YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 379 drug applications between 3 September 2025 and 9 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 108, covering 75 drug names.
2025/09/03 – 2025/09/09
- New acceptances this week
- 379
- Drugs with new generic filings (by drug name, de-duplicated)
- 75
- Accepted this week, now under review
- 112
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
379filings, 108 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 170 |
| Generic | 108 |
| New drug | 65 |
| Import | 27 |
| Unspecified | 5 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 242 |
| TCM | 74 |
| Therapeutic biologic | 60 |
| 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
75 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 | 4 | 2 | 23 |
| 3 | Finerenone Tablets | 4 | 2 | 69 |
| 4 | 左羟丙哌嗪口服溶液 · No verified English name | 3 | 1 | 8 |
| 5 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 6 | Pemafibrate Tablets | 2 | 2 | 23 |
| 7 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 8 | Diclofenac Diethylamine Emulgel | 2 | 1 | 20 |
| 9 | 复方醋酸钠葡萄糖注射液 · No verified English name | 2 | 1 | 8 |
| 10 | Levofloxacin and Sodium Chloride Injection | 2 | 1 | 14 |
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
226 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Qilu Pharmaceutical Co., Ltd. | 10 | 5 | 2 |
| 2 | Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized | 9 | 7 | 0 |
| 3 | Topfond Pharmaceutical Co., Ltd. | 8 | 8 | 0 |
| 4 | Eli Lilly and Company | 8 | 2 | 0 |
| 5 | Janssen Research & Development LLC | 5 | 1 | 0 |
| 6 | Hubei Ke Lun Pharma Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | Shanghai Ao Ke Da Pharmaceuticals Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 8 | Sichuan Pharmaceutical Formulations Co., Ltd. romanized | 4 | 1 | 0 |
| 9 | Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized | 4 | 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
126 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/09/09Import · Class 1 | FPI-2053 · No verified English nameJXSL2500172 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/09/09Import · Class 1 | [111In]-FPI-2107 · No verified English nameJXSL2500171 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/09/09Import · Class 1 | ETX-636 · No verified English nameJXHL2500264 | Ensem Therapeutics Inc.; Ensem Therapeutics (Shanghai) Limited |
| 2025/09/09Import · Class 1 | ETX-636 · No verified English nameJXHL2500263 | Ensem Therapeutics Inc.; Ensem Therapeutics (Shanghai) Limited |
| 2025/09/09Generic · Class 3 | 氯化钙注射液 · No verified English nameCYHS2503339 | Hubei Tian Sheng Pharma Co., Ltd. romanized |
| 2025/09/09Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2503336 | Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/09/09Generic · Class 3 | Cisplatin InjectionCYHS2503331 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2025/09/09Generic · Class 3 | 醋酸钠林格葡萄糖注射液 · No verified English nameCYHS2503321 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2025/09/09Generic · Class 3 | Cyclophosphamide CapsulesCYHS2503320 | Suzhou Te Rui Pharma Co., Ltd. romanized |
| 2025/09/09New drug · Class 2.3 | 止咳橘红颗粒 · No verified English nameCXZL2500076 | Kang Zhi Pharma Co., Ltd. romanized |
| 2025/09/09New drug · Class 2.2 | 注射用泰它西普 · No verified English nameCXSS2500090 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2025/09/09New drug · Class 1 | PLB-002 · No verified English nameCXSL2500777 | Pu Ling Biopharmaceuticals (Shenzhen) Co., Ltd. romanized |
| 2025/09/09New drug · Class 1 | SYS6043 · No verified English nameCXSL2500776 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2025/09/09New drug · Class 2.2 | HL016 · No verified English nameCXHL2500974 | Hui Li Pharma (Suzhou) Co., Ltd. romanized |
| 2025/09/09New drug · Class 1 | JFAN-1001甲磺酸盐胶囊 · No verified English nameCXHL2500973 | Zhejiang Jian Feng Yi En Bio Technology Co., Ltd. romanized |
| 2025/09/09New drug · Class 1 | JFAN-1001甲磺酸盐胶囊 · No verified English nameCXHL2500972 | Zhejiang Jian Feng Yi En Bio Technology Co., Ltd. romanized |
| 2025/09/09New drug · Class 1 | JFAN-1001甲磺酸盐胶囊 · No verified English nameCXHL2500971 | Zhejiang Jian Feng Yi En Bio Technology Co., Ltd. romanized |
| 2025/09/08Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2503325 | CISEN PHARMACEUTICAL CO., LTD. |
| 2025/09/08Generic · Class 3 | Netilmicin Sulfate InjectionCYHS2503318 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2025/09/08Generic · Class 3 | 中性低钙腹膜透析液(乳酸盐-G1.5%) · No verified English nameCYHS2503317 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2025/09/08Generic · Class 3 | Clindamycin Palmitate Hydrochloride GranulesCYHS2503314 | Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized; Hubei Wei Sen Pharmaceutical Co., Ltd. romanized |
| 2025/09/08Generic · Class 3 | 盐酸达克罗宁局部溶液 · No verified English nameCYHL2500163 | Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
| 2025/09/08New drug · Class 1 | CM383(SC)注射液 · No verified English nameCXSL2500775 | Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized |
| 2025/09/06Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSS2500122 | MSD International Business GmbH; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd |
| 2025/09/06Import · Class 1 | FUB523注射液 · No verified English nameJXSL2500169 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/09/06Generic · Class 3 | 复方醋酸钠葡萄糖注射液 · No verified English nameCYHS2503313 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2025/09/06Generic · Class 3 | 复方醋酸钠葡萄糖注射液 · No verified English nameCYHS2503312 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2025/09/06Generic · Class 3 | Tiopronin TabletsCYHS2503304 | Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2025/09/06Generic · Class 3 | Relugolix TabletsCYHL2500162 | Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized |
| 2025/09/06New drug · Class 1.1 | 小儿六味湿疹凝胶 · No verified English nameCXZL2500075 | Shandong Han Fang Pharmaceutical Co., Ltd. romanized |
96 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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