YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 356 drug applications between 4 March 2025 and 10 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 96, covering 72 drug names.
2025/03/04 – 2025/03/10
- New acceptances this week
- 356
- Drugs with new generic filings (by drug name, de-duplicated)
- 72
- Accepted this week, now under review
- 8
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
356filings, 96 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 165 |
| Generic | 96 |
| New drug | 56 |
| Import | 19 |
| Import re-registration | 13 |
| Unspecified | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 270 |
| Therapeutic biologic | 42 |
| TCM | 37 |
| Prophylactic biologic | 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
72 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sacubitril Valsartan Sodium Tablets | 5 | 2 | 70 |
| 2 | Polidocanol Injection | 5 | 2 | 23 |
| 3 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 4 | Bisoprolol Fumarate and Amlodipine Besylate Tablets | 2 | 2 | 9 |
| 5 | 洛索洛芬钠凝胶贴膏 · No verified English name | 2 | 2 | 9 |
| 6 | Loxoprofen Sodium Oral Solution | 2 | 2 | 6 |
| 7 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 8 | Acetylcysteine Granules | 2 | 1 | 4 |
| 9 | Levetiracetam Tablets | 2 | 1 | 6 |
| 10 | Baricitinib Tablets | 2 | 1 | 32 |
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
212 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Heilongjiang Shen Xing Biopharmaceuticals Technology Co., Ltd. romanized | 17 | 17 | 0 |
| 2 | Bayer AG | 14 | 4 | 0 |
| 3 | Shanghai Min Wei Bio Technology Co., Ltd. romanized | 8 | 1 | 0 |
| 4 | Merck Sharp & Dohme B.V. | 7 | 5 | 0 |
| 5 | Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Pfizer Inc. | 5 | 3 | 0 |
| 7 | Novo Nordisk A/S | 5 | 1 | 0 |
| 8 | Nanjing San Die Ji Pharmaceuticals Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 9 | Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 10 | Sichuan Pu Rui Te Pharma Co., Ltd. romanized | 4 | 2 | 1 |
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
101 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/03/10Import · Class 2.4 | 钇[90Y]微球注射液 · No verified English nameJXHL2500037 | Sirtex Medical Pty Ltd |
| 2025/03/10Generic · Class 3 | Sucralfate Oral SuspensionCYHS2500989 | Anhui Rui Qi Pharma Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized |
| 2025/03/10Generic · Class 3 | Aminophylline TabletsCYHS2500988 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.; Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized |
| 2025/03/10Generic · Class 3 | 奥泽沙星洗剂 · No verified English nameCYHL2500058 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2025/03/10New drug · Class 1 | XH001注射液 · No verified English nameCXSL2500215 | Beijing Xin He Rui En Bio Medical Technology Co., Ltd. romanized |
| 2025/03/09New drug · Class 1 | JMT106注射液 · No verified English nameCXSL2500214 | Shanghai Jin Man Te Bio Technology Co., Ltd. romanized |
| 2025/03/08Import · Class 1 | BMS-986365胶囊 · No verified English nameJXHL2500036 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/03/08Generic · Class 3 | Buspirone Hydrochloride TabletsCYHS2500983 | Hebei Long Hai Pharma Co., Ltd. romanized |
| 2025/03/08Generic · Class 3 | 盐酸多沙普仑注射液 · No verified English nameCYHS2500976 | Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2025/03/08Generic · Class 3 | Propafenone Hydrochloride InjectionCYHS2500968 | Nan Yang Pu Kang Heng Wang Pharma Co., Ltd. romanized; Nan Yang Pu Kang Pharma Co., Ltd. romanized |
| 2025/03/08Generic · Class 3 | Isoprenaline Hydrochloride InjectionCYHS2500967 | Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized |
| 2025/03/08Generic · Class 3 | 维生素K滴剂 · No verified English nameCYHS2500965 | Sichuan Hai Meng Zhi Sen Biopharmaceutical Co., Ltd. romanized; Tianjin Shi Zhong Yang Pharma Co., Ltd. romanized |
| 2025/03/08Generic · Class 3 | Dobutamine Hydrochloride InjectionCYHS2500964 | Wuhan Shi Jin Heng Tai Pharma Co., Ltd. romanized; Henan Pu Rui Pharma Co., Ltd. romanized |
| 2025/03/08New drug · Class 1.3 | 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2500213 | Changchun Bai Ke Bio Technology Shareholding Company romanized |
| 2025/03/08New drug · Class 1 | 注射用JS203 · No verified English nameCXSL2500212 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/03/08New drug · Class 1 | DZD8586片 · No verified English nameCXHL2500261 | Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized |
| 2025/03/08New drug · Class 1 | HRS9531注射液 · No verified English nameCXHL2500260 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/03/08New drug · Class 1 | HRS9531注射液 · No verified English nameCXHL2500259 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/03/08New drug · Class 2.1 | KEM2403注射液 · No verified English nameCXHL2500258 | Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized |
| 2025/03/07Generic · Class 3 | Memantine Hydrochloride OD TabletsCYHS2500954 | Hefei En Rui Te Pharma Co., Ltd. romanized |
| 2025/03/07Generic · Class 3 | Memantine Hydrochloride OD TabletsCYHS2500953 | Hefei En Rui Te Pharma Co., Ltd. romanized |
| 2025/03/07Generic · Class 3 | Pyridostigmine Bromide TabletsCYHS2500951 | Jilin Sheng Bo Da Wei Ye Pharmaceutical Co., Ltd. romanized |
| 2025/03/07New drug · Class 1 | SH006注射液 · No verified English nameCXSL2500211 | Nanjing Sheng He Pharma Co., Ltd. romanized |
| 2025/03/07New drug · Class 1 | BPR-102胶囊 · No verified English nameCXSL2500210 | Chengdu Bei Te Yi Kang En Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/03/07New drug · Class 1 | BPR-102胶囊 · No verified English nameCXSL2500209 | Chengdu Bei Te Yi Kang En Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/03/07New drug · Class 1.2 | LVRNA015 · No verified English nameCXSL2500208 | Zhuhai Li Fan Da Bio Technology Co., Ltd. romanized |
| 2025/03/07New drug · Class 1 | SHR-4712注射液 · No verified English nameCXSL2500207 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/03/07New drug · Class 1 | SHR-4712注射液 · No verified English nameCXSL2500206 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/03/07New drug · Class 1 | 注射用CS2009 · No verified English nameCXSL2500205 | Shen Shi Biopharmaceuticals (Shanghai) Co., Ltd. romanized; Ji Shi Pharma (Suzhou) Co., Ltd. romanized |
| 2025/03/07New drug · Class 1 | PRT-064040鼻喷雾剂 · No verified English nameCXHL2500257 | Sichuan Pu Rui Te Pharma Co., Ltd. romanized |
71 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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