Pharma Frontiers: Daily Digest of Global Pharmaceutical News - Jun 26

1.Novo Nordisk's Semaglutide injection has been approved once again in China, indicated for long-term weight management

On June 25th, Novo Nordisk announced that its once-weekly 2.4 mg semaglutide injection (brand name: Wegovy) has been approved in China for long-term weight management. Wegovy was approved by the U.S. FDA in 2021 for the indication of weight reduction in adults with obesity or overweight, with at least one weight-related comorbid condition, in conjunction with diet and exercise for long-term weight management. This is the first new drug approved by the FDA since 2014 for the control of general obesity or overweight. The approval of Wegovy in China for weight reduction marks a significant milestone in making this breakthrough medication available to the vast number of overweight and obese individuals in China. Semaglutide is a long-acting GLP-1 analogue with 94% homology to natural GLP-1 amino acid sequence, acting as a GLP-1 receptor agonist. It functions by reducing hunger and increasing satiety, thereby helping patients to eat less and lower their caloric intake to achieve weight loss. According to a previous press release from Novo Nordisk, the FDA’s approval of Wegovy was based on the results of the STEP 3a clinical trial program. In the trial involving patients without type 2 diabetes, those who continued with Wegovy treatment for 68 weeks showed an average weight reduction of 17% to 18%. Moreover, the product demonstrated good safety and tolerability throughout the program, with gastrointestinal events being the most common adverse effects. In addition, Novo Nordisk's semaglutide injection at doses of 0.25, 0.5, and 1.0 mg was approved in China for the treatment of type 2 diabetes in April 2021; oral semaglutide tablets also received approval for the treatment of type 2 diabetes in adults in China in January 2024.

2.Johnson & Johnson Announces Approval of Teclistamab Injection in China

On June 25, Johnson & Johnson announced that the application for market approval of its Teclistamab injection has been granted by the National Medical Products Administration (NMPA) of China. Teclistamab is a ready-to-use, subcutaneous, dual-specific antibody therapy targeting both BCMA (B-cell maturation antigen) and CD3. The approved indication for this drug is for monotherapy in adult patients with relapsed or refractory multiple myeloma (RRMM) who have previously received at least three lines of therapy. According to a press release from Johnson & Johnson, clinical validation has shown that Teclistamab has a high response rate in patients with relapsed or refractory multiple myeloma who have previously undergone at least triple therapy, with Chinese patients benefiting even more, achieving an overall response rate (ORR) of 76.9%.

Public information reveals that Teclistamab is a ready-to-use, subcutaneous injection targeting the BCMA on B cells and the CD3 receptor on the surface of T lymphocytes. It recruits CD3 positive T cells to BCMA-expressing myeloma cells and activates these T cells to attack the tumor cells. Previously, this product was granted Breakthrough Therapy Designation by the U.S. FDA for the treatment of multiple myeloma and was awarded the PRIME (PRIority MEdicines) designation by the European Medicines Agency (EMA).

Previously, the safety and efficacy of Teclistamab in treating adult patients with RRMM was validated in a clinical trial named MajesTEC-1. Based on the positive outcomes of this clinical trial, Teclistamab was successively approved for marketing by the European Union and the FDA in 2022 for the treatment of adult patients with RRMM. According to an earlier press release from Johnson & Johnson, it is the first dual-specific therapy approved for the treatment of multiple myeloma and the first dual-specific antibody targeting BCMA, offering an "off-the-shelf" treatment option for patients with refractory diseases.

3.Mabpharm's EGFR Monoclonal Antibody Injection CMAB009 Has Been Approved for Marketing as a First-Line Treatment for Metastatic Colorectal Cancer

On June 25, the official website of the China National Medical Products Administration (NMPA) announced that the marketing application for Mabpharm's CMAB009 injection has been formally approved. CMAB009 is a recombinant chimeric monoclonal antibody against the Epidermal Growth Factor Receptor (EGFR) and is an improved biologic product developed based on Cetuximab. This approval allows for its use in combination with FOLFIRI as a first-line treatment for metastatic colorectal cancer (mCRC). Patients with metastatic colorectal cancer generally undergo multiple lines of therapy. In clinical practice, about 50% of all mCRC patients receiving first-line chemotherapy will proceed to second-line chemotherapy, and about 25% will receive third-line chemotherapy. Most mCRC patients eventually become resistant or unresponsive to first and second-line chemotherapy (chemotherapy refractory) or are intolerant to multiple cycles of chemotherapy (chemotherapy intolerance), and currently, third-line treatment options are very limited. EGFR is an effective target for the treatment of KRAS/NRAS/BRAF wild-type mCRC. According to Mabpharm public information, CMAB009 is produced using a specific expression process that effectively avoids glycosylation modifications that could lead to hypersensitivity reactions. The safety and efficacy of the product have been validated by the results of two completed clinical trials. The clinical trial results demonstrate significant therapeutic effects of the drug, significantly reducing immunogenicity and the incidence of severe hypersensitivity and other adverse reactions. In August 2023, Simcere, a pharmaceutical company specializing in oncology innovation under Simcere Zaiming, entered into a collaboration agreement with Mabpharm regarding CMAB009. Simcere Zaiming will obtain exclusive commercial rights in Mainland China for this product, including but not limited to sales management, marketing promotions, the formulation and adjustment of related strategies, and the rights to benefits associated with these activities.

4.Junshi Biosciences' PD-1 monoclonal antibody, Toripalimab, has been approved for a new indication, treating metastatic triple-negative breast cancer

On June 25th, the website of the National Medical Products Administration (NMPA) of China announced that the new indication for Toripalimab by Junshi Biosciences has been approved. According to an earlier press release from Junshi Biosciences, the approved indication is for the use of Toripalimab in combination with albumin-bound paclitaxel (nab-paclitaxel) for the treatment of PD-L1 positive (CPS≥1) initially treated or recurrent metastatic triple-negative breast cancer. Toripalimab is a monoclonal antibody drug targeting PD-1. As of June 12, 2024, this product has been approved for nine indications in China, including melanoma, nasopharyngeal carcinoma, urothelial carcinoma, esophageal squamous cell carcinoma, non-small cell lung cancer, renal cancer, and small cell lung cancer. In October 2023, the drug also received FDA approval in the U.S. for the treatment of nasopharyngeal carcinoma. The application for the new indication of Toripalimab for triple-negative breast cancer was primarily based on the TORCHLIGHT study. This Phase III study examined the combination of Toripalimab and nab-paclitaxel for the treatment of newly diagnosed or recurrent metastatic stage IV triple-negative breast cancer, and its results were first publicized as a major research abstract (LBA) during a rapid abstract session at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. In January 2024, the findings of the TORCHLIGHT study were published in the international medical journal Nature Medicine. According to the researchers' conclusions, for patients with PD-L1 positive (CPS≥1) stage IV newly diagnosed or recurrent metastatic TNBC, the combination of Toripalimab and albumin-bound paclitaxel significantly extends the progression-free survival (PFS), shows a notable trend of improving overall survival (OS), and exhibits good safety with no new safety signals observed.

5.Avatrombopag Maleate Tablet from Fosun Pharmaceutical Approved for New Indications

On June 25, the official website of China's National Medical Products Administration (NMPA) announced the approval of the application for new indications of Avatrombopag Maleate Tablet, jointly submitted by AkaRx and Fosun Pharmaceutical. Public information reveals that this is an oral thrombopoietin receptor agonist (TPO-RA) introduced by Fosun Pharmaceutical. The newly approved indication is for the treatment of adult patients with chronic immune thrombocytopenia (ITP) who have had an inadequate response to previous therapies. Avatrombopag is an innovative small molecule drug and a thrombopoietin receptor agonist. This product can rapidly increase platelet counts within 3-5 days after treatment, and its oral administration is not restricted by the type of food, significantly enhancing the quality of life for patients with thrombocytopenia. In China, Avatrombopag was initially approved in 2020 for the treatment of thrombocytopenia associated with chronic liver disease in adult patients undergoing elective diagnostic procedures or surgery. The new indication approved is for primary immune thrombocytopenia (ITP). In September 2023, Fosun Pharmaceutical announced the primary results of the Phase 3 study in China for Avatrombopag treating adult chronic ITP, published in the international journal Research and Practice in Thrombosis and Haemostasis. Based on the full analysis set, the results at six weeks showed a platelet response rate of 77.1% in the Avatrombopag group (vs. 7.7% in the placebo group), with a difference of 69.4% between the two groups. The study reached its primary endpoint, supporting the superiority of Avatrombopag over placebo. The results were consistent in all pre-defined subgroups (splenectomy status, baseline platelet counts, baseline ITP concomitant medications) and in post-hoc subgroups (previous TPO-RA use).

6.Alnylam Subcutaneous RNAi Therapy Amvuttra Set for Regulatory Submission

On June 25th, Alnylam Pharmaceuticals announced positive top-line results from their Phase 3 HELIOS-B clinical study. Analysis revealed that its subcutaneous RNAi therapy Amvuttra (vutrisiran), as a monotherapy, reduced the risk of all-cause mortality or recurrent cardiovascular events by 33% in patients with transthyretin-mediated amyloidosis (ATTR-CM) with cardiomyopathy. Based on these positive outcomes, Alnylam plans to submit a supplemental New Drug Application (sNDA) to the U.S. FDA using a Priority Review Voucher (PRV). HELIOS-B is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study aimed at assessing the efficacy and safety of vutrisiran in reducing all-cause mortality and recurrent cardiovascular events (primary endpoints) in patients with ATTR-CM. The study enlisted a total of 655 adult patients with either hereditary or wild-type ATTR-CM, randomly assigned to receive a 25 mg dose of vutrisiran or placebo via subcutaneous injection every three months at a 1:1 ratio, with a double-blind treatment period lasting up to 36 months. After the double-blind period, all eligible trial participants may receive vutrisiran treatment in an open-label extension. The study achieved its primary endpoint, with analysis during the double-blind period showing an overall 28% and 33% reduction in the combined indicator of all-cause mortality and recurrent cardiovascular events for the total patient population (n=654; HR: 0.718, p=0.0118) and monotherapy-treated patients (i.e., patients not treated at baseline with the approved ATTR-CM therapy tafamidis, n=395; HR: 0.672, p=0.0162), respectively.

7.Walvax Biotechnology Terminates mRNA Vaccine Collaborations with Abogen Biosciences

On June 25, Walvax Biotechnology and Suzhou Abogen Biosciences terminated their technical development cooperation on an mRNA vaccine for COVID-19 and an mRNA vaccine for shingles, signing a termination agreement. Following the dissolution of this partnership, the parties will settle the costs associated with early research and development, clinical trials, and other related expenses. The board has authorized the company's chairman and management team to handle matters related to the termination, including but not limited to signing the termination agreement, settlement agreement, and related ancillary documents, and settling project costs.

The collaboration between Walvax Biotechnology and Abogen Biosciences began in May 2020, when the two companies signed a technical development cooperation agreement aimed at jointly developing a novel coronavirus mRNA vaccine. According to the agreement, Abogen Biosciences was responsible for the preclinical research, including mRNA vaccine molecular design, chemical modifications, and formulation process development, while Walvax Biotechnology took charge of QA, QC, IND, clinical research, NDA, and commercial production. However, this collaboration, which initially attracted significant attention from both primary and secondary markets, ultimately did not achieve the explosive commercial success anticipated. Even the COVID-19 mRNA vaccine ARCoVaX (commercial name AWCorna), developed in collaboration by Walvax Biotechnology and Abogen Biosciences, only received emergency use authorization in Indonesia, with actual commercial sales being negligible.

However, this does not mean that Walvax Biotechnology will exit the mRNA vaccine research and development field. On the contrary, from the perspective of organizational restructuring, Walvax Biotechnology has reaffirmed the significance of mRNA vaccine R&D within the company’s framework.

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