YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 428 drug applications between 6 June 2025 and 12 June 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 129, covering 83 drug names.
2025/06/06 – 2025/06/12
- New acceptances this week
- 428
- Drugs with new generic filings (by drug name, de-duplicated)
- 83
- Accepted this week, now under review
- 66
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
428filings, 129 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 153 |
| Generic | 129 |
| New drug | 82 |
| Import | 46 |
| Unspecified | 11 |
| Import re-registration | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 275 |
| Therapeutic biologic | 82 |
| TCM | 61 |
| Biologic | 5 |
| Prophylactic biologic | 4 |
| In vitro diagnostic reagent | 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
83 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Acetylcysteine Injection | 20 | 19 | 53 |
| 2 | Brexpiprazole Tablets | 4 | 2 | 31 |
| 3 | 苯磺酸左氨氯地平片 · No verified English name | 4 | 2 | 45 |
| 4 | Carbidopa and Levodopa Sustained-release Tablets | 3 | 2 | 2 |
| 5 | 中性低钙腹膜透析液(碳酸氢盐-G4.25%) · No verified English name | 2 | 2 | 1 |
| 6 | Ethyl Iosapentate Capsules | 2 | 2 | 27 |
| 7 | Bilastine Oral Solution | 2 | 2 | 8 |
| 8 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 9 | Lactulose Oral Solution | 2 | 1 | 34 |
| 10 | Folic acid injection | 2 | 1 | 1 |
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
281 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Merck Sharp & Dohme B.V. | 25 | 2 | 0 |
| 2 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 7 | 3 | 0 |
| 3 | Heilongjiang Lin Hai Xue Yuan Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 4 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 5 | 4 | 5 |
| 5 | Qilu Pharmaceutical Co., Ltd. | 5 | 4 | 1 |
| 6 | Xian Da Heng Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Novartis Pharma AG | 4 | 3 | 0 |
| 8 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | Rui Yang Pharmaceutical Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | Eli Lilly Nederland B.V. | 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
165 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/06/12Import · Class 2.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500095 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2025/06/12Import · Class 2.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500094 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2025/06/12Import · Class 2.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500093 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2025/06/12Import · Class 2.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500092 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2025/06/12Import · Class 2.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500091 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2025/06/12Import · Class 2.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500090 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2025/06/12Import · Class 2.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500089 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2025/06/12Import · Class 2.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500088 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2025/06/12Import · Class 2.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500087 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2025/06/12Import · Class 2.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500086 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2025/06/12Import · Class 2.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500085 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2025/06/12Import · Class 2.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500084 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2025/06/12Import · Class 2.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500083 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2025/06/12Import · Class 2.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500082 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2025/06/12Import · Class 2.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500081 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2025/06/12Import · Class 2.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500080 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2025/06/12Import · Class 2.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500079 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2025/06/12Import · Class 2.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500078 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2025/06/12Import · Class 2.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500077 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2025/06/12Import · Class 2.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500076 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2025/06/12Import · Class 2.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500075 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2025/06/12Import · Class 2.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500074 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2025/06/12Import · Class 1 | BMS-986504片 · No verified English nameJXHL2500139 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2025/06/12Import · Class 1 | Baxdrostat片 · No verified English nameJXHL2500138 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/06/12Import · Class 1 | Baxdrostat片 · No verified English nameJXHL2500137 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/06/12Import · Class 1 | ARV-471(PF-07850327)片 · No verified English nameJXHL2500136 | Pfizer Inc; Pfizer Investment CO. Ltd. |
| 2025/06/12Import · Class 1 | PF-07248144片 · No verified English nameJXHL2500135 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2025/06/12Import · Class 1 | PF-07248144片 · No verified English nameJXHL2500134 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2025/06/12Import · Class 1 | PF-07248144片 · No verified English nameJXHL2500133 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2025/06/12Generic · Class 3 | 多索茶碱口服溶液 · No verified English nameCYHS2502115 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
135 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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