YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 283 drug applications between 2 May 2026 and 8 May 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 33, covering 26 drug names.
2026/05/02 – 2026/05/08
- New acceptances this week
- 283
- Drugs with new generic filings (by drug name, de-duplicated)
- 26
- Accepted this week, now under review
- 68
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
283filings, 33 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 169 |
| New drug | 39 |
| Generic | 33 |
| Import | 30 |
| Unspecified | 11 |
| Import re-registration | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 119 |
| TCM | 115 |
| Therapeutic biologic | 43 |
| Biologic | 6 |
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
26 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Piracetam Injection | 2 | 1 | 9 |
| 2 | Dotinurad Tablets | 2 | 1 | 55 |
| 3 | Nafamostat Mesilate for Injection | 2 | 1 | 38 |
| 4 | Trazodone Hydrochloride Sustained-release Tablets | 2 | 1 | 20 |
| 5 | Mirogabalin Besilate Tablets | 2 | 1 | 61 |
| 6 | Dapagliflozin Tablets | 2 | 1 | 84 |
| 7 | Atosiban Acetate Injection | 2 | 1 | 2 |
| 8 | Fluticasone Propionate Nebuliser Suspension | 1 | 1 | 8 |
| 9 | Pemafibrate Tablets | 1 | 1 | 23 |
| 10 | 噻托溴铵吸入粉雾剂 · No verified English name | 1 | 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
174 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | AstraZeneca AB | 16 | 1 | 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 | Qinghai Di Ma Er Zang Yao Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | Pfizer Inc. | 5 | 4 | 0 |
| 6 | Jilin Sheng Zhong Yan Pharma Co., Ltd. romanized | 5 | 4 | 0 |
| 7 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 4 | 3 | 0 |
| 8 | Hui Sheng Biopharmaceutical Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Zhejiang Dao Er Bio Technology 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
68 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/05/08Import · Class 3.1 | 注射用Belantamab mafodotin · No verified English nameJXSL2600111 | GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Company Limited |
| 2026/05/08Import · Class 2.2 | 注射用Belantamab mafodotin · No verified English nameJXSL2600110 | GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Company Limited |
| 2026/05/08Import · Class 1 | 注射用BMS-986525 · No verified English nameJXSL2600109 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/05/08Import · Class 1 | Elecoglipron薄膜包衣片 · No verified English nameJXHL2600157 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/05/08Import · Class 1 | Elecoglipron薄膜包衣片 · No verified English nameJXHL2600156 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/05/08Import · Class 1 | Elecoglipron薄膜包衣片 · No verified English nameJXHL2600155 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/05/08Import · Class 1 | Elecoglipron薄膜包衣片 · No verified English nameJXHL2600154 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/05/08Import · Class 1 | Elecoglipron薄膜包衣片 · No verified English nameJXHL2600153 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/05/08Import · Class 1 | Elecoglipron薄膜包衣片 · No verified English nameJXHL2600152 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/05/08Import · Class 1 | Elecoglipron薄膜包衣片 · No verified English nameJXHL2600151 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/05/08Import · Class 1 | Elecoglipron薄膜包衣片 · No verified English nameJXHL2600150 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/05/08Import · Class 1 | LY4337713注射液 · No verified English nameJXHL2600149 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2026/05/08Import · Class 1 | Elecoglipron薄膜包衣片 · No verified English nameJXHL2600148 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/05/08Import · Class 1 | Elecoglipron薄膜包衣片 · No verified English nameJXHL2600147 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/05/08Import · Class 1 | Elecoglipron薄膜包衣片 · No verified English nameJXHL2600146 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/05/08Import · Class 1 | Elecoglipron薄膜包衣片 · No verified English nameJXHL2600145 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/05/08Import · Class 1 | Elecoglipron薄膜包衣片 · No verified English nameJXHL2600144 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/05/08Import · Class 1 | Elecoglipron薄膜包衣片 · No verified English nameJXHL2600143 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/05/08Import · Class 1 | Elecoglipron薄膜包衣片 · No verified English nameJXHL2600142 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/05/08Import · Class 1 | Elecoglipron薄膜包衣片 · No verified English nameJXHL2600141 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/05/08Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2601057 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2026/05/08Generic · Class 3 | 生理氯化钠溶液 · No verified English nameCYHS2601054 | Hebei Guang Xiang Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2026/05/08Generic · Class 3 | Nafamostat Mesilate for InjectionCYHS2601042 | Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2026/05/08Generic · Class 3 | Nafamostat Mesilate for InjectionCYHS2601040 | Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2026/05/08Generic · Class 3 | Piracetam InjectionCYHS2601035 | Jiangsu Fu Bang Pharma Co., Ltd. romanized |
| 2026/05/08Generic · Class 3 | Piracetam InjectionCYHS2601034 | Jiangsu Fu Bang Pharma Co., Ltd. romanized |
| 2026/05/08New drug · Class 1 | SYS6067注射液 · No verified English nameCXSL2600483 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2026/05/08New drug · Class 1 | SQ-23101注射液 · No verified English nameCXSL2600482 | Shenyang Xing Qi Yan Yao Co., Ltd. romanized |
| 2026/05/08New drug · Class 1 | 注射用3SC001 · No verified English nameCXSL2600481 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2026/05/08New drug · Class 1 | OTOV-102预混注射液 · No verified English nameCXSL2600479 | Xing Ao Tuo Wei (Nanjing) Bio Technology Co., Ltd. romanized |
38 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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