YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 268 drug applications between 31 May 2025 and 6 June 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 78, covering 51 drug names.
2025/05/31 – 2025/06/06
- New acceptances this week
- 268
- Drugs with new generic filings (by drug name, de-duplicated)
- 51
- Accepted this week, now under review
- 49
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
268filings, 78 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 124 |
| Generic | 78 |
| New drug | 49 |
| Import | 7 |
| Import re-registration | 6 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 162 |
| TCM | 57 |
| Therapeutic biologic | 43 |
| Biologic | 3 |
| Prophylactic biologic | 3 |
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
51 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Acetylcysteine Injection | 6 | 6 | 53 |
| 2 | Safinamide Methansulfonate Tablets | 4 | 2 | 20 |
| 3 | Dapagliflozin Tablets | 4 | 2 | 84 |
| 4 | Sodium Nitroprusside Injection | 3 | 2 | 15 |
| 5 | Minoxidil Liniment | 3 | 2 | 52 |
| 6 | Paliperidone Palmitate Injection | 3 | 1 | 8 |
| 7 | Sevelamer Carbonate Powder for oral suspension | 2 | 2 | 3 |
| 8 | Tadalafil Tablets | 2 | 1 | 23 |
| 9 | 利伐沙班颗粒 · No verified English name | 2 | 1 | 2 |
| 10 | Zoledronic Acid Injection | 2 | 1 | 2 |
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
188 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized | 10 | 6 | 0 |
| 2 | Guizhou Yi Bai Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 3 | Jiangxi Ke Rui Pharma Co., Ltd. romanized | 4 | 3 | 0 |
| 4 | Janssen-Cilag International NV | 4 | 2 | 0 |
| 5 | Liaoning Hai Shen Lian Sheng Pharmaceutical Co., Ltd. romanized | 4 | 1 | 0 |
| 6 | Jiangsu An Zheng Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 7 | Rui Yang Pharmaceutical Co., Ltd. romanized | 3 | 3 | 1 |
| 8 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 9 | Guizhou De Chang Xiang Pharmaceuticals Co., Ltd. romanized | 3 | 3 | 0 |
| 10 | Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized | 3 | 2 | 3 |
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
86 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/06/06Import · Class 1 | Clesrovimab注射液 · No verified English nameJXSS2500071 | Merck Sharp & Dohme B.V.; Patheon Manufacturing Services LLC; MSD R&D (China) Co. Ltd. |
| 2025/06/06Import · Class 1 | JSB462片 · No verified English nameJXHL2500128 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/06/06Import · Class 2.4 | 镥(177Lu)vipivotide tetraxetan注射液 · No verified English nameJXHL2500127 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/06/06Import · Class 2.2; 2.4 | TAR-210 · No verified English nameJXHL2500125 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2025/06/06Generic · Class 3 | Vitamin K1 InjectionCYHS2502012 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 2025/06/06Generic · Class 3 | Sodium Nitroprusside InjectionCYHS2502011 | Hebei Yi Pin Pharmaceutical Co., Ltd. romanized |
| 2025/06/06Generic · Class 3 | Sevelamer Carbonate Powder for oral suspensionCYHS2502009 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Jiangxi Ke Rui Pharma Co., Ltd. romanized |
| 2025/06/06Generic · Class 3 | Acetylcysteine TabletsCYHS2502008 | Jiangxi Di Sai Nuo Pharmaceuticals Group Co., Ltd. romanized |
| 2025/06/06Generic · Class 3 | Zoledronic Acid InjectionCYHS2502005 | Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized |
| 2025/06/06Generic · Class 3 | Minoxidil LinimentCYHS2502003 | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized; Guangdong Ke Hong Pharma Co., Ltd. romanized |
| 2025/06/06Generic · Class 3 | Minoxidil LinimentCYHS2502002 | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized; Guangdong Ke Hong Pharma Co., Ltd. romanized |
| 2025/06/06Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2501999 | Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized |
| 2025/06/06Generic · Class 3 | 维生素D口服溶液 · No verified English nameCYHL2500105 | Xiamen Zi Xu Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/06/06New drug · Class 2.3 | 黄厚止泻滴丸 · No verified English nameCXZL2500035 | Anhui Lei Yun Shang Pharma Co., Ltd. romanized |
| 2025/06/06New drug · Class 1 | 重组抗IL-1β人源化单克隆抗体注射液 · No verified English nameCXSS2500060 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2025/06/06New drug · Class 1 | TI-0093注射液 · No verified English nameCXSL2500461 | Yuan Yin (Beijing) Bio Technology Co., Ltd. romanized |
| 2025/06/06New drug · Class 1 | LYN101注射液 · No verified English nameCXSL2500456 | Shanghai Cai Zhi Yao Cheng Bio Technology Co., Ltd. romanized |
| 2025/06/06New drug · Class 1 | 注射用SHR-A1811 · No verified English nameCXSL2500455 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/06/06New drug · Class 3.3 | 度普利尤单抗注射液 · No verified English nameCXSL2500453 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2025/06/06New drug · Class 3.3 | 度普利尤单抗注射液 · No verified English nameCXSL2500452 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2025/06/06New drug · Class 1 | UC101 CAR-T细胞注射液 · No verified English nameCXSL2500451 | Chengdu You Sai Nuo Bio Technology Co., Ltd. romanized |
| 2025/06/06New drug · Class 2.2 | 贝伐珠单抗注射液 · No verified English nameCXSL2500450 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/06/06New drug · Class 1 | WJ22096片 · No verified English nameCXHL2500543 | Nanjing Jing Ao Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/06/06New drug · Class 1 | WJ22096片 · No verified English nameCXHL2500542 | Nanjing Jing Ao Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/06/06New drug · Class 1 | HRS-4508片 · No verified English nameCXHL2500541 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/06/06New drug · Class 1 | HRS-4508片 · No verified English nameCXHL2500540 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/06/06New drug · Class 2.2 | SN007干混悬剂 · No verified English nameCXHL2500539 | Shanghai Hui Yong Pharmaceutical Co., Ltd. romanized |
| 2025/06/06New drug · Class 1 | QL-H118片 · No verified English nameCXHL2500538 | Nanjing Qin Ling Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/06/06New drug · Class 2.4 | 注射用多西他赛(白蛋白结合型) · No verified English nameCXHL2500537 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2025/06/05Generic · Class 3 | 注射用头孢噻肟钠/氯化钠注射液 · No verified English nameCYHS2501998 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
56 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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