YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 194 drug applications between 9 April 2022 and 15 April 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 48, covering 33 drug names.
2022/04/09 – 2022/04/15
- New acceptances this week
- 194
- Drugs with new generic filings (by drug name, de-duplicated)
- 33
- 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
194filings, 48 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 97 |
| Generic | 48 |
| New drug | 24 |
| Import | 14 |
| Import re-registration | 6 |
| Unspecified | 4 |
| Drug-device combination product | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 149 |
| TCM | 26 |
| Therapeutic biologic | 15 |
| Prophylactic biologic | 4 |
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
33 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Oseltamivir Phosphate For Oral Suspension | 3 | 3 | 2 |
| 2 | Tadalafil Tablets | 3 | 1 | 23 |
| 3 | Palbociclib Capsules | 3 | 1 | 0 |
| 4 | Sitagliptin Phosphate Tablets | 3 | 1 | 2 |
| 5 | Rivaroxaban Tablets | 2 | 1 | 3 |
| 6 | Levofloxacin Eye Drops | 2 | 1 | 16 |
| 7 | Lacosamide Tablets | 2 | 1 | 0 |
| 8 | Flumazenil Injection | 2 | 1 | 2 |
| 9 | Omeprazole Sodium for Injection | 2 | 1 | 3 |
| 10 | Oxytocin Injection | 2 | 1 | 8 |
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
128 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guizhou Wei Li De Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 2 | Sanofi -aventis France | 5 | 1 | 0 |
| 3 | Zhu Zhou Qian Jin Pharma Co., Ltd. romanized | 4 | 2 | 0 |
| 4 | Hainan Pu Li Pharmaceutical Co., Ltd. romanized | 4 | 2 | 1 |
| 5 | Boehringer Ingelheim International GmbH | 4 | 1 | 0 |
| 6 | Fresenius Kabi Austria GmbH | 4 | 1 | 0 |
| 7 | Chengdu Brilliant Pharmaceutical Co., Ltd. | 3 | 2 | 3 |
| 8 | Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized | 3 | 2 | 3 |
| 9 | Biocon Pharma Limited | 3 | 1 | 0 |
| 10 | Blueprint Medicines Corporation | 3 | 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
41 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/04/15Import · Class 3.1 | 达雷妥尤单抗注射液(皮下注射) · No verified English nameJXSS2200013 | Janssen-Cilag International NV; Cilag AG; Xian-Janssen Pharmaceutical Ltd. |
| 2022/04/15Generic · Class 3 | Ebastine Oral SolutionCYHS2200600 | Hunan Pu Dao Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2022/04/15Generic · Class 3 | Carbocisteine Oral SolutionCYHS2200595 | Ningbo Zhuo Lun Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Kai Run Pharma Co., Ltd. romanized |
| 2022/04/15New drug · Class 2.2 | 苏龙嘎-4颗粒 · No verified English nameCXZL2200019 | Nei Menggu Zi Zhi Qu International Meng Yi Hospital romanized |
| 2022/04/15New drug · Class 1 | MN-08片 · No verified English nameCXHL2200237 | Guangzhou Xi Que Pharmaceuticals Co., Ltd. romanized |
| 2022/04/15New drug · Class 1 | HNC664胶囊 · No verified English nameCXHL2200236 | Guangzhou Shi Heng Nuo Kang Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/04/15New drug · Class 1 | GFH018 片 · No verified English nameCXHL2200235 | Zhejiang Jin Fang Pharma Co., Ltd. romanized |
| 2022/04/15New drug · Class 1 | GFH018 片 · No verified English nameCXHL2200234 | Zhejiang Jin Fang Pharma Co., Ltd. romanized |
| 2022/04/14Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2200593 | Jiangsu Vanguard Pharmaceutical Co., Ltd. |
| 2022/04/14Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2200589 | Hong Yue Technology (Hu Zhou) Co., Ltd. romanized; Shanxi Tong Da Pharma Co., Ltd. romanized |
| 2022/04/14Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2200580 | Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized |
| 2022/04/14New drug · Class 1.1 | ZY002妇科凝胶 · No verified English nameCXZL2200018 | Jiangsu Zheng Yang Pharma Co., Ltd. romanized |
| 2022/04/14New drug · Class 1 | NRT6003注射液 · No verified English nameCXHL2200233 | Chengdu Niu Rui Te Medical Technology Co., Ltd. romanized |
| 2022/04/14New drug · Class 1 | 68Ga-HX01注射液 · No verified English nameCXHL2200232 | He Xin (Suzhou) Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/04/13Import · Class 1 | Relatlimab/Nivolumab固定剂量复方注射液 · No verified English nameJXSL2200046 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2022/04/13Generic · Class 3 | Eptifibatide InjectionCYHS2200579 | Shenyang Shuang Ding Pharmaceutical Co., Ltd. romanized |
| 2022/04/13Generic · Class 3 | Flumazenil InjectionCYHS2200578 | Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized |
| 2022/04/13Generic · Class 3 | Flumazenil InjectionCYHS2200577 | Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized |
| 2022/04/13New drug · Class 1 | LBL-007注射液 · No verified English nameCXSL2200169 | Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized |
| 2022/04/12Import · Class 1 | Tremelimumab · No verified English nameJXSL2200045 | MedImmune LLC; AstraZeneca Global R&D (China) Co. Ltd. |
| 2022/04/12Import · Class 1 | JDQ443片 · No verified English nameJXHL2200085 | Novartis Pharma AG; China Novartis Institutes for BioMedical Reasearch Co. Ltd |
| 2022/04/12Generic · Class 3 | 洛索洛芬钠细粒剂 · No verified English nameCYHS2200568 | Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2022/04/12Generic · Class 3 | Roxatidine Acetate Hydrochloride For InjectionCYHS2200564 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Jin Si Li Pharma Co., Ltd. romanized |
| 2022/04/12New drug · Class 1 | IBI363 · No verified English nameCXSL2200168 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2022/04/12New drug · Class 1 | 注射用DNV3 · No verified English nameCXSL2200167 | Zhejiang Shi Mai Pharma Co., Ltd. romanized |
| 2022/04/12New drug · Class 1 | 注射用DNV3 · No verified English nameCXSL2200166 | Zhejiang Shi Mai Pharma Co., Ltd. romanized |
| 2022/04/12New drug · Class 1 | ZLT-001注射液 · No verified English nameCXSL2200165 | Guangzhou Zhi Ling Biopharmaceuticals Co., Ltd. romanized |
| 2022/04/12New drug · Class 1 | HRS-7983片 · No verified English nameCXHL2200231 | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2022/04/12New drug · Class 1 | HRS-7983片 · No verified English nameCXHL2200230 | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2022/04/11Import · Class 1 | CK-3773274片 · No verified English nameJXHL2200084 | Cytokinetics Incorporated; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd |
11 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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