YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 171 drug applications between 7 July 2022 and 13 July 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 35, covering 26 drug names.
2022/07/07 – 2022/07/13
- New acceptances this week
- 171
- Drugs with new generic filings (by drug name, de-duplicated)
- 26
- 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
171filings, 35 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 83 |
| Generic | 35 |
| Import | 21 |
| New drug | 18 |
| Import re-registration | 7 |
| Unspecified | 6 |
| Drug-device combination product | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 125 |
| Therapeutic biologic | 32 |
| TCM | 10 |
| Prophylactic biologic | 4 |
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
26 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Hydromorphone Hydrochloride Extended-Release Tablets | 3 | 1 | 0 |
| 2 | Aripiprazole Orally Disintegrating tablets | 3 | 1 | 1 |
| 3 | Phloroglucinol Injection | 2 | 2 | 2 |
| 4 | Ornidazole Injection | 2 | 1 | 0 |
| 5 | Escitalopram Oxalate Tablets | 2 | 1 | 6 |
| 6 | Calcium Gluconate in Sodium Chloride Injection | 2 | 1 | 5 |
| 7 | Ketorolac Tromethamine Injection | 2 | 1 | 4 |
| 8 | Canagliflozin Tablets | 1 | 1 | 8 |
| 9 | Diquafosol Sodium Eye Drops | 1 | 1 | 5 |
| 10 | 孟鲁司特钠颗粒 · No verified English name | 1 | 1 | 0 |
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
109 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Actelion Pharmaceuticals Ltd | 8 | 1 | 0 |
| 2 | Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized | 7 | 2 | 0 |
| 3 | LES LABORATOIRES SERVIER | 5 | 3 | 0 |
| 4 | CSL Behring GmbH | 5 | 1 | 0 |
| 5 | Novo Nordisk A/S | 5 | 1 | 0 |
| 6 | Pfizer Europe MA EEIG | 4 | 3 | 0 |
| 7 | Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized | 3 | 3 | 2 |
| 8 | Grunenthal GmbH | 3 | 2 | 0 |
| 9 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc. | 3 | 2 | 0 |
| 10 | NextWave Pharmaceuticals Inc a subsidiary of Tris Pharma Inc | 3 | 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
54 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/07/12Import · Class 2.2 | 司美格鲁肽片 · No verified English nameJXSL2200108 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2022/07/12Import · Class 2.2 | 司美格鲁肽片 · No verified English nameJXSL2200107 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2022/07/12Import · Class 2.2 | 司美格鲁肽片 · No verified English nameJXSL2200106 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2022/07/12Import · Class 2.2 | 司美格鲁肽片 · No verified English nameJXSL2200105 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2022/07/12Import · Class 2.2 | 司美格鲁肽片 · No verified English nameJXSL2200104 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2022/07/12Import · Class 1 | TAK-981 注射液 · No verified English nameJXHL2200179 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd |
| 2022/07/12Generic · Class 3 | Aripiprazole Orally Disintegrating tabletsCYHS2201007 | YaoPharma Co., Ltd. |
| 2022/07/12Generic · Class 3 | Aripiprazole Orally Disintegrating tabletsCYHS2201006 | YaoPharma Co., Ltd. |
| 2022/07/12Generic · Class 3 | Aripiprazole Orally Disintegrating tabletsCYHS2201005 | YaoPharma Co., Ltd. |
| 2022/07/12New drug · Class 3.2 | 注射用重组替度鲁肽 · No verified English nameCXSL2200316 | Chongqing Pai Jin Bio Technology Co., Ltd. romanized |
| 2022/07/12New drug · Class 2.4 | 盐酸米托蒽醌脂质体注射液 · No verified English nameCXHL2200497 | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. |
| 2022/07/12New drug · Class 1 | XTN003098 · No verified English nameCXHL2200496 | Shenzhen Zhong Ge Bio Technology Co., Ltd. romanized |
| 2022/07/12New drug · Class 1 | XTN003098 · No verified English nameCXHL2200495 | Shenzhen Zhong Ge Bio Technology Co., Ltd. romanized |
| 2022/07/12New drug · Class 1 | STC007注射液 · No verified English nameCXHL2200494 | Chengdu Nuo He Cheng Tai Bio Technology Co., Ltd. romanized |
| 2022/07/12New drug · Class 1 | EG017片 · No verified English nameCXHL2200493 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2022/07/11Import · Class 3.1 | 注射用重组人凝血因子IX-白蛋白融合蛋白 · No verified English nameJXSL2200118 | CSL Behring GmbH; PAREXEL CHINA CO. LTD |
| 2022/07/11Import · Class 3.1 | 注射用重组人凝血因子IX-白蛋白融合蛋白 · No verified English nameJXSL2200117 | CSL Behring GmbH; PAREXEL CHINA CO. LTD |
| 2022/07/11Import · Class 3.1 | 注射用重组人凝血因子IX-白蛋白融合蛋白 · No verified English nameJXSL2200116 | CSL Behring GmbH; PAREXEL CHINA CO. LTD |
| 2022/07/11Import · Class 3.1 | 注射用重组人凝血因子IX-白蛋白融合蛋白 · No verified English nameJXSL2200115 | CSL Behring GmbH; PAREXEL CHINA CO. LTD |
| 2022/07/11Import · Class 3.1 | 注射用重组人凝血因子IX-白蛋白融合蛋白 · No verified English nameJXSL2200114 | CSL Behring GmbH; PAREXEL CHINA CO. LTD |
| 2022/07/11Generic · Class 3 | Hydromorphone Hydrochloride Extended-Release TabletsCYHS2201047 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2022/07/11Generic · Class 3 | Hydromorphone Hydrochloride Extended-Release TabletsCYHS2201046 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2022/07/11Generic · Class 3 | Hydromorphone Hydrochloride Extended-Release TabletsCYHS2201045 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2022/07/11Generic · Class 3 | Terlipressin Acetate InjectionCYHS2201042 | Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Shanxi Wei Qi Da Guang Ming Pharmaceutical Co., Ltd. romanized |
| 2022/07/11Generic · Class 3 | Calcium Gluconate in Sodium Chloride InjectionCYHS2201041 | Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Zhejiang Guo Jing Pharma Co., Ltd. romanized |
| 2022/07/11Generic · Class 3 | Calcium Gluconate in Sodium Chloride InjectionCYHS2201040 | Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Zhejiang Guo Jing Pharma Co., Ltd. romanized |
| 2022/07/11Generic · Class 3 | Florbetaben F-18 InjectionCYHS2201037 | Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized; Tianjin Yuan Zi Gao Ke Tong Wei Su Pharmaceuticals Co., Ltd. romanized |
| 2022/07/11Generic · Class 3 | Mometasone Furoate CreamCYHS2201026 | Fu Yuan Pharma Co., Ltd. romanized |
| 2022/07/11Generic · Class 3 | Pregabalin Extended release TabletsCYHL2200057 | Qilu Pharmaceutical Co., Ltd. |
| 2022/07/11Generic · Class 3 | 盐酸溴己新雾化吸入溶液 · No verified English nameCYHL2200056 | Hainan Huluwa Pharmaceutical Group Co., Ltd. |
24 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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