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Expanded Access Policy

Release time:2024-04-19

Simcere pharma is a pharmaceutical company driven by innovative R&D, its mission is Providing Today’s Patients with Medicines of the Future across the following core therapeutic areas: oncology, central nervous system, autoimmunity and anti-infection. Simcere Zaiming is an affiliated company which focus on the oncology therapeutic area and dedicated to addressing the unmet clinical needs globally by developing disruptive therapies.


On April 8th, 2024, the U.S. Food and Drug Administration (FDA) granted SIM0500 Fast Track Designation for the Treatment of for patients with multiple myeloma, who are refractory to, or intolerant of, established therapies known to provide clinical benefit and have received≥3 prior lines of therapy including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD) and an anti-CD38 monoclonal antibody. SIM0500 is an IgG4-based tri-specific T-cell engager (TriTE) targeting GPRC5D, BCMA and CD3.


As an innovative enterprise focusing on oncology drug research and development, Zaiming’s mission is to create new standards of care and provide our medicines to patients who need them. Each medicine must undergo well-designed and well-conducted clinical trials to evaluate its efficacy and safety, demonstrating that its potential benefits outweigh its known risks to patients before it can become available by prescription.


Obtaining regulatory approval for marketing is the most efficient and rapid way to provide access to new medicines to the greatest number of patients who may benefit. Therefore, Simcere Zaiming believes its resources should be directed toward sponsoring clinical trials that support the regulatory approval of an unapproved investigational medicine, thereby offering the greatest benefit to at-risk patient populations.


We recognize, however, that there are instances when a patient has a serious or life-threatening disease or condition, for which:

·       treatment options are not available or have been exhausted,

·       enrollment into a clinical trial is not possible or justifiable, and

·       adequate supply of the investigational medicine is available to address the patient’s need.

In these cases, a treating physician may request access to the use of an investigational medicine prior to regulatory approval for a particular condition or indication, provided it is permitted by applicable local laws. The information below explains options that may be available to patients in these circumstances.


1. Clinical Trials

For new medicines to be legally approved for use, companies like Zaiming are required to evaluate their safety and effectiveness in clinical trials and submit trial results to regulatory agencies. To participate in a trial, you must meet certain criteria. For those who meet the criteria to join a clinical trial, participation offers the chance to contribute to medical research that may benefit many others. Participation in a clinical trial comes with certain risks; that is why patient “informed consent” is a required step in the process of enrolling.


2. Expanded Access or Compassionate Use

In cases where a clinical trial is not an option, and the patient has exhausted all available treatment options, regulators/health authorities may grant permission for us to provide a treating physician with an investigational drug pre-approval. Such individual use of an investigational drug pre-approval is often called “expanded access” or “compassionate use” or “early access”. Zaiming refers to these requests as expanded access. Additional information on Expanded Access may be obtained by visiting the U.S. Food and Drug Administration at: https://www.fda.gov/news-events/expanded-access/expanded-access-information-physicians.


Zaiming is not currently making its investigational products available on an expanded access basis anywhere in the world, as we believe that our clinical trials are the most appropriate way to access our investigational products. We encourage patients who are interested in accessing therapies in our pipeline to talk to their doctor about participating in a clinical trial. Information about all of our trials, including enrollment status, eligibility criteria, and locations, is available at https://www.clinicaltrials.gov/.


Zaiming strives for an equitable balance between the public interest in securing the approval of a new medicine and allowing access to certain investigational medicines that may have the potential to treat seriously ill patients who cannot be satisfactorily treated with commercially available therapies.