YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 565 drug applications between 6 May 2026 and 12 May 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 69, covering 52 drug names.
2026/05/06 – 2026/05/12
- New acceptances this week
- 565
- Drugs with new generic filings (by drug name, de-duplicated)
- 52
- Accepted this week, now under review
- 128
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
565filings, 69 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 322 |
| New drug | 103 |
| Generic | 69 |
| Import | 40 |
| Unspecified | 22 |
| Import re-registration | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 255 |
| TCM | 201 |
| Therapeutic biologic | 89 |
| Biologic | 17 |
| 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
52 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Dotinurad Tablets | 4 | 2 | 55 |
| 2 | Galanthamine Hydrobromide Oral Solution | 3 | 1 | 5 |
| 3 | 瑞维那新吸入溶液 · No verified English name | 2 | 2 | 53 |
| 4 | Sitagliptin and Metformin Hydrochloride Extended-release Tablets | 2 | 2 | 12 |
| 5 | Lidocaine and Tetracaine Cream | 2 | 1 | 2 |
| 6 | Piracetam Injection | 2 | 1 | 9 |
| 7 | Tolvaptan Orally Disintegrating Tablets | 2 | 1 | 5 |
| 8 | Nafamostat Mesilate for Injection | 2 | 1 | 38 |
| 9 | 甲磺酸帕珠沙星氯化钠注射液 · No verified English name | 2 | 1 | 2 |
| 10 | Trazodone Hydrochloride Sustained-release Tablets | 2 | 1 | 20 |
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
321 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | AstraZeneca AB | 21 | 3 | 0 |
| 2 | Tai Ji Group Chongqing Tong Jun Ge Pharmaceutical Factory Co., Ltd. romanized | 17 | 15 | 0 |
| 3 | Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized | 12 | 8 | 0 |
| 4 | Qilu Pharmaceutical Co., Ltd. | 9 | 4 | 1 |
| 5 | Pi Ai Sai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized | 6 | 6 | 0 |
| 6 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 2 | 0 |
| 7 | Novo Nordisk A/S | 5 | 5 | 0 |
| 8 | Bao Guang Pharma (Chengdu) Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Qinghai Di Ma Er Zang Yao Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | Pfizer Inc. | 5 | 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
161 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/05/12Import · Class 1 | Sorfequiline片 · No verified English nameJXHL2600163 | The Global Alliance for TB Drug Development Inc.; Global Health Innovation Institute |
| 2026/05/12Generic · Class 3 | Sodium Thiosulfate InjectionCYHS2601085 | Zhongguo Da Zhong Pharmaceutical Co., Ltd. romanized |
| 2026/05/12Generic · Class 3 | Vitamin K1 InjectionCYHS2601084 | Chongqing Lai Mei Pharma Co., Ltd. romanized; Nanjing Chen Gong Pharmaceutical Co., Ltd. romanized |
| 2026/05/12Generic · Class 3 | 甲磺酸帕珠沙星氯化钠注射液 · No verified English nameCYHS2601083 | HUNAN WARRANT PHARMACEUTICAL CO.,LTD; Hunan Kang Yuan Pharmaceutical Co., Ltd. romanized |
| 2026/05/12Generic · Class 3 | 甲磺酸帕珠沙星氯化钠注射液 · No verified English nameCYHS2601082 | HUNAN WARRANT PHARMACEUTICAL CO.,LTD; Hunan Kang Yuan Pharmaceutical Co., Ltd. romanized |
| 2026/05/12Generic · Class 3 | Tolvaptan Orally Disintegrating TabletsCYHS2601080 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2026/05/12Generic · Class 3 | Emedastine Difumarate Sustained-release CapsulesCYHS2601079 | Hainan Mei Kang Da Pharma Co., Ltd. romanized; Sichuan De Feng Pharma Co., Ltd. romanized |
| 2026/05/12Generic · Class 3 | Tolvaptan Orally Disintegrating TabletsCYHS2601078 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2026/05/12Generic · Class 3 | Galanthamine Hydrobromide Oral SolutionCYHS2601077 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2026/05/12Generic · Class 3 | Galanthamine Hydrobromide Oral SolutionCYHS2601076 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2026/05/12Generic · Class 3 | Galanthamine Hydrobromide Oral SolutionCYHS2601075 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2026/05/12Generic · Class 3 | 托吡酯口服溶液 · No verified English nameCYHS2601069 | Guo Yao Rui Fu Lai Pharma Co., Ltd. romanized; Hubei Duo Rui Pharma Co., Ltd. romanized |
| 2026/05/12New drug · Class 3.1 | 桃红四物汤颗粒 · No verified English nameCXZS2600026 | Hebei Wan Bang Fu Lin Pharma Co., Ltd. romanized |
| 2026/05/12New drug · Class 2.3 | 麝香通心滴丸 · No verified English nameCXZL2600042 | Nei Menggu Kang En Bei Pharma Co., Ltd. romanized |
| 2026/05/12New drug · Class 1 | SPY002-091, 200 mg/mL IV · No verified English nameCXSL2600506 | Pi Ai Sai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/05/12New drug · Class 1 | SPY002-091, 200 mg/mL SC · No verified English nameCXSL2600505 | Pi Ai Sai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/05/12New drug · Class 2.4 | SPY003-207, 180 mg/mL SC · No verified English nameCXSL2600504 | Pi Ai Sai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/05/12New drug · Class 2.4 | SPY003-207, 150 mg/mL IV · No verified English nameCXSL2600503 | Pi Ai Sai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/05/12New drug · Class 2.4 | SPY001-001, 180 mg/mL SC · No verified English nameCXSL2600502 | Pi Ai Sai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/05/12New drug · Class 2.4 | SPY001-001, 150mg/mL IV · No verified English nameCXSL2600501 | Pi Ai Sai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/05/12New drug · Class 2.2 | 酪酸梭菌活菌滴剂(胶囊型) · No verified English nameCXSL2600500 | Hangzhou Yuan Da Biopharmaceutical Co., Ltd. romanized |
| 2026/05/12New drug · Class 1 | 注射用 B024 · No verified English nameCXSL2600499 | Shanghai Shang Yao Jiao Lian Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/05/12New drug · Class 2.2 | 注射用重组人尿激酶原 · No verified English nameCXSL2600498 | Tian Shi Li Biopharmaceuticals Co., Ltd. romanized |
| 2026/05/12New drug · Class 1 | CT0596 CAR T细胞注射液 · No verified English nameCXSL2600497 | You Kai Ze Biopharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2026/05/12New drug · Class 1 | IxCell hUC-MSC-P注射液 · No verified English nameCXSL2600496 | Shanghai Ai Sa Er Biopharmaceuticals Co., Ltd. romanized |
| 2026/05/12New drug · Class 1 | 注射用ALK201 · No verified English nameCXSL2600495 | Shanghai An Ling Ke Biopharmaceuticals Co., Ltd. romanized |
| 2026/05/12New drug · Class 1 | 9MW5211注射液 · No verified English nameCXSL2600494 | Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized |
| 2026/05/12New drug · Class 2.2 | 依沃西单抗注射液 · No verified English nameCXSL2600493 | Kang Fang Sai Nuo Pharmaceuticals Co., Ltd. romanized |
| 2026/05/12New drug · Class 1 | JSKN033注射液 · No verified English nameCXSL2600492 | Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized |
| 2026/05/12New drug · Class 1 | GFS202A注射液 · No verified English nameCXSL2600491 | Jin Fang Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
131 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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