1. Over the past 24 hours, VCBeat has monitored four financing and investment deals and one acquisition in the biopharmaceutical sector.
Tailin Bio Listed on ChiNext, Raising 239 Million Yuan
On January 14, Tailin Biotech listed on the ChiNext board of the Shenzhen Stock Exchange. The company offered 13 million new shares at an issue price of RMB 18.35 per share, raising RMB 239 million in net proceeds, with its total share capital expanding to 51.97 million shares post-offering. According to its prospectus, Tailin Biotech is primarily engaged in the research and development, manufacturing, and sales of pharmaceutical equipment, including microbial detection and control technology systems and organic compound analysis instruments, operating within the pharmaceutical equipment manufacturing industry.
Pharmaceutical Company EQRx Founded, Completes $200 Million Series A Financing to Address Excessively High Drug Prices Worldwide
On January 12, pharmaceutical company EQRx announced its establishment and the completion of a $200 million Series A financing round. The round was led by GV, with participation from ARCH Venture Partners, Andreessen Horowitz, Casdin Capital, Section 32, Nextech, and Arboretum Ventures. The company aims to discover new drugs at low cost and sell them at lower prices to alleviate the problem of excessively high drug prices in various countries.
AI Technology Company Concerto HealthAI Completes $150 Million Series B Financing to Develop Precision Oncology Treatment Solutions
On January 14, Concerto HealthAI, a technology leader in real-world data (RWD) and precision oncology treatment solutions, announced the completion of its $150 million Series B financing round. The round was led by Declaration Partners, with participation from Maverick Ventures, AllianceBernstein PCI, and SymphonyAI. The proceeds will be used to further explore the application of RWD and AI technologies in oncology treatment and expand these technologies to other therapeutic areas. Additionally, the company will advance clinical research processes and accelerate the development of breakthrough therapies to improve patient outcomes.
Genomic Sequencing Company BioSkryb Completes $11.5 Million Seed Funding Round to Enhance Genomic and Transcriptomic Analysis Capabilities
On January 9, single-cell genomic sequencing company BioSkryb completed an $11.5 million seed financing round. The round was led by Anzu Partners, with participation from the law firm Wilson Sonsini Goodrich & Rosati. The funds will be used to advance BioSkryb’s genome amplification technology, refine the SkrybAmp system, and drive the commercialization of BioSkryb’s products, thereby enhancing the level of genomic and transcriptomic analysis for translational research and clinical diagnostics.
Yonghe Intelligent Control Subsidiary Plans to Acquire 95% Equity Stake in Dazhou Zhongke Tumor Hospital for RMB 88.6 Million
On January 13, Yonghe Intelligent Control announced that its wholly-owned subsidiary, Chengdu Yonghecheng, signed the "Equity Acquisition Agreement Regarding Dazhou Zhongke Oncology Hospital Co., Ltd." with Chengdu Yunuo Pude on January 10, 2020. Chengdu Yonghecheng intends to acquire the 95% equity interest in Dazhou Zhongke held by Chengdu Yunuo Pude through a cash payment, with the equity transfer price amounting to RMB 88.6 million. Upon completion of this equity acquisition, Dazhou Zhongke will become a controlled subsidiary of Chengdu Yonghecheng and will be included in the consolidated financial statements.
2.Approval in progress: 2 cases at the FDA, 6 cases at the NMPA
Clinical Technology Company’s Sentimag System Receives FDA Approval for Magtrace Nanoparticle Injection for Localization
Recently, the Magtrace magnetic tracer injection and monitoring system from clinical technology company Endomagnetics received FDA approval for guiding sentinel lymph node biopsy in breast cancer patients following mastectomy. Compared with standard radioactive tracers, Magtrace offers clear advantages by eliminating the need for patients to receive radioactive materials, thereby providing a safer and more convenient option for physicians.
FDA Grants Priority Review to Olaparib Combination Therapy for First-Line Maintenance Treatment in Patients with Specific Advanced Ovarian Cancer
On January 13, AstraZeneca and MSD announced that the U.S. FDA had accepted the supplemental New Drug Application (sNDA) for olaparib (brand name: Lynparza) in combination with bevacizumab, granting it Priority Review designation for first-line maintenance treatment of patients with advanced ovarian cancer who have responded completely or partially to platinum-based chemotherapy. If approved, this would mark the fourth indication for Lynparza in the treatment of ovarian cancer in the United States.
EnHua Pharmaceutical's Penehyclidine Hydrochloride Injection Approved
On January 14, Jiangsu Nhwa Pharmaceutical Co., Ltd. issued an announcement regarding the receipt of a Drug Registration Approval, stating that its penehyclidine hydrochloride injection, in three specifications, had been approved by the National Medical Products Administration (NMPA). The announcement indicated that penehyclidine hydrochloride injection is a selective anticholinergic agent. It can be used for pre-anesthetic medication to inhibit salivary and airway gland secretions, as well as for emergency treatment of organophosphate poisoning (e.g., pesticides) and for maintaining atropinization during the late stage of poisoning or after aging of cholinesterase (ChE).
Kelun Pharmaceutical's Ornidazole Tablets Pass the Generic Drug Consistency Evaluation
On January 14, Sichuan Kelun Pharmaceutical Co., Ltd. announced that it had recently received the "Approval for Supplementary Drug Application" for the chemical drug "Ornidazole Tablets," issued by the National Medical Products Administration (NMPA). The announcement indicated that ornidazole is a third-generation nitroimidazole agent, following metronidazole and tinidazole, and is widely used in clinical practice to treat various diseases caused by infections with anaerobic bacteria, Entamoeba histolytica, Giardia lamblia, Trichomonas vaginalis, and other pathogens.
Lukang Pharmaceutical’s Subsidiary Drug Montmorillonite Powder Passes Generic Drug Consistency Evaluation
On January 13, Lukang Pharma released an evening announcement stating that its controlled subsidiary, Site Pharmaceutical, had received the “Drug Supplemental Application Approval” issued by the National Medical Products Administration (NMPA) for Montmorillonite Powder. The drug has passed the consistency evaluation of quality and efficacy for generic drugs. Currently, Montmorillonite Powder is mainly used in China for the treatment of acute and chronic diarrhea in adults and children. From January to September 2019, the sales volume of Montmorillonite Powder at medical institution terminals and retail terminals in China was approximately RMB 700 million, with Site Pharmaceutical’s sales revenue from this product amounting to RMB 2.1731 million. (Tonghuashun Finance)
AbbVie’s Humira Approved in China for the Treatment of Moderate to Severe Active Crohn’s Disease in Adults
Recently, AbbVie’s Humira® (adalimumab injection) received approval from China’s National Medical Products Administration (NMPA) for the treatment of moderately to severely active Crohn’s disease in adults. Crohn’s disease is a severe, chronic inflammatory condition of the gastrointestinal tract. Currently, there is no cure for Crohn’s disease; innovative therapies and medications are needed to control disease progression, reduce complications, and improve patients’ quality of life.
Peking University Pharmaceutical’s Moxifloxacin Hydrochloride Injection Receives “Drug Registration Approval”
On January 14, Peking University Pharmaceutical announced that its Moxifloxacin Hydrochloride Injection had received the Drug Registration Approval. Moxifloxacin hydrochloride is a fourth-generation broad-spectrum fluoroquinolone anti-infective agent. Compared with the first three generations of anti-infective drugs, it demonstrates stronger antibacterial activity against common pathogens such as Gram-positive bacteria, Gram-negative bacteria, and anaerobes, while also offering the advantages of high safety and low resistance rates. (Tonghuashun Finance)
Borui Medicine’s Subsidiary Receives Drug Registration Approval for Caspofungin Acetate for Injection
On January 13, Xintai Pharmaceutical (Suzhou) Co., Ltd., a subsidiary of Borui Medicine, received the Drug Registration Approval issued and approved by the National Medical Products Administration for “Caspofungin Acetate for Injection.” The indications for this drug include: empirical treatment of suspected fungal infections in patients with neutropenia and fever; treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis, and pleural space infections; treatment of esophageal candidiasis; and treatment for patients who are refractory to or intolerant of other therapies.
Merck’s Investigational New Drug M7824: Clinical Trial Application Accepted by the CDE
Recently, Merck has once again submitted a clinical trial application in China for its key investigational new drug, M7824, which has been accepted by the Center for Drug Evaluation (CDE). Currently, Merck has initiated multiple clinical trials for M7824, implementing a comprehensive development strategy. The indications under investigation cover non-small cell lung cancer, colorectal cancer, esophageal cancer, gastric cancer, recurrent respiratory papillomatosis, gallbladder cancer/cholangiocarcinoma, prostate cancer, and various HPV-associated malignancies.
Hengrui Medicine Receives Clinical Trial Approval for Combination Therapy of Apatinib Mesylate Tablets and Gefitinib Tablets
On January 13, Hengrui Medicine announced that the Company and its subsidiary, Shanghai Hengrui Pharmaceutical Co., Ltd., had recently received the “Clinical Trial Notice” approved and issued by the National Medical Products Administration (NMPA), and would commence clinical trials in the near future. The application pertains to a clinical trial evaluating the combination of apatinib mesylate tablets and gefitinib tablets as first-line treatment for stage IIIB–IV EGFR-mutant non-squamous non-small cell lung cancer (NSCLC).
Hengrui Medicine Receives Clinical Trial Approval for Fluzoparib in Combination with Abiraterone Acetate
On January 13, Hengrui Medicine announced that the company had recently received the “Clinical Trial Approval” issued by the National Medical Products Administration (NMPA) and will initiate clinical trials in the near future. The application pertains to a Phase I study evaluating the pharmacokinetics (PK) and safety of fluzoparib in combination with abiraterone acetate in patients with metastatic castration-resistant prostate cancer (mCRPC).
Biotech Firm Genome&Company Signs Clinical Trial Collaboration and Supply Agreements with Merck and Pfizer
On January 13, biotechnology company Genome&Company announced that it had signed a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany, and Pfizer to evaluate the safety, tolerability, and biological and clinical activity of GEN-001 in combination with the human PD-L1 antibody avelumab for the treatment of multiple cancer indications. Under the terms of the agreement, Genome&Company will sponsor the study, while Merck KGaA, Darmstadt, Germany, and Pfizer will provide avelumab for the Phase 1/1b clinical trial, which is expected to initiate in the United States in 2020. Both parties will have access to the clinical data.
Bayer Partners with Exscientia to Develop Drugs for Cardiovascular Diseases and Oncology
Recently, pharmaceutical giant Bayer announced a collaboration with AI-driven drug discovery company Exscientia to develop treatments for cardiovascular diseases and oncology. Under the terms of the agreement, the two parties have already established plans for three projects. Exscientia may receive up to €240 million from Bayer, including upfront payments, research funding, and near-term clinical expenses. As part of the agreement, Exscientia may also be eligible to receive royalties.
Biopharmaceutical Company PhaseBio Partners with SFJ to Co-Develop PB2452
On January 10, biopharmaceutical company PhaseBio Pharmaceuticals announced a financing and co-development partnership with SFJ Pharmaceuticals to support the development of PB2452, a reversal agent for the antiplatelet therapy ticagrelor. Under the agreement, PhaseBio will receive up to $120 million in development funding and retain exclusive global commercial rights to PB2452.
Aro Biotherapeutics and Ionis Partner to Develop RNA Drug Delivery Technology
On January 9, Aro Biotherapeutics announced that it had entered into a license and collaboration agreement with Ionis Pharmaceuticals, a leader in RNA-targeted therapies. Under the agreement, Ionis will utilize Aro’s CENTYRIN™ technology to develop antisense oligonucleotide (ASO) drugs with targeted cell- and tissue-specific delivery. The two parties will also collaborate on the development of other early-stage product pipelines. Aro will receive an upfront cash payment, funding to support research and development activities, and payments tied to the achievement of specific development and commercial milestones, totaling up to $1.4 billion. In addition, Aro will be entitled to royalties on net sales.
EUSA Pharma and BeiGene Reach Exclusive Agreement on Development and Commercialization of Two Orphan Drugs in China
On January 13, EUSA Pharma and BeiGene announced that they had reached an exclusive agreement for the development and commercialization of the orphan biologic drugs SYLVANT® (siltuximab) and QARZIBA® (dinutuximab beta) in the Greater China region. Under the terms of the agreement, BeiGene will fund and take over the clinical development and regulatory submissions for these products in these territories. EUSA will receive an upfront payment and will be eligible to receive total payments of up to $160 million upon achieving regulatory and commercial milestones. EUSA will also be eligible to receive tiered royalties on future product sales.
Biogen and Pfizer Reach Agreement for Investigational Therapy PF-0251749
On January 13, Biogen announced an agreement with Pfizer to acquire Pfizer’s clinical-stage investigational therapy, PF-0251749. This small-molecule inhibitor of casein kinase 1 (CK1) can cross the blood-brain barrier to enter the central nervous system and is indicated for treating behavioral and neurological symptoms associated with various psychiatric or neurological disorders. The transaction includes a $75 million upfront payment, potential additional development and commercialization milestone payments totaling up to $635 million, and tiered royalties ranging from the single digits to the low teens on net sales.
Pharmaceutical Companies Incyte and MorphoSys Partner to Develop Innovative CD19 Antibody
On January 14, Incyte and MorphoSys jointly announced that they had entered into a global research, development, and commercialization collaboration agreement to co-develop and co-commercialize MorphoSys’s investigational anti-CD19 antibody tafasitamab (MOR208). The Fc region of tafasitamab has been further optimized, and the drug is currently in clinical trials for the treatment of B-cell malignancies.
Junshi Biosciences and Sirnaomics Enter into Collaboration to Conduct Clinical Studies on the Combination Therapy of Tuoyi and RNA Interference (RNAi)
On January 13, Junshi Biosciences announced a strategic collaboration with Sirnaomics to conduct clinical trials of combination therapy in China and the United States for advanced melanoma, cutaneous squamous cell carcinoma, and other clinical indications mutually agreed upon by both parties. The two drugs involved in this combination regimen are Tuoyi (toripalimab injection), an anti-PD-1 monoclonal antibody from Junshi Biosciences, and STP705 (coteralanib injection), an investigational RNA interference therapeutic from Sirnaomics.
Innovent Biologics and Coherus Reach Agreement on Commercialization Rights for IBI305 in the United States and Canada
On January 14, Innovent Biologics and Coherus BioSciences (“Coherus”) jointly announced that Innovent has licensed the commercialization rights for its bevacizumab biosimilar (Innovent’s development code: IBI305) in the United States and Canada to Coherus. Under the terms of the agreement, Coherus will pay Innovent an upfront payment and milestone payments totaling $45 million for the commercialization rights to IBI305. Additionally, Coherus will pay Innovent double-digit percentage royalties based on future sales of IBI305. If Coherus exercises its option to prioritize IBI301, the payment terms applicable to IBI301 will be consistent with those for IBI305.
【JPM2020】Gene Sequencing Company Illumina Reaches a Non-Exclusive Cooperation Agreement with Roche
On January 13, at the 38th Annual J.P. Morgan Healthcare Conference held in San Francisco, Francis deSouza, Global President of Illumina, announced a non-exclusive collaboration with Roche, a global leader in diagnostics. This partnership aims to accelerate the clinical accessibility of next-generation sequencing (NGS) in vitro diagnostic tests based on Illumina’s diagnostic sequencing systems. By leveraging their complementary strengths, Roche and Illumina will jointly develop new companion diagnostic methods to supplement the TruSight Oncology 500 (TSO 500) comprehensive cancer genomic profiling assay.
【JPM2020】Gene Sequencing Company Illumina Releases NextSeq 1000 and 2000 Sequencing Systems
On January 13, at the 38th Annual J.P. Morgan Healthcare Conference held in San Francisco, Illumina launched the NextSeq™ 1000 and NextSeq 2000 sequencing systems. This series of sequencing systems features groundbreaking system design, innovative chemistry, and an onboard bioinformatics accelerator for rapid secondary analysis. The new sequencing systems incorporate more than 75 technological innovations, including unprecedented super-resolution and novel chemistry, which significantly enhance sequencing density and throughput while reducing operational costs.
Wuhan Municipal Health Commission: As of now, a total of 41 cases of pneumonia caused by the novel coronavirus have been reported.
On January 13, the Wuhan Municipal Health Commission issued an announcement stating that, as of that date, a total of 41 confirmed cases of pneumonia caused by the novel coronavirus had been reported; seven patients had been cured and discharged, six were being treated for severe illness, one had died, and the remaining patients were in stable condition.
National Centralized Drug Procurement Fully Implemented in Yunnan
On January 13, Yunnan Province held a press conference in Kunming to announce the comprehensive implementation of the expansion of the national pilot program for centralized drug procurement and use. It was announced at the conference that the reform to expand the national pilot program for centralized drug procurement and use had been implemented in Yunnan Province on December 30, 2019. The average price reduction for selected drugs was 64%, with a maximum reduction of 98%.