YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 122 drug applications between 3 December 2022 and 9 December 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 22, covering 18 drug names.
2022/12/03 – 2022/12/09
- New acceptances this week
- 122
- Drugs with new generic filings (by drug name, de-duplicated)
- 18
- 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
122filings, 22 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 64 |
| Generic | 22 |
| New drug | 21 |
| Import | 7 |
| Import re-registration | 6 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 99 |
| Therapeutic biologic | 16 |
| TCM | 7 |
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
18 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Tedizolid Phosphate Tablets | 2 | 2 | 1 |
| 2 | Lenalidomide Capsules | 2 | 1 | 3 |
| 3 | Oseltamivir Phosphate Capsules | 2 | 1 | 39 |
| 4 | Elagolix Sodium Tablets | 2 | 1 | 2 |
| 5 | Morinidazole and Sodium Chloride Injection | 1 | 1 | 9 |
| 6 | Salbutamol Sulfate Inhalation Solution | 1 | 1 | 2 |
| 7 | Desloratadine Tablets | 1 | 1 | 0 |
| 8 | 帕拉米韦氯化钠注射液 · No verified English name | 1 | 1 | 17 |
| 9 | Fluorouracil Injection | 1 | 1 | 6 |
| 10 | Kit For The Preparation Of Gallium Ga 68 Dotatate Injection | 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
63 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized | 11 | 7 | 0 |
| 2 | Shandong Wei Gao Shu Xue Technology Zhuang Bei Co., Ltd. romanized | 11 | 2 | 0 |
| 3 | Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 4 | Hubei Hui Hai Pharmaceuticals Technology Research Institute Co., Ltd. romanized | 4 | 3 | 0 |
| 5 | Shanghai Joint Sai Er Bio Gong Cheng Co., Ltd. romanized | 4 | 1 | 0 |
| 6 | Atlantic Laboratories Corporation Ltd. | 3 | 1 | 0 |
| 7 | Janssen Research & Development LLC | 3 | 1 | 0 |
| 8 | Pfizer Inc. | 3 | 1 | 0 |
| 9 | Santen Pharmaceutical Co. Ltd. | 3 | 1 | 0 |
| 10 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 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
34 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/12/09Import · Class 1 | PF-07284892片 · No verified English nameJXHL2200347 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2022/12/09Import · Class 1 | PF-07284892片 · No verified English nameJXHL2200346 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2022/12/09Import · Class 1 | PF-07284892片 · No verified English nameJXHL2200345 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2022/12/09Generic · Class 3 | Fluorouracil InjectionCYHS2202050 | Guo Yao Yi Xin Pharmaceutical Co., Ltd. romanized; Ha Yao Group Bio Gong Cheng Co., Ltd. romanized |
| 2022/12/09Generic · Class 3 | Lidocaine Hydrochloride InjectionCYHS2202049 | Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized |
| 2022/12/09Generic · Class 3 | Gallium[68Ga ] Dotatate InjectionCYHL2200110 | Yuan Zi Gao Ke Co., Ltd. romanized |
| 2022/12/09Generic · Class 3 | Kit For The Preparation Of Gallium Ga 68 Dotatate InjectionCYHL2200109 | Yuan Zi Gao Ke Co., Ltd. romanized |
| 2022/12/09New drug · Class 1 | 重组人CD80突变体-Fc融合蛋白注射液 · No verified English nameCXSL2200595 | Xuan Zhu Bio Technology Co., Ltd. romanized; Beijing Xuan Zhu Kang Ming Bio Technology Co., Ltd. romanized |
| 2022/12/09New drug · Class 1 | SG1906注射液 · No verified English nameCXSL2200594 | Zhong Sheng Shang Jian Biopharmaceuticals (Hangzhou) Co., Ltd. romanized |
| 2022/12/09New drug · Class 1 | DBM-1152A吸入溶液 · No verified English nameCXHL2200934 | Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Shuo Bai Pharmaceutical Co., Ltd. romanized |
| 2022/12/09New drug · Class 1 | DBM-1152A吸入溶液 · No verified English nameCXHL2200933 | Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Shuo Bai Pharmaceutical Co., Ltd. romanized |
| 2022/12/09New drug · Class 1 | DBM-1152A吸入溶液 · No verified English nameCXHL2200932 | Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Shuo Bai Pharmaceutical Co., Ltd. romanized |
| 2022/12/09New drug · Class 1 | DBM-1152A吸入溶液 · No verified English nameCXHL2200931 | Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Shuo Bai Pharmaceutical Co., Ltd. romanized |
| 2022/12/09New drug · Class 1 | DBM-1152A吸入溶液 · No verified English nameCXHL2200930 | Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Shuo Bai Pharmaceutical Co., Ltd. romanized |
| 2022/12/09New drug · Class 1 | RP904片 · No verified English nameCXHL2200929 | Run Jia (Suzhou) Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/12/09New drug · Class 1 | RP904片 · No verified English nameCXHL2200928 | Run Jia (Suzhou) Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/12/08Generic · Class 3 | Minoxidil Topical SolutionCYHS2202039 | Jiangsu Chen Pai Bang De Pharma Co., Ltd. romanized |
| 2022/12/08Generic · Class 3 | Elagolix Sodium TabletsCYHL2200108 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. |
| 2022/12/08Generic · Class 3 | Elagolix Sodium TabletsCYHL2200107 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. |
| 2022/12/08New drug · Class 1 | 重组人IL12/15-PDL1B单纯疱疹Ⅰ型溶瘤病毒注射液(Vero细胞) · No verified English nameCXSL2200593 | Zhong Sheng Fu Nuo Jian Bio Technology (Shanghai) Co., Ltd. romanized |
| 2022/12/08New drug · Class 1 | KD-025细胞注射液 · No verified English nameCXSL2200592 | Nanjing Kai Di Medical Technology Co., Ltd. romanized |
| 2022/12/08New drug · Class 1 | 齐瑞索韦肠溶胶囊 · No verified English nameCXHS2200063 | Shanghai Ai Ke Bai Fa Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai He Quan Pharmaceuticals Co., Ltd. romanized |
| 2022/12/08New drug · Class 1 | 齐瑞索韦肠溶胶囊 · No verified English nameCXHS2200062 | Shanghai Ai Ke Bai Fa Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai He Quan Pharmaceuticals Co., Ltd. romanized |
| 2022/12/08New drug · Class 1 | NB004片 · No verified English nameCXHL2200927 | Ningbo Xin Wan Technology Development Co., Ltd. romanized |
| 2022/12/08New drug · Class 1 | ABSK121-NX片 · No verified English nameCXHL2200926 | Wuxi He Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/12/08New drug · Class 1 | ABSK121-NX片 · No verified English nameCXHL2200925 | Wuxi He Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/12/08New drug · Class 1 | ABSK121-NX片 · No verified English nameCXHL2200924 | Wuxi He Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/12/07Import · Class 1 | GDC-0077 · No verified English nameJXHL2200344 | F.Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2022/12/07Import · Class 1 | GDC-0077 · No verified English nameJXHL2200343 | F.Hoffmann-La Roche Ltd |
| 2022/12/07Generic · Class 3 | 帕拉米韦氯化钠注射液 · No verified English nameCYHS2202034 | Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
4 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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