YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 312 drug applications between 16 September 2022 and 22 September 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 63, covering 46 drug names.
2022/09/16 – 2022/09/22
- New acceptances this week
- 312
- Drugs with new generic filings (by drug name, de-duplicated)
- 46
- 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
312filings, 63 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 148 |
| Generic | 63 |
| New drug | 60 |
| Unspecified | 18 |
| Import | 16 |
| Import re-registration | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 231 |
| TCM | 34 |
| Therapeutic biologic | 31 |
| Biologic | 15 |
| 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
46 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Dapagliflozin And Metformin Hydrochloride Extended-Release Tablets | 5 | 1 | 0 |
| 2 | Indobufen Tablets | 3 | 2 | 6 |
| 3 | Oseltamivir Phosphate For Oral Suspension | 3 | 2 | 2 |
| 4 | Oseltamivir Phosphate Capsules | 3 | 1 | 39 |
| 5 | Tandospirone Citrate Tablets | 2 | 1 | 2 |
| 6 | Tranexamic Acid Injection | 2 | 1 | 11 |
| 7 | Teicoplanin for Injection | 2 | 1 | 6 |
| 8 | Hydrocortisone Sodium Succinate for Injection | 2 | 1 | 16 |
| 9 | Doxorubicin Hydrochloride Liposome Injection | 2 | 1 | 2 |
| 10 | Calcium Gluconate in Sodium Chloride Injection | 2 | 1 | 5 |
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
170 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hubei Mei Lin Pharma Co., Ltd. romanized | 22 | 16 | 0 |
| 2 | Shanghai Yan An Pharma Co., Ltd. romanized | 12 | 11 | 0 |
| 3 | Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized | 8 | 6 | 0 |
| 4 | Vetter Pharma-Fertigung GmbH & Co. KG | 8 | 2 | 0 |
| 5 | Da Lian Tian Shan Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 6 | Actelion Pharmaceuticals Ltd | 6 | 2 | 0 |
| 7 | Boehringer Ingelheim International GmbH | 5 | 1 | 0 |
| 8 | Sanofi -aventis France | 5 | 1 | 0 |
| 9 | Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized | 5 | 1 | 5 |
| 10 | Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized | 4 | 4 | 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
105 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/09/22Import · Class 2.2 | 注射用戈沙妥珠单抗 · No verified English nameJXSL2200169 | Everest Medicines (Singapore) Pte. Ltd.; Everest Medicines (Suzhou) Inc. |
| 2022/09/22Import · Class 1 | TAK-861片 · No verified English nameJXHL2200292 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd |
| 2022/09/22Import · Class 1 | TAK-861片 · No verified English nameJXHL2200291 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd |
| 2022/09/22Import · Class 1 | TAK-861片 · No verified English nameJXHL2200290 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd |
| 2022/09/22Generic · Class 3 | Calcium Gluconate in Sodium Chloride InjectionCYHS2201582 | Hebei Tian Cheng Pharma Co., Ltd. romanized |
| 2022/09/22Generic · Class 3 | Calcium Gluconate in Sodium Chloride InjectionCYHS2201581 | Hebei Tian Cheng Pharma Co., Ltd. romanized |
| 2022/09/22Generic · Class 3 | Ampicillin Sodium For InjectionCYHS2201580 | Guangxi Wei Chao Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Pharmaceutical Formulations Co., Ltd. romanized |
| 2022/09/22Generic · Class 3 | Lidocaine CataplasmsCYHL2200081 | Beijing Pai Chi Tai Ke Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/09/22New drug · Class 1 | BC3402注射液 · No verified English nameCXSL2200474 | Wuxi Zhi Kang Hong Yi Bio Technology Co., Ltd. romanized |
| 2022/09/22New drug · Class 1 | FKC889 · No verified English nameCXSL2200473 | Fu Xing Kai Te Bio Technology Co., Ltd. romanized |
| 2022/09/22New drug · Class 1 | CYH33片 · No verified English nameCXHL2200723 | Shanghai Hai He Drug Research Kai Fa Co., Ltd. romanized |
| 2022/09/22New drug · Class 1 | CYH33片 · No verified English nameCXHL2200722 | Shanghai Hai He Drug Research Kai Fa Co., Ltd. romanized |
| 2022/09/22New drug · Class 1 | JL1132胶囊 · No verified English nameCXHL2200721 | Jilin Sheng Jiang Lin Bio Technology Co., Ltd. romanized |
| 2022/09/22New drug · Class 1 | JL1132胶囊 · No verified English nameCXHL2200720 | Jilin Sheng Jiang Lin Bio Technology Co., Ltd. romanized |
| 2022/09/22New drug · Class 1 | HL-003片 · No verified English nameCXHL2200719 | Shanghai Ke Zhou Drug Research and Development Co., Ltd. romanized |
| 2022/09/22New drug · Class 1 | HL-003片 · No verified English nameCXHL2200718 | Shanghai Ke Zhou Drug Research and Development Co., Ltd. romanized |
| 2022/09/22New drug · Class 1 | HL-003片 · No verified English nameCXHL2200717 | Shanghai Ke Zhou Drug Research and Development Co., Ltd. romanized |
| 2022/09/22New drug · Class 2.2 | 注射用多西他赛(白蛋白结合型) · No verified English nameCXHL2200716 | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized |
| 2022/09/22New drug · Class 1 | THDBH151片 · No verified English nameCXHL2200715 | Dong Bao Zi Xing (Hangzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2022/09/22New drug · Class 1 | THDBH151片 · No verified English nameCXHL2200714 | Dong Bao Zi Xing (Hangzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2022/09/22New drug · Class 1 | THDBH151片 · No verified English nameCXHL2200713 | Dong Bao Zi Xing (Hangzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2022/09/22New drug · Class 1 | ZX-4081片 · No verified English nameCXHL2200712 | Nanjing Zheng Xiang Pharmaceuticals Co., Ltd. romanized |
| 2022/09/22New drug · Class 1 | ZX-4081片 · No verified English nameCXHL2200711 | Nanjing Zheng Xiang Pharmaceuticals Co., Ltd. romanized |
| 2022/09/21Import · Class 2.2 | 注射用Tafasitamab · No verified English nameJXSL2200168 | Incyte Biosciences Distribution B.V.; Beijing InnoCare Pharma Tech Co. Ltd. |
| 2022/09/21Import · Class 1 | LEO 152020 薄膜包衣片 · No verified English nameJXHL2200289 | LEO Pharma A/S; LEO Pharma Consultany(Shanghai) company Limited |
| 2022/09/21Import · Class 1 | 注射用TNP-2092 · No verified English nameJXHL2200288 | TenNor Therapeutics Inc.; TenNor (Suzhou) Therapeutics Limited |
| 2022/09/21Generic · Class 3 | Neostigmine Methylsulfate InjectionCYHS2201577 | Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2022/09/21Generic · Class 3 | Cilostazol TabletsCYHS2201576 | Beijing Foyou Pharma CO.,LTD |
| 2022/09/21Generic · Class 3 | Indobufen TabletsCYHS2201574 | Zhejiang Mei Di Shen Biopharmaceuticals Co., Ltd. romanized; Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized |
| 2022/09/21New drug · Class 1.2 | 枳实总黄酮苷提取物 · No verified English nameCXZS2200009 | Jiangxi Qing Feng Pharma Co., Ltd. romanized |
75 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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