YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 280 drug applications between 28 December 2023 and 3 January 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 74, covering 60 drug names.
2023/12/28 – 2024/01/03
- New acceptances this week
- 280
- Drugs with new generic filings (by drug name, de-duplicated)
- 60
- Accepted this week, now under review
- 1
DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.
Names with a public page are linked.
New acceptances this week
By application type and drug type
280filings, 74 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 130 |
| Generic | 74 |
| New drug | 55 |
| Import re-registration | 10 |
| Import | 9 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 207 |
| TCM | 34 |
| Therapeutic biologic | 34 |
| Prophylactic biologic | 5 |
DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.
Most new generic filings, by drug
60 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 注射用头孢唑肟钠 · No verified English name | 4 | 2 | 4 |
| 2 | Penicillin G Sodium For Injection | 4 | 1 | 2 |
| 3 | Levofloxacin Tablets | 2 | 2 | 7 |
| 4 | 氧 · No verified English name | 2 | 2 | 15 |
| 5 | Calcipotriol and Betamethasone Ointment | 2 | 1 | 1 |
| 6 | Dopamine Hydrochloride Injection | 2 | 1 | 3 |
| 7 | Thioctic Acid Tablets | 2 | 1 | 4 |
| 8 | Azilsartan Medoxomil Potassium Tablets | 2 | 1 | 35 |
| 9 | Sitagliptin and Metformin Hydrochloride Extended-release Tablets | 2 | 1 | 12 |
| 10 | Desmopressin Acetate Injection | 2 | 1 | 0 |
DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.
Most new acceptances, by company
183 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Nei Menggu Meng He Pharmaceutical Co., Ltd. romanized | 10 | 10 | 0 |
| 2 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized | 5 | 4 | 4 |
| 3 | Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 5 | 3 | 2 |
| 4 | Boehringer Ingelheim International GmbH | 5 | 1 | 0 |
| 5 | Jilin San Jiu Jin Fu Kang Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Ha Yao Group San Jing Qian He Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Shanghai Jin Di Jiu Zhou Pharma (An Yang) Co., Ltd. romanized | 4 | 2 | 0 |
| 8 | Shandong Luo Xin Pharma Group Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | Xizang Bang Chen Pharma Group Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | Bayer AG | 4 | 1 | 0 |
DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.
Under-review list changes
Compared across this platform's snapshots of the under-review list
Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.
DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.
Class 3 and new-drug acceptances
98 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/01/03Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSL2400001 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2024/01/03Import · Class 1 | 镥[177Lu]依多曲肽注射液 · No verified English nameJXHL2400001 | ITM Solucin GmbH; Grand Pharmaceutical (China) Co. Ltd. |
| 2024/01/03Generic · Class 3 | 氯化钙注射液 · No verified English nameCYHS2400020 | Yang Zhou Zhong Bao Pharma Co., Ltd. romanized |
| 2024/01/03Generic · Class 3 | Candesartan Cilexetil and Hydrochlorothiazide TabletsCYHS2400019 | Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized |
| 2024/01/03Generic · Class 3 | Potassium Chloride GranulesCYHS2400018 | Anhui Jia He Pharma Co., Ltd. romanized |
| 2024/01/03Generic · Class 3 | Peramivir InjectionCYHS2400009 | Shi Yao Yin Hu Pharmaceutical Co., Ltd. romanized |
| 2024/01/03Generic · Class 3 | 复方聚乙二醇电解质散(儿童型) · No verified English nameCYHS2400008 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized |
| 2024/01/03Generic · Class 3 | Thioctic Acid TabletsCYHS2400003 | Zhejiang Hua Yuan Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/01/03Generic · Class 3 | Thioctic Acid TabletsCYHS2400002 | Zhejiang Hua Yuan Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/01/03Generic · Class 3 | Methylergonovine Maleate InjectionCYHL2400002 | Zhejiang Bo Xiao Biopharmaceutical Co., Ltd. romanized |
| 2024/01/03Generic · Class 3 | Olopatadine Hydrochloride Nasal SprayCYHL2400001 | Ying Ke Rui (Heng Qin) Drug Research Institute Co., Ltd. romanized |
| 2024/01/03New drug · Class 1 | IBI129 · No verified English nameCXSL2400006 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2024/01/03New drug · Class 1 | KQ-2003自体嵌合抗原受体T细胞注射液 · No verified English nameCXSL2400005 | Ke Yi (Zhejiang) Pharma Technology Co., Ltd. romanized |
| 2024/01/03New drug · Class 2.2 | 伊基奥仑赛注射液 · No verified English nameCXSL2400004 | Nanjing Xun Lu Biopharmaceuticals Co., Ltd. romanized |
| 2024/01/03New drug · Class 1 | 注射用MK-2870 · No verified English nameCXSL2400003 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2024/01/03New drug · Class 1 | 重组人糜蛋白酶 · No verified English nameCXSL2400002 | Wuhan He Yuan Bio Technology Co., Ltd. romanized |
| 2024/01/03New drug · Class 1 | 注射用SIM0500 · No verified English nameCXSL2400001 | Shanghai Xian Xiang Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/12/30Import · Class 3.1 | 瑞利珠单抗注射液 · No verified English nameJXSS2300095 | Alexion Europe SAS; Alexion Pharma International Operations Limited Alexion Athlone Manufacturing Facility (AAMF); AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/12/30Import · Class 3.1 | 瑞利珠单抗注射液 · No verified English nameJXSS2300094 | Alexion Europe SAS; Alexion Pharma International Operations Limited Alexion Athlone Manufacturing Facility (AAMF); AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/12/30Generic · Class 3 | Levocetirizine dihydrochloride Oral SolutionCYHS2303686 | Guo Yao Group Shan Tou Jin Shi Pharmaceutical Co., Ltd. romanized |
| 2023/12/30Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2303684 | Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized |
| 2023/12/30Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2303683 | Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized |
| 2023/12/30Generic · Class 3 | Propranolol Hydrochloride InjectionCYHS2303682 | Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/12/30Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2303681 | Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized; Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized |
| 2023/12/30New drug · Class 3.3 | 四价流感病毒裂解疫苗 · No verified English nameCXSS2300101 | Zhejiang Tian Yuan Bio Pharma Co., Ltd. romanized |
| 2023/12/30New drug · Class 1 | CG-BM1异体人骨髓间充质干细胞注射液 · No verified English nameCXSL2300909 | Guangzhou Sai Juan Bio Technology Co., Ltd. romanized |
| 2023/12/30New drug · Class 1 | 3HP-2827片 · No verified English nameCXHL2301485 | Si Kang Rui Qi (Suzhou) Pharma Co., Ltd. romanized |
| 2023/12/30New drug · Class 1 | 3HP-2827片 · No verified English nameCXHL2301484 | Si Kang Rui Qi (Suzhou) Pharma Co., Ltd. romanized |
| 2023/12/30New drug · Class 1 | INV-1120胶囊 · No verified English nameCXHL2301483 | Fo Shan Shi Yuan Li Bio Technology Co., Ltd. romanized |
| 2023/12/30New drug · Class 1 | INV-1120胶囊 · No verified English nameCXHL2301482 | Fo Shan Shi Yuan Li Bio Technology Co., Ltd. romanized |
68 more not listed (at most 30 rows).
DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.