YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 452 drug applications between 8 December 2023 and 14 December 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 97, covering 71 drug names.
2023/12/08 – 2023/12/14
- New acceptances this week
- 452
- Drugs with new generic filings (by drug name, de-duplicated)
- 71
- Accepted this week, now under review
- 0
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
452filings, 97 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 242 |
| Generic | 97 |
| New drug | 64 |
| Import | 31 |
| Unspecified | 10 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 268 |
| TCM | 107 |
| Therapeutic biologic | 70 |
| Biologic | 4 |
| Prophylactic biologic | 2 |
| In vitro diagnostic reagent | 1 |
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
71 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 地氯雷他定口服溶液 · No verified English name | 4 | 4 | 26 |
| 2 | Morinidazole and Sodium Chloride Injection | 3 | 3 | 9 |
| 3 | Minoxidil Liniment | 3 | 2 | 52 |
| 4 | Tapentadol Hydrochloride Tablets | 3 | 1 | 0 |
| 5 | 二甲双胍恩格列净片(I) · No verified English name | 2 | 2 | 2 |
| 6 | Diquafosol Sodium Eye Drops | 2 | 2 | 5 |
| 7 | Ceftazidime And Avibactam Sodium For Injection | 2 | 2 | 12 |
| 8 | Norepinephrine Bitartrate Injection | 2 | 2 | 9 |
| 9 | Acetylcysteine Oral Solution | 2 | 1 | 11 |
| 10 | Quetiapine Fumarate Extended-release Tablets | 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
239 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Lan Yun Zhi He Bio Technology Co., Ltd. romanized | 49 | 38 | 0 |
| 2 | Novo Nordisk A/S | 10 | 1 | 0 |
| 3 | Tai Ji Group Sichuan Tian Cheng Pharmaceutical Co., Ltd. romanized | 8 | 8 | 0 |
| 4 | Chengdu Di Ao Pharmaceutical Group Co., Ltd. romanized | 8 | 2 | 0 |
| 5 | Boehringer Ingelheim International GmbH | 6 | 3 | 0 |
| 6 | Fresenius Kabi Austria GmbH | 6 | 1 | 0 |
| 7 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 5 | 4 | 3 |
| 8 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 5 | 4 | 4 |
| 9 | F. Hoffmann-La Roche Ltd | 5 | 3 | 0 |
| 10 | Kang Zhi Pharma Co., Ltd. romanized | 5 | 3 | 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
136 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/12/14Import · Class 1 | Cevostamab · No verified English nameJXSL2300228 | F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd. |
| 2023/12/14Import · Class 2.2 | Pozelimab注射液 · No verified English nameJXSL2300227 | Regeneron Pharmaceuticals Inc.; Zai Lab (Shanghai) Co. Ltd. |
| 2023/12/14Import · Class 2.2 | Pozelimab注射液 · No verified English nameJXSL2300226 | Regeneron Pharmaceuticals Inc.; Zai Lab (Shanghai) Co. Ltd. |
| 2023/12/14Import · Class 1 | Cemdisiran注射液 · No verified English nameJXHL2300314 | Regeneron Pharmaceuticals Inc.; Zai Lab (Shanghai) Co. Ltd. |
| 2023/12/14Import · Class 1 | Cemdisiran注射液 · No verified English nameJXHL2300313 | Regeneron Pharmaceuticals Inc.; Zai Lab (Shanghai) Co. Ltd |
| 2023/12/14Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2303473 | Hubei Kai Na Pharma Co., Ltd. romanized; Hubei Mei Si Chuang Pharma Co., Ltd. romanized |
| 2023/12/14Generic · Class 3 | Alendronate Sodium Oral SolutionCYHS2303469 | Qin Huang Dao Ai Hui Pharma Co., Ltd. romanized; Bao Ding Ai Hui Pharma Co., Ltd. romanized |
| 2023/12/14Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2303468 | Jiangsu Lianhuan Pharmaceutical Co.,Ltd. |
| 2023/12/14Generic · Class 3 | Nefopam Hydrochloride InjectionCYHS2303467 | Hainan Ai Ke Pharmaceutical Co., Ltd. romanized |
| 2023/12/14Generic · Class 3 | Dexmedetomidine Hydrochloride InjectionCYHS2303464 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized |
| 2023/12/14Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2303463 | Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized |
| 2023/12/14Generic · Class 3 | 丁酸氯维地平乳状注射液 · No verified English nameCYHS2303461 | Yangtze River Pharmaceutical Group Co., Ltd |
| 2023/12/14Generic · Class 3 | Tapentadol Hydrochloride TabletsCYHS2303460 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2023/12/14Generic · Class 3 | Tapentadol Hydrochloride TabletsCYHS2303459 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2023/12/14Generic · Class 3 | Tapentadol Hydrochloride TabletsCYHS2303458 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2023/12/14Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2303453 | Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized; Jiangxi Yin Tao Pharma Co., Ltd. romanized |
| 2023/12/14Generic · Class 3 | Potassium Aspartate InjectionCYHS2303451 | Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2023/12/14Generic · Class 3 | Abiraterone Acetate TabletsCYHL2300152 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2023/12/14Generic · Class 3 | 尿素[13C]呼气试验药盒 · No verified English nameCYHL2300151 | Shenzhen Shi Zhong He Hai De Wei Bio Technology Co., Ltd. romanized |
| 2023/12/14New drug · Class 1 | 注射用重组(酵母分泌型)人血清白蛋白-人粒细胞集落刺激因子(I)融合蛋白 · No verified English nameCXSS2300099 | Jiangsu Tai Kang Biopharmaceuticals Co., Ltd. romanized |
| 2023/12/14New drug · Class 1 | 润达基奥仑赛注射液(拟定) · No verified English nameCXSS2300098 | Shanghai Heng Run Da Sheng Bio Technology Co., Ltd. romanized; Shanghai Heng Run Da Sheng Biopharmaceutical Co., Ltd. romanized |
| 2023/12/14New drug · Class 3.4 | 注射用重组人凝血因子VIIa · No verified English nameCXSS2300097 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2023/12/14New drug · Class 1 | QX007N注射液 · No verified English nameCXSL2300860 | Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized |
| 2023/12/14New drug · Class 1 | 注射用BC001 · No verified English nameCXSL2300858 | Sichuan Lu Zhou Bu Zhang Biopharmaceutical Co., Ltd. romanized |
| 2023/12/14New drug · Class 1 | 人脂肪间充质干细胞注射液 · No verified English nameCXSL2300857 | Beijing Ai Ge Gan Xi Bao Technology Co., Ltd. romanized |
| 2023/12/14New drug · Class 1 | 注射用AMT-562 · No verified English nameCXSL2300856 | Pu Zhong Fa Xian Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/12/14New drug · Class 2.4 | 替戈拉生片 · No verified English nameCXHS2300114 | Shandong Luo Xin Pharma Group Co., Ltd. romanized |
| 2023/12/14New drug · Class 1 | 注射用HR20013 · No verified English nameCXHS2300113 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2023/12/14New drug · Class 1 | HTMC0435片 · No verified English nameCXHL2301389 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2023/12/14New drug · Class 1 | HTMC0435片 · No verified English nameCXHL2301388 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
106 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.