YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 558 drug applications between 6 February 2026 and 12 February 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 76, covering 58 drug names.
2026/02/06 – 2026/02/12
- New acceptances this week
- 558
- Drugs with new generic filings (by drug name, de-duplicated)
- 58
- Accepted this week, now under review
- 137
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
558filings, 76 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 345 |
| New drug | 79 |
| Generic | 76 |
| Import | 33 |
| Import re-registration | 14 |
| Unspecified | 11 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 286 |
| TCM | 172 |
| Therapeutic biologic | 89 |
| Biologic | 8 |
| Prophylactic biologic | 3 |
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
58 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Crisaborole Ointment | 3 | 2 | 26 |
| 2 | Levofloxacin and Sodium Chloride Injection | 3 | 1 | 14 |
| 3 | Edoxaban Tosilate Tablets | 3 | 1 | 9 |
| 4 | 注射用磷酸左奥硝唑酯二钠 · No verified English name | 2 | 2 | 22 |
| 5 | 帕拉米韦氯化钠注射液 · No verified English name | 2 | 1 | 17 |
| 6 | Telmisartan Tablets | 2 | 1 | 4 |
| 7 | Tranexamic Acid Injection | 2 | 1 | 11 |
| 8 | Betahistine Dihydrochloride Tablets | 2 | 1 | 11 |
| 9 | Promethazine Hydrochloride Injection | 2 | 1 | 11 |
| 10 | Ambroxol Hydrochloride Oral Solution | 2 | 1 | 46 |
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
273 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Chongqing Kang Ke Er Pharmaceutical Co., Ltd. romanized | 63 | 49 | 0 |
| 2 | Ha Yao Group Bio Gong Cheng Co., Ltd. romanized | 37 | 19 | 0 |
| 3 | Jiangxi Pu Li Er Pharma Co., Ltd. romanized | 28 | 27 | 0 |
| 4 | Xiu Zheng Pharma Group (Hunan) Pharma Co., Ltd. romanized | 10 | 8 | 0 |
| 5 | Guangzhou Wan Yi Te Medical Yong Pin Co., Ltd. romanized | 10 | 6 | 0 |
| 6 | Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 7 | Janssen Research & Development LLC | 6 | 2 | 0 |
| 8 | Pfizer Inc. | 6 | 2 | 0 |
| 9 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 6 | 1 | 0 |
| 10 | AstraZeneca AB | 5 | 3 | 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
138 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/02/12Generic · Class 3 | Deferasirox TabletsCYHS2600454 | Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized |
| 2026/02/12New drug · Class 1 | SHR-1918注射液 · No verified English nameCXSS2600019 | Beijing Sheng Di Pharmaceuticals Co., Ltd. romanized; Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/02/12New drug · Class 1 | 注射用ZL-6201 · No verified English nameCXSL2600217 | Zai Ding Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2026/02/12New drug · Class 1 | 人前脑神经前体细胞注射液 · No verified English nameCXSL2600214 | Shanghai Huo Jian De Biopharmaceuticals Co., Ltd. romanized; Zhejiang Huo De Bio Gong Cheng Co., Ltd. romanized |
| 2026/02/12New drug · Class 1 | 人前脑神经前体细胞注射液 · No verified English nameCXSL2600212 | Shanghai Huo Jian De Biopharmaceuticals Co., Ltd. romanized; Zhejiang Huo De Bio Gong Cheng Co., Ltd. romanized |
| 2026/02/12New drug · Class 1 | 注射用SKB565 · No verified English nameCXSL2600209 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2026/02/12New drug · Class 2.1; 2.2 | 泰它西普注射液 · No verified English nameCXSL2600208 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2026/02/12New drug · Class 1 | 注射用SIBP-A19 · No verified English nameCXSL2600207 | Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2026/02/12New drug · Class 1 | SHR-7590注射液 · No verified English nameCXSL2600206 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/02/12New drug · Class 1 | BDHK-2009片 · No verified English nameCXHL2600184 | Bo Di He Kang (Shao Xing) Bio Technology Co., Ltd. romanized |
| 2026/02/12New drug · Class 1 | BDHK-2009片 · No verified English nameCXHL2600183 | Bo Di He Kang (Shao Xing) Bio Technology Co., Ltd. romanized |
| 2026/02/12New drug · Class 1 | TM471-1胶囊 · No verified English nameCXHL2600182 | Zhi Wei Pharma Technology (Shanghai) Co., Ltd. romanized |
| 2026/02/12New drug · Class 1 | TM471-1胶囊 · No verified English nameCXHL2600181 | Zhi Wei Pharma Technology (Shanghai) Co., Ltd. romanized |
| 2026/02/11Import · Class 1 | Pegozafermin注射液 · No verified English nameJXSL2600052 | 89bio Inc.; Roche (China) Holding Ltd. |
| 2026/02/11Import · Class 1 | Pegozafermin注射液 · No verified English nameJXSL2600051 | 89bio Inc.; Roche (China) Holding Ltd. |
| 2026/02/11Import · Class 1 | Pegozafermin注射液 · No verified English nameJXSL2600050 | 89bio Inc.; Roche (China) Holding Ltd. |
| 2026/02/11Import · Class 1 | PF-08634404 · No verified English nameJXSL2600049 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/02/11Import · Class 1 | PF-08634404 · No verified English nameJXSL2600048 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/02/11Import · Class 2.1 | Nipocalimab注射液 · No verified English nameJXSL2600047 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2026/02/11Import · Class 2.1 | Nipocalimab注射液 · No verified English nameJXSL2600046 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2026/02/11Import · Class 1 | Telisotuzumab Adizutecan 注射用粉末 · No verified English nameJXSL2600045 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2026/02/11Import · Class 1 | Telisotuzumab Adizutecan 注射用粉末 · No verified English nameJXSL2600044 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2026/02/11Import · Class 1 | PF-08634404 · No verified English nameJXSL2600043 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/02/11Import · Class 1 | PF-08634404 · No verified English nameJXSL2600042 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/02/11Import · Class 1 | JDQ443片 · No verified English nameJXHL2600043 | Novartis Pharma AG; China Novartis Institutes for BioMedical Reasearch Co. Ltd |
| 2026/02/11Import · Class 1 | TAK-360片 · No verified English nameJXHL2600042 | Takeda Development Center Americas Inc.; Takeda APAC Biopharmaceutical Research and Development Company Limited |
| 2026/02/11Import · Class 1 | TAK-360片 · No verified English nameJXHL2600041 | Takeda Development Center Americas Inc.; Takeda APAC Biopharmaceutical Research and Development Company Limited |
| 2026/02/11Import · Class 1 | TAK-360片 · No verified English nameJXHL2600040 | Takeda Development Center Americas Inc.; Takeda APAC Biopharmaceutical Research and Development Company Limited |
| 2026/02/11Import · Class 1 | TAK-360片 · No verified English nameJXHL2600039 | Takeda Development Center Americas Inc.; Takeda APAC Biopharmaceutical Research and Development Company Limited |
| 2026/02/11Import · Class 1 | TAK-360片 · No verified English nameJXHL2600038 | Takeda Development Center Americas Inc.; Takeda APAC Biopharmaceutical Research and Development Company Limited |
108 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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