YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 476 drug applications between 13 August 2026 and 19 August 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 74, covering 56 drug names.
2026/08/13 – 2026/08/19
- New acceptances this week
- 476
- Drugs with new generic filings (by drug name, de-duplicated)
- 56
- Accepted this week, now under review
- 238
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
476filings, 74 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 286 |
| Generic | 74 |
| New drug | 64 |
| Import | 42 |
| Import re-registration | 6 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 229 |
| TCM | 173 |
| Therapeutic biologic | 66 |
| Prophylactic biologic | 7 |
| 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
56 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 注射用磷酸左奥硝唑酯二钠 · No verified English name | 3 | 2 | 22 |
| 2 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 3 | Pregabalin Extended release Tablets | 3 | 1 | 13 |
| 4 | 氧(液态) · No verified English name | 2 | 2 | 13 |
| 5 | Landiolol Hydrochloride for Injection | 2 | 2 | 19 |
| 6 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 7 | 醋酸地非法林注射液 · No verified English name | 2 | 2 | 8 |
| 8 | Levofloxacin Eye Drops | 2 | 1 | 16 |
| 9 | Ceftazidime for Injection | 2 | 1 | 4 |
| 10 | Caspofungin Acetate for Injection | 2 | 1 | 8 |
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
272 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shanghai Min Wei Bio Technology Co., Ltd. romanized | 14 | 1 | 0 |
| 2 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 10 | 3 | 0 |
| 3 | Jilin Gao Miao Pharma Co., Ltd. romanized | 9 | 9 | 0 |
| 4 | Eli Lilly and Company | 8 | 2 | 0 |
| 5 | Novo Nordisk A/S | 8 | 2 | 0 |
| 6 | Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized | 7 | 7 | 1 |
| 7 | Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized | 7 | 6 | 0 |
| 8 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 7 | 3 | 3 |
| 9 | F. Hoffmann-La Roche Ltd | 7 | 2 | 0 |
| 10 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 7 | 2 | 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
122 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/08/19Import · Class 3.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600075 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2026/08/19Import · Class 3.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600074 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2026/08/19Import · Class 1 | zenagamtide注射液 · No verified English nameJXSL2600216 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/08/19Import · Class 1 | zenagamtide注射液 · No verified English nameJXSL2600215 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/08/19Import · Class 1 | zenagamtide注射液 · No verified English nameJXSL2600214 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/08/19Import · Class 1 | zenagamtide注射液 · No verified English nameJXSL2600213 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/08/19Import · Class 1 | zenagamtide注射液 · No verified English nameJXSL2600212 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/08/19Import · Class 1 | zenagamtide注射液 · No verified English nameJXSL2600211 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/08/19Import · Class 1 | zenagamtide注射液 · No verified English nameJXSL2600210 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2026/08/19Import · Class 1 | BMS-986368胶囊 · No verified English nameJXHL2600357 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/08/19Import · Class 1 | BMS-986368胶囊 · No verified English nameJXHL2600356 | Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/08/19Import · Class 2.4 | Osimertinib Mesylate TabletsJXHL2600355 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2026/08/19Import · Class 2.4 | Osimertinib Mesylate TabletsJXHL2600354 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2026/08/19Generic · Class 3 | Thioctic Acid TabletsCYHS2602051 | Guangdong Jian Xin Pharmaceutical Co., Ltd. romanized |
| 2026/08/19Generic · Class 3 | Metronidazole SuppositoriesCYHL2600088 | Jiangsu Yu Xing Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/08/19New drug · Class 2.2 | 四价流感病毒裂解疫苗(MDCK细胞) · No verified English nameCXSS2600129 | Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2026/08/19New drug · Class 2.2 | 四价流感病毒裂解疫苗(MDCK细胞) · No verified English nameCXSS2600128 | Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2026/08/19New drug · Class 1 | 注射用LM-350 · No verified English nameCXSL2600880 | Li Xin Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/08/19New drug · Class 1 | IBI343 · No verified English nameCXSL2600879 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2026/08/19New drug · Class 1 | CPD705注射液 · No verified English nameCXHL2601021 | Beijing Tai De Pharmaceutical Co., Ltd. romanized |
| 2026/08/19New drug · Class 1 | CPD705注射液 · No verified English nameCXHL2601020 | Beijing Tai De Pharmaceutical Co., Ltd. romanized |
| 2026/08/19New drug · Class 1 | BW-41012注射液 · No verified English nameCXHL2601019 | Shanghai Bo Wang Pharmaceutical Co., Ltd. romanized |
| 2026/08/19New drug · Class 1 | BW-41012注射液 · No verified English nameCXHL2601018 | Shanghai Bo Wang Pharmaceutical Co., Ltd. romanized |
| 2026/08/19New drug · Class 1 | QLS1510片 · No verified English nameCXHL2601017 | Shanghai Qi Lu Pharmaceutical Research Center Co., Ltd. romanized |
| 2026/08/19New drug · Class 1 | QLS1510片 · No verified English nameCXHL2601016 | Shanghai Qi Lu Pharmaceutical Research Center Co., Ltd. romanized |
| 2026/08/19New drug · Class 1 | PSTA100胶囊 · No verified English nameCXHL2601015 | Pu Luo Si Te (Nanjing) Bio Technology Co., Ltd. romanized |
| 2026/08/19New drug · Class 1 | PSTA100胶囊 · No verified English nameCXHL2601014 | Pu Luo Si Te (Nanjing) Bio Technology Co., Ltd. romanized |
| 2026/08/19New drug · Class 1 | LY4064809片 · No verified English nameCXHL2601013 | Li Lai Suzhou Pharmaceutical Co., Ltd. romanized |
| 2026/08/19New drug · Class 1 | LY4064809片 · No verified English nameCXHL2601012 | Li Lai Suzhou Pharmaceutical Co., Ltd. romanized |
| 2026/08/19New drug · Class 1 | LY4064809片 · No verified English nameCXHL2601011 | Li Lai Suzhou Pharmaceutical Co., Ltd. romanized |
92 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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