YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 382 drug applications between 26 August 2025 and 1 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 101, covering 70 drug names.
2025/08/26 – 2025/09/01
- New acceptances this week
- 382
- Drugs with new generic filings (by drug name, de-duplicated)
- 70
- Accepted this week, now under review
- 92
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
382filings, 101 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 172 |
| Generic | 101 |
| New drug | 69 |
| Import | 28 |
| Unspecified | 8 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 256 |
| TCM | 63 |
| Therapeutic biologic | 55 |
| Biologic | 7 |
| Prophylactic 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
70 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sufentanil Citrate Injection | 4 | 1 | 0 |
| 2 | 瑞维那新吸入溶液 · No verified English name | 3 | 3 | 53 |
| 3 | Apalutamide Tablets | 3 | 3 | 18 |
| 4 | Sacubitril Valsartan Sodium Tablets | 3 | 1 | 70 |
| 5 | Ambroxol Hydrochloride Injection | 3 | 1 | 9 |
| 6 | Polidocanol Injection | 3 | 1 | 23 |
| 7 | 甘油磷酸钠注射液 · No verified English name | 2 | 2 | 7 |
| 8 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 9 | Iguratimod Tablets | 2 | 2 | 23 |
| 10 | Mupirocin Ointment | 2 | 2 | 30 |
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
216 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized | 10 | 8 | 0 |
| 2 | Eli Lilly and Company | 9 | 2 | 0 |
| 3 | Gui Lin Hua Run Tian He Pharma Co., Ltd. romanized | 7 | 7 | 0 |
| 4 | Shandong Jian Bin Pharmaceuticals Technology Co., Ltd. romanized | 7 | 6 | 0 |
| 5 | AstraZeneca AB | 5 | 2 | 0 |
| 6 | Novo Nordisk A/S | 5 | 1 | 0 |
| 7 | Takeda Canada Inc | 5 | 1 | 0 |
| 8 | Terumo Corporation Kofu Factory | 5 | 1 | 0 |
| 9 | Qilu Pharmaceutical Co., Ltd. | 5 | 1 | 0 |
| 10 | Beijing Tong Ren Tang Pharmaceutical Co., Ltd. romanized | 4 | 4 | 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
129 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/09/01Generic · Class 3 | Fluoroestradiol18F injectionCYHL2500160 | Jiangsu Hua Yi Technology Co., Ltd. romanized |
| 2025/08/30Import · Class 3.1 | 注射用Rurioctocog alfa pegol · No verified English nameJXSS2500115 | Takeda Canada Inc; Baxalta Manufacturing S.a.r.l.; Takeda (China) International Trading Co. Ltd |
| 2025/08/30Import · Class 3.1 | 注射用Rurioctocog alfa pegol · No verified English nameJXSS2500114 | Takeda Canada Inc; Baxalta Manufacturing S.a.r.l.; Takeda (China) International Trading Co. Ltd |
| 2025/08/30Import · Class 3.1 | 注射用Rurioctocog alfa pegol · No verified English nameJXSS2500113 | Takeda Canada Inc; Baxalta Manufacturing S.a.r.l.; Takeda (China) International Trading Co. Ltd |
| 2025/08/30Import · Class 3.1 | 注射用Rurioctocog alfa pegol · No verified English nameJXSS2500112 | Takeda Canada Inc; Baxalta Manufacturing S.a.r.l.; Takeda (China) International Trading Co. Ltd |
| 2025/08/30Import · Class 3.1 | 注射用Rurioctocog alfa pegol · No verified English nameJXSS2500111 | Takeda Canada Inc; Baxalta Manufacturing S.a.r.l.; Takeda (China) International Trading Co. Ltd |
| 2025/08/30Import · Class 1 | [225Ac]Ac-FL-020注射液 · No verified English nameJXHL2500250 | Full-Life Technologies GmbH; Shanghai Full-life Technologies Co. Ltd. |
| 2025/08/30Import · Class 1 | [111In]In-FL-020注射液 · No verified English nameJXHL2500249 | Full-Life Technologies GmbH; Shanghai Full-life Technologies Co. Ltd. |
| 2025/08/30Import · Class 1 | Brenipatide注射液 · No verified English nameJXHL2500248 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/08/30Import · Class 1 | Brenipatide注射液 · No verified English nameJXHL2500247 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/08/30Import · Class 1 | Brenipatide注射液 · No verified English nameJXHL2500246 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/08/30Generic · Class 3 | Metformin Hydrochloride Oral SolutionCYHS2503201 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2025/08/30Generic · Class 3 | Metformin Hydrochloride Oral SolutionCYHS2503200 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2025/08/30Generic · Class 3 | 磷酸奥司他韦颗粒 · No verified English nameCYHS2503199 | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized |
| 2025/08/30Generic · Class 3 | Fosphenytoin Sodium InjectionCYHS2503195 | Wuhan Hua Er Bio Technology Co., Ltd. romanized; Wuhan Qi Rui Pharma Co., Ltd. romanized |
| 2025/08/30Generic · Class 3 | Fosphenytoin Sodium InjectionCYHS2503194 | Wuhan Hua Er Bio Technology Co., Ltd. romanized; Wuhan Qi Rui Pharma Co., Ltd. romanized |
| 2025/08/30Generic · Class 3 | 中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2503187 | Hainan Ai Ke Pharmaceutical Co., Ltd. romanized; Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized |
| 2025/08/30Generic · Class 3 | 中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2503186 | Hainan Ai Ke Pharmaceutical Co., Ltd. romanized; Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized |
| 2025/08/30Generic · Class 3 | 中性腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2503185 | Hainan Ai Ke Pharmaceutical Co., Ltd. romanized; Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized |
| 2025/08/30Generic · Class 3 | 中性腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2503184 | Hainan Ai Ke Pharmaceutical Co., Ltd. romanized; Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized |
| 2025/08/30New drug · Class 1 | 注射用ZG006 · No verified English nameCXSL2500753 | Name not romanized; Name not romanized |
| 2025/08/30New drug · Class 1 | 注射用戈氏梭菌芽孢冻干粉 · No verified English nameCXSL2500752 | Shi Hui Da Pharma Group (Jilin) Co., Ltd. romanized |
| 2025/08/30New drug · Class 1 | 9MW3811注射液 · No verified English nameCXSL2500751 | Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized |
| 2025/08/30New drug · Class 1 | SCTC21C注射液 · No verified English nameCXSL2500750 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2025/08/30New drug · Class 2.2 | 吡仑帕奈口溶膜 · No verified English nameCXHS2500105 | Shanghai Xin Feng Pharmaceutical Co., Ltd. romanized |
| 2025/08/30New drug · Class 2.2 | 吡仑帕奈口溶膜 · No verified English nameCXHS2500104 | Shanghai Xin Feng Pharmaceutical Co., Ltd. romanized |
| 2025/08/30New drug · Class 1 | HH101785片 · No verified English nameCXHL2500933 | Shanghai Hai He Drug Research Kai Fa Co., Ltd. romanized |
| 2025/08/30New drug · Class 1 | HH101785片 · No verified English nameCXHL2500932 | Shanghai Hai He Drug Research Kai Fa Co., Ltd. romanized |
| 2025/08/30New drug · Class 2.4 | 硫酸艾玛昔替尼片 · No verified English nameCXHL2500931 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/08/30New drug · Class 2.2 | P-0264直服颗粒 · No verified English nameCXHL2500930 | Hua Yi Tai Kang Pharma Co., Ltd. romanized |
99 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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