YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 194 drug applications between 7 March 2024 and 13 March 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 42, covering 33 drug names.
2024/03/07 – 2024/03/13
- New acceptances this week
- 194
- Drugs with new generic filings (by drug name, de-duplicated)
- 33
- Accepted this week, now under review
- 0
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
194filings, 42 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 89 |
| Generic | 42 |
| New drug | 40 |
| Import | 14 |
| Import re-registration | 6 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 120 |
| Therapeutic biologic | 42 |
| TCM | 27 |
| Prophylactic biologic | 3 |
| Biologic | 2 |
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
33 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Methotrexate Injection | 3 | 2 | 11 |
| 2 | 腺苷钴胺胶囊 · No verified English name | 2 | 2 | 8 |
| 3 | Tadalafil Tablets | 2 | 1 | 23 |
| 4 | 复方氨基酸(16)双肽(1)注射液 · No verified English name | 2 | 1 | 0 |
| 5 | Lasmiditan Tablets | 2 | 1 | 0 |
| 6 | Vortioxetine Hydrobromide Tablets | 2 | 1 | 10 |
| 7 | Irinotecan Hydrochloride Injection | 2 | 1 | 2 |
| 8 | Amlodipine Besylate Tablets | 2 | 1 | 8 |
| 9 | Lidocaine and Prilocaine Cream | 1 | 1 | 24 |
| 10 | 吉非替尼片 · No verified English name | 1 | 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
121 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Ascendis Pharma Endocrinology Division A/S | 9 | 1 | 0 |
| 2 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized | 8 | 1 | 0 |
| 3 | Takeda Manufacturing Austria AG | 5 | 2 | 0 |
| 4 | Kyowa Kirin Co. Ltd. | 5 | 1 | 0 |
| 5 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized | 5 | 1 | 0 |
| 6 | Dr. Falk Pharma GmbH | 4 | 1 | 0 |
| 7 | Shanghai Pharmaceuticals Group Co., Ltd. romanized | 4 | 1 | 0 |
| 8 | Bao Tou Zhong Yao Co., Ltd. romanized | 3 | 3 | 0 |
| 9 | Guangxi Wei Jian Pharma Co., Ltd. romanized | 3 | 3 | 0 |
| 10 | Novartis Pharma Schweiz AG | 3 | 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
63 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/03/13Import · Class 1 | 盐酸来罗西利片 · No verified English nameJXHS2400020 | Genor Biopharma(USA) Inc.; Quotient Sciences - Philadelphia LLC; Genor Biopharma Co. Ltd |
| 2024/03/13Generic · Class 3 | Multiple Electrolyte Additive For InjectionCYHS2400820 | CISEN PHARMACEUTICAL CO., LTD. |
| 2024/03/13Generic · Class 3 | Famotidine InjectionCYHS2400817 | Hunan Bai Qi He Drug Research and Development Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2024/03/13Generic · Class 3 | Lasmiditan TabletsCYHL2400059 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2024/03/13Generic · Class 3 | Lasmiditan TabletsCYHL2400058 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2024/03/13New drug · Class 1 | ER2001注射液 · No verified English nameCXSL2400181 | Ai Ma Bio Technology (Nanjing) Co., Ltd. romanized |
| 2024/03/13New drug · Class 1.1 | 鼻喷重组呼吸道合胞病毒疫苗(5型副流感病毒载体) · No verified English nameCXSL2400180 | Guangzhou Si An Xin Bio Technology Co., Ltd. romanized |
| 2024/03/13New drug · Class 1 | 金纳单抗注射液 · No verified English nameCXSL2400179 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2024/03/13New drug · Class 1 | INNA1605软膏 · No verified English nameCXHL2400271 | Wuhan Yi Nuo Pharma Co., Ltd. romanized |
| 2024/03/13New drug · Class 1 | INNA1605软膏 · No verified English nameCXHL2400270 | Wuhan Yi Nuo Pharma Co., Ltd. romanized |
| 2024/03/12Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSL2400059 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2024/03/12Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2400811 | Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2024/03/12Generic · Class 3 | Loxoprofen Sodium Oral SolutionCYHS2400809 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2024/03/12New drug · Class 1.1 | FTZ浓缩丸 · No verified English nameCXZL2400014 | Shenzhen Qian Hai Ji Ao Health Technology Co., Ltd. romanized |
| 2024/03/12New drug · Class 1 | SHR-9539注射液 · No verified English nameCXSL2400178 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/03/12New drug · Class 1 | SHR-9539注射液 · No verified English nameCXSL2400177 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/03/12New drug · Class 3.3 | 重组人绒促性素注射液 · No verified English nameCXSL2400176 | Suzhou Cheng Ji Pharma Co., Ltd. romanized |
| 2024/03/12New drug · Class 1 | BPYT-01胶囊 · No verified English nameCXHL2400269 | Bai Ji You Tang (Guangdong) Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/03/12New drug · Class 1 | BPYT-01胶囊 · No verified English nameCXHL2400268 | Bai Ji You Tang (Guangdong) Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/03/12New drug · Class 1 | MK-1084片 · No verified English nameCXHL2400267 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2024/03/12New drug · Class 1 | MK-1084片 · No verified English nameCXHL2400266 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2024/03/12New drug · Class 1 | ABP2111Na片 · No verified English nameCXHL2400265 | Shanghai Ai Bo Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/03/12New drug · Class 1 | ABP2111Na片 · No verified English nameCXHL2400264 | Shanghai Ai Bo Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/03/09New drug · Class 1 | 注射用MK-2870 · No verified English nameCXSL2400175 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
| 2024/03/09New drug · Class 1 | EB160片 · No verified English nameCXHL2400263 | Zhong Shan You Li Biopharmaceuticals Co., Ltd. romanized |
| 2024/03/09New drug · Class 1 | EB160片 · No verified English nameCXHL2400262 | Zhong Shan You Li Biopharmaceuticals Co., Ltd. romanized |
| 2024/03/09New drug · Class 1 | EB160片 · No verified English nameCXHL2400261 | Zhong Shan You Li Biopharmaceuticals Co., Ltd. romanized |
| 2024/03/08Import · Class 3.1 | 注射用隆培促生长素 · No verified English nameJXSS2400025 | Ascendis Pharma Endocrinology Division A/S; Vetter Pharma-Fertigung GmbH & Co. KG; VISEN Pharmaceuticals (Shanghai) Co. Ltd. |
| 2024/03/08Import · Class 3.1 | 注射用隆培促生长素 · No verified English nameJXSS2400024 | Ascendis Pharma Endocrinology Division A/S; Vetter Pharma-Fertigung GmbH & Co. KG; VISEN Pharmaceuticals (Shanghai) Co. Ltd. |
| 2024/03/08Import · Class 3.1 | 注射用隆培促生长素 · No verified English nameJXSS2400023 | Ascendis Pharma Endocrinology Division A/S; Vetter Pharma-Fertigung GmbH & Co. KG; VISEN Pharmaceuticals (Shanghai) Co. Ltd. |
33 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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