Chengdu HitGen Secures Approval for STAR Market IPO, Aims to Raise RMB 660 Million

Chinese Academy of Medical Sciences: Eight vaccines are currently undergoing efficacy evaluation at the academy

On March 17, the Joint Prevention and Control Mechanism of the State Council held a press conference to update on the latest progress in the research and development of drugs, vaccines, and diagnostic reagents. At the conference, Qin Chuan, a researcher at the Institute of Laboratory Animal Science, Chinese Academy of Medical Sciences, stated that the scientific and technological task force had simultaneously deployed five technical routes for vaccine development, with full consideration given to the safety and efficacy of the vaccines. Currently, eight vaccine candidates are undergoing efficacy evaluation at the Chinese Academy of Medical Sciences, and the efficacy assessment for some of these vaccines has already been completed.

Ministry of Science and Technology’s Biotechnology Center: Stem Cell Therapy Shows Preliminary Efficacy in Treating COVID-19 Patients

On March 17, Zhang Xinmin, Director of the Center for Bioscience and Technology Development under the Ministry of Science and Technology, stated at a press conference held by the State Council’s Joint Prevention and Control Mechanism that, since the outbreak of the novel coronavirus pneumonia (COVID-19), the Scientific Research Task Force had promptly launched an emergency research project on the clinical application of stem cell therapy for COVID-19. Preliminary results indicated that stem cell therapy was safe and effective in treating patients with COVID-19, enabling rapid alleviation or halting the progression of dyspnea in severe and critically ill patients, with improvements observed in clinical manifestations, respiratory function, and imaging findings. Furthermore, stem cells demonstrated advantages in blocking pulmonary fibrosis progression and promoting repair of lung injury, suggesting their potential to prevent pulmonary fibrosis and improve long-term patient prognosis.

Nature Medicine: Immune Response in Mild-to-Moderate COVID-19 Patients Resembles That Against Influenza

Recently, Australian researchers published a paper in the British journal Nature Medicine stating that a study of a COVID-19 patient with mild to moderate symptoms revealed an immune response similar to that elicited by the body against influenza viruses. The researchers noted that although COVID-19 is caused by a novel virus, the immune response to SARS-CoV-2 in healthy individuals resembles the response to influenza viruses. These findings may help identify which patients are likely to recover easily and which are at risk of progressing to severe disease, and could also aid in vaccine development.

Study Finds: COVID-19 Patients Develop Potent Adaptive Immunity Prior to Recovery, with Specific Antibodies Present in Plasma

On March 16, a team of scientists from Australia published a Correspondence in Nature Medicine, reporting on the immune response kinetics in a non-severe COVID-19 patient who required hospitalization. The analysis revealed that, prior to symptom resolution, there was an increase in antibody-secreting cells (ASCs), follicular helper T cells (TFH cells), activated CD4+ and CD8+ T cells, as well as IgM and IgG antibodies capable of binding to SARS-CoV-2 in the patient’s blood. These immunological changes persisted for at least 7 days after the complete disappearance of symptoms.

Regeneron Identifies Hundreds of Virus-Neutralizing Antibodies, with Clinical Trials Expected to Launch in Early Summer

On March 18, 2020, Regeneron announced new progress in its development program for antibodies against the novel coronavirus. Using the company’s VelocImmune mouse model, researchers have generated hundreds of fully human neutralizing antibodies. Meanwhile, the company has also isolated candidate antibodies from patients who recovered from COVID-19. Regeneron will screen these candidates based on their binding affinity to the SARS-CoV-2 spike protein and other characteristics, selecting the two most effective antibodies to form a “cocktail” therapy.

3D Medicines’ COVID-19 Nucleic Acid Testing System Now Commercially Available in the U.S.

On March 18, Shanghai 3D Medicines Inc. completed the second round of FDA Emergency Use Authorization (EUA) review and officially entered the approval phase. It is reported that one month earlier, 3D Medicines had already completed all validation work for its novel coronavirus test kit in accordance with FDA requirements and standards, initiated the EUA application, and received acceptance on March 4, becoming the first company in China to do so. Unlike products from other testing companies, 3D Medicines is no longer required to submit additional validation data and EUA application materials within 15 days, thereby eliminating legal risks associated with the sale of its test kits and automated systems in the United States.

Lead Drug’s STAR Market IPO Registration Approved, with Plans to Raise RMB 660 Million

On March 17, the Shanghai Stock Exchange (SSE) disclosed that Chengdu HitGen Drug Discovery Co., Ltd.’s initial public offering (IPO) on the STAR Market had been approved. The company is the first enterprise from Sichuan Province to list on the STAR Market, the second pharmaceutical company to receive approval this week after Bio-Thera Solutions, and the second contract research organization (CRO) to list on the STAR Market following Medicilon. Chengdu HitGen plans to issue no more than 40 million A-share ordinary shares, raising a total of RMB 660 million. The proceeds will be primarily used for two projects: the construction of a new molecular design, building, and application platform, and the establishment of a new drug research and development center.

NMPA: Immediate Suspension of Metamizole Injection and Other Drug Products

Production and Sales in China: On March 17, the National Medical Products Administration (NMPA) issued the "Announcement on the Cancellation of Drug Registration Certificates for Metamizole Sodium Injection and Other Varieties (No. 29 of 2020)." The announcement stated that the NMPA had conducted post-marketing evaluations of metamizole sodium injection and other related products, concluding that these varieties pose serious adverse reactions, with risks outweighing benefits in their use within China. The announcement further specified that manufacturers are responsible for recalling marketed products such as metamizole sodium injection, and the recalled products shall be destroyed under the supervision of the drug regulatory authorities in the respective locations of the enterprises.

CSPC Pharmaceutical Group Submits Three Drugs for Marketing Approval Simultaneously; Apremilast Tablets Mark the First Domestic Filing

On March 17, the Center for Drug Evaluation (CDE) website announced that three generic drug applications from Shijiazhuang Pharma Group Ouyi Pharmaceutical Co., Ltd. had been accepted for marketing approval: apremilast tablets, tofacitinib citrate tablets, and linagliptin tablets. All three drugs were submitted under the new registration classification and, upon approval, will be deemed to have passed the consistency evaluation. According to the Insight database, Shijiazhuang Pharma Group’s apremilast tablets represent the first domestic marketing application for this product, while the originator drug has not yet been launched in China.

Shengdi Medicine’s Application for Marketing Approval of the First Generic Paricalcitol Soft Capsules Accepted

On March 17, Chengdu Shengdi Pharmaceutical, a subsidiary of Hengrui Medicine, had its marketing application for paricalcitol soft capsules accepted, making it the first company in China to file for market approval of a generic version of this product. Paricalcitol is an active vitamin D analog developed by AbbVie, indicated for the treatment of secondary hyperparathyroidism in patients with chronic renal failure undergoing hemodialysis. Compared with calcitriol, paricalcitol causes less elevation in calcium and phosphorus levels and reduces parathyroid hormone levels more rapidly, offering a survival advantage for patients on long-term hemodialysis.

Merck’s Gefapixant, a New Drug for Chronic Cough, Meets Primary Endpoints in Two Phase III Trials

On March 17, Merck & Co., Inc. (known as MSD outside the United States and Canada) announced the primary results from two pivotal Phase III trials, COUGH-1 and COUGH-2, evaluating gefapixant (MK-7264) for the treatment of refractory or unexplained chronic cough. The results at week 12 in the COUGH-1 study and at week 24 in the COUGH-2 study demonstrated that gefapixant 45 mg twice daily significantly reduced hourly cough frequency compared with placebo. However, gefapixant 15 mg twice daily failed to meet the primary efficacy endpoint of reducing cough frequency in either trial. The efficacy and safety profile of gefapixant was consistent with findings from Phase II studies. Both trials will continue to collect additional evidence.

AstraZeneca’s Imfinzi (Imfinzi) Significantly Prolongs Survival in First-Line Treatment of Extensive-Stage Small Cell Lung Cancer

Recently, AstraZeneca announced high-level results from the final analysis of the Phase III CASPIAN study (NCT03043872), which evaluated Imfinzi (durvalumab) in combination with standard-of-care (SoC) platinum-based chemotherapy as first-line treatment for patients with extensive-stage small cell lung cancer (ES-SCLC). The data demonstrated that Imfinzi plus SoC platinum-based chemotherapy provided a sustained and clinically meaningful overall survival (OS) benefit.

CDE Accepts NDA for New Indication of InnoCare’s Class 1 Innovative Drug Orelabrutinib Tablets

On March 17, the Center for Drug Evaluation (CDE) accepted the new drug application (NDA) for a new indication of InnoCare Pharma’s Class 1 innovative drug, orelabrutinib tablets, for the treatment of relapsed or refractory mantle cell lymphoma (MCL). This marks the second indication for orelabrutinib, following its NDA submission in November 2019 for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Orelabrutinib is an oral Bruton’s tyrosine kinase (BTK) inhibitor that binds irreversibly to BTK, inducing inactivation of downstream kinases and subsequent cell death.

Baiyunshan’s Yimucao Granules and Other Products Receive Drug Re-registration Approval

On March 17, Baiyunshan announced that its controlling subsidiary, Guangzhou Baiyunshan Xingqun (Pharmaceutical) Co., Ltd., and its wholly-owned subsidiaries, Guangzhou Baiyunshan Zhongyi Pharmaceutical Co., Ltd. and Guangzhou Baiyunshan Qixing Pharmaceutical Co., Ltd., have recently received the Drug Re-registration Certificates for seven drugs, including Yimucao Granules, approved and issued by the Guangdong Provincial Medical Products Administration.

Illumina Partners with IDbyDNA to Promote Next-Generation Sequencing-Based Infectious Disease Testing Solutions

On March 18, 2020, IDbyDNA announced a global strategic partnership with Illumina to promote next-generation sequencing (NGS)-based infectious disease detection and surveillance systems. IDbyDNA is a metagenomics technology company. Its Explify platform analyzes NGS data to identify and track more than 50,000 microbial species and over 3,000 common and rare pathogens.

Pfizer and BioNTech Partner to Develop mRNA COVID-19 Vaccine

On March 18, 2020, Pfizer and BioNTech jointly announced that they had signed a letter of intent to co-develop and promote a potential mRNA-based COVID-19 vaccine. BioNTech recently reached an agreement with Fosun Pharma to jointly develop its candidate mRNA COVID-19 vaccine, BNT162, in China. This vaccine is expected to enter clinical trials by the end of April this year. Under the letter of intent, both parties will immediately leverage their respective R&D facilities in the United States and Germany to carry out collaborative research and development activities. Pfizer and BioNTech will finalize financial, manufacturing, and commercialization matters related to the collaboration in the coming weeks.

2020 Hurun China Top 100 Private Healthcare Companies Released: Hengrui Medicine Ranks Highest in Value

On March 18, Hurun Report released the “2020 Hurun China Top 100 Private Healthcare Companies,” listing the top 100 domestic private enterprises in China’s healthcare sector, ranked by corporate value, including market capitalization or valuation. According to the report, the threshold for inclusion in the “2020 Hurun China Top 100 Private Healthcare Companies” was RMB 15 billion, with the total market capitalization of listed companies reaching RMB 4.7 trillion. Among them, Hengrui Medicine ranked as the most valuable enterprise in China’s healthcare sector with a market capitalization of RMB 372 billion, having also placed within the top two five and ten years ago. Mindray Bio-Medical Electronics ranked second with a market capitalization of RMB 291 billion, while WuXi AppTec ranked third with a market capitalization of RMB 175 billion.

Simcere Appoints Dr. Kevin Oliver as Senior Vice President to Drive Outward Expansion

On March 2, Simcere Pharmaceutical Group appointed Dr. Kevin Oliver as Senior Vice President of the Group, overseeing Simcere’s business development (BD) operations in the United States. It is reported that Dr. Oliver served at Merck for over 20 years, holding management positions in R&D and BD. Since 2014, he has served as the Global Head of External Alliances in Business Development at Alcon.

"Clinical Cancer Research": cfDNA-Based Testing Can Improve Diagnostic Sensitivity in Metastatic Breast Cancer

Recently, researchers from the Gerstner Center for Cancer Diagnostics at the Broad Institute of MIT and Harvard, in collaboration with Harvard University and the Dana-Farber Cancer Institute, have identified a method for diagnosing early metastatic breast cancer. By leveraging molecular residual disease (MRD) assessment technology, this approach can detect trace amounts of mutant DNA released by dying tumor cells, thereby enabling the early detection of recurrence. This method not only facilitates monitoring of breast cancer recurrence but also provides critical information to guide treatment decisions. The related findings were simultaneously published in the American Association for Cancer Research’s journal, Clinical Cancer Research.

《npj Regen Med》: Unveiling How Stem Cells Repair Cardiac Tissue Damage After a Heart Attack

Recently, a research report published in the international journal npj Regenerative Medicine revealed that scientists from the Mayo Clinic have identified a cardiac healing mechanism involving stem cell activation following a myocardial infarction. The researchers found that stem cells can restore myocardial tissue to its pre-infarction state, potentially providing new clues and insights for future studies to elucidate the mechanisms of action of these stem cells.

Scientists Are Poised to Integrate Chemotherapy and Photodynamic Therapy into a Single-Drug Regimen for Treating Drug-Resistant Cancers

Recently, a research report published in the international journal Angewandte Chemie International Edition revealed that scientists from Paris Sciences et Lettres University have found that combinations of different drugs may help overcome drug resistance in certain types of cancer. To develop an effective treatment, chemists need to design chemical conjugates that leverage distinct mechanisms of action to target multiple cellular pathways, thereby increasing the likelihood of eradicating all cancer cells compared to single-agent therapies.

PNAS: Study Reveals OxaliTEX, a Cancer Drug with Lower Toxicity

In a recent preclinical study, researchers identified a candidate drug capable of completely halting tumor growth. This agent demonstrates superior anticancer efficacy compared with many commonly used chemotherapeutic drugs, exhibits reduced toxicity and side effects, and possesses the ability to overcome drug resistance. The candidate drug, termed OxaliTEX, consists of two components: a star-shaped texaphyrin molecule that serves as a drug-delivery carrier, and a modified platinum-based compound that exerts cytotoxic effects against tumor cells. This research was conducted by scientists from the University of Texas at Austin and the University of Texas MD Anderson Cancer Center, with the findings published in the journal PNAS.

《JCI Insight》: Researchers Discover a Novel Mechanism for Sustained Pain Relief

Recently, researchers from Charité–Universitätsmedizin Berlin have discovered a new mechanism for sustained pain relief. The study found that IL-4 induces specific types of blood cells to produce endogenous opioids at sites of inflammation, thereby contributing to pain alleviation. The findings have been published in the journal JCI Insight.

《Cell Host & Microbe》: Study Finds That Mold Disrupts Lung Homeostasis and Promotes Asthma

Recently, researchers at the University of Wisconsin–Madison discovered that a common species of Aspergillus can induce asthma by attacking the protective tissue barriers deep within the lungs. This work provides new avenues for understanding and potentially preventing the development of asthma. It is reported that approximately 25 million people in the United States currently exhibit asthma symptoms, with mold-sensitive asthma accounting for one-quarter to one-half of all cases. Therefore, preventing allergic reactions to molds could significantly reduce the disease burden. The relevant findings were published in the journal Cell Host & Microbe.