YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 380 drug applications between 11 May 2023 and 17 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 72, covering 51 drug names.
2023/05/11 – 2023/05/17
- New acceptances this week
- 380
- Drugs with new generic filings (by drug name, de-duplicated)
- 51
- 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
380filings, 72 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 222 |
| Generic | 72 |
| New drug | 52 |
| Import | 17 |
| Import re-registration | 11 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 216 |
| TCM | 122 |
| Therapeutic biologic | 40 |
| Biologic | 2 |
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
51 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Metformin Hydrochloride And Empagliflozin Extended Release Tablets | 4 | 1 | 12 |
| 2 | 硝普钠氯化钠注射液 · No verified English name | 4 | 1 | 3 |
| 3 | Famotidine Injection | 3 | 3 | 8 |
| 4 | 吸入用七氟烷 · No verified English name | 3 | 1 | 0 |
| 5 | Paroxetine Hydrochloride Enteric-Coated Sustained-Release Tablets | 3 | 1 | 0 |
| 6 | 腺苷钴胺胶囊 · No verified English name | 2 | 2 | 8 |
| 7 | Ipratropium Bromide Inhalation Solution | 2 | 1 | 2 |
| 8 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 9 | Quetiapine Fumarate Extended-release Tablets | 2 | 1 | 0 |
| 10 | Tirofiban Hydrochloride And Sodium Chloride Injection | 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
189 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | An Yang Guang Sheng Heng Pharmaceutical Co., Ltd. romanized | 43 | 34 | 0 |
| 2 | Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized | 39 | 38 | 0 |
| 3 | Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized | 15 | 14 | 0 |
| 4 | AbbVie Inc. | 6 | 2 | 0 |
| 5 | Changsha Ai Bei Gao Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Bright Future Pharmaceuticals Factory | 5 | 4 | 0 |
| 7 | Anhui Hai Shen Shou Chun Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Zhong Jia Bio Technology (Hubei Sheng) Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | Hubei Lang De Pharma Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized | 4 | 1 | 4 |
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
97 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/05/17Import · Class 1 | JNJ-81201887 (AAVCAGsCD59) · No verified English nameJXSL2300095 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/05/17Import · Class 1 | JNJ-81201887 (AAVCAGsCD59) · No verified English nameJXSL2300094 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/05/17Generic · Class 3 | Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2301339 | Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized |
| 2023/05/17Generic · Class 3 | Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2301338 | Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized |
| 2023/05/17Generic · Class 3 | Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2301337 | Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized |
| 2023/05/17Generic · Class 3 | Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2301336 | Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized |
| 2023/05/17Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2301335 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2023/05/17Generic · Class 3 | Pregabalin Oral SolutionCYHS2301334 | Changzhou Si Yao Pharmaceutical Co., Ltd. romanized |
| 2023/05/17Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2301332 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized |
| 2023/05/17Generic · Class 3 | Cycloserine CapsulesCYHS2301331 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2023/05/17Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2301329 | Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized |
| 2023/05/17Generic · Class 3 | Nicorandil for InjectionCYHS2301328 | Chongqing De Cheng Yong Dao Pharmaceuticals Co., Ltd. romanized; Chongqing Huapont Pharmaceutical Co., Ltd. |
| 2023/05/17Generic · Class 3 | 硫酸特布他林口服溶液 · No verified English nameCYHS2301327 | Chengdu Li Er Pharma Co., Ltd. romanized |
| 2023/05/17Generic · Class 3 | 硫酸特布他林口服溶液 · No verified English nameCYHS2301326 | Chengdu Li Er Pharma Co., Ltd. romanized |
| 2023/05/17Generic · Class 3 | Progesterone InjectionCYHS2301325 | Beijing Pin Shang Pin Pharmaceuticals Technology Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2023/05/17Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2301324 | Jiangsu Kai Yuan Pharma Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2023/05/17New drug · Class 1 | TQH2722注射液 · No verified English nameCXSL2300348 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2023/05/17New drug · Class 1 | BBM-H803注射液 · No verified English nameCXSL2300347 | Shanghai Xin Zhi Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Mian Yi Bio Technology Co., Ltd. romanized |
| 2023/05/17New drug · Class 1 | 人源多巴胺能前体细胞注射液 · No verified English nameCXSL2300346 | Wuhan Rui Jian Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/17New drug · Class 2.2 | 培集成干扰素α-2注射液 · No verified English nameCXSL2300345 | Beijing Kai Yin Technology Co., Ltd. romanized |
| 2023/05/17New drug · Class 1 | BGB-11417薄膜包衣片 · No verified English nameCXHL2300533 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2023/05/17New drug · Class 1 | BGB-11417薄膜包衣片 · No verified English nameCXHL2300532 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2023/05/17New drug · Class 1 | LL-50注射液 · No verified English nameCXHL2300531 | Sichuan University Hua Xi Hospital romanized; Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2023/05/17New drug · Class 1 | RG003片 · No verified English nameCXHL2300530 | Shanghai Ling Da Biopharmaceuticals Co., Ltd. romanized |
| 2023/05/17New drug · Class 1 | RG003片 · No verified English nameCXHL2300529 | Shanghai Ling Da Biopharmaceuticals Co., Ltd. romanized |
| 2023/05/17New drug · Class 1 | RG003片 · No verified English nameCXHL2300528 | Shanghai Ling Da Biopharmaceuticals Co., Ltd. romanized |
| 2023/05/16Import · Class 2.2 | Glofitamab注射液 · No verified English nameJXSL2300093 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2023/05/16Import · Class 1 | CC-99282胶囊 · No verified English nameJXHL2300117 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2023/05/16Import · Class 2.4 | Infigratinib胶囊 · No verified English nameJXHL2300116 | LianBio Development (HK) Limited; Shanghai LianBio Development Co. Ltd. |
| 2023/05/16Import · Class 2.4 | Infigratinib胶囊 · No verified English nameJXHL2300115 | LianBio Development (HK) Limited; Shanghai LianBio Development Co. Ltd. |
67 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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