YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 301 drug applications between 12 July 2022 and 18 July 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 50, covering 37 drug names.
2022/07/12 – 2022/07/18
- New acceptances this week
- 301
- Drugs with new generic filings (by drug name, de-duplicated)
- 37
- Accepted this week, now under review
- 3
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
301filings, 50 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 168 |
| Generic | 50 |
| Import | 39 |
| New drug | 31 |
| Import re-registration | 8 |
| Unspecified | 3 |
| Drug-device combination product | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 238 |
| Therapeutic biologic | 34 |
| TCM | 24 |
| Prophylactic biologic | 4 |
| 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
37 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Phloroglucinol Injection | 3 | 3 | 2 |
| 2 | Palbociclib Capsules | 3 | 1 | 0 |
| 3 | Ruxolitinib Phosphate Tablets | 3 | 1 | 27 |
| 4 | Aripiprazole Orally Disintegrating tablets | 3 | 1 | 1 |
| 5 | Perampanel Tablets | 2 | 1 | 2 |
| 6 | Doxercalciferol Injection | 2 | 1 | 1 |
| 7 | Aminophylline Injection | 2 | 1 | 3 |
| 8 | Dexmedetomidine Hydrochloride Injection | 2 | 1 | 0 |
| 9 | Oxytocin Injection | 2 | 1 | 8 |
| 10 | Scopolamine Butylbromide Injection | 1 | 1 | 7 |
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
164 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 13 | 4 | 3 |
| 2 | Actelion Pharmaceuticals Ltd | 8 | 1 | 0 |
| 3 | Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized | 7 | 7 | 0 |
| 4 | Sichuan Guo Rui Pharma Co., Ltd. romanized | 7 | 2 | 0 |
| 5 | Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized | 7 | 2 | 0 |
| 6 | AstraZeneca AB | 6 | 2 | 0 |
| 7 | Novo Nordisk A/S | 6 | 2 | 0 |
| 8 | Eli Lilly and Company | 6 | 1 | 0 |
| 9 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized | 6 | 1 | 0 |
| 10 | Qingdao Rui Nai Medical Technology Co., Ltd. romanized | 5 | 5 | 5 |
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
93 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/07/18Import · Class 3.1 | 依库珠单抗注射液 · No verified English nameJXSS2200023 | Alexion Europe SAS; Alexion Athlone Manufacturing Facility (AAMF); AstraZeneca Investment (China) Co. Ltd |
| 2022/07/18Import · Class 1 | Nolasiban分散片 · No verified English nameJXHL2200201 | ObsEva S.A.; Hangzhou Yuyuan Bioscience Technology Co. Ltd. |
| 2022/07/18Import · Class 1 | Nolasiban分散片 · No verified English nameJXHL2200200 | ObsEva S.A.; Hangzhou Yuyuan Bioscience Technology Co. Ltd. |
| 2022/07/18Generic · Class 3 | Magnesium Sulfate InjectionCYHS2201096 | Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2022/07/18Generic · Class 3 | Beraprost Sodium TabletsCYHS2201090 | Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized |
| 2022/07/18Generic · Class 3 | Dobutamine Hydrochloride InjectionCYHS2201088 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 2022/07/18Generic · Class 3 | Acotiamide Hydrochloride TabletsCYHS2201087 | Beijing Ya Bao Bio Pharma Co., Ltd. romanized |
| 2022/07/18Generic · Class 3 | Salbutamol Sulfate injectionCYHS2201078 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2022/07/18Generic · Class 3 | Doxercalciferol InjectionCYHL2200060 | Nanjing Hai Rong Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/07/18Generic · Class 3 | Doxercalciferol InjectionCYHL2200059 | Nanjing Hai Rong Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/07/18Generic · Class 3 | 立他司特滴眼液 · No verified English nameCYHL2200058 | Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized |
| 2022/07/18New drug · Class 1 | 注射用SG1408 · No verified English nameCXSL2200323 | Zhong Sheng Shang Jian Biopharmaceuticals (Hangzhou) Co., Ltd. romanized |
| 2022/07/18New drug · Class 1 | HTMC0435片 · No verified English nameCXHL2200514 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2022/07/18New drug · Class 1 | HTMC0435片 · No verified English nameCXHL2200513 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2022/07/18New drug · Class 1 | HTMC0435片 · No verified English nameCXHL2200512 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2022/07/18New drug · Class 1 | HTMC0435片 · No verified English nameCXHL2200511 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2022/07/18New drug · Class 1 | HTMC0435片 · No verified English nameCXHL2200510 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2022/07/18New drug · Class 1 | HTMC0435片 · No verified English nameCXHL2200509 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2022/07/18New drug · Class 1 | HZ-A-018胶囊 · No verified English nameCXHL2200507 | Hangzhou He Zheng Pharmaceuticals Co., Ltd. romanized |
| 2022/07/18New drug · Class 1 | HZ-A-018胶囊 · No verified English nameCXHL2200506 | Hangzhou He Zheng Pharmaceuticals Co., Ltd. romanized |
| 2022/07/18New drug · Class 2.4 | Nalbuphine Hydrochloride InjectionCXHL2200505 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2022/07/18New drug · Class 1 | LF0001片 · No verified English nameCXHL2200504 | Hangzhou Ling Fang Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/07/18New drug · Class 2.2 | LJ01005颗粒 · No verified English nameCXHL2200503 | Changchun Lan Jiang Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/07/15Import · Class 1 | 锆[89Zr]吉伦妥昔单抗注射液 · No verified English nameJXSL2200123 | Telix International Pty Ltd; Grand Pharmaceutical (China) Co. Ltd |
| 2022/07/15Import · Class 1 | Talquetamab注射液 · No verified English nameJXSL2200122 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/07/15Import · Class 1 | Talquetamab注射液 · No verified English nameJXSL2200121 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/07/15Import · Class 1 | 氘可来昔替尼片 · No verified English nameJXHS2200061 | Bristol-Myers Squibb Pharma EEIG; PATHEON INC.; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2022/07/15Import · Class 2.4 | Tirzepatide注射液 · No verified English nameJXHL2200199 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2022/07/15Import · Class 2.4 | Tirzepatide注射液 · No verified English nameJXHL2200198 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2022/07/15Import · Class 2.4 | Tirzepatide注射液 · No verified English nameJXHL2200197 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
63 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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