YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 418 drug applications between 6 October 2023 and 12 October 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 104, covering 79 drug names.
2023/10/06 – 2023/10/12
- New acceptances this week
- 418
- Drugs with new generic filings (by drug name, de-duplicated)
- 79
- 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
418filings, 104 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 187 |
| Generic | 104 |
| New drug | 80 |
| Import | 20 |
| Import re-registration | 16 |
| Unspecified | 10 |
| Drug-device combination product | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 305 |
| Therapeutic biologic | 56 |
| TCM | 51 |
| Prophylactic biologic | 6 |
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
79 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Edoxaban Tosilate Tablets | 6 | 2 | 9 |
| 2 | Lactulose Oral Solution | 4 | 3 | 34 |
| 3 | Nicorandil for Injection | 3 | 2 | 1 |
| 4 | Minoxidil Liniment | 3 | 2 | 52 |
| 5 | Diquafosol Sodium Eye Drops | 2 | 2 | 5 |
| 6 | Famotidine Injection | 2 | 2 | 8 |
| 7 | Phenylephrine Hydrochloride Injection | 2 | 2 | 5 |
| 8 | Clindamycin Phosphate Topical Solution | 2 | 1 | 1 |
| 9 | Lacosamide Tablets | 2 | 1 | 0 |
| 10 | 昂丹司琼口溶膜 · No verified English name | 2 | 1 | 2 |
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
246 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guangxi Jin Xing Pharmaceutical Co., Ltd. romanized | 17 | 17 | 0 |
| 2 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 14 | 5 | 1 |
| 3 | Sichuan Sen Ke Pharmaceutical Co., Ltd. romanized | 6 | 5 | 0 |
| 4 | Jiangsu En Hua Pharma Co., Ltd. romanized | 6 | 2 | 0 |
| 5 | Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | 5 | 3 | 5 |
| 6 | Jiangsu Xin Yuan Su Pharmaceuticals Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | AstraZeneca AB | 4 | 4 | 0 |
| 8 | Janssen-Cilag SpA | 4 | 2 | 0 |
| 9 | Sichuan Kelun Pharmaceutical Co., Ltd. | 4 | 2 | 2 |
| 10 | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. | 4 | 2 | 1 |
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
131 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/10/12Import · Class 2.4 | Upadacitinib片 · No verified English nameJXHL2300251 | AbbVie Inc. |
| 2023/10/12Import · Class 2.4 | 镥(177Lu)vipivotide tetraxetan注射液 · No verified English nameJXHL2300250 | Advanced Accelerator Applications USA Inc. A Novartis Company; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2023/10/12Generic · Class 3 | Nicergoline TabletsCYHS2302722 | Jiangxi Da Sheng Pharmaceuticals Technology Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized |
| 2023/10/12Generic · Class 3 | Verapamil Hydrochloride InjectionCYHS2302717 | Guangzhou He He Pharmaceuticals Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2023/10/12Generic · Class 3 | Nicorandil for InjectionCYHS2302713 | Kang Pu Pharma Co., Ltd. romanized |
| 2023/10/12Generic · Class 3 | Nicorandil for InjectionCYHS2302711 | Kang Pu Pharma Co., Ltd. romanized |
| 2023/10/12Generic · Class 3 | Isoniazid InjectionCYHS2302710 | Hainan Qiu Shi Pharmaceuticals Technology Co., Ltd. romanized; Henan Run Hong Pharmaceutical Co., Ltd. romanized |
| 2023/10/12Generic · Class 3 | Famotidine InjectionCYHS2302706 | Jiangsu Shen Long Pharma Co., Ltd. romanized |
| 2023/10/12Generic · Class 3 | Peramivir InjectionCYHS2302704 | Shanghai Hua Yuan Anhui Jin Hui Pharmaceutical Co., Ltd. romanized |
| 2023/10/12Generic · Class 3 | Potassium Chloride InjectionCYHS2302703 | Chengdu Hua Yu Pharmaceutical Co., Ltd. romanized |
| 2023/10/12New drug · Class 1 | GC001溶瘤痘苗病毒注射液 · No verified English nameCXSL2300689 | Hangzhou Gong Chu Bio Technology Co., Ltd. romanized |
| 2023/10/12New drug · Class 1 | 注射用TQB2922 · No verified English nameCXSL2300688 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2023/10/12New drug · Class 3.3 | 德谷门冬双胰岛素注射液 · No verified English nameCXSL2300687 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2023/10/12New drug · Class 2.2 | 注射用维迪西妥单抗 · No verified English nameCXSL2300686 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2023/10/12New drug · Class 1 | 锝[99mTc]-H7ND注射液 · No verified English nameCXHL2301094 | Jia Xing Fa Bo Xin Tian Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/10/12New drug · Class 1 | KC1036片 · No verified English nameCXHL2301093 | Beijing Kang Chen Pharma Co., Ltd. romanized |
| 2023/10/12New drug · Class 1 | KC1036片 · No verified English nameCXHL2301092 | Beijing Kang Chen Pharma Co., Ltd. romanized |
| 2023/10/12New drug · Class 1 | [177Lu]Lu-XT117注射液 · No verified English nameCXHL2301091 | Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/10/12New drug · Class 1 | [64Cu]Cu-XT117注射液 · No verified English nameCXHL2301090 | Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/10/12New drug · Class 1 | QB0208-1胶囊 · No verified English nameCXHL2301089 | Beijing Qing Bo Hui Neng Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/10/12New drug · Class 1 | QB0208-1胶囊 · No verified English nameCXHL2301088 | Beijing Qing Bo Hui Neng Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/10/12New drug · Class 1 | GFH009注射液 · No verified English nameCXHL2301087 | Zhejiang Jin Fang Pharma Co., Ltd. romanized |
| 2023/10/12New drug · Class 1 | HSK39297片 · No verified English nameCXHL2301086 | Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2023/10/12New drug · Class 1 | HSK39297片 · No verified English nameCXHL2301085 | Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2023/10/12New drug · Class 1 | 注射用BL0006 · No verified English nameCXHL2301084 | Shanghai Bi Ling Bio Technology Co., Ltd. romanized |
| 2023/10/11Import · Class 1 | Lebrikizumab注射液 · No verified English nameJXSL2300178 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/10/11Import · Class 1 | AMG 509 · No verified English nameJXSL2300177 | Amgen Inc.; BeiGene (Beijing) Co. Ltd |
| 2023/10/11Import · Class 1 | VAY736注射液 · No verified English nameJXSL2300176 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2023/10/11Import · Class 1 | Nemtabrutinib片 · No verified English nameJXHL2300248 | Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2023/10/11Import · Class 1 | Nemtabrutinib片 · No verified English nameJXHL2300247 | Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
101 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.
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