YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 393 drug applications between 16 August 2023 and 22 August 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 105, covering 76 drug names.
2023/08/16 – 2023/08/22
- New acceptances this week
- 393
- Drugs with new generic filings (by drug name, de-duplicated)
- 76
- 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
393filings, 105 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 196 |
| Generic | 105 |
| New drug | 47 |
| Import | 33 |
| Unspecified | 7 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 291 |
| TCM | 53 |
| Therapeutic biologic | 39 |
| Prophylactic biologic | 6 |
| Biologic | 3 |
| 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
76 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Gadoteridol Injection | 4 | 1 | 3 |
| 2 | Urapidil Hydrochloride Injection | 3 | 2 | 6 |
| 3 | Iopromide Injection | 3 | 2 | 27 |
| 4 | 恩那度司他片 · No verified English name | 3 | 1 | 0 |
| 5 | Tadalafil Tablets | 2 | 2 | 23 |
| 6 | Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid Oral Solution | 2 | 2 | 2 |
| 7 | Potassium Chloride Injection | 2 | 2 | 10 |
| 8 | Lornoxicam for Injection | 2 | 2 | 2 |
| 9 | Bortezomib For Injection | 2 | 2 | 1 |
| 10 | Labetalol Hydrochloride Injection | 2 | 2 | 4 |
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
237 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized | 24 | 19 | 1 |
| 2 | Changsha Ai Bei Gao Pharma Co., Ltd. romanized | 11 | 11 | 0 |
| 3 | Janssen Research & Development LLC | 6 | 3 | 0 |
| 4 | Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | Guangdong Da Zhong Pharmaceutical Co., Ltd. romanized | 5 | 3 | 0 |
| 6 | Hainan Brilliant Pharmaceutical Co., Ltd. | 5 | 3 | 1 |
| 7 | Myokardia Inc. | 5 | 1 | 0 |
| 8 | Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 4 | 2 | 2 |
| 9 | Eli Lilly and Company | 4 | 1 | 0 |
| 10 | Shandong Er Ye Pharmaceutical Co., Ltd. romanized | 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
120 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/08/22Import · Class 1 | BI685509片 · No verified English nameJXHL2300195 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/08/22Import · Class 1 | BI685509片 · No verified English nameJXHL2300194 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/08/22Import · Class 1 | BI685509片 · No verified English nameJXHL2300193 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/08/22Import · Class 1 | JNJ-77242113-AAC片 · No verified English nameJXHL2300192 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/08/22Import · Class 1 | JNJ-77242113-AAC片 · No verified English nameJXHL2300191 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/08/22Generic · Class 3 | Epalrestat TabletsCYHS2302233 | Le Pu Pharmaceutical Technology Co., Ltd. romanized |
| 2023/08/22Generic · Class 3 | 复方奥美拉唑干混悬剂 · No verified English nameCYHS2302230 | Zhejiang Tong Wu Biopharmaceuticals Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2023/08/22Generic · Class 3 | 复方奥美拉唑干混悬剂 · No verified English nameCYHS2302229 | Zhejiang Tong Wu Biopharmaceuticals Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2023/08/22Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2302228 | Hainan Huluwa Pharmaceutical Group Co., Ltd. |
| 2023/08/22Generic · Class 3 | 盐酸肾上腺素注射液 · No verified English nameCYHS2302227 | Chengdu Giantech Hi-technology Development Co., Ltd.; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
| 2023/08/22Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2302225 | Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized; Yi Ling Wan Zhou International Pharmaceutical Co., Ltd. romanized |
| 2023/08/22Generic · Class 3 | Fudosteine oral solutionCYHS2302224 | Jiangsu Lianhuan Pharmaceutical Co.,Ltd.; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2023/08/22Generic · Class 3 | Sodium Thiosulfate InjectionCYHS2302223 | Chengdu Brilliant Pharmaceutical Co., Ltd. |
| 2023/08/22Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2302220 | Wuhan Jiu An Pharma Co., Ltd. romanized; Lang Tian Pharma (Hubei) Co., Ltd. romanized |
| 2023/08/22Generic · Class 3 | Procaterol Hydrochloride Solution for InhalationCYHS2302217 | Yang Zhou Zhong Bao Pharma Co., Ltd. romanized |
| 2023/08/22Generic · Class 3 | Famotidine InjectionCYHS2302215 | Jiangsu Yu Xing Pharmaceuticals Technology Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized |
| 2023/08/22Generic · Class 3 | Ketotifen Fumarate Oral SolutionCYHS2302211 | Haikou Tian Xing Jian Drug Research Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanized |
| 2023/08/22Generic · Class 3 | Nimodipine Oral SolutionCYHS2302210 | Hainan Quan Xing Pharmaceutical Co., Ltd. romanized |
| 2023/08/22Generic · Class 3 | Potassium Chloride InjectionCYHS2302209 | Heilongjiang Bo Yu Pharmaceutical Co., Ltd. romanized; Hubei Ke Lun Pharma Co., Ltd. romanized |
| 2023/08/22Generic · Class 3 | Naloxone Hydrochloride InjectionCYHS2302207 | Hubei Jin Yao Pharma Co., Ltd. romanized |
| 2023/08/22Generic · Class 3 | Naloxone Hydrochloride InjectionCYHS2302206 | Hubei Jin Yao Pharma Co., Ltd. romanized |
| 2023/08/22Generic · Class 3 | Levetiracetam in Sodium Chloride InjectionCYHS2302205 | Guizhou Fu Kang Ren Pharmaceutical Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2023/08/22Generic · Class 3 | Sodium Bicarbonate Ringer’s InjectionCYHS2302204 | Wuhan Fu Xing Bio Pharma Co., Ltd. romanized |
| 2023/08/22Generic · Class 3 | Methylprednisolone Aceponate CreamCYHL2300104 | Guangdong Hua Run Shun Feng Pharma Co., Ltd. romanized |
| 2023/08/22New drug · Class 3.3 | 利拉鲁肽注射液 · No verified English nameCXSS2300067 | Zhuhai Lian Bang Biopharmaceuticals Co., Ltd. romanized; Zhuhai Lian Bang Pharmaceutical Co., Ltd. romanized |
| 2023/08/22New drug · Class 1 | 异体内皮祖细胞(EPCs)注射液 · No verified English nameCXSL2300561 | Cheng Nuo Zai Sheng Yi Xue Technology (Beijing) Co., Ltd. romanized |
| 2023/08/22New drug · Class 1 | 注射用DR10624 · No verified English nameCXSL2300560 | Zhejiang Dao Er Bio Technology Co., Ltd. romanized |
| 2023/08/22New drug · Class 1 | 注射用DR10624 · No verified English nameCXSL2300559 | Zhejiang Dao Er Bio Technology Co., Ltd. romanized |
| 2023/08/22New drug · Class 1 | ANS014004片 · No verified English nameCXHL2300904 | Beijing An Shi Bio Technology Co., Ltd. romanized |
| 2023/08/22New drug · Class 1 | ANS014004片 · No verified English nameCXHL2300903 | Beijing An Shi Bio Technology Co., Ltd. romanized |
90 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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