YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 378 drug applications between 2 April 2025 and 8 April 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 104, covering 73 drug names.
2025/04/02 – 2025/04/08
- New acceptances this week
- 378
- Drugs with new generic filings (by drug name, de-duplicated)
- 73
- Accepted this week, now under review
- 25
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
378filings, 104 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 199 |
| Generic | 104 |
| New drug | 43 |
| Import | 21 |
| Unspecified | 7 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 217 |
| TCM | 103 |
| Therapeutic biologic | 56 |
| Prophylactic biologic | 2 |
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
73 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Tadalafil Tablets | 5 | 2 | 23 |
| 2 | Brexpiprazole Tablets | 4 | 2 | 31 |
| 3 | Vonoprazan Fumarate Tablets | 3 | 2 | 60 |
| 4 | Oxacillin Sodium for Injection | 3 | 1 | 13 |
| 5 | Letermovir Injection | 2 | 2 | 6 |
| 6 | 维生素B6注射液 · No verified English name | 2 | 2 | 10 |
| 7 | 低钙腹膜透析液(乳酸盐-G1.5%) · No verified English name | 2 | 1 | 3 |
| 8 | 低钙腹膜透析液(乳酸盐-G2.5%) · No verified English name | 2 | 1 | 4 |
| 9 | 低钙腹膜透析液(乳酸盐-G4.25%) · No verified English name | 2 | 1 | 3 |
| 10 | Dexketoprofen Trometamol Tablets | 2 | 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
213 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shaanxi Pan Long Pharma Group Co., Ltd. romanized | 13 | 11 | 0 |
| 2 | Ningbo Tian Yi Pharma Technology Co., Ltd. romanized | 12 | 6 | 12 |
| 3 | Guo Yao Group Beijing Hua Miao Pharma Co., Ltd. romanized | 11 | 10 | 0 |
| 4 | Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized | 8 | 6 | 0 |
| 5 | Shenyang Dong Xin Pharma Co., Ltd. romanized | 7 | 5 | 0 |
| 6 | Shaanxi Kang Hui Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 7 | Bayer Inc. | 6 | 1 | 0 |
| 8 | Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Shandong Er Ye Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 10 | Merck Healthcare KGaA | 5 | 3 | 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
93 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/04/08Import · Class 1 | DS-1062a · No verified English nameJXSL2500054 | ASTRAZENECA AB; AstraZeneca Investment (China) Co. Limited |
| 2025/04/08Import · Class 2.1 | Isatuximab注射液(皮下注射) · No verified English nameJXSL2500053 | Sanofi-Aventis Recherche & Développement |
| 2025/04/08Import · Class 1 | Imlunestrant 片 · No verified English nameJXHS2500045 | Eli Lilly Nederland B.V.; RECIPHARM LEGANéS S.L.U.; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/04/08Import · Class 1 | Imlunestrant片 · No verified English nameJXHS2500044 | Eli Lilly Nederland B.V.; RECIPHARM LEGANéS S.L.U.; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/04/08Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2501354 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2025/04/08Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2501353 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2025/04/08Generic · Class 3 | 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2501336 | Xizang Ao Si Bi Xiu Pharmaceuticals Co., Ltd. romanized; Hangzhou Qian Yuan Bao Ling Pharma Co., Ltd. romanized |
| 2025/04/08Generic · Class 3 | Sodium Lactate Ringer's Irrigation SolutionCYHS2501332 | Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized |
| 2025/04/08Generic · Class 3 | Voglibose Orally Dispersing TabletsCYHS2501331 | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized |
| 2025/04/08Generic · Class 3 | Trazodone Hydrochloride TabletsCYHS2501328 | Anhui Pioneer Pharmaceutical Co., Ltd |
| 2025/04/08Generic · Class 3 | 苯磺酸氨氯地平口服溶液 · No verified English nameCYHS2501327 | Shandong Ze Zheng Pharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized |
| 2025/04/08Generic · Class 3 | Oxacillin Sodium for InjectionCYHS2501324 | Chengdu Jing Fu Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Pharmaceutical Formulations Co., Ltd. romanized |
| 2025/04/08Generic · Class 3 | Oxacillin Sodium for InjectionCYHS2501323 | Chengdu Jing Fu Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Pharmaceutical Formulations Co., Ltd. romanized |
| 2025/04/08Generic · Class 3 | Oxacillin Sodium for InjectionCYHS2501322 | Chengdu Jing Fu Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Pharmaceutical Formulations Co., Ltd. romanized |
| 2025/04/08Generic · Class 3 | Peramivir InjectionCYHS2501319 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized |
| 2025/04/08Generic · Class 3 | 磷酸奥司他韦颗粒 · No verified English nameCYHS2501318 | Guangdong Rui Xing Pharmaceuticals Co., Ltd. romanized; Dong Guan Shi Jin Mei Ji Pharma Co., Ltd. romanized |
| 2025/04/08Generic · Class 3 | Sodium sulfate, magnesium sulfate, and potassium chloride TabletsCYHL2500075 | Shanxi Zhen Dong An Xin Biopharmaceutical Co., Ltd. romanized |
| 2025/04/08New drug · Class 2.2 | 冻干人用狂犬病疫苗(无血清Vero细胞) · No verified English nameCXSS2500044 | Ai Mei Rong Yu (Ningbo) Biopharmaceutical Co., Ltd. romanized |
| 2025/04/08New drug · Class 1 | 注射用ZG006 · No verified English nameCXSL2500279 | Name not romanized; Name not romanized |
| 2025/04/08New drug · Class 1 | 注射用ZG005 · No verified English nameCXSL2500278 | Name not romanized; Name not romanized |
| 2025/04/08New drug · Class 3.2 | 人凝血因子Ⅸ · No verified English nameCXSL2500277 | Yuan Da Shu Yang Sheng Ming Ke Xue (Chengdu) Co., Ltd. romanized |
| 2025/04/08New drug · Class 1 | JD012-CEL注射液 · No verified English nameCXSL2500276 | Beijing Jing Da Bio Technology Co., Ltd. romanized; Guangzhou Xi Ling Bio Technology Co., Ltd. romanized |
| 2025/04/08New drug · Class 1 | KM1溶瘤痘苗病毒注射液 · No verified English nameCXSL2500274 | Shenzhen Shi Hua Yao Kang Ming Bio Pharma Co., Ltd. romanized |
| 2025/04/08New drug · Class 1 | KSD-101注射液 · No verified English nameCXSL2500273 | Zhong Shan Heng Sai Bio Technology Co., Ltd. romanized |
| 2025/04/08New drug · Class 1 | 注射用LY4101174 · No verified English nameCXSL2500272 | Li Lai Suzhou Pharmaceutical Co., Ltd. romanized |
| 2025/04/08New drug · Class 1 | IGP-14068-TM片 · No verified English nameCXHL2500361 | Hangzhou Ying Chuang Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Mei Di Xi Biopharmaceuticals Co., Ltd. romanized |
| 2025/04/08New drug · Class 1 | IGP-14068-TM片 · No verified English nameCXHL2500360 | Hangzhou Ying Chuang Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Mei Di Xi Biopharmaceuticals Co., Ltd. romanized |
| 2025/04/08New drug · Class 1 | 177Lu-NRT6020注射液 · No verified English nameCXHL2500359 | Chengdu Niu Rui Te Medical Technology Co., Ltd. romanized |
| 2025/04/07Import · Class 2.4 | 英克司兰钠注射液 · No verified English nameJXHS2500043 | Novartis Europharm Limited; Novartis Pharmaceutical Manufacturing GmbH; Beijing Novartis Pharma Co. Ltd. |
| 2025/04/07Import · Class 1 | Lartesertib片剂 · No verified English nameJXHL2500071 | Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D 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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