01 COVID-19 Will Become the Leading Cause of Death in the United States
Recently, according to NBC reports, experts have stated that recent debates about whether the COVID-19 pandemic is over have overshadowed a more serious issue: COVID-19 will indefinitely remain a leading cause of death in the United States.
According to data from the US Centers for Disease Control and Prevention, COVID-19 was the third leading cause of death in the United States over the past two years, only behind heart disease and cancer. Since April this year, the 7-day average daily number of deaths from COVID-19 has been between 300 and 500 people. If this trend continues, there will be an estimated 113,000 to 188,000 deaths from COVID-19 annually in the US, comparable to the number of deaths caused by Alzheimer's disease, chronic lower respiratory diseases, and strokes.
The Institute for Health Metrics and Evaluation (IHME) at the University of Washington, which regularly forecasts the number of COVID-19 deaths, predicts that the number of COVID-19 deaths in the United States will decrease over the next two months. The institute also forecasts that if 80% of the public consistently wears masks, the number of COVID-19 deaths this year will significantly drop; if more people get vaccinated or receive COVID-19 treatment, the death toll could be reduced to about half of the current figure.
02 Biocytogen Raises 2.9 Billion Yuan in STAR Market IPO
On September 21, InnoCare Pharma Limited (hereinafter referred to as "InnoCare") officially rang the bell for listing on the STAR Market. According to the prospectus, InnoCare planned to issue 264,648,200 new shares at 11.03 yuan per share, with an original target of raising 4 billion yuan. The actual funds raised from this issuance amounted to approximately 2.919 billion yuan. After deducting the new share issuance expenses (excluding tax), the net proceeds totaled about 2.779 billion yuan.
03 MSD to Launch Phase III Clinical Trials for HIV Treatment Drug Islatravir
On September 20, MSD announced that it would launch a new Phase III clinical trial to evaluate the efficacy of once-daily oral administration of Islatravir (100mg) in combination with a lower dose of Doravirine (0.75mg) — DOR/ISL in patients with HIV-1 infection. The FDA has reviewed and approved this plan. Additionally, the development of monthly oral islatravir for pre-exposure prophylaxis (PrEP) will be discontinued.
Islatravir is an investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) that can inhibit the function of HIV reverse transcriptase through multiple mechanisms. The Phase III clinical trial will include a study to evaluate DOR/ISL in treatment-naïve adults with HIV-1 infection, and two studies to evaluate DOR/ISL in HIV-infected individuals who have achieved virologic suppression after receiving antiretroviral therapy (ART).
04 Yangtze River Pharmaceutical Subsidiary's Acute Pain Treatment Drug Receives NMPA Clinical Approval
Recently, YZJ-4729 Tartrate Injection, developed by Shanghai Haiyan Pharmaceutical Co., Ltd. (hereinafter referred to as Haiyan Pharmaceutical), a wholly-owned subsidiary of Yangtze River Pharmaceutical Group, has received clinical trial approval from the National Medical Products Administration (NMPA) in China. It is intended for the treatment of acute pain in adult patients who require intravenous opioid medications.
YZJ-4729 is a G-protein biased μ-opioid receptor (MOR) agonist that selectively activates the G-protein pathway to exert potent analgesic effects while avoiding activation of the β-arrestin-2 pathway to reduce opioid-related adverse reactions such as respiratory depression and gastrointestinal dysfunction. In vitro studies show that YZJ-4729 has higher bias compared to TRV130, which is already marketed in the United States — namely, it exhibits significantly weaker recruitment of β-arrestin-2 than TRV130. Additionally, it demonstrates better pharmacokinetic properties, blood-brain barrier permeability, and selectivity for other opioid receptors. In various animal pain models, YZJ-4729 shows potent dose-dependent analgesic effects. In terms of safety, the most concerning side effects of respiratory depression and constipation are much weaker than morphine and significantly better than TRV130.
05 Jieyuan Qi Biotech's Late-Stage Liver Cancer Targeted Drug Approved for New Drug Clinical Trial Application
On September 21, according to the information from the National Medical Products Administration (NMPA), the Investigational New Drug (IND) application for Ori-C101 Injection developed by Origene Biotechnology (Shanghai) Co., Ltd. ("Origene Biotechnology") has been officially approved. This marks that the first innovative drug independently developed by Origene Biotechnology, which targets GPC3 (Glypican-3) for the treatment of advanced liver cancer, is about to enter the clinical trial stage for registration in China.
