YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 323 drug applications between 1 April 2025 and 7 April 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 82, covering 59 drug names.
2025/04/01 – 2025/04/07
- New acceptances this week
- 323
- Drugs with new generic filings (by drug name, de-duplicated)
- 59
- Accepted this week, now under review
- 22
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
323filings, 82 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 172 |
| Generic | 82 |
| New drug | 42 |
| Import | 17 |
| Unspecified | 6 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 178 |
| TCM | 93 |
| Therapeutic biologic | 51 |
| Prophylactic 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
59 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Brexpiprazole Tablets | 4 | 2 | 31 |
| 2 | Tadalafil Tablets | 3 | 1 | 23 |
| 3 | 维生素B6注射液 · No verified English name | 2 | 2 | 10 |
| 4 | 低钙腹膜透析液(乳酸盐-G1.5%) · No verified English name | 2 | 1 | 3 |
| 5 | 低钙腹膜透析液(乳酸盐-G2.5%) · No verified English name | 2 | 1 | 4 |
| 6 | 低钙腹膜透析液(乳酸盐-G4.25%) · No verified English name | 2 | 1 | 3 |
| 7 | Dexketoprofen Trometamol Tablets | 2 | 1 | 0 |
| 8 | Tropicamide Phenylephrine Eye Drops | 2 | 1 | 8 |
| 9 | Fusidic Acid Cream | 2 | 1 | 15 |
| 10 | Empagliflozin Tablets | 2 | 1 | 18 |
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
175 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 | Shenyang Dong Xin Pharma Co., Ltd. romanized | 10 | 6 | 0 |
| 5 | Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized | 8 | 6 | 0 |
| 6 | Shaanxi Kang Hui Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 7 | Bayer Inc. | 6 | 1 | 0 |
| 8 | Shandong Er Ye Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 9 | Merck Healthcare KGaA | 5 | 3 | 0 |
| 10 | Chongqing Shi Yi Li Pharmaceuticals Technology Co., Ltd. romanized | 5 | 2 | 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
79 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2025/04/07Import · Class 1 | Tuvusertib片剂 · No verified English nameJXHL2500070 | Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd |
| 2025/04/07Import · Class 1 | Tuvusertib片剂 · No verified English nameJXHL2500069 | Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd |
| 2025/04/07Import · Class 1 | Tuvusertib胶囊 · No verified English nameJXHL2500068 | Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd |
| 2025/04/07Import · Class 1 | Tuvusertib胶囊 · No verified English nameJXHL2500067 | Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd |
| 2025/04/07Generic · Class 3 | Acyclovir Sodium InjectionCYHS2501313 | Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Henan Pu Rui Pharma Co., Ltd. romanized |
| 2025/04/07Generic · Class 3 | Acyclovir Sodium InjectionCYHS2501312 | Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Henan Pu Rui Pharma Co., Ltd. romanized |
| 2025/04/07Generic · Class 3 | 维生素K滴剂 · No verified English nameCYHS2501309 | Chongqing Wan Lin Biopharmaceuticals Technology Co., Ltd. romanized; Da Lian Mei Chuang Pharma Co., Ltd. romanized |
| 2025/04/07New drug · Class 3.1 | 开心散 · No verified English nameCXZS2500015 | Anhui Hua Run Jin Chan Pharma Co., Ltd. romanized |
| 2025/04/07New drug · Class 1 | CM512注射液 · No verified English nameCXSL2500275 | Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized |
| 2025/04/07New drug · Class 2.2 | 塔戈利单抗注射液 · No verified English nameCXSL2500271 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2025/04/07New drug · Class 1 | 注射用SKB315 · No verified English nameCXSL2500270 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2025/04/07New drug · Class 1 | 注射用SSGJ-612 · No verified English nameCXSL2500269 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2025/04/07New drug · Class 1 | SSGJ-707注射液 · No verified English nameCXSL2500268 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2025/04/07New drug · Class 1 | 重组抗IL-1β人源化单克隆抗体注射液 · No verified English nameCXSL2500267 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2025/04/07New drug · Class 1 | 注射用TQB6411 · No verified English nameCXSL2500266 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2025/04/07New drug · Class 1 | 68Ga-NRT6020注射液 · No verified English nameCXHL2500358 | Chengdu Niu Rui Te Medical Technology Co., Ltd. romanized |
| 2025/04/07New drug · Class 2.1; 2.2 | JMHT05 · No verified English nameCXHL2500357 | Hunan Jiudian Pharmaceutical Co., Ltd |
| 2025/04/07New drug · Class 2.1; 2.2 | JMHT05 · No verified English nameCXHL2500356 | Hunan Jiudian Pharmaceutical Co., Ltd |
| 2025/04/03Import · Class 3.1 | 注射用德曲妥珠单抗 · No verified English nameJXSS2500041 | Daiichi Sankyo Europe GmbH; Baxter Oncology GmbH; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD. |
| 2025/04/03Import · Class 3.1 | 本瑞利珠单抗注射液 · No verified English nameJXSS2500040 | AstraZeneca AB; Name not romanized |
| 2025/04/03Import · Class 3.1 | 本瑞利珠单抗注射液 · No verified English nameJXSS2500039 | AstraZeneca AB; Name not romanized |
| 2025/04/03Import · Class 2.2 | Ravulizumab注射液 · No verified English nameJXSL2500052 | Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/04/03Import · Class 2.2 | Ravulizumab注射液 · No verified English nameJXSL2500051 | Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/04/03Import · Class 1 | Bimagrumab注射液 · No verified English nameJXSL2500050 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/04/03Import · Class 1 | Bimagrumab注射液 · No verified English nameJXSL2500049 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/04/03Import · Class 2.2 | 注射用佐妥昔单抗 · No verified English nameJXSL2500048 | Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd. |
| 2025/04/03Generic · Class 3 | Diprophylline InjectionCYHS2501299 | Shandong Yi Jian Pharma Co., Ltd. romanized |
| 2025/04/03Generic · Class 3 | Acetylcysteine TabletsCYHS2501292 | Hainan Sai Li Ke Pharma Co., Ltd. romanized |
49 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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