Transcenta Completes $100M Series B+ Financing, NMPA Approves Zhengda Qingjiang's Celecoxib Capsules, and China Releases Real-World Evidence Guidelines
Transcenta Holding Completes $100 Million Series B+ Financing, with China Renaissance Serving as Exclusive Financial Advisor
On January 8, Transcenta Holding, an international biopharmaceutical company with integrated capabilities spanning drug discovery, process development, clinical development, and manufacturing, announced the successful completion of its $100 million Series B+ financing round. The round was co-led by China Resources Zhengda Life Science Fund and Fortune Capital (Dachen Caizhi). New investors participating in the follow-on investment included Yipu Capital, China Merchants Capital’s Guodiao M&A Fund, and China Equity Group. Existing investors, including Lilly Asia Ventures, Temasek, Hillhouse Capital, Tengyue Partners, Sequoia Capital China, and ARCH Venture Partners, continued their participation. China Renaissance served as the exclusive financial advisor for this transaction.
AI Drug Design Company Deep Genomics Completes $40 Million Series B Financing to Expand Its AI Discovery Platform
On January 7 (U.S. time), AI-driven drug design company Deep Genomics announced the completion of a $40 million Series B financing round. The funds will be used to advance its investigational therapy for Wilson’s disease into clinical stages and to expand the company’s proprietary artificial intelligence discovery platform, thereby supporting the development of novel therapies for a broader range of common diseases.
Gene Sequencing Company TwinStrand Completes $16 Million Series A Financing to Accelerate Pipeline Development
On January 7 (U.S. time), gene sequencing company TwinStrand Biosciences announced the completion of a $16 million Series A financing round. The round was led by Madrona Venture Group, with participation from Alexandria Venture Investments, Ridgeback Capital, and Sahsen Ventures. The funds will be used to accelerate the development of its product pipeline and support the expansion of company infrastructure and pharmaceutical partnerships.
VectivBio Completes $35 Million Financing to Advance Clinical Development of Apraglutide
On January 7 (U.S. time), VectivBio, a company dedicated to developing drugs for severe rare diseases, announced the completion of a $35 million financing round to further advance the clinical development of its lead candidate, apraglutide, a glucagon-like peptide-2 (GLP-2) analog for the treatment of patients with short bowel syndrome (SBS). VectivBio stated that it expects to obtain Phase 2 trial data for apraglutide in the treatment of SBS patients in the first quarter of 2020.
Biotech Firm Debut Closes $2.6 Million Seed Round to Expand Scientific Team
On January 7, U.S. biotechnology company Debut Biotechnology completed a $2.6 million seed financing round, led by U.S. venture capital firm KdT Ventures, with participation from Better Ventures, FTW Ventures, and SpringTide Ventures. The funds will be used to expand the scientific team, further develop the company’s business, and establish a pilot production system for initial scale-up manufacturing.
NMPA Approves Marketing Application for Zhengda Qingjiang’s Celecoxib Capsules
On January 8, Zhengda Qingjiang announced that its marketing application for celecoxib capsules, filed under the new Class 4 regulatory pathway, had been approved by the National Medical Products Administration (NMPA), which is deemed equivalent to passing the consistency evaluation. Celecoxib is a COX-2 inhibitor jointly developed by Pfizer and Astellas, and it is primarily used in clinical practice for the treatment of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and acute pain in adults.
NMPA Releases “Guiding Principles for Real-World Evidence to Support Drug Development and Review (Trial)”
On January 7, the National Medical Products Administration (NMPA) issued the *Guiding Principles for Using Real-World Evidence to Support Drug Development and Review (Trial)*, aiming to further guide and standardize the use of real-world evidence in supporting drug development and regulatory review, thereby ensuring the quality and efficiency of drug development efforts. The *Principles* mainly consist of six parts: relevant definitions of real-world studies; sources and applicability of real-world data; use of real-world evidence to support regulatory decision-making on drugs; basic design of real-world studies; evaluation of real-world evidence; and communication with regulatory review agencies.
CStone Pharmaceuticals’ CS1001 in Combination with Chemotherapy for First-Line Treatment of Esophageal Squamous Cell Carcinoma: Phase III Trial Completes Dosing of First Patient
On January 8, CStone Pharmaceuticals (Suzhou) Co., Ltd. announced that the first patient had been dosed in its Phase III clinical trial of CS1001, an anti-PD-L1 monoclonal antibody, in combination with chemotherapy as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC). This multicenter clinical trial, named GEMSTONE-304, aims to evaluate the efficacy and safety of CS1001 combined with FP (fluorouracil and cisplatin) chemotherapy as first-line therapy in patients with unresectable locally advanced, recurrent, or metastatic ESCC.
Gracell Biotechnologies Conducts Clinical Study of GC027 for the Treatment of Relapsed or Refractory T-Cell Malignancies
On January 8, Gracell Biotechnologies Inc. announced the initiation of a clinical study for GC027, the first off-the-shelf CAR-T candidate product developed using the TruUCAR™ technology platform. This clinical trial will comprehensively evaluate the safety, pharmacokinetic, and pharmacodynamic profiles of GC027 in the treatment of relapsed or refractory T-cell malignancies, thereby laying the groundwork for registrational clinical trials.
Kyowa Kirin’s Nourianz Seeks EU Approval for Treating Off Episodes in Parkinson’s Disease Patients
Recently, Japanese pharmaceutical company Kyowa Kirin announced that the European Medicines Agency (EMA) has accepted its Marketing Authorization Application (MAA) for Nourianz (istradefylline tablets) as an adjunctive therapy to levodopa-based regimens for adult patients with Parkinson’s disease (PD) experiencing “OFF” episodes. This medication will offer a new non-dopaminergic pharmacological approach to treating “OFF” episodes in patients with PD.
Incyte’s Marketing Authorization Application for Targeted Anti-Cancer Drug Pemigatinib Accepted by EMA
Recently, Incyte announced that the European Medicines Agency (EMA) has accepted its Marketing Authorization Application (MAA) for pemigatinib, a targeted anticancer drug. The application is for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) fusions or rearrangements, whose disease has relapsed or is refractory after at least one prior systemic therapy. The EMA has confirmed that the MAA submission is sufficiently complete to initiate the formal review process.
Merck’s Keytruda Plus Chemotherapy Fails to Extend Survival in Phase III Study as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer
Recently, Merck & Co., a giant in tumor immunotherapy, announced the results of the Phase III KEYNOTE-604 study (NCT03066778) evaluating Keytruda (pembrolizumab) combined with chemotherapy as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). The results showed that the study met one of its dual primary endpoints: the Keytruda plus chemotherapy group demonstrated a statistically significant improvement in progression-free survival (PFS) compared to the chemotherapy-alone group. Regarding the other primary endpoint, overall survival (OS), the Keytruda plus chemotherapy group showed improvement compared to the chemotherapy-alone group, but the data did not reach statistical significance according to the prespecified statistical analysis plan.
AstraZeneca Announces Positive Results for Tagrisso as First-Line Treatment for EGFR-Mutant Lung Cancer
Recently, the overall survival (OS) results from the Phase III FLAURA trial (NCT02296125), which evaluated AstraZeneca’s targeted anticancer drug Tagrisso (osimertinib) as first-line treatment for advanced non-small cell lung cancer (NSCLC) with EGFR mutations, were published in the prestigious international medical journal The New England Journal of Medicine. The study demonstrated that Tagrisso prolonged overall survival (OS) compared with comparator EGFR-TKIs. Furthermore, Tagrisso also extended progression-free survival in patients with central nervous system metastases.
Pharmaceutical Company Apellis Announces Positive Phase III Results for Complement C3 Inhibitor
On January 7, Apellis Pharmaceuticals announced positive results from the Phase III PEGASUS study of pegcetacoplan (APL-2), a complement C3 inhibitor, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).
Company News: Hua Medicine Achieves Success in Two Phase I Clinical Studies, Benefiting Over 30 Million Diabetes Patients in China
On January 7, Hua Medicine announced successful Phase I clinical trial results for its investigational candidates HMM0110 and HMM0111. Both studies were based on dorzagliatin, the company’s first-in-class novel drug. The results of the former study demonstrated that dorzagliatin is effective in patients with type 2 diabetes and chronic kidney disease, potentially benefiting more than 30 million such patients in China. The latter study showed that combining dorzagliatin with sitagliptin, a classic glucose-lowering agent, yields significantly enhanced efficacy, offering new insights into the clinical use of antidiabetic medications.
CDE Accepts Clinical Trial Application for Novartis’ Novel RNA-Targeted Therapy TQJ230 Injection
On January 8, Novartis’ clinical trial application for the TQJ230 injection was accepted by the Center for Drug Evaluation (CDE). Currently, this drug is in global Phase III clinical trials. If approved, it will become the first-in-class therapy specifically targeting elevated lipoprotein(a). TQJ230, formerly known as AKCEA-APO(a)-LRx, is an investigational drug from Akcea Therapeutics, an affiliate of Ionis Pharmaceuticals, designed for targeted cardiovascular treatment. Novartis is now responsible for the global development and commercialization of this drug.
Tasly’s Qishen Yiqi Dripping Pills Approved for Clinical Trials for New Indications
On January 7, Tasly announced that the company had received the “Clinical Trial Notification” approved and issued by the National Medical Products Administration (NMPA) for new indications of Qishen Yiqi Dripping Pills. The newly applied indication is chronic heart failure (Qi deficiency and blood stasis syndrome).
Taiji Group’s Gegen Qinlian Capsules Receive Approval for Supplemental Drug Application
On January 7, Taiji Group announced that its wholly-owned subsidiary, Fuling Pharmaceutical Factory, had recently received the "Drug Supplemental Application Approval" issued and approved by the National Medical Products Administration (NMPA), granting approval for the production of its product, Gegen Qinlian Capsules. The indicated functions and indications of Gegen Qinlian Capsules are to release muscle tension, clear heat, and stop diarrhea; they are used for diarrhea with abdominal pain, yellow and sticky stools, and a burning sensation in the anus.
Advaxis Announces FDA Approval of Investigational New Drug Application for ADXS-504 in the Treatment of Prostate Cancer
On January 7, 2020, Advaxis, Inc., a clinical-stage biotechnology company, announced that the U.S. Food and Drug Administration (FDA) had approved the Investigational New Drug (IND) application for ADXS-504, its investigational prostate cancer candidate under the ADXS-HOT platform, to initiate Phase 1 clinical trials.
Innovent Biologics and Sirnaomics Enter Strategic Partnership to Launch Clinical Study of Sintilimab Combined with RNAi Therapy
On January 8, Innovent Biologics and Sirnaomics jointly announced that the two companies had entered into a strategic collaboration for clinical research to conduct joint studies in the United States evaluating the combination of Innovent’s PD-1 antibody drug Tyvyt® (sintilimab injection) and Sirnaomics’ RNAi candidate STP705 (coteranine injection) for the treatment of tumors, such as hepatocellular carcinoma and cholangiocarcinoma.
AstraZeneca Partners with MiNA to Develop Novel Drugs for Metabolic Diseases
On January 7, AstraZeneca and MiNA Therapeutics jointly announced that they would collaborate to develop novel therapeutics for metabolic diseases, leveraging MiNA’s small activating RNA (saRNA) development platform. This partnership combines MiNA’s expertise in the discovery and development of saRNA-based drugs with AstraZeneca’s experience in identifying metabolic disorders and delivering breakthrough therapies to patients, aiming to create next-generation treatments for individuals affected by metabolic diseases.
Aosaikang Signs Licensing Agreement with Shield, Securing Exclusive Rights in China for Maltol Iron Capsules
On January 8, Asklepios BioPharmaceutical issued an announcement stating that its wholly-owned subsidiary, Jiangsu Asklepios BioPharmaceutical Co., Ltd., has signed a License Agreement with UK-based Shield Therapeutics. Under the agreement, Jiangsu Asklepios BioPharmaceutical has obtained exclusive rights in China to develop, manufacture, and commercially promote ferric maltose capsules, a next-generation oral iron product from Shield for the treatment of iron deficiency in adults (with or without anemia), along with future expandable dosage forms and indications. According to the agreement, Jiangsu Asklepios BioPharmaceutical will pay Shield a total of $62.8 million in upfront and subsequent milestone payments.
Lisite Plans to Transfer 29 Product Varieties to Aohong Pharmaceutical
On January 7, 2020, the Sichuan Provincial Medical Products Administration published on its official website the “Public Notice of the Sichuan Provincial Medical Products Administration Regarding the Transfer Out of 29 Drug Varieties, Including Glutamine Granules, from Chengdu Lister Pharmaceutical Co., Ltd.” The notice indicated that Chengdu Lister Pharmaceutical Co., Ltd. planned to transfer out 29 drug varieties, comprising 5 active pharmaceutical ingredients (APIs), 1 granule formulation, and 23 chemical injectables, with Jinzhou Aohong Pharmaceutical Co., Ltd. designated as the proposed transferee.
Business CollaborationCuris Signs Option and License Agreement with ImmuNext to Develop and Commercialize Anti-VISTA Antibodies
On January 7, 2020, U.S. biotechnology company Curis, Inc. announced that it had obtained exclusive global rights to CI-8993, an anti-VISTA monoclonal antibody for cancer treatment, from ImmuNext Inc. CI-8993 is a clinical-stage monoclonal antibody designed to antagonize the V-domain Ig-containing suppressor of T-cell activation (VISTA) signaling pathway.
Santen Pharmaceutical Invests in and Builds Suzhou Factory, Primarily for the Production of Ophthalmic Solutions
On January 6, Santen Pharmaceutical Co., Ltd. of Japan announced that it had selected an industrial plot in the Suzhou Industrial Park for the construction of a second manufacturing facility by Santen Pharmaceutical (China) Co., Ltd. Tafluprost (eye drops, brand name “Taflotan”), a product under Santen’s portfolio, was included in the National Reimbursement Drug List following the 2019 insurance reimbursement negotiations. The new Santen factory in Suzhou will primarily be used to produce eye drop products.