Bio-Thera Solutions Secures Approval for Sci-Tech Innovation Board IPO

Bio-Thera’s IPO on the STAR Market Approved for Registration

On January 14, the China Securities Regulatory Commission (CSRC) announced that Bio-Thera Solutions’ initial public offering (IPO) on the STAR Market had been approved for registration. According to the prospectus, the company plans to issue no more than 60 million A-share ordinary shares, raising a total of RMB 2 billion, primarily to fund drug research and development.

Biotech Firm Kyverna Secures $25 Million in Series A Funding to Develop Cell Therapies for Autoimmune Diseases

On January 15, 2020, biotechnology company Kyverna Therapeutics announced the completion of a $25 million Series A financing round. Investors in this round included Vida Ventures, Westlake Village BioPartners, and Gilead Sciences. Kyverna plans to use the proceeds from this financing to continue developing its cell therapy platform for the treatment of severe autoimmune diseases.

Biotech Firm Nicoya Secures $10 Million in Series A Funding to Advance Digital Transformation in Drug Discovery

On January 14, 2020, Nicoya, a Canadian supplier of advanced analytical instruments for the biotechnology and pharmaceutical industries, announced the completion of its $10 million Series A financing round. The round was led by Whitecap Venture Partners, with participation from Garage Capital, MaRS IAF, Laurier Startup Fund, and the Waterloo University Student Venture Fund. The company plans to use the proceeds to accelerate new product development in drug discovery, expand its existing team from 50 to 80 employees over the next year, and extend its business presence into additional international markets.

Nektar’s New Drug Application for NKTR-181, a mu-opioid receptor agonist, Receives Unanimous Negative Vote from FDA Advisory Committee

On January 15, 2020, an FDA advisory panel voted unanimously (27–0), a rare occurrence, against the marketing application for Nektar’s mu-opioid receptor agonist NKTR-181 (loxicodegol). In the Phase III Summit-7 clinical trial, which enrolled 7,610 participants, the product significantly reduced pain scores compared with placebo in opioid-naïve patients with back pain. After 12 weeks of treatment, the reductions in pain scores were 1.25 and 0.56 in the two groups, respectively, thereby meeting the primary endpoint of the trial.

Youhe Pharma’s YH002 Antibody Project Receives FDA Approval for Clinical Trials

On January 15, 2020, Eucure, a company dedicated to developing oncology and immunology antibody drugs with independent intellectual property rights, announced that the U.S. Food and Drug Administration (FDA) had approved its Investigational New Drug (IND) application for YH002, paving the way for clinical trials in the United States. The FDA’s approval of clinical trials for YH002 marks the second major milestone achieved by Eucure’s platform for in vivo efficacy screening using humanized mouse models targeting specific therapeutic targets.

Huabang Pharmaceutical's Betahistine Mesilate Tablets Pass the Consistency Evaluation

Recently, Huapont Pharmaceutical’s application for Betastine Besylate Tablets under the New Category 4 was approved, deemed as having passed the consistency evaluation, making it the first company in China to obtain this registration approval. Betastine besylate is a highly selective histamine H1 receptor antagonist (inverse agonist) that controls histamine release at its source and exerts multiple anti-allergic effects. It has demonstrated definitive efficacy in treating skin-related allergic conditions such as urticaria, pruritic dermatoses, and eczematous dermatitis, as well as allergic rhinitis.

Acasti Announces That Phase 3 Study of CaPre (ω-3 Phospholipids) for the Treatment of Severe Hypertriglyceridemia Missed Primary Endpoint

Recently, Acasti Pharma’s CaPre (omega-3 phospholipids) missed the primary endpoint in the Phase III TRILOGY 1 study for the treatment of severe hypertriglyceridemia (blood triglyceride levels: 500–1500 mg/dL). However, Acasti believes that CaPre still has potential, stating that the study failed due to a pronounced reduction in triglyceride levels in the placebo group.

andHUTCHMED Initiates Phase II Clinical Trial in China for Solid Tumors to Evaluate Surufatinib and Tuoyi Combination Therapy

Recently, Hutchison China MediTech Limited announced the initiation of a Phase II clinical trial in China to evaluate surufatinib in combination with Tuoyi (toripalimab, the first domestically produced PD-1 monoclonal antibody developed by Junshi Biosciences) for the treatment of patients with advanced solid tumors. This study follows the recently completed Phase I dose-finding study and the successful determination of the Phase II combination dosing regimen for surufatinib and Tuoyi.

Abeona Initiates Phase 3 Clinical Trial of EB-101 for Recessive Dystrophic Epidermolysis Bullosa

Recently, Abeona Therapeutics, a clinical-stage biopharmaceutical company, announced that it had received approval from the Institutional Review Board (IRB) at Stanford University to initiate the pivotal Phase III VIITAL trial. This trial aims to evaluate EB-101 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), a severe, life-threatening genetic skin disorder characterized by blistering of the skin and systemic involvement. Currently, most patients planned for enrollment in the VIITAL study have completed the pre-screening process at Stanford University, and the company expects the first patient to receive treatment in the first quarter of 2020.

AbbVie’s Skyrizi Meets Primary Endpoint in Head-to-Head Phase III Trial Against Novartis’ Cosentyx for Plaque Psoriasis

Recently, AbbVie announced that its head-to-head Phase III study (NCT03478787) evaluating Skyrizi (risankizumab) versus Novartis’s Cosentyx (secukinumab) for the treatment of plaque psoriasis met both its primary and all secondary endpoints. The results demonstrated that the Skyrizi group achieved significantly higher skin clearance rates compared with the Cosentyx group, thereby meeting the primary endpoint of superiority in PASI 90 response (defined as at least a 90% improvement from baseline in the Psoriasis Area and Severity Index) at Week 52.

PPD Reportedly Raises IPO Proceeds Target to $1 Billion and Opens Two New Offices in China

Recently, SEC filings from CRO giant PPD disclosed plans to raise up to $100 million through an initial public offering (IPO). However, analysts at Renaissance Capital believe this figure is likely merely a placeholder to ensure a successful IPO, predicting that the company could raise as much as $1 billion. PPD also stated that, in addition to pursuing the IPO, it will strengthen its operations and leadership team in China, aiming to provide clinical development, laboratory services, regulatory affairs, clinical site implementation, patient recruitment, and post-approval services to biopharmaceutical companies globally and in China. PPD’s expansion includes enlarging its clinical development offices in Beijing and Shanghai and opening new offices in Guangzhou and Shenyang.

Jilin Drug Administration Plans to Issue the “Certificate of Qualification for Internet Drug Information Services” to Lanya Haohai Pharmaceutical

On January 15, 2020, the Jilin Provincial Medical Products Administration issued an announcement stating that, in accordance with the relevant provisions of the former State Food and Drug Administration’s Measures for the Administration of Internet Drug Information Services, the Jilin Provincial Medical Products Administration intended to issue a Certificate of Qualification for Internet Drug Information Services to Changchun Lanya Haohai Pharmaceutical Technology Co., Ltd.

Merck CEO Ken Frazier: At Least Five More Blockbuster Oncology Assets Beyond Keytruda

At the 38th J.P. Morgan Healthcare Conference, Merck CEO Ken Frazier addressed the question, “What is the next cash cow after Keytruda?” by highlighting several key oncology assets. These included Lynparza (olaparib), co-developed with AstraZeneca; Lenvima (lenvatinib), co-developed with Eisai; and V114, a pneumococcal conjugate vaccine currently in development. He also mentioned a HIF-2α inhibitor for renal cell carcinoma in early-stage development, as well as a non-covalent BTK inhibitor acquired from ArQule at the end of 2019.

Vertex Pharmaceuticals to Expand Focus Beyond Cystic Fibrosis

From January 13 to 16, the 38th J.P. Morgan Healthcare Conference was held in San Francisco. At the conference, Reshma Kewalramani, Executive Vice President of Global Drug Development and Medical Affairs and Chief Medical Officer (CMO) at Vertex Pharmaceuticals, stated that the company would not only continue to focus on cystic fibrosis but also expand into areas such as APOL1-mediated kidney disease, pain, alpha-1 antitrypsin deficiency (AATD), sickle cell disease, beta-thalassemia, Duchenne muscular dystrophy (DMD), and type 1 diabetes.

Regeneron Pharmaceuticals Is Confident About the Next Decade

From January 13 to 16, the 38th J.P. Morgan Healthcare Conference was held in San Francisco. During the conference, Len Schleifer, President and CEO of Regeneron, stated in his speech that the company had separated the ownership rights of two products, Praluent and Kevzara, with Sanofi. Regeneron will receive a share of royalties from Sanofi’s sales markets and will focus more on the commercialization of Dupixent. George Yancopoulos, Chief Scientific Officer of Regeneron, mainly highlighted progress on some of the company’s pipeline products, including PD-1 and several bispecific antibodies. Both executives agreed that the next decade holds great promise, and Regeneron is likely to evolve from a biotechnology company into a large-scale biopharmaceutical enterprise.

Teva to Prioritize the Promotion of Biosimilars and Expand Austedo and Ajovy in China

At the 38th J.P. Morgan Healthcare Conference, Teva CEO Kåre Schultz stated that in its next phase of strategic planning, the company will optimize manufacturing, leverage its expertise in generics to promote biosimilars, and develop and expand the presence of Austedo (for Huntington’s disease) and Ajovy (for migraine prevention) in China, which may soon offset the revenue losses caused by the continued decline in Copaxone sales.

Amgen is Developing New Indications for Otezla and Expanding into International Markets

On January 14, at the 38th annual J.P. Morgan Healthcare Conference held in San Francisco, Amgen CEO Bob Bradway stated that following the $13.4 billion acquisition of Celgene’s new psoriatic arthritis drug Otezla, the company is developing new indications for the drug and expanding into international markets. Bradway told investors that while the focus in the biopharmaceutical sector is on “innovation, innovation, innovation,” Amgen’s strength lies in “execution, execution, execution.”

*Nature*: Immune cells targeting Epstein-Barr virus discovered in the cerebrospinal fluid of Alzheimer’s disease patients

Recently, a research report published in the international journal Nature revealed that scientists from Stanford University discovered immune cells unable to clear viruses in the brains of deceased Alzheimer’s disease patients and in the cerebrospinal fluid of living patients. The researchers not only identified high levels of these immune cells but also found that these remarkably abundant T cells could be used to “target” features of the Epstein-Barr virus (EBV).

《Nat Cell Biol》: Scientists Successfully Cultivate Human Immune Cells in Petri Dishes

Recently, a research report published in the international journal Nature Cell Biology revealed that scientists from the Murdoch Children's Research Institute have successfully cultured human immune cells in petri dishes for the first time worldwide. The findings may help scientists understand the pathogenesis of diseases such as childhood leukemia and type 1 diabetes, and researchers are currently conducting more in-depth studies to uncover the underlying mechanisms.