YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 452 drug applications between 30 July 2025 and 5 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 108, covering 81 drug names.
2025/07/30 – 2025/08/05
- New acceptances this week
- 452
- Drugs with new generic filings (by drug name, de-duplicated)
- 81
- Accepted this week, now under review
- 91
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
452filings, 108 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 215 |
| Generic | 108 |
| New drug | 78 |
| Import | 28 |
| Import re-registration | 16 |
| Unspecified | 5 |
| Drug-device combination product | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 279 |
| TCM | 98 |
| Therapeutic biologic | 69 |
| Unspecified | 3 |
| Prophylactic biologic | 2 |
| 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
81 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sacubitril Valsartan Sodium Tablets | 4 | 2 | 70 |
| 2 | Cefditoren Pivoxil Granules | 3 | 2 | 18 |
| 3 | Dapagliflozin Tablets | 3 | 2 | 84 |
| 4 | Finerenone Tablets | 3 | 2 | 69 |
| 5 | Levetiracetam Tablets | 3 | 1 | 6 |
| 6 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 7 | Omega-3-acid ethyl ester 90 Soft Capsules | 2 | 2 | 11 |
| 8 | Pemafibrate Tablets | 2 | 2 | 23 |
| 9 | 双氯芬酸钠盐酸利多卡因注射液 · No verified English name | 2 | 2 | 8 |
| 10 | 头孢克肟干混悬剂 · No verified English name | 2 | 2 | 3 |
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
277 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Sichuan Kelun Pharmaceutical Co., Ltd. | 14 | 5 | 1 |
| 2 | Shanxi Hua Kang Pharma Co., Ltd. romanized | 10 | 9 | 0 |
| 3 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 8 | 3 | 0 |
| 4 | Qilu Pharmaceutical Co., Ltd. | 7 | 4 | 1 |
| 5 | Amgen Inc. | 6 | 3 | 0 |
| 6 | Novo Nordisk A/S | 6 | 2 | 0 |
| 7 | Henan Xin Xiang Hua Xing Pharmaceutical Factory romanized | 6 | 2 | 0 |
| 8 | AstraZeneca UK Limited | 6 | 1 | 0 |
| 9 | Changchun Hai Wai Pharmaceutical Group Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 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
130 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/08/05Import · Class 2.2 | Lebrikizumab注射液 · No verified English nameJXSL2500140 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/08/05Import · Class 1 | AZD0486 · No verified English nameJXSL2500139 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/08/05Import · Class 1 | AZD0486 · No verified English nameJXSL2500138 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/08/05Generic · Class 3 | 盐酸肾上腺素注射液 · No verified English nameCYHS2502823 | CISEN PHARMACEUTICAL CO., LTD. |
| 2025/08/05Generic · Class 3 | Polymyxin B sulfate for InjectionCYHS2502821 | Hebei Rui Jian Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized |
| 2025/08/05Generic · Class 3 | 异丙托溴铵沙丁胺醇吸入喷雾剂 · No verified English nameCYHS2502820 | Nanchang Gu Sen Biopharmaceutical Co., Ltd. romanized |
| 2025/08/05Generic · Class 3 | Ebastine Oral SolutionCYHS2502814 | Chongqing Xi Er An Pharma Co., Ltd. romanized |
| 2025/08/05Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2502813 | Jiangxi Ke Wei Pharmaceutical Co., Ltd. romanized; Jiangxi He Ying Pharma Co., Ltd. romanized |
| 2025/08/05New drug · Class 2.3 | 小儿肺热咳喘口服液 · No verified English nameCXZL2500062 | Heilongjiang Kui Hua Pharma Co., Ltd. romanized |
| 2025/08/05New drug · Class 1 | QLS2309注射液 · No verified English nameCXSL2500659 | Qilu Pharmaceutical Co., Ltd. |
| 2025/08/05New drug · Class 1 | SYS6010 · No verified English nameCXSL2500658 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2025/08/05New drug · Class 1 | IBI3009 · No verified English nameCXSL2500657 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/08/05New drug · Class 1 | SYS6043 · No verified English nameCXSL2500656 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2025/08/05New drug · Class 1 | DP303c注射液 · No verified English nameCXSL2500655 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2025/08/05New drug · Class 1 | SYS6002 · No verified English nameCXSL2500654 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2025/08/05New drug · Class 3.3 | 精蛋白人胰岛素混合注射液(30R) · No verified English nameCXSL2500653 | Heng Jing He Chuang Biopharmaceuticals (Zhejiang) Co., Ltd. romanized |
| 2025/08/05New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHS2500091 | Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized; CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2025/08/05New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHS2500090 | Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized; CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2025/08/05New drug · Class 1 | SYH2061注射液 · No verified English nameCXHL2500812 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized; CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. |
| 2025/08/05New drug · Class 1 | HRS-2430注射液 · No verified English nameCXHL2500811 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/08/05New drug · Class 1 | HRS-2430注射液 · No verified English nameCXHL2500810 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/08/05New drug · Class 2.4 | 注射用西罗莫司(白蛋白结合型) · No verified English nameCXHL2500809 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2025/08/05New drug · Class 2.2 | DM2080贴 · No verified English nameCXHL2500808 | Beijing De Mo Gao Ke Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/08/05New drug · Class 2.2 | DM2080贴 · No verified English nameCXHL2500807 | Beijing De Mo Gao Ke Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/08/05New drug · Class 2.3 | 多替拉韦拉米夫定替诺福韦片 · No verified English nameCXHL2500806 | Shanghai Di Sai Nuo Pharmaceuticals Group Co., Ltd. romanized |
| 2025/08/04Generic · Class 3 | Polaprezinc GranulesCYHS2502808 | Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized; Guangdong An Nuo Pharma Co., Ltd. romanized |
| 2025/08/04Generic · Class 3 | Betamethasone Sodium Phosphate InjectionCYHS2502807 | Anhui Jun Da Gao Ke Pharmaceuticals Technology Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2025/08/04Generic · Class 3 | 中性腹膜透析液(乳酸盐-G2.5%) · No verified English nameCYHS2502806 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2025/08/04Generic · Class 3 | 中性低钙腹膜透析液(乳酸盐-G2.5%) · No verified English nameCYHS2502805 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2025/08/04Generic · Class 3 | Magnesium Sulfate InjectionCYHS2502804 | Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized |
100 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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