YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 383 drug applications between 3 May 2026 and 9 May 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 45, covering 35 drug names.
2026/05/03 – 2026/05/09
- New acceptances this week
- 383
- Drugs with new generic filings (by drug name, de-duplicated)
- 35
- Accepted this week, now under review
- 89
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
383filings, 45 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 224 |
| New drug | 55 |
| Generic | 45 |
| Import | 39 |
| Unspecified | 14 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 173 |
| TCM | 137 |
| Therapeutic biologic | 61 |
| Biologic | 9 |
| 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
35 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 瑞维那新吸入溶液 · No verified English name | 2 | 2 | 53 |
| 2 | Sitagliptin and Metformin Hydrochloride Extended-release Tablets | 2 | 2 | 12 |
| 3 | Piracetam Injection | 2 | 1 | 9 |
| 4 | Dotinurad Tablets | 2 | 1 | 55 |
| 5 | Nafamostat Mesilate for Injection | 2 | 1 | 38 |
| 6 | Trazodone Hydrochloride Sustained-release Tablets | 2 | 1 | 20 |
| 7 | Eldecalcitol Soft Capsules | 2 | 1 | 8 |
| 8 | Mirogabalin Besilate Tablets | 2 | 1 | 61 |
| 9 | Dapagliflozin Tablets | 2 | 1 | 84 |
| 10 | Atosiban Acetate 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
227 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | AstraZeneca AB | 21 | 3 | 0 |
| 2 | Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized | 12 | 8 | 0 |
| 3 | Tai Ji Group Chongqing Tong Jun Ge Pharmaceutical Factory Co., Ltd. romanized | 9 | 8 | 0 |
| 4 | Qilu Pharmaceutical Co., Ltd. | 8 | 3 | 1 |
| 5 | Bao Guang Pharma (Chengdu) Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Qinghai Di Ma Er Zang Yao Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Pfizer Inc. | 5 | 4 | 0 |
| 8 | Jilin Sheng Zhong Yan Pharma Co., Ltd. romanized | 5 | 4 | 0 |
| 9 | Novo Nordisk A/S | 4 | 4 | 0 |
| 10 | Roche Pharma (Schweiz) AG | 4 | 3 | 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
98 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/05/09Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSS2600041 | MSD International Business GmbH; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd |
| 2026/05/09Import · Class 2.2 | 德莫奇单抗注射液 · No verified English nameJXSL2600114 | GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd. |
| 2026/05/09Import · Class 2.2 | 德莫奇单抗注射液 · No verified English nameJXSL2600113 | GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd. |
| 2026/05/09Import · Class 2.2 | 注射用替奈普酶 · No verified English nameJXSL2600112 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2026/05/09Import · Class 1 | AZD2265 · No verified English nameJXHL2600162 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/05/09Import · Class 1 | AZD9574 · No verified English nameJXHL2600161 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/05/09Import · Class 1 | AZD9574 · No verified English nameJXHL2600160 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/05/09Import · Class 1 | AZD9574 · No verified English nameJXHL2600159 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/05/09Import · Class 1 | AZD9574 · No verified English nameJXHL2600158 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/05/09Generic · Class 3 | Acetylcysteine InjectionCYHS2601066 | Jiangsu An Bi Sheng Pharmaceutical Co., Ltd. romanized |
| 2026/05/09Generic · Class 3 | Polymyxin B sulfate for InjectionCYHS2601064 | Hu Zhou Ya Se Pharmaceutical Co., Ltd. romanized |
| 2026/05/09Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2601058 | Anhui Huan Qiu Pharma Co., Ltd. romanized |
| 2026/05/09Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2601053 | Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized; Ningbo Shuang Cheng Pharma Co., Ltd. romanized |
| 2026/05/09Generic · Class 3 | 阿普昔腾坦片 · No verified English nameCYHL2600058 | Qilu Pharmaceutical Co., Ltd. |
| 2026/05/09New drug · Class 1.1 | 張其鋒百寳丹胶囊 · No verified English nameCXZL2600041 | Sen Lin Sheng Tai Nong Ye (Liao Cheng) Co., Ltd. romanized |
| 2026/05/09New drug · Class 1.1 | 芪黄正气颗粒 · No verified English nameCXZL2600040 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized; Shanghai Tu Feng Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Zhong Pharmaceuticals University romanized |
| 2026/05/09New drug · Class 2.2 | 注射用芦康沙妥珠单抗 · No verified English nameCXSS2600080 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2026/05/09New drug · Class 2.2 | 注射用芦康沙妥珠单抗 · No verified English nameCXSS2600079 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2026/05/09New drug · Class 1 | 注射用AX-023(冻干) · No verified English nameCXSL2600488 | Beijing An Xin Huai De Bio Technology Co., Ltd. romanized |
| 2026/05/09New drug · Class 1.2 | RG003-02注射液 · No verified English nameCXSL2600487 | Ren Jing (Suzhou) Bio Technology Co., Ltd. romanized; Zhongguo Yi Xue Ke College Pharmaceuticals Bio Technology Research Institute romanized |
| 2026/05/09New drug · Class 1 | SKB575(HBM7575)注射液 · No verified English nameCXSL2600486 | He Bo Pharmaceuticals (Shanghai) Co., Ltd. romanized; Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2026/05/09New drug · Class 1 | MWN110注射液 · No verified English nameCXSL2600485 | Shanghai Min Wei Bio Technology Co., Ltd. romanized |
| 2026/05/09New drug · Class 1 | 注射用IMW-1001 · No verified English nameCXSL2600484 | Long Qi Biopharmaceutical (Hangzhou) Co., Ltd. romanized |
| 2026/05/09New drug · Class 1.3 | 重组呼吸道合胞病毒疫苗(CHO细胞) · No verified English nameCXSL2600480 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2026/05/09New drug · Class 1 | QLS1403片 · No verified English nameCXHL2600546 | Qilu Pharmaceutical Co., Ltd. |
| 2026/05/09New drug · Class 1 | QLS1403片 · No verified English nameCXHL2600545 | Qilu Pharmaceutical Co., Ltd. |
| 2026/05/09New drug · Class 1 | QLS1403片 · No verified English nameCXHL2600544 | Qilu Pharmaceutical Co., Ltd. |
| 2026/05/09New drug · Class 1 | CS0159片 · No verified English nameCXHL2600543 | Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/05/09New drug · Class 1 | TB-D004C注射液 · No verified English nameCXHL2600540 | Shenzhen Shi Tu Wei An Chuang Technology Kai Fa Co., Ltd. romanized |
| 2026/05/09New drug · Class 1 | TB-D004C注射液 · No verified English nameCXHL2600539 | Shenzhen Shi Tu Wei An Chuang Technology Kai Fa Co., Ltd. romanized |
68 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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