YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 296 drug applications between 3 September 2022 and 9 September 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 58, covering 41 drug names.
2022/09/03 – 2022/09/09
- New acceptances this week
- 296
- Drugs with new generic filings (by drug name, de-duplicated)
- 41
- 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
296filings, 58 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 151 |
| Generic | 58 |
| New drug | 38 |
| Import | 29 |
| Unspecified | 15 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 201 |
| TCM | 46 |
| Therapeutic biologic | 45 |
| Prophylactic biologic | 3 |
| Biologic | 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
41 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Diquafosol Sodium Eye Drops | 3 | 3 | 5 |
| 2 | Carfilzomib For Injection | 3 | 1 | 0 |
| 3 | Lidocaine Hydrochloride Injection | 3 | 1 | 6 |
| 4 | Sitagliptin Phosphate Tablets | 3 | 1 | 2 |
| 5 | Rivaroxaban Fine Granules | 2 | 1 | 0 |
| 6 | Ipratropium Bromide Inhalation Solution | 2 | 1 | 2 |
| 7 | Ozagrel Sodium Injection | 2 | 1 | 3 |
| 8 | Olaparib Tablets | 2 | 1 | 0 |
| 9 | Tranexamic Acid Injection | 2 | 1 | 11 |
| 10 | Parecoxib Sodium for 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
157 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized | 32 | 29 | 0 |
| 2 | Bayer AG | 14 | 12 | 0 |
| 3 | Eli Lilly and Company | 9 | 3 | 0 |
| 4 | Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized | 8 | 7 | 0 |
| 5 | Janssen-Cilag International NV | 6 | 5 | 0 |
| 6 | Baxalta US Inc. | 6 | 1 | 0 |
| 7 | Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized | 6 | 1 | 0 |
| 8 | Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized | 5 | 3 | 0 |
| 9 | Guo Yao Group Gong Ye Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Novartis Pharma AG | 4 | 2 | 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
79 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/09/09Import · Class 3.1 | 安纳白介素注射液(预充式) · No verified English nameJXSS2200034 | Swedish Orphan Biovitrum AB (publ); Hospira Zagreb d.o.o.; SOBI Pharma (Shanghai) Company Limited |
| 2022/09/09Import · Class 3.1 | 古塞奇尤单抗注射液 · No verified English nameJXSL2200163 | Janssen-Cilag International NV; Xian Janssen Pharmaceutical Ltd. |
| 2022/09/09Import · Class 3.1 | 注射用培重组人凝血因子Ⅷ · No verified English nameJXSL2200162 | Baxalta US Inc.; Takeda(China) International Trading Co. Ltd |
| 2022/09/09Import · Class 3.1 | 注射用培重组人凝血因子Ⅷ · No verified English nameJXSL2200161 | Baxalta US Inc.; Takeda(China) International Trading Co. Ltd |
| 2022/09/09Import · Class 3.1 | 注射用培重组人凝血因子Ⅷ · No verified English nameJXSL2200160 | Baxalta US Inc.; Takeda(China) International Trading Co. Ltd |
| 2022/09/09Import · Class 3.1 | 注射用培重组人凝血因子Ⅷ · No verified English nameJXSL2200159 | Baxalta US Inc.; Takeda(China) International Trading Co. Ltd |
| 2022/09/09Import · Class 3.1 | 注射用培重组人凝血因子Ⅷ · No verified English nameJXSL2200158 | Baxalta US Inc.; Takeda(China) International Trading Co. Ltd |
| 2022/09/09Import · Class 3.1 | 注射用培重组人凝血因子Ⅷ · No verified English nameJXSL2200157 | Baxalta US Inc.; Takeda(China) International Trading Co. Ltd |
| 2022/09/09Generic · Class 3 | Calcium Gluconate in Sodium Chloride InjectionCYHS2201498 | Hui Yin Bi Group Fu Zhou Pharmaceutical Co., Ltd. romanized; Hui Yin Bi Group Jiangxi Dong Ya Pharmaceutical Co., Ltd. romanized |
| 2022/09/09Generic · Class 3 | Calcium Gluconate in Sodium Chloride InjectionCYHS2201497 | Hui Yin Bi Group Fu Zhou Pharmaceutical Co., Ltd. romanized; Hui Yin Bi Group Jiangxi Dong Ya Pharmaceutical Co., Ltd. romanized |
| 2022/09/09Generic · Class 3 | Bromhexine Hydrochloride InjectionCYHS2201492 | Hainan Huluwa Pharmaceutical Group Co., Ltd. |
| 2022/09/09New drug · Class 3.3 | 水痘减毒活疫苗 · No verified English nameCXSS2200078 | Beijing Min Hai Bio Technology Co., Ltd. romanized |
| 2022/09/09New drug · Class 2.4 | ZHB107-108舌下片 · No verified English nameCXSL2200454 | Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized |
| 2022/09/09New drug · Class 2.4 | ZHB107-108舌下片 · No verified English nameCXSL2200453 | Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized |
| 2022/09/09New drug · Class 2.4 | ZHB107-108舌下片 · No verified English nameCXSL2200452 | Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized |
| 2022/09/09New drug · Class 2.4 | ZHB107-108舌下片 · No verified English nameCXSL2200451 | Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized |
| 2022/09/09New drug · Class 2.4 | ZHB107-108舌下片 · No verified English nameCXSL2200450 | Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized |
| 2022/09/09New drug · Class 2.4 | ZHB107-108舌下片 · No verified English nameCXSL2200449 | Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized |
| 2022/09/09New drug · Class 1 | FB-1071 · No verified English nameCXHL2200663 | Fu Bei Biopharmaceuticals Technology (Beijing) Co., Ltd. romanized |
| 2022/09/08Import · Class 1 | DS-1062a · No verified English nameJXSL2200156 | Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2022/09/08Import · Class 1 | Tigulixostat片 · No verified English nameJXHL2200281 | LG CHEM LTD.; PAREXEL China Co. Ltd. |
| 2022/09/08Import · Class 1 | Tigulixostat片 · No verified English nameJXHL2200280 | LG CHEM LTD.; PAREXEL China Co. Ltd. |
| 2022/09/08Import · Class 1 | NBQ72S · No verified English nameJXHL2200279 | NANTONG BENCAO QUADRIGA MEDICAL TECHNOLOGY HK LIMITED; PAREXEL China Co. Ltd. |
| 2022/09/08Generic · Class 3 | Roxatidine Acetate Hydrochloride For InjectionCYHS2201488 | Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized |
| 2022/09/08Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2201487 | Jiangsu Guang Cheng Pharma Co., Ltd. romanized |
| 2022/09/08Generic · Class 3 | Rivaroxaban Fine GranulesCYHS2201485 | Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2022/09/08Generic · Class 3 | Rivaroxaban Fine GranulesCYHS2201484 | Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2022/09/08Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2201479 | Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Tong Da Pharma Co., Ltd. romanized |
| 2022/09/08Generic · Class 3 | Tranexamic Acid InjectionCYHS2201478 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2022/09/08Generic · Class 3 | Tranexamic Acid InjectionCYHS2201477 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
49 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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