Guofeng, currently the National Head of Innovative Products, will oversee the Respiratory Business in North China; Lin Ziming, currently the National Head of Established Products, will oversee the Respiratory Business in South China. Under this restructuring, the sales team for Trelegy (an innovative product) will be integrated into the sales team for Seretide (an established product) to conduct collaborative academic promotion, while Anoro (which was newly included in the National Reimbursement Drug List at the end of last year) will have a dedicated sales team for its promotion.

2020 CSCO Breast Cancer Diagnosis and Treatment Guidelines Released: CDK4/6 Inhibitors Fully Included in Level I Recommendations

On April 10, experts from the Breast Cancer Committee of the Chinese Society of Clinical Oncology (CSCO BC) convened an innovative remote video conference to release the “2020 CSCO Guidelines for Diagnosis and Treatment of Breast Cancer” in a novel format. This guideline update incorporates the latest international research advancements, places significant emphasis on contributions from China, takes drug accessibility into account, and optimizes treatment regimens. Of particular note is the comprehensive elevation in the status of CDK4/6 inhibitors, with their level of evidence upgraded from Level II to Level I. These agents now cover the entire population of patients who are either endocrine therapy-naïve or previously treated, firmly establishing them as the preferred first-line treatment recommendation for hormone receptor-positive (HR+) advanced breast cancer.

Ministry of Science and Technology: Multiple candidate therapeutic antibodies targeting SARS-CoV-2 have been obtained

On April 14, the Joint Prevention and Control Mechanism of the State Council held a press conference to update on scientific breakthroughs in drug development and vaccine research for COVID-19. Sun Yanrong, Deputy Director of the Biotechnology Development Center under the Ministry of Science and Technology, stated that the scientific research task force is actively advancing the deployment and progress of a new round of projects. Monoclonal antibodies have remained a key research focus; during the early stages of scientific efforts, multiple domestic teams were assigned to conduct corresponding R&D work targeting monoclonal antibodies. To date, several candidate therapeutic antibodies targeting SARS-CoV-2 have been obtained, and efforts will be further intensified to advance research in this area.

“NCCN Clinical Practice Guidelines in Oncology for Ovarian Cancer” 2020 V1 Update: Niraparib as First-Line Maintenance Therapy Becomes the New Standard

In March this year, the 2020 V1 edition of the NCCN Clinical Practice Guidelines in Oncology for Ovarian Cancer was released. The latest version features substantial updates to first-line maintenance therapy for ovarian cancer, with PARP inhibitors now established as the new standard of care for first-line maintenance treatment. Based on the results of the PRIMA study, the updated NCCN guidelines recommend niraparib monotherapy for first-line maintenance treatment in the broad population of patients with ovarian cancer who have not previously received bevacizumab, as well as for BRCA-positive patients who have received bevacizumab in the first-line setting. Furthermore, the application for the new indication of niraparib for first-line maintenance treatment of advanced ovarian cancer has been accepted in China.

《Nature》: Scientists Map the World’s Largest Human Protein Interactome, HuRI, for the First Time

Recently, a research report published in the international journal Nature by scientists from the University of Toronto and other institutions mapped out the world’s largest protein interaction network, which may be crucial for revealing how to maintain health and elucidating the causes of diseases. More than 80 researchers from countries including the United States and Canada collaborated to create this largest-ever human protein interaction map. Titled the Human Reference Interactome (HuRI), the map includes 52,569 interactions among 8,275 human proteins.

《CAEJ》: Synthetic Gold Nanoparticles Developed to Target and Kill Cancer Cells

Recently, a research report published in the international journal Chemistry–A European Journal described how scientists from New York University and other institutions developed a novel one-step synthesis method to produce water-stable and user-friendly gold nanoparticles. These nanoparticles can be heated using simple green lasers, thereby enhancing their ability to penetrate and destroy malignant cells while facilitating the release of chemotherapy drugs. The unique design of these nanoparticles also reduces drug side effects and has the potential to improve patients’ quality of life.

*Nature Cancer*: New Method Converts Colon Cancer Cells into Normal Cells

Recently, biologists at the University of California, Irvine, discovered that using a modified natural substance alongside current methods can improve the treatment of colon cancer. This finding stems from their research into the role of a specific amino acid in tumor development and potential strategies to reverse this process. Their paper was published in Nature Cancer.

《Cell Rep.》: Unveiling the Molecular Mechanisms by Which Intermittent Fasting Alters Hepatic Enzymes to Effectively Help Prevent Multiple Diseases

Recently, a research report published in the international journal Cell Reports revealed how intermittent fasting affects the liver to help prevent disease, based on studies by scientists from the University of Sydney and other institutions using advanced analytical tools. These findings may help scientists develop new interventions to reduce disease risk and determine the optimal fasting intervals.

《Neurochem Int》: Study Reveals How Brain Cancer Cells Turn Normal Cells into Their Accomplices

A new study published in the journal Neurochemistry International indicates that gliomas alter the function of astrocytes, which normally prevent the brain from becoming overloaded with excitatory chemicals. This may lead to seizures in many patients with brain cancer.

*Nature*: Unveiling the Role of Specific Inflammasomes in Neural Developmental Remodeling

Recently, a research report published in the international journal Nature revealed that surveillance of DNA damage by the AIM2 inflammasome may shape neural development. In this study, researchers found that the AIM2 inflammasome may contribute to normal brain development, while disruption of this genotoxic stress immune sensor could lead to behavioral abnormalities. During infection, activation of the AIM2 inflammasome in response to double-stranded DNA damage may trigger cytokine production and pyroptosis, a form of cell death mediated by gasdermin D.

*Nature*: Unveiling the Role of Specialized Inflammasomes in Neural Developmental Remodeling

Recently, a research report published in the international journal Nature revealed that surveillance of DNA damage by the AIM2 inflammasome may shape neural development. In this study, researchers found that the AIM2 inflammasome may contribute to normal brain development, while disruption of this genotoxic stress immune sensor could lead to behavioral abnormalities. During infection, activation of the AIM2 inflammasome in response to double-strand DNA damage may trigger cytokine production and pyroptosis, a form of cell death mediated by gasdermin D.

Sci Adv: Scientists Develop Specialized Platform for COVID-19 Vaccine Production

Recently, a research report published in the international journal Science Advances announced that scientists from the University of Bristol and Imophoron plan to begin evaluating the safety and efficacy of their COVID-19 vaccine candidates in preclinical studies. Imophoron is currently developing a novel, highly adaptable, easy-to-manufacture, and rapidly responsive vaccine production platform, aiming to create more vaccines that can effectively combat current and future infectious diseases. A key advantage of this platform is the rapid identification and development of vaccine candidates, along with their capacity for large-scale production.

《Cell》: Distinct Processing Modes of lncRNAs May Promote Their Non-Conserved Functions in Stem Cells

Recently, a research report published in the international journal Cell by Chen Lingling’s team from the Shanghai Institute of Biochemistry and Cell Biology, Chinese Academy of Sciences, revealed that differential processing of homologous sequences in long non-coding RNAs (lncRNAs) leads to distinct subcellular localizations in human and mouse embryonic stem cells, subsequently resulting in functional differences in pluripotency regulation across species. The findings suggest that conserved lncRNAs may achieve functional evolution through non-conserved RNA processing and localization mechanisms.

*Nature*: Scientists Successfully Map Functional Blueprint of Multiple Oncogenic Mutations in a Single Oncogene

Recently, a research report published in the international journal Nature presented a blueprint drawn by scientists from Japan’s National Cancer Center and other institutions, mapping multiple mutations within individual oncogenes and elucidating their associated functions. In this study, researchers conducted a pan-cancer analysis of 60,954 cancer samples, ultimately identifying 14 pan-cancer oncogenes and six cancer-type-specific oncogenes. Among these oncogenes, the incidence of multiple driver mutations was higher than expected; specifically, multiple mutations (MMs) were present in 9% of samples harboring at least one mutation in these genes. These findings provide new insights and clues for future efforts to clarify the molecular mechanisms by which oncogenes drive carcinogenesis and to develop novel targeted therapies.