Keros Therapeutics Prices IPO and Surges 25.50% on Nasdaq Debut

Golden Oak Medicine Completes Over RMB 100 Million in Series A Funding for the Development of Tumor Genetic Testing Products

On April 9, 2020, Beijing Xiangxin Biotechnology Co., Ltd. (also known as Jinxiang Medicine) announced the completion of its Series A financing round, raising over RMB 100 million. The round was led by Sino-Ocean Capital, with participation from Yingdi Capital, Lingxian Capital, and other investors. The funds raised will be used for the research and development of tumor gene testing products, commercial promotion, and regulatory filings, aiming to build a comprehensive medical service system for tumor biomarker screening, diagnosis, and treatment based on genetic big data.

Keros Therapeutics Lists on Nasdaq, Closing Up 25.50% on First Day

On April 8, U.S. time, Keros Therapeutics listed on the Nasdaq with an issue price of $16 per share, offering a total of 5 million shares. The stock rose to $20.85 in after-hours trading on its debut day and closed at $20.08, up 25.50%. Keros is a biopharmaceutical company focused on hematologic and musculoskeletal disorders, dedicated to discovering and developing differentiated therapies that modulate the TGF-β (transforming growth factor-beta) signaling pathway to treat conditions with high unmet medical needs. Its two most advanced product candidates, KER-050 and KER-047, have both entered clinical trials. Prior to its public listing, Keros secured three rounds of financing, totaling $90 million.

Pfizer’s Therapy for Metastatic Colorectal Cancer with BRAF V600E Mutation Approved by FDA

On April 9, Pfizer announced that the U.S. FDA had approved Braftovi® (encorafenib) in combination with cetuximab (marketed as Erbitux®) for the treatment of adult patients with metastatic colorectal cancer (CRC) harboring BRAF V600E mutations (as detected by an FDA-approved test) who had received prior therapy. This regimen is the first and only targeted therapy approved by the FDA specifically for adult patients with previously treated metastatic CRC carrying the BRAF V600E mutation.

Kangzhi Pharmaceutical’s Ibuprofen Granules Pass the Generic Drug Consistency Evaluation

On April 8, Kangzhi Pharmaceutical announced that its wholly-owned subsidiary, Hebei Kangzhi, had recently received the "Approval for Supplementary Drug Application" for Ibuprofen Granules from the National Medical Products Administration (NMPA). The Ibuprofen Granules manufactured by Hebei Kangzhi have passed the consistency evaluation of quality and efficacy for generic drugs. As a commonly used antipyretic and analgesic medication, Ibuprofen Granules are included in the "National Reimbursement Drug List for Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance" (2019 Edition) and are classified as Class A reimbursable drugs under the medical insurance scheme.

Yangtze River Pharmaceutical Group’s Docetaxel Injection Marketing Application Accepted by CDE

On April 8, the Center for Drug Evaluation (CDE) accepted Yangtze River Pharmaceutical Group’s marketing application for Docetaxel Injection, filed under Category 4 of generic drug registration. The acceptance numbers are CYHS2000238 and CYHS2000237. Previously, Yangtze River Pharmaceutical Group had submitted a supplementary application for consistency evaluation of the 2.0 ml:80 mg specification of this product. According to data from Menet, sales of docetaxel at public medical institutions in China reached RMB 4.82 billion in 2018. Docetaxel is a taxane antineoplastic agent primarily indicated for advanced breast cancer, ovarian cancer, and non-small cell lung cancer. It also demonstrates certain efficacy against head and neck cancers, small cell lung cancer, gastric cancer, pancreatic cancer, and melanoma.

Ausecan’s Application for Marketing Approval of Lenvatinib Mesylate Capsules Accepted by the CDE

On March 28, 2020, the Center for Drug Evaluation (CDE) accepted Aosaikang’s marketing application for Lenvatinib Mesylate Capsules, filed as a Class 4 generic drug. Lenvatinib is an oral multi-target tyrosine kinase inhibitor (TKI) developed by Eisai of Japan. Its global sales in the first three quarters of 2019 reached JPY 80.5 billion, representing a year-on-year increase of 186%. In March 2018, Eisai and Merck & Co. entered into a strategic collaboration agreement for the global joint development and commercialization of lenvatinib. According to financial reports disclosed by Merck, lenvatinib’s global sales amounted to USD 404 million in 2019.

Eisai Submits Marketing Authorization Application for Anti-Cancer Drug DENILEUKIN DIFTITOX in Japan

Recently, Eisai Co., Ltd. announced that it has submitted a marketing authorization application in Japan for DENILEUKIN DIFTITOX (recombinant) (generic name; development code: E7777) for the treatment of relapsed or refractory cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL). DENILEUKIN DIFTITOX (recombinant) is a fusion protein of interleukin-2 (IL-2) and the receptor-binding domain of diphtheria toxin, which specifically binds to IL-2 receptors on the surface of tumor lymphocytes.

Acceler’s onsotatercept Receives FDA Breakthrough Therapy Designation for Improving Pulmonary Vascular Resistance

On April 9, biopharmaceutical company Acceleron Pharma announced that the U.S. FDA has granted Breakthrough Therapy Designation to its investigational drug sotatercept for the treatment of patients with pulmonary arterial hypertension (PAH). Sotatercept, developed by Acceleron, is designed as a selective ligand trap for TGF-β to rebalance BMPR-2 signaling. Last year, sotatercept was granted Orphan Drug Designation by the U.S. FDA for the treatment of PAH patients.

GlaxoSmithKline Announces Success of Phase III Study of Anti-inflammatory Drug Nucala for Nasal Polyps

Recently, GlaxoSmithKline (GSK) announced positive results from the pivotal Phase III SYNAPSE study evaluating the anti-inflammatory drug Nucala (mepolizumab) in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). Notably, this marks the first time an anti-IL-5 biologic has reported positive Phase III data for the treatment of CRSwNP, thereby expanding the range of eosinophil-driven diseases for which Nucala has demonstrated efficacy. Based on the results of the SYNAPSE study, GSK plans to advance regulatory submissions for a new indication of Nucala in the treatment of CRSwNP in 2020. If approved, Nucala will compete directly with Dupixent.

North China Pharmaceutical Completes Phase III Clinical Trial of Recombinant Humanized Anti-Rabies Virus Injection

On April 8, North China Pharmaceutical Company announced that its subsidiary, North China Pharmaceutical Group New Drug Research and Development Co., Ltd., had independently developed a Class 1 new drug, Recombinant Human Rabies Immunoglobulin Injection (200 IU/vial, 500 IU/vial), which has completed Phase III clinical trials and obtained the Phase III clinical trial report. The trial concluded that rhRIG, in combination with human rabies vaccine, met both the primary and secondary efficacy endpoints for post-exposure prophylaxis in individuals with Category III suspected rabies virus exposure. It demonstrated a favorable safety profile and achieved the protocol-defined objectives, confirming that the investigational drug, Recombinant Human Rabies Immunoglobulin Injection (rhRIG), is safe and effective.

Biopharmaceutical Company Seneca Announces Latest Progress in Phase II Clinical Trial of NSI-566 for Chronic Ischemic Stroke

Recently, biopharmaceutical company Seneca Biopharma announced the latest progress of its non-GCP-compliant Phase II trial being conducted at Beijing Bayi Brain Hospital. The trial evaluates the use of neural stem cells NSI-566 in treating chronic ischemic stroke. Seneca stated that as of March 31, 2020, follow-up assessments had been completed for 60% of the subjects. The company indicated that it expects to release the trial data in the second half of 2020, as previously planned. NSI-566 is a spinal cord-derived neural stem cell line isolated from the spinal cord tissue of a single aborted fetus and expanded epigenetically.

Novartis’ TQJ230 Injection Approved for Clinical Trials in China to Reduce Cardiovascular Risk

On April 7, Novartis’ TQJ230 injection was approved for clinical trials in China to reduce cardiovascular risk. This is an antisense oligonucleotide (ASO) therapy; Novartis acquired the global development and commercialization rights to this drug for $150 million in February 2019. TQJ230 was discovered by Ionis Pharmaceuticals and co-developed with Akcea Therapeutics. Currently, the drug is in global Phase III clinical trials. If approved, it will become the first-in-class therapy specifically targeting elevated lipoprotein(a).

Merck’s Keytruda Approved for Cervical Cancer Clinical Trial in China

On April 8, Merck & Co.’s pembrolizumab injection received approval in China for a clinical trial to treat cervical cancer. This indication had already been approved by the FDA in June 2018, making Keytruda the first PD-1 inhibitor approved for the treatment of advanced cervical cancer.

Kelun Pharmaceutical’s Innovative Antibody-Drug Conjugate SKB264 for Injection Receives Clinical Trial Approval Notice

On April 9, Kelun Pharmaceutical announced that its controlled subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., had received a Clinical Trial Approval from the National Medical Products Administration (NMPA) for its antibody-drug conjugate (ADC), “SKB264 for Injection.” SKB264 for Injection is an ADC targeting trophoblast cell surface antigen 2 (TROP-2), which is highly expressed in various epithelial-derived tumors. The drug’s conjugation method and small-molecule toxin are independently developed with proprietary intellectual property rights, and it is intended for the treatment of malignant solid tumors.

Zai Lab and Regeneron Reach $190 Million Collaboration, Securing Rights to Oncology Bispecific Antibody REGN1979

On April 9, 2020, Zai Lab and Regeneron announced a strategic collaboration for the development and commercialization of REGN1979, a CD20xCD3 bispecific antibody, in mainland China, Hong Kong, Taiwan, and Macau. This collaboration will support the global clinical development of REGN1979, including an ongoing Phase II clinical study in B-cell non-Hodgkin lymphoma (B-NHL), which may serve as a registrational trial. Furthermore, upon regulatory approval of REGN1979 in China, Zai Lab will leverage its own commercialization team to advance its commercial launch within the agreed territories. Under the terms of the agreement, Regeneron received a $30 million upfront payment and is eligible to receive up to $160 million in regulatory and sales milestone payments.

Cell Therapy Company T-Cure Collaborates with the U.S. National Cancer Institute to Advance Clinical Development of TCR-T Products

Recently, cell therapy company T-Cure Bioscience signed a licensing agreement with the U.S. National Cancer Institute (NCI), obtaining exclusive global development rights for the KK-LC-1-specific TCR-T product, and will jointly advance the product’s clinical development with NCI. The product has completed preclinical development, and Phase I multicenter clinical trials in the United States targeting multiple tumor types, including gastric cancer, triple-negative breast cancer, and cervical cancer, are planned to launch in the third quarter of 2020.

Wantai Bio, GSK, and Xiamen University Collaborate to Develop COVID-19 Vaccine

On April 2, Wantai Bio and GlaxoSmithKline (GSK) jointly announced that they had initiated a research collaboration to evaluate the recombinant protein-based candidate vaccine for the 2019 coronavirus (COVID-19 XWG-03), developed by Wantai Bio in partnership with Xiamen University. GSK will provide its pandemic-preparedness vaccine adjuvant system to Yangshengtang Xiamen Wantai for use in the preclinical evaluation of the 2019 coronavirus vaccine co-developed by the latter and Xiamen University.

Raffles Pharma and Xuancheng Meinuohua Pharmaceutical Enter into Strategic Partnership for CDMO Services in the Field of Innovative Small-Molecule Drugs

On April 8, 2020, Guangdong Raffles Pharmaceutical Technology Co., Ltd. and Xuancheng Menovo Pharmaceutical Co., Ltd., a key controlled subsidiary of Ningbo Menovo Pharmaceutical Co., Ltd., signed a strategic cooperation agreement in Xuanzhou District, Xuancheng City, Anhui Province. The two parties reached an in-depth strategic partnership on CDMO services in the field of small-molecule innovative drugs. Under the agreement, Raffles Pharmaceutical will be responsible for early-stage route exploration and process development of new drug intermediates for clients, while Xuancheng Menovo will handle the scale-up manufacturing of the relevant new drug intermediates developed by Raffles Pharmaceutical. The first collaborative project between the two parties involves providing R&D and manufacturing services to a NASDAQ-listed biotechnology company in the United States.

Biotech Company Arrakis Reaches Agreement with Roche to Develop RNA-Targeting Small Molecule Drugs

On April 8, biotechnology company Arrakis Therapeutics and Roche signed a strategic collaboration and license agreement. The two parties will work together to discover RNA-targeting small molecule (rSM) drugs against a range of targets across all of Roche’s R&D areas, including oncology, immunology and infectious diseases, neuroscience, ophthalmology, and rare diseases. Under the terms of the agreement, Roche will make an upfront cash payment of $190 million to Arrakis. The company will also be eligible for various preclinical, clinical, commercial, and sales milestone payments, as well as royalties on any commercialized products. Although specific figures have not been disclosed, they indicate that the potential total value could exceed billions of dollars.

Biopharmaceutical Company Cytovia Develops NK Cell-Based Bispecific Antibodies to Help Address the COVID-19 Crisis

On April 9, 2020, biopharmaceutical company Cytovia Therapeutics announced that it was expanding its pipeline and collaborating with Macromoltek, an antibody development company that leverages computer algorithms to redesign drugs, to develop NK cell-based bispecific antibodies aimed at helping address the urgent COVID-19 crisis.

Biotech Firm Novavax to Launch Human Trials of COVID-19 Vaccine in Mid-May

On April 8, biotechnology company Novavax announced that it had identified a coronavirus vaccine candidate, NVX-CoV2373. This stable prefusion protein is manufactured using Novavax’s proprietary nanoparticle technology, and a first-in-human trial is scheduled to commence in mid-May. Novavax’s proprietary Matrix-M™ adjuvant will be used in combination with NVX-CoV2373 to enhance the immune response and stimulate high levels of neutralizing antibodies.

Guangdong Unveils “Ten Policies for Innovation in Biomedicine”

On April 8, the Department of Science and Technology of Guangdong Province, in conjunction with eight other provincial ministries and commissions, issued the Notice on Several Policy Measures to Promote the Innovative Development of the Biopharmaceutical Industry. The measures include establishing Guangzhou-Shenzhen-Hong Kong and Guangzhou-Zhuhai-Macao biopharmaceutical science and technology innovation clusters, with Guangzhou and Shenzhen as their cores. Major provincial projects for basic and applied basic research in the biopharmaceutical field will be organized and implemented to advance source innovation and breakthroughs in foundational underlying technologies. Several joint laboratories involving Guangdong, Hong Kong, and Macao will be established and developed around key areas of the biopharmaceutical industry. A cluster of major scientific and technological infrastructure facilities for biopharmaceuticals will be created. Additionally, a “one-stop online” mechanism for the review and approval of drugs and medical devices will be established and improved, among ten initiatives that include prioritized review and approval for the registration of innovative drugs and medical devices urgently needed for clinical use.

Zhejiang Releases 2019 Drug Procurement Data: Atorvastatin Calcium Tablets Top the Distribution Value Rankings

On April 7, the Zhejiang Provincial Drug and Medical Device Procurement Platform released a bulletin on the ranking of drug distribution amounts for 2019. The bulletin disclosed multiple rankings for drug procurement in Zhejiang Province in 2019, including the top 200 products by distribution amount, the top 20 traditional Chinese medicine (TCM) injections by distribution amount, the top 20 antibacterial injections by distribution amount, and the top 20 oral antibacterial formulations by distribution amount. Atorvastatin Calcium Tablets topped the list for distribution amount. The other drugs ranking in the top ten were: Budesonide Suspension for Inhalation, Clopidogrel Bisulfate Tablets, Cefoperazone Sodium and Sulbactam Sodium for Injection (1:1), Amlodipine Besylate Tablets, Acarbose Tablets, Entecavir Dispersible Tablets, Insulin Glargine Injection, Rosuvastatin Calcium Tablets, and Trastuzumab for Injection.

Indirect comparison between aflibercept and monoclonal antibodies indicates that aflibercept requires six fewer injections over two years.

On April 9, the results of a network meta-analysis comparing the visual benefits and treatment burden between intravitreal aflibercept injection and ranibizumab under the “Treat-and-Extend” (T&E) regimen were published in the journal Therapeutic Advances. According to the analysis, patients with neovascular (wet) age-related macular degeneration (wet AMD) treated with aflibercept received six fewer injections over two years compared with those treated with ranibizumab, while achieving comparable visual benefits.

《PNAS》: Severe COVID-19 Patients Treated with Convalescent Plasma Show Significant Clinical Improvement Within 3 Days

On April 6, a research team from China revealed in a PNAS paper that a single dose (200 mL) of convalescent plasma was well tolerated as an adjunct to maximal supportive care and antiviral drugs in 10 adult patients with severe COVID-19. This treatment significantly increased or maintained neutralizing antibody levels at high titers, leading to the clearance of viremia within 7 days. Meanwhile, severe COVID-19 patients receiving convalescent plasma therapy showed rapid improvement in clinical symptoms and related indicators within 3 days. Within 3 days after convalescent plasma infusion, blood oxygen saturation increased, lymphocyte counts rose (from 0.65×10⁹/L to 0.76×10⁹/L), and C-reactive protein levels decreased (from 55.98 mg/L to 18.13 mg/L).

“Diabetes Care”: Metformin May Improve the Risk of Renal Failure and Death from Nephropathy

Recently, a study published in *Diabetes Care*, a journal of the American Diabetes Association (ADA), reported that medication and survival analyses involving more than 10,000 patients with type 2 diabetes and chronic kidney disease (CKD) showed that metformin use was associated with reduced risks of all-cause mortality and end-stage renal disease (ESRD), without increasing the risk of lactic acidosis.