YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 389 drug applications between 6 September 2025 and 12 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 94, covering 69 drug names.
2025/09/06 – 2025/09/12
- New acceptances this week
- 389
- Drugs with new generic filings (by drug name, de-duplicated)
- 69
- Accepted this week, now under review
- 101
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
389filings, 94 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 177 |
| Generic | 94 |
| New drug | 72 |
| Import | 30 |
| Unspecified | 8 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 238 |
| TCM | 78 |
| Therapeutic biologic | 69 |
| Biologic | 3 |
| 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
69 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sacubitril Valsartan Sodium Tablets | 3 | 2 | 70 |
| 2 | Bilastine Tablets | 2 | 2 | 7 |
| 3 | Loxoprofen Sodium Oral Solution | 2 | 2 | 6 |
| 4 | Bromhexine Hydrochloride Oral Solution | 2 | 2 | 22 |
| 5 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 6 | Lactulose Oral Solution | 2 | 1 | 34 |
| 7 | Dexamethasone Sodium Phosphate Injection | 2 | 1 | 5 |
| 8 | 复方醋酸钠葡萄糖注射液 · No verified English name | 2 | 1 | 8 |
| 9 | Levofloxacin and Sodium Chloride Injection | 2 | 1 | 14 |
| 10 | 帕拉米韦氯化钠注射液 · No verified English name | 2 | 1 | 17 |
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
233 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized | 18 | 11 | 0 |
| 2 | Eli Lilly and Company | 13 | 4 | 0 |
| 3 | Pfizer Inc. | 10 | 5 | 0 |
| 4 | AstraZeneca AB | 7 | 4 | 0 |
| 5 | Qilu Pharmaceutical Co., Ltd. | 7 | 3 | 0 |
| 6 | Janssen Research & Development LLC | 7 | 1 | 0 |
| 7 | Roche Pharma (Schweiz) AG | 6 | 2 | 0 |
| 8 | Shanghai Shi Ling Pharmaceutical Co., Ltd. romanized | 6 | 1 | 0 |
| 9 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Ren He Yi Kang Hui Ze Pharma Hebei Co., Ltd. romanized | 4 | 4 | 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
133 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/09/12Import · Class 2.4 | Dabrafenib mesylate CapsulesJXHS2500099 | Novartis Europharm Limited; Siegfried Barbera S.L.; Novartis Pharmaceutical Manufacturing LLC; Beijing Novartis Pharma Co. Ltd. |
| 2025/09/12Import · Class 2.4 | Dabrafenib mesylate CapsulesJXHS2500098 | Novartis Europharm Limited; Siegfried Barbera S.L.; Novartis Pharmaceutical Manufacturing LLC; Beijing Novartis Pharma Co. Ltd. |
| 2025/09/12Import · Class 2.4 | 甲苯磺酸利特昔替尼胶囊 · No verified English nameJXHL2500282 | Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd. |
| 2025/09/12Import · Class 2.4 | 甲苯磺酸利特昔替尼胶囊 · No verified English nameJXHL2500281 | Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd. |
| 2025/09/12Import · Class 1 | Retatrutide注射液 · No verified English nameJXHL2500280 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/09/12Import · Class 1 | Retatrutide注射液 · No verified English nameJXHL2500279 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/09/12Import · Class 1 | Retatrutide注射液 · No verified English nameJXHL2500278 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/09/12Import · Class 1 | Retatrutide注射液 · No verified English nameJXHL2500277 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/09/12Import · Class 1 | Retatrutide注射液 · No verified English nameJXHL2500276 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/09/12Generic · Class 3 | Lidocaine Hydrochloride GelCYHS2503390 | Beijing Zhong Tai Bang Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/09/12Generic · Class 3 | Phentolamine Mesilate InjectionCYHS2503386 | Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized |
| 2025/09/12Generic · Class 3 | Isotretinoin Soft CapsulesCYHS2503385 | Hong Jian Pharmaceutical (Shanghai) Co., Ltd. romanized; Shanghai Xin Hua Lian Pharmaceutical Co., Ltd. romanized |
| 2025/09/12Generic · Class 3 | Verapamil Hydrochloride InjectionCYHS2503384 | Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized; Ya Bao Pharma Group Co., Ltd. romanized |
| 2025/09/12Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2503383 | Henan Zhong Jie Pharma Co., Ltd. romanized |
| 2025/09/12Generic · Class 3 | Potassium Chloride Oral SolutionCYHS2503376 | Hebei Hua Chen Pharma Group Co., Ltd. romanized |
| 2025/09/12Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2503374 | Da Lian Bai Li Tian Hua Pharmaceutical Co., Ltd. romanized; Shandong Jian Dao Pharmaceutical Co., Ltd. romanized |
| 2025/09/12New drug · Class 1.1 | 椒七止痛凝胶贴膏 · No verified English nameCXZS2500038 | Hunan Jiudian Pharmaceutical Co., Ltd |
| 2025/09/12New drug · Class 1 | 安尼妥单抗注射液 · No verified English nameCXSS2500093 | Shanghai Jin Man Te Bio Technology Co., Ltd. romanized; Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized |
| 2025/09/12New drug · Class 1 | 注射用经应激诱导的间充质干细胞衍生物 · No verified English nameCXSL2500794 | Da Er Wen Qi Dian (Hubei) Biopharmaceutical Co., Ltd. romanized |
| 2025/09/12New drug · Class 1 | 注射用SKB500 · No verified English nameCXSL2500790 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2025/09/12New drug · Class 1 | SK-NK注射液 · No verified English nameCXSL2500789 | Sai Ao Si Bo Bio Technology (Beijing) Co., Ltd. romanized; Sai Ao Si Bo Bio Technology (Zhengzhou) Co., Ltd. romanized |
| 2025/09/12New drug · Class 2.2 | 塔戈利单抗注射液 · No verified English nameCXSL2500788 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2025/09/12New drug · Class 1 | HRS9531注射液 · No verified English nameCXHL2500998 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/09/12New drug · Class 1 | HRS9531注射液 · No verified English nameCXHL2500997 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/09/12New drug · Class 1 | HRS9531注射液 · No verified English nameCXHL2500996 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/09/12New drug · Class 2.4 | 伯瑞替尼肠溶胶囊 · No verified English nameCXHL2500995 | Beijing Pu Run Ao Bio Technology Co., Ltd. romanized |
| 2025/09/12New drug · Class 2.4 | 伯瑞替尼肠溶胶囊 · No verified English nameCXHL2500994 | Beijing Pu Run Ao Bio Technology Co., Ltd. romanized |
| 2025/09/11Import · Class 1 | Insulin efsitora alfa 注射液 · No verified English nameJXSS2500123 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/09/11Import · Class 2.4 | BMS-986165片 · No verified English nameJXHL2500283 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2025/09/11Generic · Class 3 | 拉考沙胺颗粒 · No verified English nameCYHS2503370 | Hainan Wei Kang Pharmaceutical (Qian Shan) Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
103 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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