BeiGene is making history by expanding access to life-changing drugs in China! For the first time ever, drugs are being added to the nation’s Reimbursement Drug List, giving more people access to groundbreaking treatments. This is a monumental moment for BeiGene and the Chinese healthcare system, providing hope and opportunity to those in need.
BeiGene is thrilled to announce that tislelizumab, KYPROLIS, and XGEVA have been included on the latest National Reimbursement Drug List (NRDL) in China, making them more accessible and affordable to patients across the country. Thanks to the recent reforms, the Chinese National Healthcare Security Administration (NHSA) has created a basic medical insurance system that provides universal coverage. We at BeiGene are proud to be part of this vision, and are committed to making innovative medicines available to people everywhere.
The National Repository of Drugs and Liquids (NRDL) has recently updated its catalogue to include a range of new medicines and their respective indications. These additions have expanded the range of treatments available to patients and healthcare professionals, ensuring they have access to the most up-to-date and effective treatments.
Tislelizumab is now included in four new indications in NRDL:
Treat your advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) or squamous NSCLC quickly and effectively with a platinum-containing regimen – even if you are EGFR and ALK negative and have already been through or cannot tolerate prior chemotherapy.
For adult patients with advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, the treatment option is available. Patients with advanced colorectal cancer who have experienced disease progression after fluoropyrimidines, oxaliplatin and irinotecan treatments can be treated, as well as those with other advanced solid tumors who have experienced disease progression and have no satisfactory alternative treatment options. Don’t let advanced solid tumors stand in the way of a healthier tomorrow – get the treatment you need today!
Patients with locally advanced or metastatic esophageal squamous cell carcinoma who have not responded to or cannot tolerate their first-line standard chemotherapy now have a treatment option that could potentially improve the outcome of their condition.
As a frontline therapy for patients suffering from recurrent or metastatic nasopharyngeal cancer, medical professionals are taking new and innovative approaches to care. By leveraging the latest advances in medical technology, treatment plans are tailored to meet the needs of each individual patient, providing them with the best possible chance of a successful outcome.
KYPROLIS is now included in its approved indication
For adult patients with relapsed or refractory multiple myeloma, the treatment options have been expanded to include those who have received at least two prior therapies, including a proteasome inhibitor and an immunomodulatory agent. Now, these patients can look forward to an improved prognosis and a new lease on life.
XGEVA is successfully renewed in NRDL
For patients suffering from giant cell tumor of the bone (GCTB) that cannot be surgically removed, or where the risk of serious complications from surgery is high, there is now a treatment option available on the National Reimbursement Drug List (NRDL) as of 2020.
About Tislelizumab
Tislelizumab is a revolutionary humanized IgG4 anti-PD-1 monoclonal antibody that has been specifically designed to help your body’s immune cells detect and fight tumors more effectively. By minimizing binding to Fcγ receptors on macrophages, this cutting-edge antibody provides a powerful weapon in the battle against cancer.
Tislelizumab is a groundbreaking new investigational medicine from BeiGene’s immuno-oncology biologics program, which is being tested for its ability to treat both solid tumors and hematologic malignancies. This cutting-edge therapy is being evaluated as both a monotherapy and in combination with other treatments.
The far-reaching tislelizumab clinical development program has seen an impressive 11,500 participants take part in 21 registration-enabling trials, spanning 30 countries and regions around the world. This expansive research program is certainly making waves in the medical community.
Tislelizumab, a potential new treatment for unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) and non-small cell lung cancer, is currently under review by the U.S. and European Union (E.U.) regulators. This exciting development could bring much-needed relief to those suffering from these conditions.
About KYPROLIS® (carfilzomib) for injection
KYPROLIS is a revolutionary drug approved in 2012 that has since been widely prescribed to over 200,000 patients worldwide. Its unique mechanism of action works by blocking proteasomes, leading to a buildup of proteins in cells that can, in some cases, even cause cell death. This is particularly true in myeloma cells, which are already known to possess a higher amount of abnormal proteins. KYPROLIS has revolutionized how we treat certain diseases and has given new hope to many patients.
KYPROLIS is approved in the U.S. for the following:
The FDA has recently approved the use of a new medication for adult patients suffering from relapsed or refractory multiple myeloma. This medication can be used in combination with Lenalidomide and dexamethasone, dexamethasone alone, daratumumab and dexamethasone, or daratumumab and hyaluronidase-fihj and dexamethasone, and has been shown to be effective for patients who have already received one or more lines of therapy. This breakthrough medication offers a new option for those struggling with this difficult disease.
KYPROLIS has been welcomed with open arms in more than 40 countries across the world, including Algeria, Argentina, Australia, Bahrain, Belarus, Brazil, Canada, Chile, China, Colombia, Ecuador, Egypt, the European Union, India, Israel, Japan, Jordan, Kazakhstan, Kuwait, Lebanon, Malaysia, Mexico, Morocco, New Zealand, Oman, Peru, Philippines, Qatar, Russia, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Switzerland, Thailand, Turkey, the United Arab Emirates, and the United Kingdom. With its approval, KYPROLIS has become an important part of healthcare in these countries, offering much-needed relief to those who are suffering from debilitating medical conditions.
U.S. KYPROLIS® (carfilzomib) Important Safety Information
Cardiac Toxicities
Patients taking KYPROLIS have been reported to experience new or worsening pre-existing cardiac issues, such as congestive heart failure, pulmonary edema, decreased ejection fraction, restrictive cardiomyopathy, myocardial ischemia, and in some cases, even myocardial infarction – including fatalities. Shockingly, some of these events have been seen even in those with normally functioning ventricles. In some instances, cardiac arrest has even resulted in death within one day of taking KYPROLIS.
Monitor patients carefully for any signs or symptoms of cardiac failure or ischemia. If cardiac toxicity is suspected, act quickly and evaluate the situation. For Grade 3 or 4 cardiac adverse events, suspend KYPROLIS until the patient has recovered, and then consider whether to restart at a lower dose level based on your own assessment of benefits and risks.
It’s essential to make sure you’re properly hydrated before taking your Cycle 1 dose. However, be aware that too much fluid intake can lead to volume overload, particularly for those at risk of cardiac failure. To ensure your safety, monitor your fluid intake closely and adjust accordingly.
For elderly patients aged 75 and up, the risk of cardiac failure is a real concern. Those with New York Heart Association Class III and IV heart failure, recent myocardial infarction, conduction abnormalities, angina, or arrhythmias must take extra precaution when considering KYPROLIS treatment. A comprehensive medical assessment is essential before embarking on treatment and ongoing monitoring and fluid management is necessary for the duration of treatment.
Acute Renal Failure
Patients with advanced, relapsed, and refractory multiple myeloma who received KYPROLIS monotherapy have been reported to experience cases of acute renal failure, some of which have been fatal. Therefore, it is important to monitor renal function through regular measurement of serum creatinine and/or estimated creatinine clearance, and to reduce or withhold dose as appropriate.
Tumor Lysis Syndrome
Tumor Lysis Syndrome (TLS) can be a deadly condition, especially for those with a high tumor burden. To reduce the risk of TLS, patients should be adequately hydrated before each dose, particularly during the first cycle of treatment. Additionally, uric acid-lowering drugs can be considered for those at risk. Monitoring for TLS is essential, and treatment should be withheld until the condition has been resolved.
Pulmonary Toxicity
Acute Respiratory Distress Syndrome (ARDS), acute respiratory failure, and acute diffuse infiltrative pulmonary diseases such as pneumonitis and interstitial lung disease can be life-threatening and have led to fatal events. If you experience drug-induced pulmonary toxicity while taking KYPROLIS, it is important to discontinue its use immediately.
Pulmonary Hypertension
Pulmonary arterial hypertension (PAH) is a serious condition that requires careful evaluation with cardiac imaging and/or other tests as indicated. Until the condition has resolved or returned to baseline, KYPROLIS should be withheld, and a benefit/risk assessment should be conducted to determine if treatment should be restarted.
Dyspnea
Patients treated with KYPROLIS have reported dyspnea, so it’s important to evaluate this symptom and rule out any underlying cardiopulmonary conditions such as cardiac failure and pulmonary syndromes. If the dyspnea is Grade 3 or 4, it’s essential to stop KYPROLIS until the symptom resolves or returns to its baseline. After that, it’s essential to carefully consider whether to restart based on a thorough benefit/risk assessment.
Hypertension
High blood pressure can be a dangerous and even fatal side effect of taking KYPROLIS. It is important to get your blood pressure checked before starting KYPROLIS and to monitor it regularly while taking the medication. If your blood pressure cannot be sufficiently controlled, you must stop taking KYPROLIS and get it evaluated. Before restarting the medication, it is important to assess the potential benefits and risks.
Venous Thrombosis
Patients being treated with KYPROLIS in combination with dexamethasone or lenalidomide plus dexamethasone should be aware of the risk of developing venous thromboembolic events such as deep venous thrombosis and pulmonary embolism. To reduce this risk, thromboprophylaxis is recommended, tailored to the individual patient’s underlying risk factors.
Patients using hormonal contraception may be at an increased risk for thrombosis, so it is important to consider alternative methods of contraception during treatment. Taking the time to find a different, effective form of birth control could make all the difference in preserving your health.
Infusion Reactions
Beware of infusion reactions with GAMMAGARD S/D! These reactions can range from mild to life-threatening and can occur immediately following or up to 24 hours after administration. Symptoms to watch out for include fever, chills, arthralgia, myalgia, facial flushing, facial edema, laryngeal edema, vomiting, weakness, shortness of breath, hypotension, syncope, chest tightness, or angina. To reduce the risk of experiencing such a reaction, premedicate with dexamethasone. If you experience any of the listed symptoms, seek immediate medical attention!
Hemorrhage
Be aware that serious and even fatal cases of hemorrhage have been reported. These hemorrhagic events can range from gastrointestinal, pulmonary, and intracranial bleeding, as well as epistaxis. If you notice any signs or symptoms of blood loss, seek medical attention immediately, and adjust or withhold your dose as necessary.
Thrombocytopenia
Patients receiving KYPROLIS may experience thrombocytopenia, however, the platelet count generally recovers to baseline levels before the start of the next cycle. Healthcare providers should monitor platelet counts regularly, and dose modifications may be necessary to ensure the best possible outcome.
Hepatic Toxicity and Hepatic Failure
KYPROLIS has been linked to serious, and even fatal cases of hepatic failure. It is essential to monitor liver enzymes regularly to avoid any potentially dangerous side effects. If necessary, the dose should be adjusted accordingly to ensure the safety of the patient.
Thrombotic Microangiopathy
Be aware that thrombotic microangiopathy, including thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), has been known to occur and can even be fatal. Monitor closely for any signs or symptoms of TTP/HUS and discontinue use of KYPROLIS if it is suspected. If the diagnosis of TTP/HUS is ruled out, KYPROLIS may be restarted, though the safety of doing so has not been established.
Posterior Reversible Encephalopathy Syndrome (PRES)
If PRES is suspected in patients taking KYPROLIS, it’s essential to discontinue and evaluate with an appropriate imaging scan. Unfortunately, the safety of restarting KYPROLIS after PRES has been reported is unknown. Therefore, it is important to be vigilant and aware of the potential symptoms of PRES when taking KYPROLIS.
Increased Fatal and Serious Toxicities in Combination with Melphalan and Prednisone in Newly Diagnosed Transplant-ineligible Patients
In a clinical trial of transplant-ineligible patients with newly diagnosed multiple myeloma comparing KYPROLIS, melphalan, and prednisone (KMP) vs bortezomib, melphalan, and prednisone (VMP), a higher incidence of serious and fatal adverse events was observed in patients in the KMP arm. KMP is not indicated for transplant-ineligible patients with newly diagnosed multiple myeloma.
Embryo-fetal Toxicity
When pregnant, the use of KYPROLIS could present a risk to the unborn baby and should be avoided. Women who are expecting should consult their doctor before taking this medication, as it has the potential to cause fetal harm.
While pregnant, it is essential to exercise caution when considering the use of KYPROLIS. This medication could pose a potential risk to the unborn baby, and so pregnant women should reach out to their doctor for advice before taking it. Unfortunately, KYPROLIS has the capacity to cause harm to the fetus, so it’s best to err on the side of caution and check with a medical professional first.
Adverse Reactions
Patients receiving combination therapy may experience a variety of adverse reactions, the most common being anemia, diarrhea, fatigue, hypertension, pyrexia, upper respiratory tract infection thrombocytopenia, cough, dyspnea and insomnia. While these reactions may be unpleasant, they can also be a sign that the treatment is working.
Patients taking monotherapy may experience a range of adverse reactions, the most common of which include anemia, fatigue, thrombocytopenia, nausea, pyrexia, dyspnea, diarrhea, headache, cough, and edema peripheral. While these effects can be uncomfortable, they are usually temporary and can be managed with proper medical care.
About XGEVA® (denosumab)
XGEVA is a revolutionary treatment option for bone-related issues, targeting the RANK ligand pathway to prevent the formation, function, and survival of osteoclasts. It is indicated for the prevention of SREs in patients with bone metastases from solid tumors, as well as for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone. In the U.S., it is also approved for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. XGEVA is an innovative and highly effective solution for those facing bone-related issues.
XGEVA is an innovative treatment option designed to help prevent skeletal-related events in both multiple myeloma and bone metastases from solid tumors. With XGEVA, patients can feel confident that their bones are supported, giving them greater peace of mind and quality of life.
XGEVA U.S. Important Safety Information
Hypocalcemia
XGEVA® can cause life-threatening hypocalcemia, so it is essential to correct any pre-existing hypocalcemia before starting treatment. Monitor calcium levels, especially in the first weeks after initiating therapy, and supplement with calcium, magnesium, and vitamin D if necessary. Additionally, be aware that the use of calcimimetics and other medications that can lower calcium levels may further increase the risk of hypocalcemia. Patients should contact their healthcare professional immediately if they experience any symptoms of hypocalcemia.
Patients with severe renal dysfunction (creatinine clearance below 30 mL/minute and/or on dialysis) may be at a heightened risk for hypocalcemia, particularly when calcium and vitamin D supplementation is inadequate or absent. Therefore, it is important to carefully monitor calcium levels and calcium and vitamin D intake in these individuals.
Hypersensitivity
XGEVA® is not for everyone – if you have a known hypersensitivity to the drug, including anaphylaxis, it’s essential to avoid using it. Anaphylaxis has been reported with use of XGEVA® and reactions may include hypotension, dyspnea, upper airway edema, lip swelling, rash, pruritus, and urticaria. If you experience any of these symptoms, it’s crucial to seek medical help immediately and discontinue XGEVA® therapy permanently.
Drug Products with Same Active Ingredient
Patients should take care to avoid taking Prolia® (denosumab) if they are receiving XGEVA® – the two medications are not compatible.
Osteonecrosis of the Jaw
XGEVA® has been linked to Osteonecrosis of the Jaw (ONJ), an incredibly painful condition that can manifest in symptoms such as jaw pain, toothache, and gingival erosion. In clinical trials, it was found that the longer the duration of exposure to XGEVA®, the higher the risk of developing ONJ. Persistent pain or slow healing of the mouth or jaw after dental surgery may also be signs of this condition.
Those who have had a tooth extracted, neglected their oral hygiene, or use a dental appliance may be more susceptible to developing Osteonecrosis of the Jaw (ONJ). Other risk factors include taking immunosuppressants, receiving treatments with angiogenesis inhibitors, being on corticosteroids, having diabetes, and experiencing gingival infections. It is important to be aware of such risks to help prevent the onset of ONJ.
As part of your XGEVA® therapy, we recommend that you have an oral examination and appropriate preventive dentistry prior to starting treatment. We also advise that you take proper care of your oral hygiene. While you are on XGEVA®, it is best to avoid any invasive dental procedures, and if one is necessary, your XGEVA® treatment may need to be temporarily interrupted. If you are suspected of having or developing ONJ while on XGEVA®, you should receive care from a dentist or an oral surgeon as extensive dental surgery to treat ONJ may make the condition worse.
Atypical Subtrochanteric and Diaphyseal Femoral Fracture
Atypical femoral fractures have been observed in some cases involving XGEVA®. These fractures can occur anywhere along the femoral shaft, from slightly below the lesser trochanter to above the supracondylar flare, and tend to be transverse or short oblique in orientation without any sign of fragmentation.
Atypical femoral fractures most commonly occur with minimal or no trauma to the affected area. They may be bilateral and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs. A number of reports note that patients were also receiving treatment with glucocorticoids (e.g. prednisone) at the time of fracture. During XGEVA® treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture. Patients presenting with an atypical femur fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of XGEVA® therapy should be considered, pending a risk/benefit assessment, on an individual basis.
Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone (GCTB) and in Patients with Growing Skeletons
Hypercalcemia is a serious condition that can require hospitalization if left untreated. In particular, XGEVA®-treated patients with GCTB and those with growing skeletons within one year of treatment discontinuation are at risk of developing hypercalcemia, which can lead to acute renal injury. Therefore, it is important to monitor for signs and symptoms of hypercalcemia after treatment discontinuation and take prompt action to treat it appropriately.
Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation
When treatment with denosumab is discontinued, there is an increased risk for multiple vertebral fractures (MVF) in patients with risk factors for or a history of osteoporosis or prior fractures. Evaluating the individual patient’s risk for vertebral fractures is essential for those who have stopped XGEVA® treatment.
Embryo-Fetal Toxicity
XGEVA® has the potential to cause severe harm to unborn babies when administered to a pregnant woman. Animal studies have shown that the use of XGEVA® could result in damaging reproductive effects. It is imperative that pregnant women avoid using this medication.
Advise female patients of reproductive potential to use effective contraception during XGEVA® therapy and for at least 5 months after the last dose. Remind them of the potential harm to a fetus if XGEVA® is taken during pregnancy or if pregnancy occurs while using XGEVA®. Ensure that patients are aware of the risks associated with this medication and the importance of using contraception.
Adverse Reactions
Patients receiving XGEVA® to treat bone metastasis from solid tumors may experience common adverse reactions such as fatigue/asthenia, hypophosphatemia, and nausea. The most serious adverse reaction reported was dyspnea, while the most frequent cause of discontinuation was osteonecrosis or hypocalcemia.
Patients with multiple myeloma who take XGEVA® may experience a variety of side effects, the most common being diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache. While pneumonia was the most serious adverse reaction, the most commonly reported reason for discontinuing XGEVA® was osteonecrosis of the jaw.
About BeiGene
At BeiGene, we are revolutionizing the world of oncology treatments, providing innovative and affordable medicines to more patients than ever before. Our expansive portfolio of therapeutics is being rapidly developed through our own capabilities and collaborations. We are devoted to making healthcare more accessible to those who need it, with a team of more than 9,000 members across five continents, including offices in Cambridge U.S., Basel Switzerland, and Beijing China.
Forward-Looking Statements
BeiGene is taking strides to expand patient access and affordability with the potential inclusion of tislelizumab, KYPROLIS, and XGEVA in the NRDL. Our commitment to global health is to make innovative medicines more accessible and affordable for many patients around the world. We have ambitious plans and goals to revolutionize the healthcare industry, but our progress is subject to various factors – including the efficacy and safety of our drug candidates, regulatory agency actions, and our ability to obtain and maintain intellectual property. Moreover, the COVID-19 pandemic has had an impact on our operations, as outlined in our most recent quarterly report.