YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 281 drug applications between 9 July 2022 and 15 July 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 50, covering 35 drug names.
2022/07/09 – 2022/07/15
- New acceptances this week
- 281
- Drugs with new generic filings (by drug name, de-duplicated)
- 35
- 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
281filings, 50 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 148 |
| Generic | 50 |
| Import | 45 |
| New drug | 23 |
| Import re-registration | 10 |
| Unspecified | 3 |
| Drug-device combination product | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 218 |
| Therapeutic biologic | 39 |
| TCM | 19 |
| 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
35 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Phloroglucinol Injection | 4 | 4 | 2 |
| 2 | Palbociclib Capsules | 3 | 1 | 0 |
| 3 | Hydromorphone Hydrochloride Extended-Release Tablets | 3 | 1 | 0 |
| 4 | Ruxolitinib Phosphate Tablets | 3 | 1 | 27 |
| 5 | Aripiprazole Orally Disintegrating tablets | 3 | 1 | 1 |
| 6 | Aminophylline Injection | 2 | 1 | 3 |
| 7 | Dexmedetomidine Hydrochloride Injection | 2 | 1 | 0 |
| 8 | Oxytocin Injection | 2 | 1 | 8 |
| 9 | Calcium Gluconate in Sodium Chloride Injection | 2 | 1 | 5 |
| 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
152 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 | Sichuan Guo Rui Pharma Co., Ltd. romanized | 7 | 2 | 0 |
| 4 | Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized | 7 | 2 | 0 |
| 5 | Novo Nordisk A/S | 6 | 2 | 0 |
| 6 | Eli Lilly and Company | 6 | 1 | 0 |
| 7 | LES LABORATOIRES SERVIER | 5 | 3 | 0 |
| 8 | Novartis Pharma AG | 5 | 2 | 0 |
| 9 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 5 | 2 | 3 |
| 10 | CSL Behring GmbH | 5 | 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
89 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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. |
| 2022/07/15Import · Class 2.4 | Tirzepatide注射液 · No verified English nameJXHL2200196 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2022/07/15Import · Class 2.4 | Tirzepatide注射液 · No verified English nameJXHL2200195 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2022/07/15Import · Class 2.4 | Tirzepatide注射液 · No verified English nameJXHL2200194 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2022/07/15Import · Class 1 | AZD5305 · No verified English nameJXHL2200193 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2022/07/15Import · Class 1 | AZD5305 · No verified English nameJXHL2200192 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2022/07/15Import · Class 1 | AZD5305 · No verified English nameJXHL2200191 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2022/07/15Import · Class 1 | AZD5305 · No verified English nameJXHL2200190 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2022/07/15Generic · Class 3 | Procaterol Hydrochloride Oral SolutionCYHS2201079 | Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2022/07/15Generic · Class 3 | Aminophylline InjectionCYHS2201076 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2022/07/15Generic · Class 3 | Aminophylline InjectionCYHS2201075 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2022/07/15Generic · Class 3 | Dexmedetomidine Hydrochloride InjectionCYHS2201074 | NANJING ZENKOM PHARMACEUTICAL CO.,LTD. |
| 2022/07/15Generic · Class 3 | Dexmedetomidine Hydrochloride InjectionCYHS2201073 | NANJING ZENKOM PHARMACEUTICAL CO.,LTD. |
| 2022/07/15Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2201072 | Ling Kang Pharma Group Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanized |
| 2022/07/15New drug · Class 3.3 | 德谷胰岛素注射液 · No verified English nameCXSS2200067 | Hui Sheng Biopharmaceutical Co., Ltd. romanized |
| 2022/07/15New drug · Class 3.3 | 德谷胰岛素注射液 · No verified English nameCXSS2200066 | Hui Sheng Biopharmaceutical Co., Ltd. romanized |
| 2022/07/15New drug · Class 1 | 注射用重组人凝血因子VIIa-Fc融合蛋白 · No verified English nameCXSL2200322 | Jiangsu Cheng Si Biopharmaceutical Co., Ltd. romanized |
| 2022/07/15New drug · Class 1 | 注射用重组人凝血因子VIIa-Fc融合蛋白 · No verified English nameCXSL2200321 | Jiangsu Cheng Si Biopharmaceutical Co., Ltd. romanized |
| 2022/07/14Import · Class 3.1 | 艾加莫德α注射液 · No verified English nameJXSS2200022 | argenx BV; Vetter Pharma-Fertigung GmbH & Co. KG; Zai Lab (Shanghai) Co. Ltd. |
| 2022/07/14Import · Class 1 | CAEL-101注射液 · No verified English nameJXSL2200120 | Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd. |
| 2022/07/14Import · Class 1 | CPI-006注射液 · No verified English nameJXSL2200119 | Corvus Pharmaceuticals Inc.; Angel Pharmaceuticals Co. Ltd. |
| 2022/07/14Import · Class 1 | LTT462 · No verified English nameJXHL2200189 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2022/07/14Import · Class 1 | LTT462 · No verified English nameJXHL2200188 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2022/07/14Import · Class 1 | TNO155 · No verified English nameJXHL2200187 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
59 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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