TianGuangShi Completes RMB 1.13 Billion Series C1 and C2 Financing; MaiKeKang Biotech Secures Nearly RMB 100 Million in Pre-A Round and Files IPO Prospectus

Tian Guangshi Completes C1 and C2 Financing Rounds Totaling 1.13 Billion Yuan to Support Its R&D of Biologic Drugs

On April 16, biopharmaceutical company TGR Biotech announced the completion of its C1 and C2 financing rounds, raising RMB 1.13 billion. The round was led by CICC Qide Fund, with participation from investment institutions including SDIC Chuanghe, Yuexiu Industrial Fund, and BOCOM International. This financing will continue to support the research and development and commercialization of its biologics.

Maikokang Biologics Completes Nearly RMB 100 Million Pre-A Financing Round, Advancing Multiple Novel Vaccine Pipelines into Clinical Trials

On April 16, Chengdu Micron Biotech Co., Ltd. announced the completion of its Pre-A financing round, raising nearly RMB 100 million. This round was exclusively invested by KIP Capital (Korea Investment Partners). The funds will primarily be used to advance Micron Biotech’s pipeline candidates for an elderly shingles vaccine and a novel rotavirus vaccine into clinical trials.

Biotech Firm MOMA Secures $86 Million in Series A Funding to Advance Development of Its Molecular Machine Drug Discovery Platform

Recently, biotechnology company MOMA Therapeutics announced the completion of an $86 million Series A financing round, with investors including Third Rock Ventures, Nextech Invest, Cormorant Asset Management, Creacion Ventures, Casdin Capital, and Rock Springs Capital. The funds will be used to develop next-generation precision therapies targeting microscopic “molecular machines” within the human body. The company’s molecular machine drug discovery platform is based on studying all conformational states of molecular machines to identify small-molecule binders, enabling MOMA to discover compounds that affect enzyme function by disrupting their ordered conformational cycles.

Lead Drug Candidate Listed on STAR Market, Raising CNY 835 Million in IPO

On April 16, HitGen (Chengdu HitGen Drug Discovery Co., Ltd.), a leading CRO in the field of drug discovery, officially listed on the STAR Market of the Shanghai Stock Exchange. China International Capital Corporation Limited served as the lead underwriter. The company issued a total of 40.68 million shares at an offering price of RMB 20.52 per share. At 9:30 a.m. today, HitGen’s opening price was RMB 40, representing a surge of 94.93%. The projects funded by the proceeds from this stock issuance are all aligned with the company’s core business and future development strategy. The raised funds will be primarily used for two initiatives: the construction of a new molecular design, construction, and application platform, and the establishment of a new drug research and development center.

Merck & Co. Launches Herceptin Biosimilar Ontruzant in the United States

On April 15, Merck announced the U.S. launch of Ontruzant (trastuzumab), a biosimilar to Roche’s branded drug Herceptin (trastuzumab). Ontruzant is indicated for all indications approved for Herceptin, including HER2-positive early breast cancer, HER2-positive metastatic breast cancer, and HER2-positive metastatic gastric cancer (adenocarcinoma of the stomach or gastroesophageal junction). Ontruzant was co-developed by Merck and Samsung Bioepis, with Samsung Bioepis responsible for research, development, and manufacturing, and Merck handling commercialization.

UroGen Pharma’s Jelmyto for Upper Tract Urothelial Cancer Approved by FDA

On April 16, the U.S. Food and Drug Administration (FDA) announced the approval of Jelmyto (mitomycin gel), developed by UroGen Pharma, for the treatment of low-grade upper tract urothelial carcinoma (UTUC). The press release noted that this is the first approved drug therapy specifically indicated for this patient population. Jelmyto is an alkylating agent that inhibits the transcription of DNA into RNA, halts protein synthesis, and deprives cancer cells of their proliferative capacity. It had previously been granted Fast Track designation, Orphan Drug designation, Priority Review, and Breakthrough Therapy designation by the FDA.

Xintai Pharmaceutical's Micafungin Sodium for Injection Approved for Market Launch

On April 14, the National Medical Products Administration (NMPA) approved the marketing application for Micafungin Sodium for Injection, an antifungal drug submitted by Sintai Pharmaceutical under the legacy Class 6 regulatory pathway. Micafungin Sodium for Injection was first approved in China in April 2006 for the treatment of fungemia, respiratory tract mycoses, and gastrointestinal mycoses caused by Aspergillus and Candida species.

Bowei Bio Initiates Phase III Clinical Trial of Recombinant Human Papillomavirus 9-Valent HPV Vaccine

On April 8, Shanghai Bowei Biotechnology Co., Ltd. registered and initiated the Phase III clinical trial of its recombinant human papillomavirus (HPV) nonavalent vaccine (types 6/11/16/18/31/33/45/52/58; Hansenula yeast-expressed). The trial aims to evaluate the protective efficacy of the HPV nonavalent vaccine in Chinese women aged 20–45 years, as well as its immunogenicity and safety in this population. This double-blind, randomized, parallel-group Phase III clinical trial plans to enroll 8,000 women aged 20–45 years in China, who will receive either the HPV nonavalent or quadrivalent vaccine.

Latest Results from the NICHE Study Released: Promising Data on Neoadjuvant Immunotherapy for Early-Stage Colorectal Cancer

Recently, according to the latest results from the exploratory Phase II clinical trial NICHE, patients with non-metastatic colon cancer may benefit from short-course immunotherapy (ipilimumab plus nivolumab) while awaiting surgery. Among them, 100% of patients with mismatch repair deficiency (dMMR) benefited from this treatment, while 27% of patients with proficient mismatch repair (pMMR) also derived benefit. The related article was published in Nature Medicine.

Harbour BioMed’s HBM9161 Approved for Phase 2/3 Clinical Trial in Primary Immune Thrombocytopenia

On April 15, Harbour BioMed announced that the seamless Phase 2/3 clinical trial design for its therapeutic antibody HBM9161 has been approved by the National Medical Products Administration (NMPA) of China. This clinical trial will evaluate the safety and efficacy of HBM9161 in the treatment of primary immune thrombocytopenia (ITP). The approval allows for direct transition to Phase 3 following the first interim analysis of the Phase 2 trial, thereby accelerating the clinical development of this global first-in-class novel drug in China.

Yi Miao Shenzhou’s CAR-T Cell Drug IM19 Receives Clinical Trial Approval Notice

On April 15, Beijing Imunopharm Biotechnology Co., Ltd. announced that its IM19 gene-cell therapy, based on chimeric antigen receptor T-cell (CAR-T) technology, had received a clinical trial approval notice from the National Medical Products Administration (NMPA). In an investigator-initiated clinical study targeting relapsed/refractory non-Hodgkin lymphoma, conducted in collaboration with Peking University Cancer Hospital, IM19 enrolled a total of 22 patients, achieving an objective response rate of 73%.

Binhui Biologics’ PD-1 + Oncolytic Virus Combination Therapy Approved for Clinical Trials to Treat Solid Tumors

On April 15, Binhui Biotechnology’s recombinant human GM-CSF oncolytic herpes simplex virus type 2 (OH2) injection (Vero cells) received implicit clinical trial approval for use in combination with Hanzhong Bio’s PD-1 inhibitor (HX008 injection) to treat advanced solid tumors (such as breast cancer and melanoma) that are unresectable and have failed standard therapy. OH2 injection as a monotherapy has already entered Phase II clinical trials. Since 2020, OH2 injection has received approval for multiple clinical trials to be used in combination with PD-L1 or PD-1 inhibitors for the treatment of solid tumors. Binhui Biotechnology stated that it will take the lead in initiating three Phase I clinical trials in China combining OH2 injection with Keytruda, HX008, and LP002 (Houde Aoke, PD-L1).

Two Clinical Trials of Remdesivir in China Ended Early

On April 15, according to the latest update posted on ClinicalTrials.gov, the clinical trial of remdesivir for treating patients with mild-to-moderate COVID-19, conducted at Wuhan Jinyintan Hospital, has been suspended due to the effective control of the epidemic in China and the resulting inability to recruit eligible participants. However, the designation of the trial for mild-to-moderate cases as “suspended” indicates that while the trial has ended prematurely, it may be resumed in the future. On April 11, China had to halt the clinical trial of remdesivir for treating patients with severe COVID-19 due to a shortage of participants.

Immunology Company Vir Announces Positive Phase II Trial Results for Hepatitis B Drug VIR-2218

Recently, immunology company Vir Biotechnology announced additional interim data from an ongoing Phase II patient trial of its hepatitis B drug VIR-2218, as well as results from a Phase I trial in healthy volunteers. The interim results showed that all patients who received two doses of VIR-2218 (administered one month apart) exhibited significant dose-dependent and sustained reductions in HBsAg within 24 weeks after initiating treatment. Similar reductions in HBsAg levels were observed in both hepatitis B e antigen-negative (HBeAg-) and -positive (HBeAg+) patients. Furthermore, VIR-2218 was well tolerated, with most treatment-emergent adverse events (AEs) being mild in severity, and no clinically significant elevations in alanine aminotransferase (ALT) were observed.

Biopharmaceutical Company Ansun Enrolls First Patient in DAS181 Proof-of-Concept Trial

Recently, biopharmaceutical company Ansun Biopharma announced the enrollment of the first patient in a proof-of-concept study to evaluate the safety and efficacy of DAS181. DAS181 is the company’s investigational recombinant sialidase for the treatment of severe COVID-19 infection. The first stage of this randomized, double-blind study is expected to enroll 22 patients from approximately twelve sites across the United States. Following an interim data assessment, the company plans to initiate the second stage of this adaptive-design trial, enrolling approximately 60 additional patients in the United States and Europe.

Novartis and TScan Reach Hundreds of Millions in Collaboration to Develop Innovative T-Cell Therapies

Recently, biopharmaceutical company TScan Therapeutics announced a collaboration agreement with Novartis to discover and develop novel T-cell receptor (TCR) cell therapies. Under the terms of the agreement, both parties will leverage TScan’s proprietary platform to develop new TCR cell therapies, granting Novartis rights to develop TCR cell therapies targeting up to three new targets. Additionally, Novartis will retain options for additional targets and TCRs arising from the collaboration. The deal includes an upfront payment and research funding totaling $30 million, as well as potential milestone payments based on clinical, regulatory, and sales achievements, which could amount to hundreds of millions of dollars.

Onc360 Oncology Pharmacy Partners with AstraZeneca

Recently, Onc360, the largest independent oncology pharmacy in the United States, announced that it has been selected by AstraZeneca as the specialty pharmacy partner for Koselugo (selumetinib), a novel targeted anticancer drug. Koselugo is an oral kinase inhibitor indicated for pediatric patients aged ≥2 years with neurofibromatosis type 1 (NF1) to treat symptomatic, inoperable plexiform neurofibromas (PN) associated with NF1.

Citius Pharmaceuticals Partners with Novellus to Develop Novel Stem Cell Therapy for COVID-19

Recently, Citius Pharmaceuticals announced that it has entered into a six-month exclusive option agreement with Novellus to license a novel stem cell therapy for COVID-19. Matt Angel, Chief Scientific Officer at Novellus, stated, “Leveraging our mRNA-based cellular reprogramming technology, Novellus can provide virtually unlimited mesenchymal stem cells (MSCs) to treat patients with acute respiratory distress syndrome (ARDS), including critically ill patients with COVID-19.”

Antengene Appoints Thomas Karalis as Head of Asia-Pacific Market

Gilead Sciences Prepares to Acquire Partial Stake in IO Firm Arcus

Recently, Bloomberg reported that Gilead Sciences is preparing to acquire a partial stake in the immuno-oncology company Arcus Biosciences, although specific details remain undisclosed. Arcus was established several years ago by the original team from Flexus, with support from major oncology giants such as Novartis and Celgene. Its core assets include the TIGIT antibody AB154 and several small-molecule immune activators. The small-molecule portfolio primarily targets the purine pathway, with clinical candidates including AB680, an inhibitor of the ATP/ADP-hydrolyzing enzyme CD73, and AB928, an antagonist of the purinergic receptor A2A. Arcus also has a PD-1 antibody in its pipeline, which may be an essential drug for Gilead to effectively compete in the oncology market.

NMPA Revises GMP Appendix for Blood Products

On April 15, the Center for Food and Drug Inspection and Verification, under the National Medical Products Administration (NMPA), released the “Appendix to Good Manufacturing Practice for Pharmaceutical Products: Blood Products (Draft for Comments),” initiating the revision of this key regulation governing the production and quality management of blood products. The draft appendix remains consistent with the current version and imposes stringent compliance requirements on enterprise leaders. For instance, Article 6 stipulates that the person in charge of the enterprise shall possess professional knowledge of blood products and have undergone training in relevant legal and regulatory matters. From a regulatory perspective, this mandates that leaders responsible for blood product operations prioritize the study of laws and regulations and strengthen their accountability for compliance.

Johns Hopkins University in the United States Releases Guidelines on Convalescent Plasma Therapy for COVID-19

Recently, Johns Hopkins University in the United States published clinical practice guidelines for convalescent plasma therapy in COVID-19 survivors in the Journal of Clinical Investigation. The guidelines summarize a series of clinical trials conducted by hospitals that are currently participating in or planning to participate in the convalescent plasma therapy program led by Johns Hopkins University. The provided protocols include detailed content on criteria for eligible plasma donors, how hospitals can mobilize donors and collaborate with local and national blood centers, methods for pre-screening donors, and the risks and potential benefits of this therapy.

Nature Communications: The development of T-cell response profiles aids in understanding immune diseases

A recent study by the Wellcome Sanger Institute has shown that even well-trained memory T cells are not as rigid as previously thought and can respond to new immune signals. This finding has implications for immunology research and could help improve our understanding of how the body responds to infections, among other things. The study was published in Nature Communications. It demonstrates that T cells exhibit continuity in their responses to other chemical signals, indicating that they are not as specific as once believed. The researchers found that even well-trained memory T cells can be triggered by other novel immune signals.

Nature: Direct Conversion of Skin Cells into Photoreceptors Restores Vision in Mice

Recently, researchers have discovered a technique to directly reprogram skin cells into light-sensitive rod photoreceptors for vision. Lab-made rods enabled blind mice to detect light after the cells were transplanted into their eyes. Funded by the National Eye Institute (NEI), this study was published in Nature on April 15.

《Cell Rep》: A New Approach to Treating Malignant Liver Cancer

In a recent study, researchers identified the most critical genes that may drive rare but lethal liver cancers, providing a roadmap for developing drugs targeting these genes. In their article published in Cell Reports, the authors employed ChRO-Seq (Chromatin Run-On Sequencing), a technology developed by Cornell University, which enables genome-wide transcriptional profiling. This technique allowed the researchers to determine which regions of DNA are potentially activated in fibrolamellar carcinoma compared with healthy liver tissue, and to identify such activated regions relative to all other publicly available cancer types with similar data. By elucidating these underlying mechanisms, the researchers discovered a potentially effective combination therapy.