YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 316 drug applications between 14 May 2023 and 20 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 51, covering 38 drug names.
2023/05/14 – 2023/05/20
- New acceptances this week
- 316
- Drugs with new generic filings (by drug name, de-duplicated)
- 38
- 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
316filings, 51 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 188 |
| Generic | 51 |
| New drug | 48 |
| Import | 15 |
| Import re-registration | 9 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 194 |
| TCM | 83 |
| Therapeutic biologic | 34 |
| Biologic | 3 |
| Prophylactic 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
38 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 | Paroxetine Hydrochloride Enteric-Coated Sustained-Release Tablets | 3 | 1 | 0 |
| 3 | Indobufen Tablets | 2 | 2 | 6 |
| 4 | 腺苷钴胺胶囊 · No verified English name | 2 | 2 | 8 |
| 5 | Isoprenaline Hydrochloride Injection | 2 | 1 | 7 |
| 6 | Naloxone Hydrochloride Injection | 2 | 1 | 1 |
| 7 | Dapoxetine Hydrochloride Tablets | 2 | 1 | 20 |
| 8 | 硫酸特布他林口服溶液 · No verified English name | 2 | 1 | 4 |
| 9 | Carbocisteine Oral Solution | 2 | 1 | 6 |
| 10 | Fluvoxamine Maleate 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
149 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized | 64 | 63 | 0 |
| 2 | Zhong Jia Bio Technology (Hubei Sheng) Co., Ltd. romanized | 24 | 12 | 0 |
| 3 | Ping Guang Pharmaceutical Co., Ltd. romanized | 14 | 14 | 0 |
| 4 | AbbVie Inc. | 6 | 2 | 0 |
| 5 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 4 | 3 | 3 |
| 6 | Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized | 4 | 1 | 4 |
| 7 | Shanghai Yin Nuo Biopharmaceuticals Gong Cheng Co., Ltd. romanized | 4 | 1 | 0 |
| 8 | Shandong Qidu Pharmaceutical Co., Ltd. | 4 | 1 | 0 |
| 9 | Tian Sheng Pharmaceutical Group Co., Ltd. romanized | 3 | 2 | 0 |
| 10 | Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized | 3 | 2 | 3 |
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
88 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/05/19Import · Class 1 | Cenerimod片 · No verified English nameJXHL2300122 | Idorsia Pharmaceuticals Ltd; Idorsia (Beijing) Pharmaceuticals Co. Ltd |
| 2023/05/19Import · Class 1 | Aficamten片 · No verified English nameJXHL2300121 | Cytokinetics Incorporated; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd |
| 2023/05/19Import · Class 1 | Aficamten片 · No verified English nameJXHL2300120 | Cytokinetics Incorporated; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd |
| 2023/05/19Generic · Class 3 | Naloxone Hydrochloride InjectionCYHS2301360 | Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2023/05/19Generic · Class 3 | Naloxone Hydrochloride InjectionCYHS2301359 | Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2023/05/19Generic · Class 3 | Digoxin InjectionCYHS2301354 | Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
| 2023/05/19Generic · Class 3 | 头孢丙烯干混悬剂 · No verified English nameCYHS2301353 | Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Pharmaceutical Factory romanized |
| 2023/05/19Generic · Class 3 | Memantine Hydrochloride Oral SolutionCYHS2301351 | Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanized |
| 2023/05/19New drug · Class 1 | 自体抗CLL-1嵌合抗原受体T细胞注射液 · No verified English nameCXSL2300359 | Guangzhou Bai Ji Ji Yin Technology Co., Ltd. romanized |
| 2023/05/19New drug · Class 2.2 | 贝伐珠单抗注射液 · No verified English nameCXSL2300358 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2023/05/19New drug · Class 2.2 | 贝伐珠单抗注射液 · No verified English nameCXSL2300357 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2023/05/19New drug · Class 1 | 靶向GPRC5D嵌合抗原受体自体T细胞注射液 · No verified English nameCXSL2300356 | Yuan Qi Bio Technology (Shanghai) Co., Ltd. romanized |
| 2023/05/19New drug · Class 3.3 | 冻干b型流感嗜血杆菌结合疫苗 · No verified English nameCXSL2300355 | Chengdu Ou Lin Bio Technology Co., Ltd. romanized |
| 2023/05/19New drug · Class 1 | 注射用QLF3108 · No verified English nameCXSL2300354 | Qilu Pharmaceutical Co., Ltd. |
| 2023/05/19New drug · Class 1 | KL590586胶囊 · No verified English nameCXHL2300541 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2023/05/19New drug · Class 1 | KL590586胶囊 · No verified English nameCXHL2300540 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2023/05/19New drug · Class 1 | KL590586胶囊 · No verified English nameCXHL2300539 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2023/05/19New drug · Class 1 | 注射用MT1002 · No verified English nameCXHL2300538 | Shaanxi Mai Ke Ao Te Technology Co., Ltd. romanized |
| 2023/05/19New drug · Class 1 | 注射用MT1002 · No verified English nameCXHL2300537 | Shaanxi Mai Ke Ao Te Technology Co., Ltd. romanized |
| 2023/05/18Import · Class 1 | BI 764532 输注用浓缩粉末 · No verified English nameJXSL2300096 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/05/18Generic · Class 3 | Indobufen TabletsCYHS2301349 | Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized |
| 2023/05/18Generic · Class 3 | Indobufen TabletsCYHS2301348 | Jewim Pharmaceutical (Shandong) Co., Ltd. |
| 2023/05/18Generic · Class 3 | Isoprenaline Hydrochloride InjectionCYHS2301346 | Chengdu Giantech Hi-technology Development Co., Ltd.; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized |
| 2023/05/18Generic · Class 3 | Isoprenaline Hydrochloride InjectionCYHS2301345 | Chengdu Giantech Hi-technology Development Co., Ltd.; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized |
| 2023/05/18Generic · Class 3 | Carbocisteine Oral SolutionCYHS2301344 | Ningbo Zhuo Lun Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/05/18Generic · Class 3 | Carbocisteine Oral SolutionCYHS2301343 | Ningbo Zhuo Lun Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/05/18Generic · Class 3 | Amisulpride Oral SolutionCYHS2301342 | Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2023/05/18New drug · Class 3.2 | 尼妥珠单抗注射液 · No verified English nameCXSS2300035 | Bai Tai Bio Pharma Co., Ltd. romanized |
| 2023/05/18New drug · Class 1 | 注射用DR10624 · No verified English nameCXSL2300353 | Zhejiang Dao Er Bio Technology Co., Ltd. romanized |
| 2023/05/18New drug · Class 1 | 注射用DR10624 · No verified English nameCXSL2300352 | Zhejiang Dao Er Bio Technology Co., Ltd. romanized |
58 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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