Progress in drug research and development
1. Anjin C5aR antagonist "Avamipram" approved for market in China
On November 5th, the official website of NMPA announced that the marketing application for avacopan capsules jointly developed by Anjin and CSL Vifor has been approved, presumably for the treatment of anti neutrophil cytoplasmic antibody (ANCA) - related vasculitis (AAV). Afakepan is a complement 5a receptor (C5aR) antagonist that inhibits the interaction between C5aR and the allergen C5a, blocking C5a mediated neutrophil activation and migration. The drug was approved by the US FDA in October 2021 for use in combination with standard treatment regimens including glucocorticoids to treat adult active severe ANCA associated vasculitis (MPA and GPA). In July 2024, Anjin reached an agreement with CSL Vifor to acquire commercial rights to Avamipram in Asia and Latin America, including the mainland Chinese market.

2. Pfizer PARP inhibitor "Terazopanib" approved in China
On November 5th, the NMPA official website announced that Pfizer's Terazopanib Capsules have been approved for sale in China. According to Pfizer's previous press release, talazoparib is an oral PARP inhibitor approved in China for metastatic castration resistant prostate cancer (mCRPC). Tarrazopril has been approved by the US FDA (trade name: Talzenna) in 2018 for the treatment of adult patients with BRCA mutation, HER2 negative local advanced or metastatic breast cancer. In June 2023, the product's new indication was re approved by the FDA for the treatment of mCRPC patients with HRR gene mutations in combination with enzalutamide. In a phase 3 TALAPRO-2 trial targeting mCRPC patients, a favorable overall survival (OS) trend was observed with the combination therapy of talazolparib, along with statistically and clinically significant rPFS data. Compared with placebo combined with enzalutamide, the combination therapy of talazolparib reduced the risk of disease progression or death in mCRPC patients by 55%.

3. Beierda Pharmaceutical's third-generation EGFR inhibitor approved for new indications in China
On November 5th, the official website of NMPA just announced that the application for the new indication of Class 1 new drug, remitinib mesylate capsules, submitted by Beierda Pharmaceutical, has been approved. Public information shows that remitinib is a third-generation EGFR inhibitor small molecule drug, and its first indication was approved by NMPA for second-line treatment of EGFR T790M mutation positive NSCLC adult patients in May 2024. According to the official website of Beierda Pharmaceutical, the newly approved indication for this drug is first-line NSCLC. According to a previous study published in BMC Medicine, a phase 2a clinical trial evaluated the efficacy and safety of remitinib as first-line treatment for locally advanced or metastatic/recurrent EGFR mutant NSCLC patients. The study included 43 patients, and as of the data deadline of December 23, 2021, the ORR assessed by BICR was 83.7%; The median DoR is 19.3 months. The median PFS assessed by BICR and researchers were 20.7 months and 22.0 months, respectively. The data about OS is not yet mature.

4. Nivolumab approved as first-line treatment for urothelial carcinoma in China
On November 5th, Bristol Myers Squibb (BMS) announced that the new indication for nivolumab (Chinese trade name: Oudiwo) has been approved by the National Medical Products Administration for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma in combination with cisplatin and gemcitabine. After this approval, Oudiwo has become the first and currently the only immunotherapy approved for first-line treatment of advanced urothelial carcinoma in China. This approval is based on positive data from the Phase III study CheckMate-901. Data shows that at a median follow-up of approximately 33 months, patients receiving combination chemotherapy with oxaliplatin and sequential monotherapy with oxaliplatin had an overall survival rate of 21.7 months (18.9 months in the chemotherapy group), significantly reducing the risk of death by 22% (HR=0.78, p=0.0171); The median PFS was 7.9 months (7.6 months in the chemotherapy group), significantly reducing the risk of disease progression or death by 28% (HR=0.72, p=0.0012). In terms of treatment response, the combination of Odiwo and chemotherapy also showed clinically significant improvements: ORR reached 57.6% (chemotherapy group 43.1%); 21.7% of patients achieved CR, which is nearly twice the proportion of the chemotherapy group (11.8%); And the median duration of CR can reach 37.1 months, which is nearly three times longer than the chemotherapy group (13.2 months).

5. The new dosage form of AstraZeneca BTK inhibitor "Akotinib" has been approved in China
On November 5th, the NMPA official website announced that AstraZeneca's application for listing acalabrutinib malate tablets has been approved. Akotinib is a BTK inhibitor, and its capsule form has been approved in China before. This is the first time that a tablet form has been approved for market in China. Akotinib capsules have been approved for marketing in multiple countries and regions around the world, including China, for the treatment of adult mantle cell lymphoma (MCL) patients who have received at least one previous treatment; And monotherapy is suitable for adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have received at least one treatment in the past. In August 2022, AstraZeneca announced that the tablet form of Axitinib was approved in the United States for all current indications of capsule form. In August 2022, AstraZeneca announced that the tablet form of Axitinib was approved in the United States for all current indications of capsule form.

6. Jinsai Pharmaceutical's "Long acting Growth Hormone" New Indication Approved in China
On November 5th, Changchun High tech announced that its subsidiary Jinsai Pharmaceutical's application for a new indication of polyethylene glycol recombinant human growth hormone injection (Jinsai Zeng) has been approved for use in idiopathic short stature (ISS). In 2003, the US FDA first approved recombinant human growth hormone for idiopathic short stature. Since 2021, NMPA has approved recombinant human growth hormone injection for the treatment of idiopathic short stature. At present, multiple short acting recombinant human growth hormones have been approved for this indication worldwide, but Jinsai Zeng is the first long-acting growth hormone approved for this indication worldwide.

7. Tiwa Company's new Huntington's disease drug is declared for market in China
On November 5th, the latest announcement on the CDE official website stated that the application for the marketing of the 5.1 class new drug, deuterated butyrazine sustained-release tablets, submitted by Tiva Company, has been accepted. According to public information, deuterated butyrazine is a deuterated drug of the vesicular monoamine transporter 2 (VMAT2) inhibitor butyrazine, which has been approved in China for the treatment of Huntington's disease and delayed onset motor disorders. This time, the new formulation of the product's sustained-release tablets has been declared for market in China.

Industry News
350 million US dollars! Royalty collaborates with Syndax
On November 4th, Royalty Pharma and Syndax Pharmaceuticals jointly announced a $350 million synthetic patent fee financing agreement based on the net sales of Niktimvo (axatilimab csfr) in the United States. According to the terms of the agreement, Syndax received a prepayment of $350 million in exchange for a royalty fee of 13.8% of Niktimvo's net sales in the United States. The maximum royalty payment to Royalty Pharma will reach 2.35 times. Niktimvo (axatilimab csfr) is an anti-CSF-1R antibody that was approved by the FDA on August 14th for chronic graft-versus-host disease (cGVHD) in adult and pediatric patients weighing at least 40 kilograms after at least two systemic treatment failures.

Source: https://pharm.jgvogel.cn/c1458655.shtml